tag:blogger.com,1999:blog-39636992569617705472024-02-08T11:31:41.903-05:00DE Health LawA blog hosted by Balick and Balick about Delaware Health Law. As one of the oldest law firms in Delaware, Balick and Balick has extensive knowledge of the intricacies and nuances of Delaware law, courts, and agencies.Adam Balickhttp://www.blogger.com/profile/13884178295632586175noreply@blogger.comBlogger66125tag:blogger.com,1999:blog-3963699256961770547.post-28656805775848576032016-04-13T11:20:00.001-04:002016-04-13T11:20:40.885-04:00Medicare Overpayment Rule: Part 2 – Proactive and Reactive Compliance<span style="font-family: Georgia,"Times New Roman",serif;"><br /></span>
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">Written By <a href="http://balick.com/natetrexler.html">Nate Trexler</a> </span></span><br />
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">This blog is the second post in a
series discussing the Centers for Medicare and Medicaid Services’ Final Rule
regarding the obligation to report and return Medicare overpayments.<span> </span>The first post discussed the basic requirement
to report and return Medicare overpayments and two highlights of the rule—when
an overpayment is “identified” and the 6-year lookback period.<span> </span>The first post can be viewed <a href="http://dehealthlaw.blogspot.com/2016/02/cms-issues-final-rule-on-providers.html">here.</a><span> </span>In this post, we discuss the impact of the
rule on providers’ compliance initiatives (or lack thereof).</span></span>
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<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">As we said in the first post, a
provider must report and return overpayments within 60 days of identification
of an overpayment or the date any corresponding cost report is due.<span> </span>“Identification” is defined as when a person has,
or should have through the exercise of reasonable diligence, determined and
quantified the amount of the overpayment.<span>
</span>A person “should have determined” that the person received an overpayment
if the person fails to exercise “reasonable diligence” and the person, in fact,
received an overpayment.<span> </span>CMS believes
that this definition provides an incentive for providers to exercise reasonable
diligence in determining whether an overpayment exists.<span> </span>Otherwise, CMS believes that providers may
avoid compliance efforts that might uncover overpayments.</span></span></div>
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<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">So, if a provider received an
overpayment, but failed to conduct “reasonable diligence,” the overpayment is
deemed to be “identified” and clock starts to tick on the report and return
requirement.<span> </span>CMS did not define
“reasonable diligence” in the final rule.<span>
</span>Importantly, however, CMS stated in its commentary that “reasonable
diligence” includes proactive compliance efforts as well as the timely investigation
of credible information regarding potential overpayments.<span> </span>In regard to proactive compliance efforts,
CMS stated that undertaking no such efforts or minimal efforts to monitor claim
accuracy could/would subject the provider to liability under the rule based on
the failure to exercise “reasonable diligence.”<span>
</span>In other words, if a provider received an overpayment, but had no actual
knowledge of such overpayment, the provider may still be exposed to liability
if the provider engaged in no or minimal compliance activities to monitor the
accuracy of Medicare claims.</span></span></div>
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<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">What does this mean for providers,
particularly Delaware physicians?<span> </span>The
final rule does not require the adoption of a compliance program.<span> </span>As in the past, CMS recognizes that compliance
activities necessarily (and appropriately) vary based on the provider’s type
and size.<span> </span>However, it is clear that CMS
believes providers have a “clear duty” to engage in proactive compliance
efforts.<span> </span>What remains unclear is whether
the government and whistleblowers will attempt to bolster False Claims Act
complaints by latching onto a provider’s failure to engage in any (or minimal)
proactive compliance measures, even in the absence of actual knowledge of an
overpayment.<span> </span></span></span></div>
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<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">Regardless of the False Claims Act
implications of this Final Rule, what is clear is that the trajectory of the government’s
scrutiny in guarding against Medicare fraud, waste, and abuse continues put the
onus to identify and return overpayments on the providers who receive them.<span> </span>Proactive compliance measures remain the best
way to avoid the enforcement radar.<span>
</span>Delaware providers should consider the types of measures they should be
taking to ensure the accuracy of their claims.</span></span></div>
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;"> </span></span><br />
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">But
what should Delaware providers do once a proactive compliance audit reveals an
overpayment? In the next post in this series, we will discuss the process of
investigation when a provider receives “credible information” regarding a
potential overpayment.</span></span>Adam Balickhttp://www.blogger.com/profile/13884178295632586175noreply@blogger.com0tag:blogger.com,1999:blog-3963699256961770547.post-37033152800173151322016-02-24T12:51:00.000-05:002016-02-24T12:51:24.567-05:00CMS Issues the Final Rule on Providers’ Obligation to Report and Return Overpayments<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">Written By <a href="http://balick.com/natetrexler.html">Nate Trexler</a> </span></span><br />
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<![endif]--><span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">On February 12, 2016, the Centers for
Medicare and Medicaid Service (“CMS”) published a final rule regarding the
Affordable Care Act’s requirement that providers report and return
overpayments.<span> </span>It has been a long road to
this point.<span> </span>Back in 2012, we wrote about
<a href="http://dehealthlaw.blogspot.com/2012/02/cms-issues-proposed-rule-on-reporting.html">CMS’ proposed rule</a>, which
introduced quite a bit of uncertainty in the process of investigating
overpayments and ultimately reporting and returning those overpayments.<span> </span>After nearly four years, and after
considering approximately 200 pieces of commentary from interested parties, CMS
has finalized the rule, further outlining provider responsibilities under the
Affordable Care Act’s requirement.</span></span></div>
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<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">The Affordable Care Act was enacted on
March 23, 2010 and established a requirement that a person who has received an
overpayment must report and return the overpayment to the appropriate party and
to notify that party of the reason for the overpayment.<span> </span>The Act requires that an overpayment be
reported and returned by the latter of 60 days from the date on which the
overpayment was identified or the day any corresponding cost report is due, if
applicable.<span> </span>Importantly, the Act
specified that any overpayment that was retained by a person after the deadline
for reporting and returning an overpayment constituted an obligation under the
Federal False Claims Act, which could lead to significant liability.<span> </span>This requirement became effective immediately
on March 23, 2010, and for almost six years, providers have been under an
obligation to report and return overpayments.<span>
</span>Still, for those six years, a number of questions remained.</span></span></div>
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<div class="MsoNormal">
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">In this multi-part blog, we will
discuss broad highlights from the Final Rule and some more in-depth takeaways.<span> </span>In this blog post, we discuss how the Final
Rule defines when an overpayment is “identified” and the lookback period for
reporting and returning overpayments.</span></span></div>
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<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;"><b>Two Highlights of the Final Rule</b></span></span></div>
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<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">At
the outset, the Final Rule applies only to Medicare Parts A and B. A separate
rule applies to Medicare Parts C and D, but there is no rule with respect to
Medicaid overpayments.</span></span></div>
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<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">The
Final Rule defines an “overpayment” to be any funds that a person has received
or retained under Medicare Parts A and B to which the person, after applicable
reconciliation, is not entitled. It does not matter how the overpayment
occurred, even if by honest mistake.</span></span></div>
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<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">One
major highlight from the Final Rule is that providers have the ability to
investigate whether an overpayment exists without starting the 60-day
clock.<span> </span>As described above, the Act
requires a person to report and return an overpayment by the latter of 60 days
from the date on which the overpayment was <b>identified</b>
or the date any corresponding cost report is due.<span> </span>The Final Rule has defined “identified” as
when a person “has, or should have through the exercise of reasonable
diligence,” determined <b>and quantified</b>
the amount of the overpayment.<span> </span>A person
“should have determined” that the person received an overpayment if the person
fails to exercise reasonable diligence and the person in fact received an
overpayment.<span> </span>This definition clarified confusion
as to whether time spent investigating and quantifying a known (or suspected)
overpayment would essentially toll the 60-day deadline.<span> </span>However, CMS makes clear the providers must
still exercise “reasonable diligence,” which requires both <b>proactive and reactive</b> compliance measures.<span> </span>Reactive investigations must occur in a
“timely manner,” which CMS considers to be “at most 6 months from receipt of
credible information, except in extraordinary circumstances.”<span> </span>CMS’s commentary on proactive compliance
measures will be discussed in a subsequent blog post.</span></span></div>
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<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">The
second major highlight of the Final Rule is the six-year lookback period.<span> </span>Under the rule, providers must report and
return an overpayment if the provider identifies the overpayment within six years
of the date the overpayment was received.<span>
</span>The impact of this lookback period is that if a provider obtains
credible information of a potential overpayment, the provider needs to conduct
reasonable diligence to determine whether they have received an overpayment,
which may extend back six years from the date the provider received the
credible information.<span> </span>CMS even commented
on the fact that various Medicare audits, including RAC audits, may be time
limited (e.g., only the last 3 years), but they serve as credible information
of a potential overpayment going back further.<span>
</span>As part of reasonable diligence, providers need to determine whether
they have received overpayments, based on the same issues identified in the
Medicare audit, going back 6 years.<span> </span>This
lookback period effectively expands the sometimes shorter audit authority of
Medicare contractors, putting the onus on providers to complete the entire six
year audit.</span></span></div>
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<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">The
text of the Final Rule may be viewed <a href="https://www.federalregister.gov/articles/2016/02/12/2016-02789/medicare-program-reporting-and-returning-of-overpayments">here.</a></span></span></div>
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;"> </span></span><br />
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">In the next blog post, we will discuss some broader
takeaways from the Final Rule and how providers can ensure they have
appropriate and robust compliance programs in place to address the overarching
concerns of these requirements.</span></span><br />
Adam Balickhttp://www.blogger.com/profile/13884178295632586175noreply@blogger.com0tag:blogger.com,1999:blog-3963699256961770547.post-65888615823308616662016-02-04T11:09:00.001-05:002016-02-04T11:09:29.955-05:00Delaware Dental Board Proposes “Fee-Splitting” Prohibition<div class="MsoNormal">
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<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">Written By <a href="http://balick.com/joanneceballos.html">Joanne Ceballos</a> </span></span></div>
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<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">The Delaware
Board of Dentistry and Dental Hygiene is proposing an amendment to its
regulations to ban what it characterizes as “fee-splitting.”<span> </span>The proposed amendment provides that a
dentist or dental hygienist may be disciplined for “engaging directly or
indirectly in the provision or receipt of anything of value for recommending a
dentist or hygienist's services.”<span> </span>The
proposed regulation, however, permits the offering or receipt of “office gifts”
on a quarterly basis if the value of the gifts does not exceed $1,000 annually
and the gifts are “unrelated to a specific referral.”<span> </span>As the federal and state Anti-Kickback
statutes generally prohibit offering or receiving anything of value in exchange
for the referral of federal or state health care program business, dentists who
provide services payable by federal or state health care programs cannot rely
solely on the proposed state regulation as a guideline for permissible
gift-giving.<span> </span></span></span></div>
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<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;"><span> </span></span></span></div>
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">The comparison
between the Dental Board’s proposed regulation and fee-splitting regulations applicable
to other Delaware health care providers is interesting.<span> </span>The Board of Medical Licensure and Discipline
prohibits payment of a fee by a physician to another physician who has referred
a patient to him, “unless the fee is in proportion to the work actually
performed by the referring physician.” 24 Del. Admin. Code 1700 Board of
Medical Licensure and Discipline 8.1.9.<span> </span><span> </span>The regulation, while inartfully worded, seems
to provide an exception for the sharing of fees among a physician employer and
a physician employee. Otherwise, a physician cannot pay another physician a
“fee” for referrals.<span> </span>It is unclear
whether a “fee” would include non-monetary gifts.<span> </span>The proposed Dental Board regulation, on the
other hand, clearly applies to “anything of value.” Of course, as stated above,
federal and state statutes generally prohibit physicians from offering or
accepting anything of value in exchange for referrals where payment may be
made, in whole or in part, by a federal or state healthcare program.</span></span><br />
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<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;"> </span></span></div>
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<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">Delaware
physical therapists and athletic trainers are subject to a broad fee-splitting
statute which not only prevents them from “transferring fees” to referral
sources, but also prevents them from working in the same practice with referral
sources, e.g., physicians, as well as any “relative” or “business associate” of
a referral source, neither of which is defined in the statute.<span> </span>§24 Del. C. 2616(a)(8).<span> </span>The BMLD regulation does not encompass
“relatives” and “business associates.”<span> </span>The
proposed Dental Board regulation arguably applies to any scenario where a third
person receives or offers anything of value in exchange for referrals on behalf
of a dentist or dental hygienist, as it proscribes “engaging directly or<i> indirectly</i> in the provision or receipt
of anything of value.”</span></span></div>
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<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;"> </span></span></div>
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">The
Board of Dentistry and Dental Hygiene will hold a public hearing on the
proposed regulation on March 17, 2016, and will accept written comments until April
1, 2016.<span> </span>Click <a href="http://regulations.delaware.gov/register/february2016/proposed/19%20DE%20Reg%20724%2002-01-16.htm">here</a> for the text of the proposed regulations
and for more information about the hearing and how to submit written comments. </span></span><br />
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;"><br /></span></span>Adam Balickhttp://www.blogger.com/profile/13884178295632586175noreply@blogger.com0tag:blogger.com,1999:blog-3963699256961770547.post-90145379045853822642016-01-27T14:58:00.000-05:002016-01-27T14:58:43.283-05:00New Stark Law Exception for Sharing Space and Equipment<div class="MsoNormal">
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<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">Written By <a href="http://balick.com/natetrexler.html">Nate Trexler</a> </span></span></div>
