Proposed Regulations to Require Accreditation of Medical, Dental and Podiatry Practices

On April 1st, the Department of Health and Social Services (“DHSS”), through the Office of Health Facilities Licensing and Certification, published proposed regulations governing accreditation standards and safety and sanitation standards that, if implemented, would apply to all medical offices, dentist offices and podiatry offices where certain invasive procedures are performed. Physicians, dentists, and podiatrists who perform even minor medical procedures in their offices while utilizing “any level of anesthesia” should carefully review the regulations, as the Delaware health care community will undoubtedly be surprised by the proposed new requirements that may soon apply to these practices.

Anyone interested in these regulations may submit comments and concerns to the DHSS in writing on or before April 30th. We feel there is a great deal to be concerned about.

The regulations were drafted as a result of House Bill 47 and House Bill 144, which require the DHSS to establish standards with respect to safety and sanitary conditions and to establish standards for a facility accreditation program, respectively. While these bills provide a framework for the DHSS’s regulations, the agency’s proposed regulations seem to go further than the General Assembly intended. The regulations would apply to “medical facilities” that perform “invasive medical procedures” utilizing “any level of anesthesia.” (Any facility already licensed pursuant to Title 16 such as ASCs, freestanding emergency centers, or freestanding birthing centers are exempt). A “medical facility” explicitly includes the office of a physician, dentist, podiatrist, group practice or clinic. “Invasive medical procedures” are defined broadly, including any procedure structurally altering the human body by the incision or destruction of tissues. “Any level of anesthesia” shall include local anesthesia, nitrous oxide inhalation, minimal or moderate intravenous, intramuscular or rectal sedation, deep sedation, general anesthesia, or major conduction blockade.

These regulations have potentially far-reaching applicability in the Delaware medical community. Even health care practices that perform such procedures on an infrequent or limited basis, will be bound by these regulations. Any health care practice meeting these definitions would be required to be accredited by an outside accrediting agency within six months of the effective date of the regulations. The regulations propose standards with respect to safety and sanitary conditions and they attempt to define the accreditation process for such facilities. However, to our knowledge no accrediting agency or company has yet been approved. The cost and timing of the accreditation process remains unknown. However, anyone who has been through an accreditation process will certainly appreciate the unlikelihood of completing that process within the timeframe provided.

Beyond the challenges of accreditation, the regulations prompt unanswered questions, and may produce potentially troubling application of the law. One significant concern is that the proposed regulations would make physician/dentist/podiatrist quality of care a basis for discipline. In other words, as currently written, these proposed regulations would give the DHSS the right to impose discipline for quality of care concerns that are unrelated to the types of environmental concerns, such as environmental safety and sanitary concerns, that prompted the General Assembly to enact these laws. For example, the proposed regulations define certain predicate events (“adverse events”) that impose a duty to self-report to the DHSS. Some of these “adverse events” are clearly aimed at physician/dentist/podiatrist behavior, as opposed to safety and sanitary conditions. Facilities subject to these regulations would have to report any suspected abuse, neglect, or mistreatment, the admission of the patient to another facility due to complications, and serious cardiovascular events.

What kind of discipline would the DHSS be able to impose? Under the proposed regulations, the DHSS would have authority to impose any order it “deems necessary to protect the public health,” including the authority to close a facility, even prior to a hearing. This is the most troubling aspect of the proposed regulations. It may seem unimaginable that the DHSS would unilaterally close an entire health care practice, but as currently written, these proposed regulations allow that to happen. Patients of a medical practice need to be seen for a variety of services, including evaluation and management. Concerns related to the performance of minimally invasive procedures should not be a basis for shuttering an entire practice.

Now is the time to act. It is imperative for Delaware health care providers to review the regulations and consider how they may affect their practices if finalized. If no one voices concern, these regulations are likely to be finalized. Again, comments must be submitted to DHSS by Tuesday, April 30. Feel free to contact us to share your concerns.

The regulations may be viewed in their entirety at: http://regulations.delaware.gov/register/april2013/proposed/16%20DE%20Reg%201033%2004-01-13.htm

Delaware General Assembly Considers Expanding Immunity Connected to Mental Health Assessments

Pending in the Delaware Senate is a bill already passed unanimously in Delaware’s House of Representatives clarifying the law on immunity with regard to the process to detain or not detain a person for an involuntary mental health evaluation. House Bill #9 provides that immunity to civil damages and criminal penalties extends to peace officers, medical doctors, credentialed mental health screeners, and the facility in which the medical doctor or credentialed mental health screener practices, only for harm resulting from the mental health assessment, resulting clinical decision, and involuntary hold necessary until the person is presented to a designated psychiatric treatment facility, as required by the statute, and only if the peace officer, medical doctor, etc., did not intentionally inflict harm or engage in willful or wanton misconduct in connection with those activities. Once an individual is detained in a psychiatric facility for purposes of the statutorily required examination by a psychiatrist, neither the examining psychiatrist nor facility is immune from ordinary negligence claims. The proposed legislation is based on the recommendations of the HJR 17 Study Group created to review Delaware’s civil mental health laws. The text of the bill is available at http://legis.delaware.gov/LIS/LIS147.NSF/vwLegislation/HB+9?open.

