General Assembly Puts Limits on In-Office Dispensing of Controlled Substances

Practitioners who have established in-office dispensing as a convenience to patients, as well as the patients who look to their doctor to dispense medications, are going to see those systems impacted by a recent bill signed by the Governor.  In yet another measure intended to address the prescription drug abuse epidemic in Delaware, Senate Bill 119 was signed into law on July 3, 2013 to limit the in-office dispensing of controlled substances. 
 
The law provides that any practitioner permitted to dispense controlled substances shall only be permitted to dispense the amount deemed medically necessary for a 72 hour supply.  The synopsis of the bill indicates that this represents an “emergency supply,” though those words do not appear in the statute.  Therefore, there is some indication that the General Assembly does not believe practitioners should be dispensing controlled substances from their offices as a matter of course, but only in cases of emergencies.  The dispensing practitioners are also explicitly subject to the reporting requirements of the Delaware Prescription Monitoring Program.
 
It is clear that lawmakers want to monitor who is dispensing, when that person is dispensing, and how much that person is dispensing. It is important to note, however, that the law only limits dispensing, and does not impact the prescribing of controlled substances.

Shared Responsibility for Proper Prescribing and Dispensing of Controlled Substances

Delaware pharmacists have recently been reminded of their “corresponding responsibility” under Delaware and federal law.   Regulations provide that while “the responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner . . . a corresponding responsibility rests with the pharmacist who fills the prescription.”  21 CFR § 1306.04; Delaware Controlled Substances Act Regulation 4.3.1

This responsibility can create tension between prescribing practitioners and pharmacists, who are at times obligated to confirm the validity and appropriateness of a controlled substance prescription.  Many prescribing practitioners are reporting receiving frequent calls from pharmacists, who are asking questions about the reasons certain controlled substances have been prescribed.  

Earlier this week, the federal government sent a significant remainder to the health care community that pharmacists and pharmacies can and will be held accountable for the failure to comply with these regulations. On June 11, 2013, the Walgreen Company (the nation’s largest pharmacy operator) agreed to pay $80 million to resolve DEA charges that several Walgreens pharmacies did not properly control oversight and handling of narcotic painkillers, particularly oxycodone.  The $80 million settlement is the largest ever paid by a pharmacy chain.

According to the DEA, six Florida Walgreens pharmacies were responsible for “an unprecedented number” of record keeping and dispensing violations under the federal Controlled Substances Act, allowing prescription painkillers to be diverted for abuse or to the black market.  The DEA alleged that the retail pharmacies knew or should have known that the prescriptions were not for legitimate medical use.

Delaware pharmacists and prescribers are partners in guarding against prescription drug diversion and misuse.  As with any good partnership, open communication will benefit the partnership.

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.