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<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">Physicians
often ask about sharing space or equipment with colleagues.<span> </span>For a number of reasons, regulatory
compliance often makes the proposed arrangement impractical, if not impossible.<span> </span><span> </span>However, a new Stark exception will, for the
first time, permit space and equipment sharing without having to satisfy the
sometimes onerous and impractical lease requirements.<span> </span></span></span></div>
<br />
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">The
federal Ethics in Patient Referrals Act, more commonly known as “Stark,”
prohibits physicians from referring patients for designated health services
payable by Medicare to entities with which the physician has a financial
relationship, unless the arrangement satisfies an exception.<span> </span>As a general matter, if an entity (which includes
a physician or group practice) provides space or equipment to a referring
physician, Stark is triggered and the physician is prohibited from referring
patients for DHS to the entity.<span> </span>To avoid
application of Stark, you need to structure the relationship between the
parties to comply with an exception.<span> </span>When
it comes to providing space or equipment, one historically looked to comply
with the exceptions for leases of space or equipment.<span> </span>The problem with those exceptions is that
they require the written lease agreement to provide for the exclusive use of
the space or equipment during the lease term, and leases could not be on an “as
needed” basis.<span> </span>Generally, the leasing
entity and the physician could not “share” the same space or equipment during
the lease term.</span></span>
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<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">However,
effective January 1, 2016, a new Stark exception permits physicians and
hospitals or other physician groups to share “space, equipment, personnel,
items, supplies or services” in non-exclusive “timeshare” arrangements.<span> </span>To satisfy the exception, the arrangement
must satisfy nine specific conditions.</span></span></div>
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<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">The
arrangement must be in writing and signed by the parties, specifying the
premises, equipment, personnel, items, supplies, and/or services covered by the
arrangement.<span> </span>Importantly, the exception
will only cover arrangements between a physician (or the physician’s group) and
either a hospital or a different physician group.<span> </span>The premises, equipment, etc. covered by the
arrangement must be used “predominantly” for the provision of evaluation and
management services to patients, as CMS wished to avoid scenarios where
arrangements were set up so the physician only used the premises, equipment,
etc. for the purpose of delivering designated health services.<span> </span>If equipment is involved, it must be located
in the same building where the evaluation and management services are furnished
and may not be used to furnish DHS that is not incidental to those
services.<span> </span>Advanced imaging equipment,
radiation therapy equipment, and clinical or pathology laboratory equipment is generally
excluded from the exception.</span></span></div>
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<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">Furthermore,
as is the hallmark of many Stark exceptions, the arrangement may not be
conditioned on the referral of patients by the physician to the hospital or
physician organization and the arrangement must be commercially reasonable in
the absence of referrals between the parties.<span>
</span>Compensation must be set in advance and at fair market value.<span> </span>Compensation may not be on a “per click” or
other similar basis and cannot be based on a percentage of revenue raised,
earned, billed or collected.<span>
</span>Essentially, the exception only permits compensation based on a flat fee
or based on time, such as per hour or per day.<span>
</span>The arrangement must not violate the federal anti-kickback statute or
any federal or state law or regulation governing billing or claims submission.</span></span></div>
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<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">Finally,
the arrangement cannot convey a possessory leasehold interest in the space or
equipment that is the subject of the arrangement.<span> </span>In other words, if it is a true lease, as
opposed to a timeshare, licensing-type arrangement, the parties must comply
with the original Stark space or equipment lease exceptions.</span></span></div>
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<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">The new exception
gives physicians and hospitals options outside of the traditional lease exceptions,
and those interested in timeshare arrangements should discuss compliance with
counsel.<span> </span>In addition, those providers
with arrangements currently structured under the space or equipment lease
exceptions should review the arrangements with counsel and consider whether
they may be restructured under the new timeshare exception to better suit the
purpose of the relationship.</span></span></div>
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<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">The
new exception may be found at 42 CFR § 411.357(y).</span></span>Adam Balickhttp://www.blogger.com/profile/13884178295632586175noreply@blogger.com1tag:blogger.com,1999:blog-3963699256961770547.post-89570537994989360432016-01-21T14:03:00.000-05:002016-01-21T14:03:04.929-05:00GAO Analyzes Connection Between Hospital-Physician Consolidation and Increased Medicare Spending for Evaluation and Management Services, Recommends Equalizing Rates for E/M Services in Office and Hospital Outpatient Settings<!--[if gte mso 9]><xml>
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<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">Written By
Joanne Ceballos</span></span></div>
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<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">On December 21,
2015, the United States Government Accountability Office (GAO) issued a report
entitled, “Increasing Hospital-Physician Consolidation Highlights Need for
Payment Reform.” (Click <span style="color: blue;"><a href="http://www.gao.gov/assets/680/674347.pdf">here</a></span>
for the full report.) <span> </span>The GAO’s study
was prompted by an inquiry from lawmakers about the more than 8 percent rise in
Medicare expenditures for services rendered in hospital outpatient departments
(HOPD) between 2007 and 2013, as compared to a 5 percent increase in total
Medicare Part B spending during the same time frame.<span> </span>Some policymakers questioned whether the
increase in HOPD spending might be attributable to the growing number of
hospital acquisitions of physician practices (“vertical consolidation”),
resulting in services that were typically performed in physician offices being
performed instead in HOPDs, resulting in higher reimbursement.<span> </span>For example, in 2015, Medicare’s total
payment rate for E/M office visits ranged from $58 to $86 higher when performed
in an HOPD compared to a physician office. This discrepancy is due to the fact
that when the service is provided in a physician office, Medicare makes a
single payment to the physician at Medicare’s physician fee schedule rate, but
when the service is provided in an HOPD, Medicare makes two payments, one at
the physician fee schedule facility rate and another payment to the hospital,
typically at the hospital outpatient prospective payment system (OPPS) rate. The
GAO noted that although, beginning in 2014, CMS revised its formula for payment
of HOPD E/M visits, the revised approach still results in higher total reimbursement
for E/M services performed in HOPDs.<span> </span></span></span></div>
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<br /></div>
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<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">The GAO
confirmed the trend of vertical consolidation, noting that between 2007 and
2013 the number of vertically consolidated hospitals increased from about 1,400
to 1,700, while the number of vertically consolidated physicians nearly doubled
from about 96,000 to 182,000. The GAO then used various analytical methods to
determine if there was a correlation between consolidation and the increase in
HOPD spending.<span> </span>The GAO found that the percentage
of E/M office visits performed in HOPDs, rather than in physician offices, was approximately
10 percent higher in counties with the highest levels of vertical consolidation.<span> </span></span></span></div>
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<br /></div>
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">The
GAO recommended that Medicare equalize reimbursement for Evaluation &
Management (E/M) services regardless of provider setting, and, absent
equalization of E/M reimbursement rates in the HOPD and office settings, the
Medicare program would pay more than necessary for E/M services.<span> </span>The report notes that the Bipartisan Policy
Center and Medicare Payment Advisory Commission (MedPAC) have estimated that
equalizing payment rates for services, including E/M services, performed in
HOPDs and physician offices could save Medicare between $1 billion and $2
billion annually.<span> </span>The GAO acknowledged,
however, that legislative action would be required to achieve equalization as
CMS lacks statutory authority to equalize total payment rates between HOPDs and
physician offices.</span></span>Adam Balickhttp://www.blogger.com/profile/13884178295632586175noreply@blogger.com0tag:blogger.com,1999:blog-3963699256961770547.post-68433019079962925522015-12-11T16:00:00.002-05:002015-12-11T16:00:53.597-05:00Federal Trade Commission Issues Guidance on How State Licensing Boards May Avoid Antitrust Scrutiny<!--[if gte mso 9]><xml>
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<span style="font-family: "georgia" , "serif";">Written by
<a href="http://balick.com/joanneceballos.html">Joanne Ceballos</a></span></div>
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<br /></div>
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<span style="font-family: "georgia" , "serif";">Earlier this
year DE Health Law reported on a decision by the U.S. Supreme Court, <i style="mso-bidi-font-style: normal;">North Carolina State Board of Dental Examiners
v. Federal Trade Commission</i>, holding that a state professional licensing
board could be liable under federal antitrust laws for engaging in
anticompetitive behavior in the absence of “active supervision” of the board by
the state. <span style="mso-spacerun: yes;"> </span>In particular, the Supreme
Court held that a state board on which a controlling number of decision makers
are active market participants in the occupation the board regulates may invoke
the “state action defense” to federal antitrust enforcement only when two
requirements are satisfied: first, the challenged restraint must be clearly
articulated and affirmatively expressed as state policy; and second, the policy
must be actively supervised by a state official (or state agency) that is not a
participant in the market that is being regulated.<span style="mso-spacerun: yes;"> </span>(Click <a href="http://dehealthlaw.blogspot.com/2015/03/us-supreme-court-affirms-state.html"><b style="mso-bidi-font-weight: normal;"><span style="color: #4f81bd; mso-themecolor: accent1;">here</span></b></a> to review the
previous post.) </span></div>
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<br /></div>
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<span style="font-family: "georgia" , "serif";">In the wake of
the Supreme Court’s decision, state officials sought guidance from the Federal
Trade Commission regarding antitrust compliance for state boards regulating
occupations.<span style="mso-spacerun: yes;"> </span>In response, the FTC’s
Bureau of Competition issued a 13-page document (available by clicking <a href="https://www.ftc.gov/system/files/attachments/competition-policy-guidance/active_supervision_of_state_boards.pdf?utm_source=govdelivery"><b style="mso-bidi-font-weight: normal;"><span style="color: #548dd4; mso-themecolor: text2; mso-themetint: 153;">here</span></b></a>) that provides an overview of
antitrust considerations implicated by the activities of state licensing boards
and also offers specific examples of when “active state supervision” is
required and what may constitute “active state supervision” for purposes
of<span style="mso-spacerun: yes;"> </span>the “state action defense.” </span></div>
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<br /></div>
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<span style="font-family: "georgia" , "serif";">The state must
exercise “active supervision” over a board “on which a controlling number of decision
makers are active market participants.”<span style="mso-spacerun: yes;">
</span>According to the guidance, an “active market participant” is an
individual who is licensed by the board or “provides any service subject to the
regulatory authority of the board.”<span style="mso-spacerun: yes;"> </span><span style="mso-spacerun: yes;"> </span>Active market participants constitute a
“controlling number of decision makers” if they comprise a majority of the
board, or if they effectively control the board’s decisions as a matter of
procedure or custom.<span style="mso-spacerun: yes;"> </span>While the guidance
cautions that whether a board is controlled by active market participants is a
fact-bound inquiry, it provides several examples of scenarios when a board
might be considered controlled by active market participants even when
licensees comprise a minority of the board’s voting members.<span style="mso-spacerun: yes;"> </span></span></div>
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<br /></div>
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<span style="font-family: "georgia" , "serif";">As to what may
constitute “active state supervision” that satisfies the state action defense,
the guidance identifies a number of factors the FTC will consider, namely
whether the “supervisor” (1) has obtained the information necessary for a
proper evaluation of the action recommended by the regulatory board; (2) has
evaluated the substantive merits of the recommended action and assessed whether
the recommended action comports with the standards established by the state
legislature; and (3) has issued a written decision approving, modifying, or
disapproving the recommended action, and explaining the reasons and rationale
for such decision.<span style="mso-spacerun: yes;"> </span>The guidance goes on
to give examples of what might be considered satisfactory state supervision in
the contexts of a board’s issuance of a regulation with potential
anticompetitive effects and a board’s administration of its disciplinary
process.</span></div>
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<br /></div>
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<span style="font-family: "georgia" , "serif";">With the
exception of the Board of Examiners of Nursing Home Administrators, the
majority of members of all the boards licensing health care professionals in
Delaware are required by statute to be licensees and, hence, “active market
participants.”<span style="mso-spacerun: yes;"> </span>Accordingly, the Supreme
Court’s decision and the FTC’s subsequent guidance are particularly relevant to
the conduct of those boards.<span style="mso-spacerun: yes;"> </span></span></div>
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<br /></div>
<div class="MsoNormal">
<span style="font-family: "georgia" , "serif";">Labels:<span style="mso-spacerun: yes;"> </span>Antitrust, Licensing Board, State Action</span></div>
Adam Balickhttp://www.blogger.com/profile/13884178295632586175noreply@blogger.com0tag:blogger.com,1999:blog-3963699256961770547.post-72898887918141855762015-09-04T13:13:00.000-04:002015-09-04T13:13:04.148-04:00Five Years Post-Bradley<!--[if gte mso 9]><xml>
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<![endif]--><span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">Written
By <a href="http://balick.com/joanneceballos.html">Joanne Ceballos</a> </span></span><br />
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<div class="MsoNormal">
<span style="font-size: small;"><span style="font-family: "Georgia","serif";">Five
years ago, on September 1, 2010, one of the nine “Bradley” bills, House Bill
459, took effect in Delaware.<span> </span>Among
other things, this bill clarified the obligations of hospitals to report any disciplinary
action affecting a physician’s privileges, the obligations of law enforcement
to report unprofessional conduct by a physician, and that a physician’s failure
to report unprofessional conduct of another physician is itself unprofessional
conduct.<span> </span>Subsequent legislation
incorporated “failure to report” into the definition of “unprofessional
conduct” applicable to other health care professionals as well.<span> </span></span></span></div>
<span style="font-size: small;">
</span><div class="MsoNormal">
<br /></div>
<span style="font-size: small;">
</span><div class="MsoNormal">
<span style="font-size: small;"><span style="font-family: "Georgia","serif";">The
Delaware Division of Professional Regulation’s website includes links to lists
of physicians and nurses who have been publicly disciplined.<span> </span>The physician list dates back to 1963, the
nurse list back to 1990.<span> </span>As one might
expect, the number of physicians and nurses who were disciplined by their