American Hospital Association Strikes Back at the RACs

Many health care providers are familiar with the costly exercise of fighting a Recovery Audit Contractor’s (“RAC”) determination of an overpayment through the administrative appeal process. But where providers take on the expense, the statistics on appeal are largely favorable. For fiscal year 2011, 43.4% of RAC determinations were reversed in the providers’ favor. The problem is that of the 903,372 claims identified as overpayments by RACs, only 56,620 claims were appealed at any level. Of those 56,620 claims, the 24,458 claims overturned during the appeal process translate to $37.9 million, or $1,550 per case. The low appeal rate is likely due to frustration, costs of appeal, and other high-priority issues, such as patient care. For hospitals, the biggest fight has centered on the RACs’ intense focus on inpatient care. In the first quarter of 2012, the claims most frequently identified by RACs as overpaid related to the provision of service on an inpatient basis when, according to the RAC, only outpatient service was necessary, despite the fact that the services were largely conceded to be reasonable and medically necessary. Reports indicate that when hospitals pursue appeals of these RAC determinations, they are successful 75% of the time. But the biggest problem is that where the RAC correctly determines that an inpatient admission was not warranted, hospitals are not being paid under Part B for outpatient care. In other words, while the only problem cited by the RAC is the setting where services were provided, claims for the services are being denied in their entirety, and hospitals are receiving no reimbursement for the underlying reasonable and medically necessary services provided. This issue is now at the center of a lawsuit filed by the American Hospital Association (“AHA”) and several hospitals against the Secretary of Health and Human Services. The AHA argues that the Social Security Act requires CMS to reimburse hospitals for reasonable and medically necessary services, and that by allowing the RACs to claw back the entire payment for the inpatient services under Part A and then denying payment under Part B, CMS is running afoul of federal law. The AHA seeks an order declaring the practice to deny all payment invalid and an order that the hospitals be paid in full for the reasonable and medically necessary services that CMS concedes were provided to beneficiaries. The complaint can be viewed at the AHA’s website: www.aha.org.

Delaware Bar Association Health Law Section Seminar

Please plan to attend a very special CLE/CME Seminar, “Health Law 101: What Every Lawyer and Healthcare Provider Should Know,” on Friday, November 30th, 2012, at the Medical Society of Delaware’s Conference Center in Newark. During this all-day seminar leading Delaware health law practitioners will cover a range of health law topics, from recent HIPAA-related developments and federal fraud and abuse laws to state law topics such as prescription drug monitoring and medical malpractice litigation. You can view the full agenda on the attached registration form. A link to the form on the DSBA’s website is also below. The seminar is not only approved for 6 hours of CLE credit, including 1 hour of Ethics credit, it is also approved for AMA PRA Category 1 Credit.TM http://www.dsba.org/cle/pdfs/HealthLaw2012.pdf This promises to be an interesting and informative event!