respective professional boards increased dramatically beginning in 2010.<span> </span>With respect to physicians, prior to 2010 the
highest number of physicians disciplined by what was then the Board of Medical
Practice was 10 physicians in 2008.<span> </span>Of
the ten physicians disciplined that year, two of them had their licenses
revoked.<span> </span>In 2010, 15 physicians were
disciplined, and while no licenses were revoked in 2010, 12 physicians received
some type of suspension, including six emergency temporary suspensions.<span> </span>According the DPR’s list, from 1963 through
2009, a total of only 11 physicians (including Earl Bradley) had their licenses
suspended (although 24 licenses were revoked during the same time period, with
the highest number of revocations being 4 in 2007).<span> </span>Below are figures for physician disciplinary
actions for the period from 2011 to the present (the DPR last updated the
physician list on August 25, 2015):</span></span></div>
<div class="MsoNormal">
<br /></div>
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<div class="MsoNormal">
<b style="mso-bidi-font-weight: normal;"><u><span style="font-family: "Georgia","serif"; font-size: 9.0pt;">Year</span></u></b><span style="font-family: "Georgia","serif"; font-size: 9.0pt;"></span></div>
</td>
<td style="border-left: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 81.0pt;" valign="top" width="108">
<div class="MsoNormal">
<b style="mso-bidi-font-weight: normal;"><u><span style="font-family: "Georgia","serif"; font-size: 9.0pt;">Physicians Disciplined</span></u></b><span style="font-family: "Georgia","serif"; font-size: 9.0pt;"></span></div>
</td>
<td style="border-left: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 1.15in;" valign="top" width="110">
<div class="MsoNormal">
<b style="mso-bidi-font-weight: normal;"><u><span style="font-family: "Georgia","serif"; font-size: 9.0pt;">Suspensions</span></u></b><span style="font-family: "Georgia","serif"; font-size: 9.0pt;"><span style="mso-tab-count: 1;"> </span></span></div>
</td>
<td style="border-left: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 76.5pt;" valign="top" width="102">
<div class="MsoNormal">
<b style="mso-bidi-font-weight: normal;"><u><span style="font-family: "Georgia","serif"; font-size: 9.0pt;">Revocations</span></u></b><span style="font-family: "Georgia","serif"; font-size: 9.0pt;"></span></div>
</td>
</tr>
<tr style="mso-yfti-irow: 1;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 49.5pt;" valign="top" width="66">
<div class="MsoNormal">
<span style="font-family: "Georgia","serif"; font-size: 9.0pt;">2011</span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 81.0pt;" valign="top" width="108">
<div class="MsoNormal">
<span style="font-family: "Georgia","serif"; font-size: 9.0pt;">22</span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 1.15in;" valign="top" width="110">
<div class="MsoNormal">
<span style="font-family: "Georgia","serif"; font-size: 9.0pt;">7</span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 76.5pt;" valign="top" width="102">
<div class="MsoNormal">
<span style="font-family: "Georgia","serif"; font-size: 9.0pt;">1</span></div>
</td>
</tr>
<tr style="mso-yfti-irow: 2;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 49.5pt;" valign="top" width="66">
<div class="MsoNormal">
<span style="font-family: "Georgia","serif"; font-size: 9.0pt;">2012</span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 81.0pt;" valign="top" width="108">
<div class="MsoNormal">
<span style="font-family: "Georgia","serif"; font-size: 9.0pt;">23</span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 1.15in;" valign="top" width="110">
<div class="MsoNormal">
<span style="font-family: "Georgia","serif"; font-size: 9.0pt;">5</span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 76.5pt;" valign="top" width="102">
<div class="MsoNormal">
<span style="font-family: "Georgia","serif"; font-size: 9.0pt;">2</span></div>
</td>
</tr>
<tr style="mso-yfti-irow: 3;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 49.5pt;" valign="top" width="66">
<div class="MsoNormal">
<span style="font-family: "Georgia","serif"; font-size: 9.0pt;">2013</span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 81.0pt;" valign="top" width="108">
<div class="MsoNormal">
<span style="font-family: "Georgia","serif"; font-size: 9.0pt;">35</span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 1.15in;" valign="top" width="110">
<div class="MsoNormal">
<span style="font-family: "Georgia","serif"; font-size: 9.0pt;">6</span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 76.5pt;" valign="top" width="102">
<div class="MsoNormal">
<span style="font-family: "Georgia","serif"; font-size: 9.0pt;">3</span></div>
</td>
</tr>
<tr style="mso-yfti-irow: 4;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 49.5pt;" valign="top" width="66">
<div class="MsoNormal">
<span style="font-family: "Georgia","serif"; font-size: 9.0pt;">2014</span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 81.0pt;" valign="top" width="108">
<div class="MsoNormal">
<span style="font-family: "Georgia","serif"; font-size: 9.0pt;">34</span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 1.15in;" valign="top" width="110">
<div class="MsoNormal">
<span style="font-family: "Georgia","serif"; font-size: 9.0pt;">3</span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 76.5pt;" valign="top" width="102">
<div class="MsoNormal">
<span style="font-family: "Georgia","serif"; font-size: 9.0pt;">4</span></div>
</td>
</tr>
<tr style="mso-yfti-irow: 5; mso-yfti-lastrow: yes;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 49.5pt;" valign="top" width="66">
<div class="MsoNormal">
<span style="font-family: "Georgia","serif"; font-size: 9.0pt;">2015</span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 81.0pt;" valign="top" width="108">
<div class="MsoNormal">
<span style="font-family: "Georgia","serif"; font-size: 9.0pt;">17
(to date)</span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 1.15in;" valign="top" width="110">
<div class="MsoNormal">
<span style="font-family: "Georgia","serif"; font-size: 9.0pt;">1</span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 76.5pt;" valign="top" width="102">
<div class="MsoNormal">
<span style="font-family: "Georgia","serif"; font-size: 9.0pt;">2</span></div>
</td>
</tr>
</tbody></table>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
<span style="font-size: small;"><span style="font-family: "Georgia","serif";">As
illustrated above, in 2011 and 2012, the Board of Medical Licensure and
Discipline sanctioned double the number of physicians it had disciplined during
its former peak year of 2008, and three times as many physicians in 2013 and
2014 as it had in 2008.<span> </span>While the number
of suspensions increased more or less proportionately (the 12 suspensions
imposed in 2010 being somewhat of an aberration), the number of revocations did
not.<span> </span>Thus the figures indicate that
while more violations of the physician licensing statute and regulations are
being reported and investigated, there has not been a concomitant increase in
violations that merit the most serious sanction of revocation. </span></span></div>
<span style="font-size: small;">
</span><div class="MsoNormal">
<br /></div>
<span style="font-size: small;">
</span><div class="MsoNormal">
<span style="font-family: "Georgia","serif"; font-size: 11.0pt;"><span style="font-size: small;">The
list of publicly disciplined nurses also shows a jump in the numbers beginning
in 2010.<span> </span>Prior to 2010, the highest
number of nurses publicly disciplined in a given year was 43 in 2005, with the
Board of Nursing suspending seven and revoking two licenses.<span> </span>After 2005, the number of disciplinary
actions declined steadily to 14 in 2009, when the Board revoked one license and
suspended one license.<span> </span>In 2010, the
Board disciplined about two and a half times as many nurses as it had in 2009,
suspending 16 of them and revoking 6 licenses.<span>
</span>The figures for the period from 2010 to the present are as follows (the DPR
last updated the nurse list on August 17, 2015):</span><span style="mso-spacerun: yes;"> </span></span></div>
<div class="MsoNormal">
<br /></div>
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<tbody>
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<div class="MsoNormal">
<b style="mso-bidi-font-weight: normal;"><u><span style="font-family: "Georgia","serif"; font-size: 9.0pt;">Year</span></u></b><span style="font-family: "Georgia","serif"; font-size: 9.0pt;"></span></div>
</td>
<td style="border-left: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 81.0pt;" valign="top" width="108">
<div class="MsoNormal">
<b style="mso-bidi-font-weight: normal;"><u><span style="font-family: "Georgia","serif"; font-size: 9.0pt;">Nurses Disciplined</span></u></b><span style="font-family: "Georgia","serif"; font-size: 9.0pt;"></span></div>
</td>
<td style="border-left: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 1.15in;" valign="top" width="110">
<div class="MsoNormal">
<b style="mso-bidi-font-weight: normal;"><u><span style="font-family: "Georgia","serif"; font-size: 9.0pt;">Suspensions</span></u></b><a href="https://www.blogger.com/blogger.g?blogID=3963699256961770547#_ftn1" name="_ftnref1" style="mso-footnote-id: ftn1;" title=""><span class="MsoFootnoteReference"><span style="font-family: "Georgia","serif"; font-size: 9.0pt;"><span style="mso-special-character: footnote;"><span class="MsoFootnoteReference"><span style="font-family: "Georgia","serif"; font-size: 9.0pt; mso-ansi-language: EN-US; mso-bidi-font-family: "Times New Roman"; mso-bidi-language: AR-SA; mso-fareast-font-family: Calibri; mso-fareast-language: EN-US; mso-fareast-theme-font: minor-latin;">[1]</span></span></span></span></span></a><span style="font-family: "Georgia","serif"; font-size: 9.0pt;"></span></div>
</td>
<td style="border-left: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 76.5pt;" valign="top" width="102">
<div class="MsoNormal">
<b style="mso-bidi-font-weight: normal;"><u><span style="font-family: "Georgia","serif"; font-size: 9.0pt;">Revocations</span></u></b><span style="font-family: "Georgia","serif"; font-size: 9.0pt;"></span></div>
</td>
</tr>
<tr style="mso-yfti-irow: 1;">
<td style="border-top: none; border: solid windowtext 1.0pt; mso-border-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 49.5pt;" valign="top" width="66">
<div class="MsoNormal">
<span style="font-family: "Georgia","serif"; font-size: 9.0pt;">2010</span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 81.0pt;" valign="top" width="108">
<div class="MsoNormal">
<span style="font-family: "Georgia","serif"; font-size: 9.0pt;">39</span></div>
</td>
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<div class="MsoNormal">
<span style="font-family: "Georgia","serif"; font-size: 9.0pt;">16</span></div>
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<div class="MsoNormal">
<span style="font-family: "Georgia","serif"; font-size: 9.0pt;">6</span></div>
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<span style="font-family: "Georgia","serif"; font-size: 9.0pt;">2011</span></div>
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<div class="MsoNormal">
<span style="font-family: "Georgia","serif"; font-size: 9.0pt;">47</span></div>
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<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 1.15in;" valign="top" width="110">
<div class="MsoNormal">
<span style="font-family: "Georgia","serif"; font-size: 9.0pt;">13</span></div>
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<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 76.5pt;" valign="top" width="102">
<div class="MsoNormal">
<span style="font-family: "Georgia","serif"; font-size: 9.0pt;">4</span></div>
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<span style="font-family: "Georgia","serif"; font-size: 9.0pt;">2012</span></div>
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<div class="MsoNormal">
<span style="font-family: "Georgia","serif"; font-size: 9.0pt;">68</span></div>
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<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 1.15in;" valign="top" width="110">
<div class="MsoNormal">
<span style="font-family: "Georgia","serif"; font-size: 9.0pt;">14</span></div>
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<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 76.5pt;" valign="top" width="102">
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<span style="font-family: "Georgia","serif"; font-size: 9.0pt;">4</span></div>
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<span style="font-family: "Georgia","serif"; font-size: 9.0pt;">2013</span></div>
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<div class="MsoNormal">
<span style="font-family: "Georgia","serif"; font-size: 9.0pt;">83</span></div>
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<span style="font-family: "Georgia","serif"; font-size: 9.0pt;">42</span></div>
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<span style="font-family: "Georgia","serif"; font-size: 9.0pt;">3</span></div>
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<span style="font-family: "Georgia","serif"; font-size: 9.0pt;">2014</span></div>
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<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 81.0pt;" valign="top" width="108">
<div class="MsoNormal">
<span style="font-family: "Georgia","serif"; font-size: 9.0pt;">68</span></div>
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<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 1.15in;" valign="top" width="110">
<div class="MsoNormal">
<span style="font-family: "Georgia","serif"; font-size: 9.0pt;">26</span></div>
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<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 76.5pt;" valign="top" width="102">
<div class="MsoNormal">
<span style="font-family: "Georgia","serif"; font-size: 9.0pt;">0</span></div>
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<span style="font-family: "Georgia","serif"; font-size: 9.0pt;">2015</span></div>
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<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 81.0pt;" valign="top" width="108">
<div class="MsoNormal">
<span style="font-family: "Georgia","serif"; font-size: 9.0pt;">69
(to date)</span></div>
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<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 1.15in;" valign="top" width="110">
<div class="MsoNormal">
<span style="font-family: "Georgia","serif"; font-size: 9.0pt;">17</span></div>
</td>
<td style="border-bottom: solid windowtext 1.0pt; border-left: none; border-right: solid windowtext 1.0pt; border-top: none; mso-border-alt: solid windowtext .5pt; mso-border-left-alt: solid windowtext .5pt; mso-border-top-alt: solid windowtext .5pt; padding: 0in 5.4pt 0in 5.4pt; width: 76.5pt;" valign="top" width="102">
<div class="MsoNormal">
<span style="font-family: "Georgia","serif"; font-size: 9.0pt;">0</span></div>
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<span style="font-family: "Georgia","serif"; font-size: 11.0pt;"> </span></div>
<div class="MsoNormal">
<span style="font-size: small;"><span style="font-family: "Georgia","serif";">While
the Board of Nursing had imposed at least one suspension every year from 1990
through 2009, the number of suspensions in proportion to the total number of
disciplinary actions in a given year was generally less than a third.<span> </span>In 2009, however, over 40 percent of the
sanctions imposed were suspensions, and half the sanctions imposed in 2013 were
suspensions.<span> </span>As with physicians,
however, the number of revocations did not increase proportionately to the
number of disciplinary actions.</span></span></div>
<span style="font-size: small;">
</span><div class="MsoNormal">
<br /></div>
<span style="font-size: small;">
</span><div class="MsoNormal">
<span style="font-size: small;"><span style="font-family: "Georgia","serif";">The
tables above demonstrate that since the Bradley legislation was enacted, the total
number of disciplinary sanctions imposed on physicians and nurses was the
highest in 2013<span> </span>(thus far).<span> </span>It remains to be seen whether the numbers
will level off or decline in the coming years.<span>
</span></span></span></div>
<span style="font-size: small;">
</span><div style="mso-element: footnote-list;">
<span style="font-size: small;"><br clear="all" />
</span><hr align="left" size="1" width="33%" />
<span style="font-size: small;">
</span><div id="ftn1" style="mso-element: footnote;">
<span style="font-size: small;">
</span><div class="MsoFootnoteText">
<span style="font-size: small;"><a href="https://www.blogger.com/blogger.g?blogID=3963699256961770547#_ftnref1" name="_ftn1" title=""><span class="MsoFootnoteReference"><span><span class="MsoFootnoteReference"><span style="font-family: "Times New Roman","serif";">[1]</span></span></span></span></a> <span style="font-family: "Georgia","serif";">“Temporary suspensions”
and “Stayed suspensions” are not included in the below figures.</span></span></div>
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<![endif]--><span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;"></span></span>Adam Balickhttp://www.blogger.com/profile/13884178295632586175noreply@blogger.com0tag:blogger.com,1999:blog-3963699256961770547.post-74830139441321885512015-08-05T13:47:00.000-04:002015-08-05T13:47:00.154-04:00New Guidance on Mobile Device Security for Health Care Providers<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">Written By <a href="http://balick.com/joanneceballos.html">Joanne Ceballos</a></span></span><br />
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<![endif]--><span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">At
the end of July the National Institute of Standards and Technology of the U.S.
Department of Commerce (“NIST”) released a draft practice guide, <i>Securing Electronic Health Records on Mobile
Devices</i>, that demonstrates how health care IT professionals can use
existing technologies, including commercially available and open source tools,
to better protect electronic protected health information (“ePHI”) systems and
facilitate secure sharing of ePHI through mobile devices.<span> </span>According to the guide, the full text of
which is available <a href="https://nccoe.nist.gov/projects/use_cases/health_it/ehr_on_mobile_devices"><b><span style="color: #4f81bd;">here</span></b></a>, “many health care
providers are using mobile devices in health care delivery before they have
appropriate privacy and security protections in place.”<span> </span>The guide is intended to provide a technical
roadmap for achieving HIPAA-compliant use of mobile devices by health care
professionals. </span></span>
<br />
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">In
order to arrive at their recommended solution, which can be implemented as
outlined in the guidance or customized to a particular health care provider’s
IT environment, NIST simulated interaction among mobile devices and an EHR
system supported by the IT infrastructure of a medical
organization.<span> </span>They tested hypothetical
scenarios in which a primary care physician uses a mobile device to send a
referral containing a patient’s clinical information to another physician, to
send an electronic prescription to a pharmacy, or to add information to a
patient’s electronic health record.<span> </span>In
each scenario the mobile device interacts with an EHR system.</span></span></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">Health
care providers using mobile devices to access or transmit patients’ ePHI are
well-advised to confirm that their IT professionals are familiar with the guide’s
recommendations.<span> </span>Business Associates of
health care providers who access or transmit ePHI via mobile devices should
also consult with their IT personnel to determine whether those recommendations
should be implemented by the Business Associate.<span> </span></span></span></div>
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<br /></div>
<div class="MsoNormal">
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;"><span>Comments of the draft guidance may be submitted to NIST by September 25, 2015 via e-mail at HIT_NCCoE@nist.gov. </span><span> </span><span> </span></span></span></div>
<br />Adam Balickhttp://www.blogger.com/profile/13884178295632586175noreply@blogger.com1tag:blogger.com,1999:blog-3963699256961770547.post-38557249591089221692015-06-09T16:08:00.001-04:002015-06-09T16:08:52.958-04:00Governor Markell Signs Delaware Medical Orders for Scope of Treatment Act<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;"> Written By <a href="http://balick.com/joanneceballos.html">Joanne Ceballos</a> </span></span><br />
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">On May 28<sup>th</sup>
Governor Markell signed House Bill No. 64, the Delaware Medical Orders for
Scope of Treatment or “DMOST” Act.<span> </span>The
legislation establishes a clinical process to facilitate communication between
an adult patient with a “serious illness or frailty” and the patient’s physician
(or other health care practitioner licensed to write medical orders under Title
24 of the Delaware Code) who “would not be surprised if [the patient] died
within the next year” regarding what life-sustaining treatments, if any, the
patient wishes to receive. <span> </span>Based on that
consultation, the legislation allows the physician to complete a DMOST form
documenting the patient’s wishes as a medical order intended to be honored by
personnel attending the patient in any health care setting, including the
patient’s home, a health care institution, or by emergency personnel.</span></span>
<br />
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">The legislation
makes clear that a DMOST form differs from an advance health care
directive.<span> </span>While an advance health care
directive may be made by any adult and is intended to express the individual’s
preferences with respect to life-sustaining treatment in the event the
individual is incapacitated, a medical order is required to give effect to
those preferences, and a new order must be issued if the individual is
transferred from one health care setting to another.<span> </span>The DMOST form, on the other hand, is a
medical order that is intended to be effective in any health care setting,
whether or not the individual is incapacitated, although a patient with
decision-making capacity may at any time void the DMOST form or otherwise
request treatment different from that specified on the form. The legislation
also provides that a DMOST form may be completed after consultation between an
individual’s physician and the individual’s authorized representative if the
individual lacks capacity.<span> </span></span></span></div>
<div class="MsoNormal">
<br /></div>
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<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">Health-care
practitioners and providers, institutions, and emergency-care providers (as all
defined by the Act) have an obligation to treat a patient who has a completed
DMOST form in accordance with the directions and options indicated on such
form, except as otherwise provided in the Act.<span>
</span>In addition, the legislation provides guidance regarding how conflicts
between health-care practitioners and a patient’s authorized representative may
be resolved and how conflicts between an advance health care directive, a DMOST
form, a patient’s expressed oral or written directives, or the decisions of a
patient’s authorized representative should be resolved in determining the scope
of treatment.<span> </span>The failure to act in
accordance with the Act’s requirements can result in professional discipline
and civil monetary penalties.</span></span></div>
<div class="MsoNormal">
<br /></div>
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<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">The bill
authorizes the Department of Health and Social Services to promulgate
regulations regarding the process for completion, modification and revocation
of the DMOST form as well as directing the Department to prepare a standard
DMOST form.<span> </span>It also requires Delaware
health care providers to honor a medical order form executed in another state
if it is valid under the laws of that state or meets the requirements for a
valid DMOST form.<span> </span>A majority of states
have enacted legislation similar to the DMOST Act, although they may refer to
it as POLST (“Physician’s Orders for Life Sustaining Treatment”), MOLST
(“Medical Orders for Life Sustaining Treatment”), or a like term.<span> </span>In fact, regulations of the Delaware
Department of Public Health previously permitted Delaware health care providers
to use a MOLST form, but in 2013 the Department directed Delaware health care
providers to stop using the form due to concerns that it was being used beyond
the parameters specified in the regulation.<span>
</span>The DMOST Act, and regulations promulgated thereto, should provide more
clarity about the proper use and function of the DMOST form.<span> </span></span></span></div>
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<br /></div>
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">The
DMOST Act takes effect upon the adoption of regulations by DHSS which the bill
specifies will occur no later than a year from the legislation’s enactment.<span> </span>Click <a href="http://legis.delaware.gov/LIS/LIS148.NSF/vwLegislation/HB+5?open">here</a> to
review the full text of the DMOST Act.</span></span>Adam Balickhttp://www.blogger.com/profile/13884178295632586175noreply@blogger.com2tag:blogger.com,1999:blog-3963699256961770547.post-65479988028212681182015-05-18T10:30:00.000-04:002015-05-18T10:30:55.133-04:00Delaware General Assembly Passes Telemedicine Bill<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">Written By <a href="http://balick.com/joanneceballos.html">Joanne Ceballos</a></span></span><br />
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<![endif]--><span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">On May 14<sup>th</sup>
the Delaware General Assembly passed HB 69 amending Title 18, the state’s
Insurance Code, and Title 24, governing health care professions and
occupations, to facilitate the use of “telehealth” and “telemedicine” in the
delivery of health care to patients located in Delaware. The bill defines
“telehealth” as “the use of information and communications technologies
consisting of telephones, remote patient monitoring devices or other electronic
means which support clinical health care, provider consultation, patient and
professional health-related education, public health, health administration,
and other services as described in regulation.”<span>
</span>“Telemedicine” is defined as “a form
of telehealth which is <span style="color: black;">the delivery of clinical health
care services by means of real time two-way audio, visual, or other telecommunications
or electronic communications, including the application of secure video
conferencing [to] facilitate the assessment, diagnosis, consultation,
treatment, education, care management and self-management of a patient’s health
care by a health care provider practicing within his or her scope of practice
as would be practiced in-person with a patient.” </span></span></span><br />
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;"><span style="color: black;"></span></span></span><br />
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<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;"><span style="color: black;">The proposed amendments to the Insurance Code would
require health insurers to cover telehealth and telemedicine services at the
same reimbursement rates as in-person consultations.<span> </span>The proposed amendments to the Medical
Practice Act, Chapter 17 of Title 24, include a new section 1769D authorizing physicians
to practice telehealth and telemedicine.<span>
</span>Under section 1769D, diagnosis and treatment via telemedicine is only
permitted if<span> </span>(1) the physician has
previously conducted an in-person examination of the patient, (2) there is
another Delaware-licensed healthcare provider present with the patient, (3) the
diagnosis is based on both audio and visual communication, or (4) the service
meets the standards for establishing a physician-patient relationship pursuant
to guidelines established by major medical specialty societies, such as
radiology or pathology. </span></span></span></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;"><span style="color: black;">The bill also authorizes the professional boards of the
following health care professions to promulgate regulations governing the use
telehealth and telemedicine by such professionals:<span> </span>physician assistants, respiratory therapists,
genetic counselors, podiatrists, chiropractors, dentists, nurses, occupational
therapists, optometrists, pharmacists, mental health and chemical dependency
counselors, psychologists, dietitians and social workers.<span> </span>A bill authorizing the use of “telehealth” in
the practice of physical therapy was previously signed by the Governor in
August 2014 (see December 3, 2014 DE Health Law Blog regarding the regulations
proposed by the Examining Board of Physical Therapists pursuant to that
bill).<span> </span></span></span></span></div>
<div class="MsoNormal">
<br /></div>
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<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;"><span style="color: black;">The full text of HB
69 can be viewed by clicking <a href="http://legis.delaware.gov/LIS/LIS148.NSF/2bede841c6272c888025698400433a04/64f03d09b27d08ae85257e030051ea4b?OpenDocument&Highlight=0,telemedicine">here</a>. </span></span></span></div>
Adam Balickhttp://www.blogger.com/profile/13884178295632586175noreply@blogger.com1tag:blogger.com,1999:blog-3963699256961770547.post-81904365188132644982015-05-08T12:03:00.000-04:002015-05-08T12:03:32.075-04:00Medicare Enrollment Deadline Looms for Delaware Dentists<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">Written By <a href="http://balick.com/natetrexler.html">Nate Trexler</a></span></span><br />
<br />
<div class="MsoNormalCxSpFirst">
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">Most
dentists have never had the need to consider Medicare enrollment, based on the
fact that Medicare Part B covers a small amount of dental services (for
example, services that are an integral part of a covered procedure and for
extractions done in preparation for radiation treatment for neoplastic diseases
involving the jaw).<span> </span>But for the many
dentists who treat Medicare patients with Part D prescription drug plans, June
1, 2015 marks an important deadline.</span></span></div>
<div class="MsoNormalCxSpMiddle">
<br /></div>
<div class="MsoNormalCxSpMiddle">
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;"><span></span>Last May, the Centers for Medicare
and Medicaid Services (“CMS”) published a final rule that requires dentists to
either enroll in or opt out of Medicare in order to prescribe Medicare covered
medication to qualifying patients with Part D prescription drug plans.<span> </span>If a dentist does not enroll or opt out, but
prescribes such medication to his or her patient, the Part D sponsor or its
pharmaceutical benefit manager must deny the pharmacy claim for the drug.<span> </span>The Part D sponsor or its pharmaceutical
benefit manager must also deny requests for reimbursement from patients for a
drug prescribed by a dentist that has not enrolled in or opted out of Medicare.<span> </span>CMS has directed dentists to either enroll in
or opt out of Medicare by June 1, 2015 in order to ensure sufficient processing
time for their patients’ prescription drug claims and to prevent claims from
being denied by Part D plans.</span></span></div>
<div class="MsoNormalCxSpMiddle">
<br /></div>
<div class="MsoNormalCxSpMiddle">
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;"><span></span>While dentists are not billing or
receiving payment for prescription drugs, the practical concern is how
pharmacies and patients will react.<span> </span>It
is possible that a pharmacy will refuse a prescription, knowing it will be
denied payment, or make the patient pay out of pocket.<span> </span>Patients, then, will suffer a similar denial
for reimbursement from the drug plan.<span>
</span>Unfortunately, all fingers will point back to the dentist who prescribed
the necessary medication, but who did not enroll in or opt out of Medicare.</span></span></div>
<div class="MsoNormalCxSpMiddle">
<br /></div>
<div class="MsoNormalCxSpMiddle">
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;"><span></span>When examining the options CMS has
provided, “opting out” may seem like the simple solution.<span> </span>However, opting out is not quite as simple
as informing Medicare that you are choosing not to enroll.<span> </span>To become an “opt-out provider,” the dentist must
file an affidavit with the regional Medicare Administrative Contractor <i>and</i> enter into private contracts with
each patient.<span> </span>These contracts must meet
specific requirements.</span></span></div>
<div class="MsoNormalCxSpMiddle">
<br /></div>
<div class="MsoNormalCxSpMiddle">
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">On the other hand, dentists may
enroll as a “full” provider or as only an “ordering/referring” provider.<span> </span>Enrolling as an “ordering/referring provider”
will enable patients to receive coverage for prescription drugs and will also
allow colleagues to whom you refer Medicare Part B covered services to receive
Medicare reimbursement.<span> </span>Each of these
options has different requirements and forms.</span></span></div>
<div class="MsoNormalCxSpMiddle">
<br /></div>
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">
The
ADA voiced opposition to the rule, noting that this new requirement will affect
the majority of dental practices.<span>
</span>Delaware dentists should consider their enrollment options and, if
prescribing medication to Medicare beneficiaries covered by a Part D plan,
submit an enrollment application or opt-out affidavit by June 1, 2015.</span></span>Adam Balickhttp://www.blogger.com/profile/13884178295632586175noreply@blogger.com0tag:blogger.com,1999:blog-3963699256961770547.post-4870293308109436582015-04-06T12:50:00.000-04:002015-04-06T12:50:47.138-04:00U.S. Supreme Court Rules Against Medicaid Providers Seeking Higher Reimbursement Rates<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;"> Written By <a href="http://balick.com/joanneceballos.html">Joanne Ceballos</a></span></span><br />
<span style="font-family: Georgia,"Times New Roman",serif;"><br /></span>
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">In a 5-4
decision issued on March 31, 2015, the U.S. Supreme Court ruled that Medicaid
providers cannot sue state Medicaid agencies pursuant to Section 30(A) of the
Medicaid Act for failure to raise reimbursement rates.<span> </span>A January 20, 2015 post on this blog
describes the background of the case, <i>Armstrong
v. Exceptional Child Center, Inc.</i><span>
</span>Justice Scalia, writing for the majority, opined that the Supremacy
Clause of the U.S. Constitution does not provide a basis to imply a private
right of action to enjoin a state law or regulation that is inconsistent with
federal law. <span> </span>The majority further
reasoned that because the Medicaid Act expressly authorizes the Secretary of
the U.S. Department of Health and Human Services to withhold Medicaid funds if
a state does not comply with the Act’s funding requirements, by providing this
remedy Congress had signaled its intent to foreclose other remedies. <span> </span>The full text of the Court’s opinion is
available <a href="http://www.supremecourt.gov/opinions/14pdf/14-15_d1oe.pdf">here</a>.</span></span>
Adam Balickhttp://www.blogger.com/profile/13884178295632586175noreply@blogger.com0tag:blogger.com,1999:blog-3963699256961770547.post-8195615774763821452015-03-31T15:52:00.000-04:002015-03-31T15:52:00.247-04:00Negative OIG Advisory Opinion Regarding Exclusive Arrangements Between Labs and Physician Practices<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">Written By <a href="http://balick.com/natetrexler.html">Nate Trexler</a></span></span><br />
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<![endif]--><span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">On
March 25, the Department of Health and Human Services Office of Inspector
General (“OIG”) released Advisory Opinion 15-04 in which it concluded that an exclusive
arrangement between a laboratory (“Requestor Lab”) and physician practices
could generate prohibited remuneration under the anti-kickback statute.<span> </span>Furthermore, the OIG concluded that the
proposed arrangement could violate the prohibition on charging Federal health
care programs substantially in excess of usual charges, for which a provider
may be excluded from participation in Federal health care programs.</span></span><br />
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;"> </span></span>
<br />
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<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">The
Requestor Lab proposed to enter into agreements with physician practices to
provide all laboratory services for the practices’ patients and waive all the
fees where Requestor Lab is out-of-network.<span>
</span>According to the Requestor Lab, some physician practices desire to work
with a single laboratory “for ease of communication and consistency in the
reporting of test results.”<span> </span>For example,
different laboratories utilize different methods of reporting test results and
require different interfaces for reporting tests to the lab.<span> </span>However, some patients’ insurers require the
use of a specific lab and will not reimburse any other lab under out-of-network
benefits (“Exclusive Plans”).</span></span></div>
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<br /></div>
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<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">Under
the proposed arrangement, where a test is ordered for an Exclusive Plan
patient, the Requestor Lab would not charge the patient, physician practice, or
secondary insurer for the test.<span> </span>The
laboratory would bill all other patients not under an Exclusive Plan, including
Federal health care program beneficiaries. <span> </span>The Requestor Lab stated that neither the
physician nor the practice would receive any financial benefit from the
laboratory’s provision of services at no charge to the patients with Exclusive
Plans.<span> </span>The physicians would not draw the
samples, and thus could not bill for the blood draw or the testing.<span> </span>The Requestor Lab would provide a free
limited-use EMR interface for submitting orders and receiving results, which
the OIG had previously determined is not remuneration under the anti-kickback
statute.</span></span></div>
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<br /></div>
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<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">The
OIG concluded that the proposed arrangement could potentially generate
prohibited remuneration under the anti-kickback statute.<span> </span>Even though the Requestor Lab certified that
physicians and physician practices would receive no financial benefit, the OIG
concluded that a combination of factors would amount to remuneration to the
physicians in exchange for their referrals for services to the Requestor Lab.<span> </span>The OIG found that the Requestor Lab would
reduce administrative and possibly financial burdens (e.g., electronic record
interface fees) associated with using multiple laboratories, and, as such, the OIG
could not conclude that there was no possibility that the laboratory was not
offering remuneration to induce the referral of Federal health care program
business.</span></span></div>
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<br /></div>
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<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">In
addition to the anti-kickback statute analysis, the OIG noted that it has the
authority to exclude providers from participation in Federal health care
programs that it concludes have submitted or caused to be submitted bills or
requests for payment to Medicare or Medicaid containing charges for items or
services furnished “substantially in excess” of usual charges, unless good
cause is shown.<span> </span>The OIG concluded that
the proposed arrangement could result in a two-tiered pricing structure, where
a substantial number of patients (those insured by Exclusive Plans) would
receive services for free, regardless of financial need, and where other
patients, including Federal health care program beneficiaries, would be
charged.<span> </span>The OIG noted that the only
reason for the proposed arrangement was to remove the obstacle that prevented
the physician practices from referring all laboratory business to the
laboratory.<span> </span>While the OIG could not
conclude whether the laboratory would violate the substantially in excess
provision, it opined that the risk was too high to grant the arrangement
prospective immunity under the advisory opinion.</span></span></div>
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<br /></div>
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<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;"><span></span>Advisory
Opinion 15-04 continues the OIG’s long-standing skepticism of
physician-laboratory arrangements.</span></span></div>
Adam Balickhttp://www.blogger.com/profile/13884178295632586175noreply@blogger.com0tag:blogger.com,1999:blog-3963699256961770547.post-39687134602320081892015-03-18T09:33:00.000-04:002015-03-18T09:33:18.480-04:00Delaware Drug-related Regulatory Updates<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">Written By <a href="http://balick.com/joanneceballos.html">Joanne Ceballos</a></span></span><br />
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<![endif]--><span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">Drug-related
revisions to the regulations governing nurses and pharmacists practicing in
Delaware took effect on March 11, 2015.<span>
</span>For nurses, “unprofessional conduct” that may lead to disciplinary
action now expressly includes diverting, possessing, obtaining, supplying or
administering illegal drugs.<span> </span>For
pharmacists, a new regulation expressly requires that dispensed medications
returned to a pharmacy “by the public” must be disposed of in accordance with
Delaware and federal controlled substances laws, and “proposed disposal methods
must be authorized by the Delaware Office of Controlled Substances and federal
authority.”</span></span>
<br />
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<br /></div>
<div class="MsoNormal">
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">There are also
changes to both the nursing and pharmacy regulations with respect to
educational/training requirements.<span> </span>For
nurses, one Continuing Medical Education hour (60 minutes) now equals one
contact hour (as opposed to 1.2 contact hours).<span>
</span>For pharmacists who administer immunizations and other injectable
medications, the required CPR certification must be obtained through hands-on
education as opposed to an online course.</span></span></div>
Adam Balickhttp://www.blogger.com/profile/13884178295632586175noreply@blogger.com0tag:blogger.com,1999:blog-3963699256961770547.post-55758248574632946462015-03-03T12:47:00.000-05:002015-03-03T12:47:34.108-05:00U.S. Supreme Court Affirms: State Licensing Boards Without Active State Supervision Susceptible to Antitrust Suits for Anticompetitive Behavior<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">Written By <a href="http://balick.com/natetrexler.html">Nate Trexler</a> </span></span><br />
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;"></span></span><br />
<div class="MsoNormalCxSpFirst" style="line-height: normal;">
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">On February 25, the US Supreme
Court released its decision in <a href="http://www.supremecourt.gov/opinions/14pdf/13-534_19m2.pdf"><i>North Carolina State Board of Dental Examiners v.