OIG RELEASES 2013 WORK PLAN

Yesterday the OIG issued its Work Plan describing the activities the OIG plans to initiate or continue with respect to HHS programs and operations in fiscal year 2013. The Plan identifies areas of government focus for each type of healthcare provider, as well as the OIG’s planned activities related to its oversight of Medicare Part A and B contractors, Medicare Part C and D programs, state Medicaid plans, and public health and human services agencies within the U.S. Department of Health and Human Services. With respect to particular healthcare providers, the Plan identifies 11 new initiatives related to hospitals, 3 related to nursing homes, 2 related to home health agencies, 8 related to medical equipment suppliers, and 8 related to all other providers and suppliers. The new hospital initiatives include a review of Medicare payments made to hospitals for beneficiary discharges that should have been coded as transfers, a review of Medicare payments made to hospitals for beneficiary discharges that were coded as discharges to a swing bed in another hospital, and an analysis of costs incurred by Medicare related to inpatient hospital claims for canceled surgical procedures. For nursing homes, two of the new initiatives relate to evaluating whether states are properly performing oversight functions mandated by federal regulations, specifically whether State survey agencies verified correction plans for deficiencies identified during nursing home recertification surveys, and the extent to which CMS and the States oversee the accuracy and completeness of Minimum Data Set (MDS) data submitted by nursing facilities. The OIG plans to determine the extent to which home health agencies are complying with the statutory requirement that physicians who certify beneficiaries as eligible for Medicare home health services have face-to-face encounters with the beneficiaries. The OIG will also review which home health agencies are complying with State requirements for conducting criminal background checks of applicants and employees. With respect to medical equipment and supplies, the OIG plans to audit payments for lower limb prosthetics, power mobility devices and blood glucose test strips and lancets. As to all other providers, the OIG’s new initiatives include reviews of Medicare Part B claims for personally performed anesthesia services to determine whether they were supported in accordance with Medicare requirements, an examination of questionable billing practices for ophthalmological services during 2011, and a review of questionable billing for electrodiagnostic testing, which is used in the diagnosis and treatment of nerve or muscle damage and includes the needle electromyogram and the nerve conduction test. These efforts described in these new initiatives, as well as the others identified in the OIG Work Plan, are in addition to the OIG’s ongoing audits and analyses of numerous other provider-specific issues, all of which are outlined in the Work Plan, which is available at http://go.usa.gov/Y2Cx. The OIG is also planning a webcast on October 24, 2012, during which top OIG personnel will describe the OIG’s priorities for combating fraud, waste and abuse in federal health care programs for 2013. More information about the webcast is available at the above link.

CMS Proposes Raising Medicaid Payments to Primary Care Physicians

In a proposed rule announced on Wednesday, CMS seeks to provide states more than $11 billion in new funds to improve Medicaid primary care from 2013 through 2014. The proposal, if finalized, would implement requirements of the Patient Protection and Affordable Care Act designed to help primary care physicians and networks prepare for the increased enrollment following implementation of healthcare reform. Assuming the Affordable Care Act is not declared unconstitutional by the Supreme Court this summer, CMS will likely finalize the rule later in the year. The Affordable Care Act requires that Medicaid reimburse certain primary care specialties, including family medicine, general internal medicine, and pediatric medicine, at the levels of Medicare reimbursement for calendar years 2013 and 2014. This increase in payment is entirely funded by the federal government and States will not need to provide matching payments. Currently, the national average Medicaid payment rate is only two-thirds of what Medicare pays. In Delaware, the payment rate is 54% and below, according to data published by American Medical News. Some physicians are expressing concern about what will happen after 2014 to practices that accept more patients during the pay increase. Once the payment rates return to current numbers after 2014, will primary care practices suffer the consequences of taking in a larger patient population with lower paying insurance? The rule can be read here. (http://www.ofr.gov/OFRUpload/OFRData/2012-11421_PI.pdf)Comments are due June 11th.

Board of Medical Licensure and Discipline Proposes New Licensure Requirements

The United States Supreme Court’s review of the Affordable Care Act dominates the news and is on the minds of health care attorneys across the country. The constitutional fate of the Act will be decided when the Supreme Court releases its opinion in June, an event all health care providers will anticipate as the landscape of American health care awaits its fate.

Yet, there are still local developments to report that affect Delaware practitioners. In recent months the Delaware Board of Medical Licensure and Discipline has grappled with the degree to which a practitioner must demonstrate clinical competency in order to obtain a license, particularly when the applicant has been away from clinical practice for an extended period of time. The Board’s focus on this issue has been reflected in two recent written decisions.

So it was no surprise that earlier this month, the Board published notice of a proposed rule that amends “outdated” requirements for license renewal and for examination of practitioners out of clinical practice for three or more years seeking initial licensure in the State. Under the proposed rule, practitioners seeking initial licensure, but who have been out of clinical practice for three or more years, must demonstrate clinical competency. The proposed rule will require such practitioners to complete an approved “clinical and didactic” practice assessment program and demonstrate that the applicant has kept current with BMLD CME requirements.

The proposed rule indicates that a list of approved practice assessment programs will be posted on its website. Nothing has been posted yet and it will be interesting to see the list. From our experience, the availability of clinical and didactic practice assessment programs is somewhat limited, with the most prominent programs located in Colorado and California. We are also aware that a similar program is underway in Pennsylvania.

The proposed rule also seeks to make important procedural changes to the license renewal process. For any provider who fails to renew a license within one year after it expires, the renewal process will not be available. Instead, the practitioner will be required to seek licensure under the same conditions that govern applicants for new licensure and the requirements that govern reentry to practice.

Additionally, all applicants seeking renewal of a license after it has expired must certify that he or she has not practiced in Delaware while the license has expired.

A public hearing on the proposed rule will be held on April 3, 2012. More information on the hearing and the text of the proposed rule can be found at http://regulations.delaware.gov/register/march2012/proposed/15%20DE%20Reg%201293%2003-01-12.htm.