Federal Trade Commission</i></a>, reaffirming the rule that state
professional licensing boards controlled by active market participants that are
not “actively supervised” by the State do not enjoy state-action immunity from
antitrust enforcement.<span> </span>As a result, both
regulators and regulated health care professionals may find a need to
reevaluate state licensing board activity.</span></span></div>
<span style="font-size: small;">
</span><span style="font-size: small;">
</span><div class="MsoNormalCxSpMiddle" style="line-height: normal;">
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">Like most states, including
Delaware, the North Carolina legislature created a board—the State Board of
Dental Examiners—to regulate the “practice of dentistry.”<span> </span>By state law, a majority of the Board was
comprised of practicing dentists.<span> </span>In
2003, North Carolina dentists started to complain to the Board about
nondentists offering teeth whitening services at lower costs.<span> </span>The Board appointed a dentist member to lead
an investigation into nondentists offering these services.<span> </span>The investigation led the Board to issue
cease-and-desist letters to these nondentists, warning that the unlicensed
practice of dentistry was a crime and either strongly implying or expressly
stating that teeth whitening constituted “the practice of dentistry.”<span> </span>The Board also convinced the North Carolina
Board of Cosmetic Art Examiners to warn cosmetologists against providing such
services and even wrote letters to shopping mall operators to advise them to
remove teeth whitening kiosks because that activity violated the North Carolina
Dental Practice Act.<span> </span>The Act did not
specify that teeth whitening constituted the practice of dentistry.<span> </span>As intended, nondentists ceased offering
teeth whitening services in North Carolina.</span></span></div>
<div class="MsoNormalCxSpMiddle" style="line-height: normal; text-indent: 0.5in;">
<br /></div>
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<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">In 2010, the Federal Trade
Commission “FTC”) filed an administrative complaint charging the Board with
violating Federal antitrust law.<span>
</span>Essentially, the FTC alleged that the Board’s resolute action to exclude
nondentists from the market for teeth whitening services was anticompetitive
and an unfair method of competition.<span> </span>An
Administrative Law Judge (“ALJ”) rejected the Board’s argument that the Board
was immune from antitrust enforcement under the state action immunity
doctrine.<span> </span>Ultimately, the case was
decided on the merits in favor of the FTC, and the FTC ordered the Board to
stop sending cease and desist letters and to issue notices to all earlier
recipients explaining the Board’s proper scope of authority.<span> </span>The Board filed a petition for review to the
Fourth Circuit, which subsequently affirmed the FTC’s decision.<span> </span>The Supreme Court granted certiorari on the
issue of whether the Board enjoyed state action immunity.</span></span></div>
<div class="MsoNormalCxSpMiddle" style="line-height: normal; text-indent: 0.5in;">
<br /></div>
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<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">The Supreme Court restated the
standard for state action immunity set forth in <i>Parker v. Brown</i>, which provides that antitrust laws confer immunity
on the anticompetitive conduct of States that are acting in their sovereign
capacity.<span> </span>The Board argued that its
members were conferred with the power of the State by virtue of the State creating
the Board to regulate the practice of dentistry.<span> </span>The Court disagreed that creation of the
Board was enough.<span> </span>Where a nonsovereign
actor is controlled by active market participants, such as the Board, the actor
will only enjoy <i>Parker</i> immunity if:
(1) the action is clearly articulated and affirmatively expressed as state
policy; and (2) the policy is “actively supervised” by the State.<span> </span>The second requirement was at the heart of
the parties’ arguments.</span></span></div>
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<br /></div>
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<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">In its holding, the Court made
clear that where a State empowers a licensing board run by a majority of
members that practice the profession they regulate, “the need for supervision
is manifest.”<span> </span>Where a board is
essentially controlled by active market participants, there is a risk that
private interests may lead to anticompetitive regulation.<span> </span>The Board did not claim that the State of
North Carolina exercised any supervision over its conduct regarding teeth
whitening.<span> </span>The Court held that because
there was no active supervision of the Board’s actions, the Board was not
immune to antitrust laws.</span></span></div>
<div class="MsoNormalCxSpMiddle" style="line-height: normal; text-indent: 0.5in;">
<br /></div>
<div class="MsoNormalCxSpMiddle" style="line-height: normal;">
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">In its decision, the Court
established the parameters for what a State must do in order for its agencies
controlled by active market participants to enjoy immunity from antitrust laws.<span> </span>At the very least, the inquiry is whether the
State provides “realistic assurance” that an agency’s anticompetitive conduct
promotes state policy, rather than the actor’s self-interest.<span> </span>The Court stated that to satisfy the
requirement, a “supervisor,” who may not be an active market participant, must
look at a board’s decision and review its <i>substance</i>,
and act on the power, if necessary, to veto or modify decisions to ensure such
decisions achieve state policy.</span></span></div>
<div class="MsoNormalCxSpMiddle" style="line-height: normal; text-indent: 0.5in;">
<br /></div>
<div class="MsoNormalCxSpMiddle" style="line-height: normal;">
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">The Court’s decision in <i>North Carolina State Board of Dental
Examiners v. Federal Trade Commission</i> should prompt states to review the
composition and conduct of their licensing boards.<span> </span>Where a board is controlled by a majority of
individuals who practice the profession they seek to regulate, states should
seek to actively supervise the board decisions if immunity is desired.</span></span></div>
Adam Balickhttp://www.blogger.com/profile/13884178295632586175noreply@blogger.com0tag:blogger.com,1999:blog-3963699256961770547.post-40658839202767383982015-02-20T11:36:00.000-05:002015-02-20T11:36:32.973-05:00OIG Issues New Advisory Opinion that Sheds Additional Light on How the Government Views Beneficiary Inducements<div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">Written By <a href="http://balick.com/joanneceballos.html">Joanne Ceballos</a></span></span><span style="font-family: "Georgia","serif"; mso-fareast-font-family: "Times New Roman";"> </span></div>
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<span style="font-family: "Georgia","serif"; mso-fareast-font-family: "Times New Roman";">The
federal Civil Monetary Penalties statute, 42 U.S.C. 1320a–7a, allows the
government to impose Civil Money Penalties “(“CMPs”) when it determines that a
health care provider has offered remuneration to a federal health care program
beneficiary to influence the beneficiary to select the provider for services
paid for by Medicare or Medicaid. Similarly, the federal Anti-Kickback
Statute, 42 U.S.C. 1320a–7b(b), prohibits offering remuneration in exchange for
referrals of federal health care program business. These statutes
generally prevent a health care provider from advertising or offering free
goods or services to federal health care program beneficiaries to induce them
to obtain services from the provider that are payable by federal health care
programs. However, exceptions to this general prohibition do exist, and
earlier this month the OIG issued Advisory Opinion No. 15-01, which sheds
light on how the OIG evaluates arrangements where non-cash inducements are
provided to federal health care program beneficiaries. </span><span style="mso-fareast-font-family: "Times New Roman";"></span></div>
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<br /></div>
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<span style="font-family: "Georgia","serif"; mso-fareast-font-family: "Times New Roman";">The
Opinion was issued in response to a request by a provider of care coordination
and intervention services (“Provider”) under a state’s Medicaid-funded Maternal
Infant Health Program (the “Program”). To advance the Program’s goal of
promoting healthy pregnancies, positive birth outcomes, and infant health and
development, the Provider’s services include psychosocial and nutritional
assessments, coordination with other medical care providers and Medicaid Health
Plans, and family planning education. The state sponsoring the Program
directed Program providers to market their services to the target population
and to medical care providers who would be potential referral sources,
including advertising and offering incentives, such as free diapers, to
Medicaid beneficiaries participating in the Program. Accordingly, the Provider
advertised and offered one free pack of diapers (with a value of less than
$5.00) to Program-eligible Medicaid beneficiaries who attended an initial
consultation with the Provider, and beneficiaries who enrolled in the Program
continued to receive a pack of free diapers at each visit with the Provider up
to the Program maximum of ten visits. The Provider also advertised and
offered a free play yard, valued at approximately $50.00, to each beneficiary
who completed all ten visits.</span><span style="mso-fareast-font-family: "Times New Roman";"></span></div>
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<span style="font-family: "Georgia","serif"; mso-fareast-font-family: "Times New Roman";">The
OIG concluded that while the arrangement could potentially generate prohibited
remuneration under the AKS if the requisite intent to induce or reward
referrals of federal health care program business was present, it would not
impose administrative sanctions under the CMP statute for two reasons.
First, the OIG noted that the free diapers, with a value of less than $5.00 per
item and $50.00 in the aggregate (assuming a beneficiary attended and received
a package of diapers at all ten Program visits) are “nominal value” incentives
that are permissible under the OIG’s long-standing interpretation of the CMP
statute permitting non-cash incentives to a federal health care program
beneficiary of no more than $10 per item, or $50 in the aggregate on an annual
basis. Second, the OIG noted that both the diapers and the play yards satisfy
the requirements of the Preventive Care Exception in the CMP statute, 42 U.S.C.
1320a–7a(i)(6)(D). </span><span style="mso-fareast-font-family: "Times New Roman";"></span></div>
<div class="MsoNormal" style="line-height: 150%; margin-bottom: .0001pt; margin-bottom: 0in;">
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<span style="font-family: "Georgia","serif"; mso-fareast-font-family: "Times New Roman";">The
regulatory criteria for preventive care incentives to be excluded from the
definition of remuneration for purposes of the CMP statute are: (1) the
incentive must be given to promote preventive care services, defined as
“prenatal service or a post-natal well-baby visits or a specific clinical
service described in the current U.S. Preventive Services Task Force's <i>Guide
to Clinical Preventive Services</i>;” (2) the incentive cannot be cash or an
instrument convertible to cash; (3) the value of the incentive cannot be
disproportionately large in relationship to the value of the preventive care
service; and (4) the delivery of the preventive care service is not tied
(directly or indirectly) to the provision of other services reimbursed in whole
or in part by Medicare or Medicaid. 42 C.F.R. 1003.101. The OIG
concluded that the free play yards, whether offered alone or in combination with
the free diapers, satisfied all the regulatory criteria of the Preventive Care
Exception. While it is easily understood how the Provider’s incentives
comported with the first three regulatory requirements, it is less apparent how
the Provider’s delivery of prenatal and post-natal counseling could be
considered “not tied (directly or indirectly) to the provision of other
services (namely, prenatal and post-natal well baby visits) reimbursed” by
Medicaid, since a primary purpose of the Provider’s services is to encourage
pregnant Medicaid beneficiaries to obtain proper prenatal and post-natal
medical care. The OIG reasoned, however, that even though the Provider’s
preventive services are “intended to supplement the medical care that Program
beneficiaries receive, Program services are not tied, directly or indirectly,
to the provision of that care.” In other words, Medicaid beneficiaries
could avail themselves of the Provider’s services whether or not they obtained
the recommended medical services.</span><span style="mso-fareast-font-family: "Times New Roman";"></span></div>
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<span style="font-family: "Georgia","serif"; mso-fareast-font-family: "Times New Roman";">While
the AKS and CMP statutes generally prohibit health care providers from offering
Medicare and Medicaid beneficiaries incentives to seek their services, the
Preventive Care Exception is one of a number of statutory exceptions to the
definition of remuneration in the CMP statute. Providers seeking to
market and promote their services to federal health care program beneficiaries
are well-advised to take into consideration the parameters set by these
statutes and their related regulations for such activities. </span><span style="font-family: "Georgia","serif";"></span></div>
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Adam Balickhttp://www.blogger.com/profile/13884178295632586175noreply@blogger.com1tag:blogger.com,1999:blog-3963699256961770547.post-88740998794113215322015-01-20T14:21:00.001-05:002015-01-20T14:21:43.654-05:00U.S. Supreme Court Considers Whether Providers May Sue State Medicaid Officials for Failing to Raise Reimbursement Rates<!--[if gte mso 9]><xml>
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<![endif]--><span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">Written By
<a href="http://balick.com/joanneceballos.html">Joanne Ceballos </a> </span></span></div>
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<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">On Tuesday,
January 20, 2015, the United States Supreme Court heard oral argument in a case
brought by providers of residential rehabilitation services to Medicaid
eligible individuals against the Director and Deputy Director of Idaho's
Department of Health and Welfare (IDHW) challenging IDHW's failure to raise
Medicaid reimbursement rates that had been in effect since July 1, 2006.<span> </span>The question the Supreme Court is considering
is whether Medicaid providers may sue state officials under Section 30(A) of
the Medicaid Act, 42 U.S.C. §1396a(a)(30)(A), which requires states accepting
federal Medicaid funding to establish a “state plan,” which, among other
things, provides “methods and procedures relating to the utilization of, and
the payment for, care and services available under the plan … as may be
necessary to assure that payments are consistent with efficiency, economy, and
quality of care.”<span> </span></span></span></div>
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<br /></div>
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<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">The case, <i>Armstrong v. Exceptional Child Center, Inc.</i>,
was instituted by the residential rehabilitation service providers in 2009
after the IDHW failed to raise reimbursement rates consistent with studies
commissioned by IDHW because Idaho's Legislature did not appropriate $4 million
in funding necessary to cover the increased rates.<span> </span>The providers sued the IDHW for maintaining
the July 2006 reimbursement rates on the ground they did not take into account
providers’ actual costs, and, accordingly, violated Section 30(A)’s requirement
that “payments [to providers] are consistent with efficiency, economy, and
quality of care.”<span> </span>The United States
District Court for the District of Idaho granted summary judgment to the providers,
citing precedent from the Ninth Circuit Court of Appeals, which had previously
held that Section 30(A) requires a state Medicaid agency to consider actual
provider costs when setting rates.<span> </span></span></span>
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<br /></div>
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<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">The Ninth
Circuit upheld the district court’s judgment, and the IDHW petitioned the U.S.
Supreme Court, which granted the petition solely on the question of whether the
providers could even bring an action against the state Medicaid agency to
enforce Section 30(A) when Congress had not expressly authorized such an action
in the federal Medicaid statute.<span> </span>The
providers take the position that the Supremacy Clause of the United States
Constitution affords them a private right of action to enjoin a state law or
regulation that is inconsistent with federal law, in this case Section 30(A) of
the Medicaid Act.<span> </span>The Attorneys General
of 27 states, including Delaware, filed an amicus brief with the Supreme Court
urging it to reject the providers’ position, arguing principally that private
rights of action to enforce federal law must be created by Congress.</span></span></div>
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;"><span style="line-height: 115%;"> </span></span></span><br />
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<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;"><span style="line-height: 115%;">The Supreme Court’s decision is expected to have an
impact, one way or the other, on providers’ ability to bring legal challenges
against state Medicaid agencies regarding reimbursement rates.<span> </span>DE Health Law Blog will report on the Supreme
Court’s opinion when it is issued.</span></span></span></div>
Adam Balickhttp://www.blogger.com/profile/13884178295632586175noreply@blogger.com0tag:blogger.com,1999:blog-3963699256961770547.post-64235273653692825252015-01-08T13:04:00.000-05:002015-01-08T13:04:05.485-05:00CMS Issues Proposed Revisions to Medicare Regulations and State Survey Agency Guidance with Respect to Same-Sex Spouses<!--[if gte mso 9]><xml>
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<![endif]--><span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">Written By
<a href="http://balick.com/joanneceballos.html">Joanne Ceballos</a></span></span>
<br />
<div class="MsoNormal">
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">On December 12<sup>th</sup>
the Centers for Medicare and Medicaid Services issued a proposed rule to revise
Medicare regulations to afford same-sex spouses equal rights in Medicare and
Medicaid participating facilities.<span> </span>The
proposed changes to Medicare conditions of participation (CoPs) for providers,
conditions for coverage (CfCs) for suppliers, and requirements for long-term
care facilities, follow the U.S. Supreme Court’s decision in <i>United States v. Windsor</i>, 570 U.S.12,
133 S.Ct. 2675 (2013), finding unconstitutional a section of the federal
Defense of Marriage Act that prohibited recognition, in federal statutes and
regulations, of same-sex marriages lawfully entered into or recognized under
state law.<span> </span>The proposed revisions to
certain regulatory definitions and patient rights’ provisions are intended to
clarify that where state law or facility policy provides or allows certain
rights or privileges to a patient’s opposite-sex spouse, a patient’s same-sex
spouse must be afforded equal treatment if the marriage is valid in the
jurisdiction in which it was celebrated.<span>
</span>With a majority of states recognizing same-sex marriage, the proposed
rule places same-sex spouses on equal footing with opposite-sex spouses when
dealing with Medicare and Medicaid providers in most circumstances.<span> </span>The text of the proposed regulations can be
viewed by clicking <a href="https://www.federalregister.gov/articles/2014/12/12/2014-28268/medicare-and-medicaid-program-revisions-to-certain-patients-rights-conditions-of-participation-and">here</a>.<span> </span></span></span></div>
<div class="MsoNormal">
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;"><span> </span></span></span></div>
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">On the same date
CMS’s proposed rule was published in the Federal Register, CMS issued guidance
to state survey agency directors clarifying references in certain sections of
the State Operations Manual as follows:</span></span>
<div class="MsoNormal" style="margin: 0in 0.5in 10pt;">
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">“spouse” means an
individual who is married to another individual as a result of marriage lawful
where it was entered into including a lawful same-sex marriage, regardless of whether
the jurisdiction where the provider or supplier providing health care services
to the individual is located, or in which the spouse lives, permits such
marriages to occur or recognizes such marriages;</span></span></div>
<div class="MsoNormal" style="margin: 0in 0.5in 10pt;">
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">“marriage” means
a marriage lawful where it was entered into, including a lawful same-sex marriage,
regardless of whether the jurisdiction where the provider or supplier providing
health care services to the individual is located, or in which the spouse
lives, permits such marriages to occur or recognizes such marriages;</span></span></div>
<div class="MsoNormal" style="margin: 0in 0.5in 10pt;">
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">“family”
includes, but is not limited to, an individual’s “spouse” (see above); and</span></span></div>
<div class="MsoNormal" style="margin: 0in 0.5in 10pt;">
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">“relative,” when
used as a noun, includes, but is not limited to an individual’s “spouse” (see above).</span></span></div>
<div align="center" class="MsoNormal" style="margin: 0in 0.5in 10pt; text-align: center;">
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">****</span></span></div>
<div class="MsoNormal" style="margin: 0in 0.5in 10pt;">
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">[W]here CMS
regulations explicitly require an interpretation in accordance with State law, wherever
the text of a regulation or associated guidance uses the above terms or includes
a reference to a patient’s or resident’s “representative,” “surrogate,” “support
person,” “next-of-kin,” or similar term in such a manner as would normally
implicitly or explicitly include a spouse, the terms are to be interpreted consistent
with the guidance above.</span></span></div>
<div class="MsoNormal">
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">The text of
CMS’s guidance to state survey agency directors can be viewed by clicking <a href="http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-15-13.pdf">here</a>.</span></span></div>
<div class="MsoNormal">
<br /></div>
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">While CMS is
accepting comments on the proposed rule through February 10, 2015, the guidance
to surveyors states that is effective immediately, so the affected providers,
namely, hospitals, psychiatric hospitals, critical access hospitals, long term
care facilities, hospices, and organ procurement organizations, must promptly
revise their policies and procedures to conform to CMS guidance.<span> </span><span> </span></span></span>
Adam Balickhttp://www.blogger.com/profile/13884178295632586175noreply@blogger.com0tag:blogger.com,1999:blog-3963699256961770547.post-73003384660017968032014-12-10T08:44:00.001-05:002014-12-10T08:44:41.029-05:00New Rule Expands Bases on Which Providers Can Be Excluded from Participation in Medicare<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">Written By <a href="http://balick.com/melonyanderson.html">Melony Anderson</a><span style="line-height: 107%;"> </span></span></span></div>
<div class="MsoNormal">
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;"><span style="line-height: 107%;">On December 3, the Centers for Medicare & Medicaid
Services (“CMS”) issued a new rule that enhances CMS’s ability to exclude or
remove providers from participation in Medicare. According to a press release issued by CMS,
the new rule is designed to “prevent physicians and other providers with unpaid
debt from re-entering Medicare, remove providers with patterns or practices of
abusive billing, and implement other provisions to help save more than $327
million annually.”</span></span></span></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;"><span style="line-height: 107%;">The new rule has several provisions. The first, and most significant given CMS’s
stated purpose for the rule, is as follows: </span></span></span></div>
<br />
<div class="MsoNormal" style="margin-left: 0.5in;">
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;"><span style="line-height: 107%;">CMS may now deny enrollment if
the provider, supplier or owner thereof was previously the owner of a provider
or supplier that had a Medicare debt that existed when the latter’s enrollment
was voluntarily terminated, involuntarily terminated or revoked AND</span></span></span></div>
<div class="MsoNormal" style="margin-left: 0.5in;">
<br /></div>
<div class="MsoListParagraphCxSpFirst" style="margin-left: 81pt; text-indent: -13.5pt;">
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;"><span style="line-height: 107%;">·<span style="-moz-font-feature-settings: normal; -moz-font-language-override: normal; font-size-adjust: none; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span><span style="line-height: 107%;">The
owner left the provider or supplier that had the Medicare debt within 1 year of
that provider or supplier’s voluntary termination, involuntary termination, or
revocation;</span></span></span></div>
<div class="MsoListParagraphCxSpMiddle" style="margin-left: 81pt; text-indent: -13.5pt;">
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;"><span style="line-height: 107%;">·<span style="-moz-font-feature-settings: normal; -moz-font-language-override: normal; font-size-adjust: none; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span><span style="line-height: 107%;">The
Medicare debt has not been fully repaid; AND</span></span></span></div>
<div class="MsoListParagraphCxSpLast" style="margin-left: 81pt; text-indent: -13.5pt;">
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;"><span style="line-height: 107%;">·<span style="-moz-font-feature-settings: normal; -moz-font-language-override: normal; font-size-adjust: none; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span></span><span style="line-height: 107%;">CMS
determines that the uncollected debt poses an undue risk of fraud, waste or
abuse.</span></span></span></div>
<div class="MsoListParagraphCxSpLast" style="margin-left: 81pt; text-indent: -13.5pt;">
<br /></div>
<div class="MsoNormal">
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;"><span style="line-height: 107%;">There are terms under which the provider, supplier or owner
thereof can avert the denial, including repaying the debt in full, or agreeing
to a repayment schedule for the entire debt if the provider meets the criteria
for an extended repayment schedule provided by 42 C.F.R. </span><span style="line-height: 107%;">§</span><span style="color: #363636; line-height: 107%;">401.607.</span></span></span></div>
<div class="MsoNormal">
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;"><span style="color: #363636; line-height: 107%;"> </span><span style="line-height: 107%;"> </span></span></span></div>
<div class="MsoNormal">
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;"><span style="line-height: 107%;">To illustrate how this rule may be applied, consider the
following example. Provider ABC is owned
by Owner X. ABC terminates its
enrollment in Medicare. At the time of
the termination, ABC had an outstanding Medicare debt. Owner X leaves ABC less than a year after the
termination. Thereafter, as long as
ABC’s debt remains unpaid, Owner X may be excluded from participating in
Medicare, either as a provider or supplier or as an owner thereof, if CMS
determines that the outstanding debt poses an “undue risk of fraud, waste or
abuse.” It is not clear from the rules
what CMS considers to constitute an “undue risk”, and whether that is based on
a dollar figure, or some other criteria.
Owner X may avoid denial if he/she agrees to a repayment schedule for
the debt, or pays the debt in full. </span></span></span></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;"><span style="line-height: 107%;">The new rule also expands the bases on which CMS can deny
enrollment or revoke billing privileges based on prior felony convictions. Under the prior rule, CMS could deny
enrollment to any provider, supplier or owner who was convicted of a state or
federal felony in the prior 10 years.
The new rule expands that to include “managing employees”. </span></span></span></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;"><span style="line-height: 107%;">CMS can now revoke Medicare billing privileges if the
provider or supplier has a “pattern or practice of submitting claims that fail
to meet Medicare requirements”, including the requirement that the service be
reasonable and necessary. Many
commenters to the proposed rule suggested that the provision was arbitrary and
subjective, granting too much discretion to CMS. CMS responded by stating that “sporadic
billing errors would not result in revocation”.
CMS does not define “pattern or practice”, but listed several factors
that would be considered, including: (1)
percentage of submitted claims that were denied; (2) total number of claims
denied; (3) the reason(s) for the claim denials; (4) whether there is a history
of final adverse actions; (5) the time period over which the pattern has continued;
and (6) how long the provider has been enrolled in Medicare. With respect to factors (1) and (2), CMS
declined to establish objective numerical thresholds. </span></span></span></div>
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<br /></div>
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<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;"><span style="line-height: 107%;">The new rule also provides that revoked providers must
submit all remaining claims within 60 days after revocation. Revoked providers and suppliers may now only
submit a corrective action plan where the revocation was based on noncompliance
with the enrollment requirements, or the enrollment application. In other words, a revocation based on provider
or supplier conduct is no longer eligible for a corrective action plan.</span></span></span></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;"><span style="line-height: 107%;">The new rule goes into effect on February 3, 2015.</span></span></span></div>
Adam Balickhttp://www.blogger.com/profile/13884178295632586175noreply@blogger.com0tag:blogger.com,1999:blog-3963699256961770547.post-8684475688684718492014-12-03T11:19:00.000-05:002014-12-03T11:19:30.735-05:00Physical Therapists’ Board Proposes Telehealth and Dry Needling Regulations<!--[if gte mso 9]><xml>
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<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">Written by <a href="http://balick.com/joanneceballos.html">Joanne Ceballos</a></span></span><span style="font-family: "Georgia","serif";"> </span><br />
<span style="font-family: "Georgia","serif";">In August of this year
Governor Markell signed a bill overhauling Chapter 26 of Title 24 relating to
the practice of physical therapy and athletic training.<span style="mso-spacerun: yes;"> </span>Among other things, the legislation expanded
the scope of practice to include telehealth and dry needling.<span style="mso-spacerun: yes;"> </span><span style="mso-spacerun: yes;"> </span>Further
to the legislation, the Examining Board of Physical Therapists and Athletic
Trainers has proposed regulations regarding standards and requirements for the
practice of telehealth by physical therapists, athletic trainers, and physical
therapist assistants, as well as prerequisites for the performance of dry
needling by physical therapists.<span style="mso-spacerun: yes;">
</span>Proposed Regulation 14.0 restates the statutory definition of
“telehealth” as “the use of electronic communications to provide and deliver a
host of health-related information and health-care services, including physical
therapy and athletic training-related information and services, over large and
small distances. <span style="mso-spacerun: yes;"> </span>Telehealth encompasses
a variety of health care and health promotion activities, including education,
advice, reminders, interventions, and monitoring of interventions.” <span style="mso-spacerun: yes;"> </span>The proposed regulation provides that a
Delaware-licensed physical therapist, athletic trainer or physical therapist
assistant may conduct a telehealth session with a patient who is located in
Delaware at the time of the session after obtaining the patient’s written
informed consent specifying at a minimum the risks and limitations of the use
of electronic communications in the provision of care, the potential disruption
of electronic communication during the telehealth session, and the potential
for breach of confidentiality of protected health information using electronic
communications.<span style="mso-spacerun: yes;"> </span>The proposed regulation
requires the licensee to “ensure that the electronic communication is secure to
maintain confidentiality … as required by HIPAA and other applicable Federal
and State laws.”<span style="mso-spacerun: yes;"> </span>Finally, the proposed
regulation specifies that all evaluations (initial, reevaluations, discharge),
and every other supervisory visit, must be performed in person as opposed to
via telehealth.<span style="mso-spacerun: yes;"> </span> </span><br />
<br />
<span style="font-family: "Georgia","serif";">Proposed regulation 15.0
related to dry needling quotes the statutory definition, i.e., "an
intervention that uses a thin filiform needle to penetrate the skin and
stimulate underlying muscular tissue, connective tissues and myofascial trigger
points for the management of neuromusculoskeletal pain and movement
impairments; is based upon Western medical concepts; and requires a physical therapy
examination and diagnosis," and clarifies that dry needling is not within
the scope of practice of <span style="mso-spacerun: yes;"> </span>athletic trainers,
physical therapy assistants or physical therapy aides.<span style="mso-spacerun: yes;"> </span>To perform dry needling, a physical therapist
must have no less than two years of active clinical experience as a PT and must
complete 54 hours of in-person dry needling education in a Board-approved
program (PTs who have completed 25 hours of such education at the time the
regulation is enacted may continue to practice dry needling but must complete
the required 54 hours of education within two years).<span style="mso-spacerun: yes;"> </span>The proposed regulation requires a
physician’s referral specific for dry needling, specifies the minimum contents
for written informed consent (which must include the PT’s “level of education
regarding supervised hours of training in dry needling”), and addresses
documentation requirements.</span><span style="font-family: "Georgia","serif";"> </span><br />
<br />
<span style="font-family: "Georgia","serif";">A complete version of the
proposed regulations can be viewed by clicking <a href="http://regulations.delaware.gov/register/december2014/proposed/18%20DE%20Reg%20447%2012-01-14.htm">here</a>.</span><span style="font-family: "Georgia","serif";"></span><span style="font-family: "Georgia","serif";"> </span><br />
<br />
<span style="font-family: "Georgia","serif";">A public hearing on the
proposed regulations will be held on January 27, 2015 at 4:30 p.m. in the
second floor conference room A of the Cannon Building, 861 Silver Lake
Boulevard, Dover, Delaware.<span style="mso-spacerun: yes;"> </span>Written
comments may be submitted to Sandra Wagner, Examining Board of Physical
Therapists and Athletic Trainers, 861 Silver Lake Boulevard, Dover, Delaware
19904, by February 11, 2015.</span><span style="font-family: "Georgia","serif";">
</span>Adam Balickhttp://www.blogger.com/profile/13884178295632586175noreply@blogger.com0tag:blogger.com,1999:blog-3963699256961770547.post-63164972024972328562014-11-25T10:34:00.000-05:002014-11-25T10:34:23.630-05:00New Requirements for Delaware Free Standing Surgical Centers<!--[if gte mso 9]><xml>
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<![endif]--><span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">Written By <a href="http://balick.com/natetrexler.html">Nate Trexler</a></span></span><br />
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">On
November 1, the Delaware Department of Health and Social Services (“DHSS”)
promulgated new regulations governing the licensure and operation of free
standing surgical centers (“FSSCs”), more commonly referred to as ambulatory
surgery centers.<span> </span>The comprehensive
regulatory changes became effective November 11 and raise a number of new
issues for owners and potential investors of FSSCs.</span></span>
<br />
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<br /></div>
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;"><span></span>Most significant of these new
changes is that any modification of ownership and control (“MOC”) of a facility
will result in the current license being “void,” requiring the facility to seek
licensure as a new applicant.<span>
</span>Importantly, the regulation explicitly states that the FSSC must then
meet the current design and construction standards recognized by DHSS.<span> </span>“MOC” is defined by the regulations to be “a
change of ownership or transfer of responsibility for the FSSC’s operation” and
will occur “whenever the ultimate legal authority for the responsibility of the
FSSC’s operation is transferred.”<span> </span>The
regulation includes a number of examples of an MOC, including the transfer of a
majority interest to a new owner.</span></span>
<div class="MsoNormal">
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<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;"><span></span>In responding to comments on this
new requirement, DHSS stated that it “follows a protocol to ensure the
continuity of operations during the transition.”<span> </span>Licensees have not been apprised of exactly
what this “protocol” is or how it actually works.<span> </span>What is troubling is that the FSSC license is
“void” upon an MOC; this carries rather strong connotations. <span> </span>Reapplication for a license following an MOC
is apparently not just about approving ownership, but reapproving the operation
<i>and physical environment</i> of a
currently operational facility, regardless of the history of quality care and
excellent patient outcomes.<span> </span>Before going
forward with an ownership change, the facility should reach out to DHSS to
understand the protocol, the time frame for approval, and the impact on the
viability of the facility that relies on ongoing relationships with providers.</span></span>
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<br /></div>
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;"><span></span>Also of significance is the rule
that licenses will be issued for specific hours of operation and FSSCs may not
operate beyond those hours.<span> </span>In addition,
if a prospective licensee or a currently licensed FSSC wishes to accommodate
patient stays of 23 hours and 59 minutes, it must request approval in writing
from the local government having jurisdiction.</span></span>
<div class="MsoNormal">
<br /></div>
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">Multiple commenters inquired whether
the new regulations would impact a 1995 Delaware Attorney General’s opinion
that exempted single specialty diagnostic endoscopy and pain management centers
from licensure as FSSCs.<span> </span>While DHSS
would not amend the regulations to specifically exempt these facilities, it did
recognize that the Attorney General’s Office opinion was still in effect.</span></span>
<div class="MsoNormal">
<br /></div>
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">Finally, in one brief sentence, the
new regulations provide that a license is subject, at any time, to revision or
revocation by the State.<span> </span>Unlike
regulations that govern licensure of other types of facilities and health care
providers, this regulation does not tie the revision or revocation to any
specific reason (such as violation of the regulations) or detail any process
due to the licensee to challenge such a decision.<span> </span>The State Administrative Procedures Act does
not apply to DHSS in regard to process for case decisions or judicial review of
such decisions.</span></span>
<div class="MsoNormal">
<br /></div>
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">FSSC prospective licensees, current
licensees, and potential investors in these facilities should review the new
regulations carefully.<span> </span>The former
regulations were wholly rewritten, and in addition to the above, the new regulations
set forth requirements relating to the governing body, administration and
personnel, medical staff, and nursing services, among other things.<span> </span>Current licensees should be aware that they
are not grandfathered under the prior regulations, and will be subject to
compliance with all new regulatory requirements.<span> </span></span></span><br />
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;"><span> </span></span></span>
<br />
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<div class="MsoNormal">
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<div class="MsoNormal">
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<div class="MsoNormal">
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<div class="MsoNormal">
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<div class="MsoNormal">
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<div class="MsoNormal">
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<div class="MsoNormal">
<span style="font-family: Georgia,"Times New Roman",serif;"></span><span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">The
regulations can be reviewed <a href="http://regulations.delaware.gov/register/november2014/final/18%20DE%20Reg%20378%2011-01-14.htm">here</a>.</span></span>
</div>
Adam Balickhttp://www.blogger.com/profile/13884178295632586175noreply@blogger.com0tag:blogger.com,1999:blog-3963699256961770547.post-90162083583403539402014-11-10T09:25:00.000-05:002014-11-10T09:26:03.995-05:00HHS Office of Inspector General Fraud and Abuse Focus: FY 2015 Work Plan<!--[if gte mso 9]><xml>
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<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">Written By <a href="http://balick.com/natetrexler.html">Nathan Trexler </a></span></span><!--[if gte mso 9]><xml>
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<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">Each
year, the Office of Inspector General (“OIG”) at the Department of Health and
Human Services announces the agency’s new and continuing initiatives to combat
health care fraud and abuse. The annual
OIG Work Plan helps health care providers understand new, and some recurring,
areas that the OIG believes are key in the fight to protect the federal
fisc. We have previously discussed such
key initiatives to help Delaware providers identify and focus on potential
areas of compliance risk before issues arise (<a href="http://dehealthlaw.blogspot.com/2011/10/oig-issues-its-2012-work-plan.html">2012</a>,
<a href="http://dehealthlaw.blogspot.com/2012/10/oig-releases-2013-work-plan.html">2013</a>,
<a href="http://dehealthlaw.blogspot.com/2014/03/the-2014-oig-work-plan-as-guide-to.html">2014</a>).</span></span></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;">The OIG
released its FY 2015 Work Plan on October 31, and our review has revealed some
key initiatives:</span></span></div>
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<br /></div>
<div class="MsoNormal">
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;"><b><u>Physicians and other Practitioners:</u></b></span></span></div>
<div class="MsoNormal">
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;"><b><u><br /></u></b></span></span></div>
<ul style="margin-top: 0in;" type="disc">
<li class="MsoNormal"><span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;"><i>Anesthesia
services and payments for personally performed services.</i> The OIG plans to review Part B claims
for personally performed anesthesia services to determine whether claims
met Medicare requirements and to determine whether services reported with
the “AA” service code modifier met Medicare requirements.</span></span></li>
<li class="MsoNormal"><span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;"><i>Ophthalmologist
inappropriate and questionable billing</i>. In
2010, Medicare allowed more than $6.8 billion for services provided by
ophthalmologists. The OIG will
review claims data to identify potentially inappropriate and questionable
billing for services during calendar year 2012.</span></span></li>
<li class="MsoNormal"><span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;"><i>Physician
place-of-service coding errors</i>. The OIG will review coding on Part B
claims for services performed in ASCs and hospital outpatient
departments. The OIG has previously
determined that physicians are not always correctly coding nonfacility
places of services, which may result in higher payments.</span></span></li>
<li class="MsoNormal"><span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;"><i>Chiropractic
services</i>. The OIG announced its continued
intentions related to chiropractic services. The agency previously discovered
inappropriate payments and will continue its review to determine whether
payments for chiropractic services were claimed in accordance with
Medicare requirements. The OIG has
identified one example of a chiropractor with a 93% error rate and
inappropriate Medicare payments of nearly $700,000. The OIG plans to make recommendations to
reduce Medicare vulnerabilities with respect to chiropractic services.</span></span></li>
<li class="MsoNormal"><span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;"><i>Diagnostic
Radiology</i>. The OIG will review high-cost diagnostic
radiology tests to determine medical necessity and the extent to which
utilization has increased.</span></span></li>
<li class="MsoNormal"><span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;"><i>Independent
clinical lab billing requirements</i>. The OIG plans to review Medicare
payments to independent labs to determine compliance with billing
requirements, and use the results to identify clinical labs that routinely
submit improper claims in order to identify overpayments for recoupment. </span></span></li>
</ul>
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<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;"><b><u>Hospitals</u></b></span></span></div>
<div class="MsoNormal">
<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;"><b><u><br /></u></b></span></span></div>
<ul style="margin-top: 0in;" type="disc">
<li class="MsoNormal"><span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;"><i>New inpatient
admission criteria</i>. The OIG will continue to focus on how
the two-midnight rule is impacting hospital billing and examine the
variability among hospitals.</span></span></li>
<li class="MsoNormal"><span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;"><i>Oversight of
provider-based status</i>. Since provider-based status allows
facilities to bill as hospital outpatient departments, it can result in
high Medicare payments for services furnished at the facility and may
increase beneficiary coinsurance liability. The OIG will determine whether
provider-based facilities are meeting CMS criteria.</span></span></li>
<li class="MsoNormal"><span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;"><i>Inpatient
claims for mechanical ventilation</i>. The OIG will review Medicare payments
for inpatient claims with certain MS-DRG assignments that require
mechanical ventilation. The purpose
of the review is to determine whether hospitals’ DRG assignments and
Medicare payments were appropriate.<i> </i></span></span></li>
</ul>
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<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;"><b><u>Hospice and Home Health</u></b><span style="-moz-font-feature-settings: normal; -moz-font-language-override: normal; font-size-adjust: none; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span><span style="-moz-font-feature-settings: normal; -moz-font-language-override: normal; font-size-adjust: none; font-stretch: normal; font-style: normal; font-variant: normal; font-weight: normal; line-height: normal;"> </span><i> </i></span></span></div>
<br />
<ul>
<li><span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;"><i>Hospices in assisted living
facilities and hospice general inpatient care</i>. The OIG
continues to scrutinize hospice billings, which are also a focus for False
Claims Act relators, and will review the use of hospice general inpatient care
to determine whether the level of care is being misused.</span></span></li>
<li><span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;"><i>Home health prospective payment
system requirements</i>. Prior OIG work found that one in four home
health agencies had questionable billing and CMS has designated newly enrolling
agencies as high-risk providers. With
that in mind, the OIG will continue to review and scrutinize HHA documentation
to determine whether it supports claims paid by Medicare.</span></span></li>
</ul>
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<span style="font-family: Georgia,"Times New Roman",serif;"><span style="font-size: small;"></span></span></div>
<div class="MsoNormal">
</div>
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</div>
Adam Balickhttp://www.blogger.com/profile/13884178295632586175noreply@blogger.com0tag:blogger.com,1999:blog-3963699256961770547.post-77895778353186651592014-10-28T15:06:00.000-04:002014-10-28T15:06:51.227-04:00With CMPs for Employing Excluded Individuals on the Rise, Providers Should Review Their Exclusion Check Policies<div class="MsoNormal">
<a href="http://balick.com/joanneceballos.html"><span style="font-family: Georgia,"Times New Roman",serif;">Written By Joanne Ceballos</span></a></div>
<div class="MsoNormal">
O<span style="font-family: Georgia,"Times New Roman",serif;">ver the past
three months the Office of Inspector General of the U.S. Department of Health
and Human Services (“OIG”) has imposed civil monetary penalties (“CMP”) on 13
health care providers who employed individuals excluded from participating in
Medicare and Medicaid.<span style="mso-spacerun: yes;"> </span>Most of these
CMPs (10) were imposed on health care providers who self-reported the issue to
the OIG, which likely explains the rise in these types of matters.<span style="mso-spacerun: yes;"> </span>The CMPs ranged from $10,000 imposed against
a surgery center to $1.9 million levied against a diagnostic laboratory and
imaging company.<span style="mso-spacerun: yes;"> </span>With the average amount
of settlements with the OIG for employing excluded individuals in the range of
$275,000, providers who bill Medicare and Medicaid should review their policies
and processes for screening their employees and contractors against the OIG’s
List of Excluded Individuals and Entities (“LEIE”) at <a href="http://exclusions.oig.hhs.gov/">http://exclusions.oig.hhs.gov/</a>.</span></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
<span style="font-family: Georgia,"Times New Roman",serif;">Two fundamental
considerations in formulating an exclusion check policy are (1) who should be
screened, and (2) how frequently should screening occur?</span></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
<span style="font-family: Georgia,"Times New Roman",serif;">With respect to
the first issue, providers may wonder whether they only need to screen
individuals who will be rendering patient care services that will be billed to
federal health care programs.<span style="mso-spacerun: yes;"> </span>Federal exclusion
laws and regulations prohibit payment by a federal health care program for
items or services furnished by, at the medical direction of, or upon
prescription by an excluded individual.<span style="mso-spacerun: yes;"> </span>Moreover,
excluded individuals may not serve in a management role or provide
administrative services to an entity that bills federal health care programs
unless such services are wholly unrelated to federal health care programs.<span style="mso-spacerun: yes;"> </span>An excluded individual may, however, have an
ownership interest in a health care provider that bills federal health care
programs but the individual and provider may be subject to CMPs if the
individual provides management or administrative services to the provider.<span style="mso-spacerun: yes;"> </span>As a practical matter, therefore, an
exclusion check policy should provide for screening of owners, management,
administrative and clinical employees, as well as independent contractors.</span></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
<span style="font-family: Georgia,"Times New Roman",serif;">As to the
frequency of screening, no federal statute or regulation expressly requires
screening, let alone that it be conducted at particular intervals.<span style="mso-spacerun: yes;"> </span>Screening, however, is obviously a provider’s
first line of defense in avoiding a CMP for employing an excluded
individual.<span style="mso-spacerun: yes;"> </span>The OIG recommends screening
upon hire and “periodically” thereafter.<span style="mso-spacerun: yes;">
</span>In its <i style="mso-bidi-font-style: normal;">Special Advisory Bulletin
on the Effect of Exclusion from Participation in Federal Health Care Programs</i>,
the OIG does note that the LEIE is updated monthly, so monthly screening
“minimizes potential overpayment and CMP liability.”<span style="mso-spacerun: yes;"> </span>In 2011, the Centers for Medicare and
Medicaid Services (“CMS”) issued regulations requiring states to screen
Medicaid providers on a monthly basis.<span style="mso-spacerun: yes;">
</span>Some states have, in turn, imposed a monthly screening obligation on
their Medicaid providers.<span style="mso-spacerun: yes;"> </span>Although
Delaware’s Division of Medicaid and Medical Assistance does not currently
require Medicaid providers to conduct monthly exclusion checks of their
employees and contractors, frequent checks are obviously preferable.<span style="mso-spacerun: yes;"> </span>Whatever a provider decides with respect to
how often to conduct exclusion checks, the important thing is to establish a
regular exclusion check process and follow it.<span style="mso-spacerun: yes;">
</span><span style="mso-spacerun: yes;"> </span></span></div>
Adam Balickhttp://www.blogger.com/profile/13884178295632586175noreply@blogger.com1tag:blogger.com,1999:blog-3963699256961770547.post-28449759298896835292014-09-30T12:19:00.000-04:002014-10-07T13:45:19.148-04:00HIPAA Compliance: Two Things to do Going Forward <div class="MsoNormal">
<span style="font-family: Georgia,"Times New Roman",serif;"><a href="http://balick.com/joanneceballos.html">Written By Joanne Ceballos</a> </span><br />
<span style="font-family: Georgia,"Times New Roman",serif;"></span></div>
<div class="MsoNormal">
<span style="font-family: Georgia,"Times New Roman",serif;">Since the publication over 20 months ago of the HIPAA Final
Omnibus Rule, there has been no shortage of recommendations and advice to
health care providers from trade organizations, industry consultants, attorneys
and the Office of Civil Rights of the U.S. Department of Health & Human
Services (“OCR”) about the steps providers should take in order to achieve
HIPAA compliance.<span style="mso-spacerun: yes;"> </span>Last week marked a
final deadline for Omnibus Rule compliance—September 23, 2014, was the date by
which covered entities were required to update their agreements with business
associates to include certain provisions required under the Rule.<span style="mso-spacerun: yes;"> </span></span></div>
<div class="MsoNormal">
<span style="font-family: Georgia,"Times New Roman",serif;"><br /></span></div>
<div class="MsoNormal">
<span style="font-family: Georgia,"Times New Roman",serif;">Despite the volume of available guidance, health care providers
may not appreciate that the process they went through over the past year should
be repeated on a regular basis. In particular, covered entities are required to
review and modify their HIPAA security measures “as needed to continue
provision of reasonable and appropriate protection of electronic protected
health information [ePHI].”<span style="mso-spacerun: yes;"> </span>45 CFR
164.306(e).<span style="mso-spacerun: yes;"> </span>In other words, providers
who create, store or transmit ePHI should conduct another HIPAA Security Risk
Assessment when they make changes to their information systems, or when they
are apprised of new potential external threats to existing systems.<span style="mso-spacerun: yes;"> </span>The failure of providers to reassess their
HIPAA security measures following changes in IT infrastructure and applications
was a recurring deficiency discovered during OCR’s Pilot HIPAA Audit program,
and will be a focus of the new round of audits OCR is beginning this fall.<span style="mso-spacerun: yes;"> </span>Providers can minimize the possibility of having
an outdated Security Risk Assessment by simply planning to conduct one on a
regular basis, perhaps annually or biannually depending on the size of the
covered entity’s operations.<span style="mso-spacerun: yes;"> </span></span></div>
<div class="MsoNormal">
<span style="font-family: Georgia,"Times New Roman",serif;"><br /></span></div>
<div class="MsoNormal">
<span style="font-family: Georgia,"Times New Roman",serif;">Another aspect of HIPAA compliance that providers should
repeat on a regular basis is training regarding the requirements of the HIPAA
Privacy and Security Rules.<span style="mso-spacerun: yes;"> </span>While HIPAA
regulations do not expressly require training to be conducted at prescribed
intervals, another focus of the OCR’s audits this fall will be whether covered
entities have provided training on the HIPAA standards that are necessary or
appropriate for a workforce member to perform his/her job duties.<span style="mso-spacerun: yes;"> </span>As with any type of training, in order for
HIPAA training to be effective in facilitating employees’ understanding of the
regulatory requirements in the context of their job duties, it should be
conducted with some regularity, and at least on an annual basis.<span style="mso-spacerun: yes;"> </span>Employees who handle medical records requests
should receive more in depth training about the patient rights’ provisions of
the HIPAA Privacy Rule. </span></div>
<div class="MsoNormal">
<span style="font-family: Georgia,"Times New Roman",serif;">If you are a provider who has invested time and effort over
the past year reinvigorating your HIPAA compliance program, preserve the value
of your investment by conducting risk assessments and training on an ongoing
basis. </span></div>
Adam Balickhttp://www.blogger.com/profile/13884178295632586175noreply@blogger.com0tag:blogger.com,1999:blog-3963699256961770547.post-83902767508046383072014-09-24T08:35:00.000-04:002014-10-07T13:46:55.920-04:00Physician Supervision Requirements under CMS Regulations - False Claims Act Cases on the Rise<a href="http://balick.com/melonyanderson.html"><span style="font-size: small;"><span style="font-family: Georgia,"Times New Roman",serif;">Written By Melony Anderson</span></span></a><br />
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<![endif]--><span style="font-family: "Georgia","serif";">In 2013, the Department of
Justice collected over $3.8 billion in qui tam and non-qui tam settlements and
judgments under the False Claims Act (“FCA”). Of the total amount
collected, $2.7 billion, or 70% were in cases in which the Department of Health
and Human Services (“HHS”) was the primary client agency. In comparison,
cases from the Department of Defense represented just 1% of the total
collections. Surprisingly, the total numbers for 2013 were actually
slightly lower than 2012 numbers. In 2012, total collections were $4.9
billion, with HHS cases representing $3.1 billion, or 63%. </span><br />
<br />
<span style="font-family: "Georgia","serif";">Notwithstanding the slight
decrease in total judgments and settlements, it is clear that one type of case
under the FCA is beginning to account for an increasing portion of the
total: cases where the government has alleged that the services were not
properly supervised by a physician or a qualified non-physician provider
(“NPP”), such as a licensed physical therapist. </span><br />
<div style="margin-bottom: .0001pt; margin: 0in;">
<br /></div>
<div style="margin-bottom: .0001pt; margin: 0in;">
<span style="font-family: "Georgia","serif";">CMS
regulations define three types of physician supervision: </span></div>
<div style="margin-bottom: .0001pt; margin: 0in;">
<span style="font-family: "Georgia","serif";">·
<u>General supervision</u>: the physician or NPP must be available by
telephone. </span></div>
<div style="margin-bottom: .0001pt; margin: 0in;">
<span style="font-family: "Georgia","serif";">·
<u>Direct supervision</u>: the physician or NPP must be “immediately
available” and “interruptible” throughout the performance of the
procedure. The physician or NPP does not need to be present in the
room. CMS will not explicitly define “immediate” but has said that the
requirement is not met where the physician or NPP is “so physically far
away…from the location where…outpatient services are being furnished that he or
she could not intervene right away.” </span></div>
<div style="margin-bottom: .0001pt; margin: 0in;">
<span style="font-family: "Georgia","serif";">·
<u>Personal supervision</u>: the physician or NPP must be in the room
during the procedure. </span></div>
<span style="font-family: "Georgia","serif";">In order to bill Medicare or
Medicaid for certain services, the service must have been appropriately
supervised under these definitions. The government takes the position
that services billed but not properly supervised are not “reasonable and
necessary” and are, therefore, false claims. For example, MRIs with
contrast require direct supervision. Although the supervising physician
need not be in the room during the treatment, the physician must be
“immediately available” somewhere on the premises. What is more, it is
not enough that any physician or NPP is immediately available – the supervising
physician or NPP must have within his or her State scope of practice and
hospital privileges the ability to perform the service or procedure.
</span><br />
<div style="margin-bottom: .0001pt; margin: 0in;">
<span style="font-family: "Georgia","serif";">The
following recent settlements provide some insight into the types of services
where the government is paying close attention: </span></div>
<div style="margin-bottom: .0001pt; margin: 0in;">
<span style="font-family: "Georgia","serif";">·
A Florida hospital and doctor group settled with the government for $3.5
million. The allegations in that case were that the group billed
Medicare, Medicaid and TRICARE for radiation oncology services (which require
direct supervision) that were performed without the necessary
supervision. In particular, the government alleged that the services were
often performed while the defendant doctors were on vacation or were working at
another radiation oncology clinic. </span></div>
<div style="margin-bottom: .0001pt; margin: 0in;">
<span style="font-family: "Georgia","serif";">·
In April 2013, a North Carolina neurologist and his practice paid $2 million to
resolve allegations under the False Claims Act that the neurologist had
improperly billed for intravenous immunoglobulin therapy services, which
require direct supervision. The government alleged that the services had
been performed by registered nurses when the neurologist was not present in the
office suite. There were no allegations that any patients had been
harmed; what is more, in many instances there were other physicians on site and
the neurologist himself was, in his words, “no more than 8 seconds away” from
the office suite. </span></div>
<div style="margin-bottom: .0001pt; margin: 0in;">
<span style="font-family: "Georgia","serif";">·
A Georgia-based collection of companies settled a False Claims Act case for
$1.2 million in April 2013. The allegations in that case were that the
companies had billed for contrast MRI procedures where only clerical staff and
technicians were onsite. </span></div>
<span style="font-family: "Georgia","serif";">It is worth noting that most, if
not all, of the major settlements involved physician supervision over services
that require direct supervision, rather than general or personal. This is
perhaps not surprising: general and personal supervision are clearly and
understandably defined, whereas CMS has declined to provide specific time or
distance limits that would meet the definition of “immediate” and
“interruptible” for direct supervision. </span><br />
<div style="margin-bottom: .0001pt; margin: 0in;">
<br /></div>
<div style="margin-bottom: .0001pt; margin: 0in;">
<span style="font-family: "Georgia","serif";">Direct
supervision is required for most outpatient services. The following is a
non-exclusive list of services that require direct supervision: </span></div>
<div style="margin-bottom: .0001pt; margin: 0in;">
<span style="font-family: "Georgia","serif";">·
Diagnostic services furnished to outpatients, including drugs and biologicals
required in the performance of those services (for example, MRIs with
contrast);</span></div>
<div style="margin-bottom: .0001pt; margin: 0in;">
<span style="font-family: "Georgia","serif";">·
IV therapy services, such as chemotherapy</span></div>
<div style="margin-bottom: .0001pt; margin: 0in;">
<span style="font-family: "Georgia","serif";">·
Physical and occupational therapy (a licensed therapist must provide direct
supervision)</span></div>
<div style="margin-bottom: .0001pt; margin: 0in;">
<span style="font-family: "Georgia","serif";">·
Pulmonary, cardiac and intensive cardiac rehabilitation; </span></div>
<div style="margin-bottom: .0001pt; margin: 0in;">
<span style="font-family: "Georgia","serif";">·
Glaucoma screening examinations; and</span></div>
<div style="margin-bottom: .0001pt; margin: 0in;">
<span style="font-family: "Georgia","serif";">·
Services and supplies provided “incident to” a physician’s services in a
non-institutional setting (such as a physician’s office)
</span></div>
<br />
<span style="font-family: "Georgia","serif";">Understanding the level of
supervision that a particular service or treatment requires is extremely
important, particularly for health care providers who bill for services that
they do not perform themselves. The consequences for billing for services
where the requisite level of supervision was not present could be dire and
could include not only significant financial liability, but exclusion from
federally funded healthcare programs. </span><br />
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<![endif]-->Adam Balickhttp://www.blogger.com/profile/13884178295632586175noreply@blogger.com0