Category Archives: Healthcare

Temporary Blanket Waivers for Certain Stark Law Penalties

Among the many federal agency actions taken in response to the health and economic consequences of the COVID-19 outbreak is an interesting and much unpublicized one related to the Stark Law, a healthcare fraud and abuse law that prohibits physicians from referring patients for certain designated health services paid for by Medicare to any entity in which they have a “financial relationship.”

On March 30, 2020, the Centers for Medicare and Medicaid Services (“CMS”) unexpectedly announced temporary nationwide Section 1135 blanket waivers (retroactive to March 1, 2020) for certain Stark Law penalties of the Social Security Act. By relaxing some restrictions on payments and referrals, hospitals and healthcare providers should find it easier to collaborate during this time when the healthcare system is confronting an unprecedented pandemic.

The blanket waivers are narrowly tailored and require entities to act in good faith to provide care in response to the United States national emergency declared due to the COVID-19 outbreak. The blanket waivers do not excuse any otherwise illegal  fraud or abuse and those using the blanket waivers must be satisfying one of the six explicitly defined COVID-19 purposes. A further requirement is that the otherwise illegal relationship must fall into the one of the eighteen permitted relationships. Because of these complex requirements the potential use of any waiver will require fact-intensive analysis of each relationships’ circumstances and conditions. Continue reading

Required Action for Healthcare Providers Receiving Relief

Healthcare providers should note that HHS has deposited funds in many of your bank accounts.  The funds are from two programs, the CMS Accelerated and Advance Program and the CARES Act Provider Relief Fund.  The CMS Accelerated and Advance Program is a loan against future payments from government healthcare programs and must be repaid (likely from reductions in future payments).  The CARES Act Provider Relief Fund is a grant program, but in order to retain the money you have received providers must sign and deliver an attestation within 30 days following receipt of the funds.  The clock has already started to run.  There has been much confusion about the CARES Act payment because the certification required that the provider be involved in the treatment or diagnosis of potential COVID-19 patients.  CMS has clarified, however, that any patient is a potential COVID-19 patient.  The newly published HHS Cares Act data page where you can access the required attestation and instructions and learn more about this important update.

Healthcare Providers: Florida Legislature Expands Scope of Practice for Pharmacists and APRNs

On March 11, 2020, just two days before the end of the 2020 Florida Legislative Regular Session, the Legislature passed two bills which have special significance given the escalation of fear related to COVID-19 or Coronavirus disease. House Bill (“HB”) 389 expands the practice of pharmacists by allowing them to test and treat patients for certain chronic medical conditions and minor, uncomplicated acute medical conditions. HB 609 authorizes qualified advanced practice registered nurses (“APRNs”) to independently operate primary care practices without physician supervision.

Both bills were signed within hours of passage by Governor DeSantis, but the new laws will not take effect until July 1, 2020, which could be after the Coronavirus pandemic has hopefully lessened, but too late to respond to the immediate need for additional healthcare providers in those Florida counties which have declared a state of emergency due to Coronavirus. When the new laws go into effect this summer, Florida will join seventeen other states with expanded pharmacist practice, and twenty-one states and the District of Columbia with independent practice status for APRNs.

The new laws will have profound effects upon the delivery of healthcare in Florida, including some good, some bad, as well as the predictable and unpredictable. Looking specifically at senior living facilities, APRN expanded practice should have beneficial effects including the reduction in unnecessary hospitalization of long-term care patients. The hospitalization of elderly patients often causes irreversible decline in function and exposes them to hospital-acquired illnesses and delirium. An expanded practice APRN will allow for more timely diagnosis and medical treatment when a patient has a change of condition in the long-term care facility. The APRN can intervene and treat the patient in place at the facility, instead of transferring the patient to the hospital for assessment. Thus, expanded practice APRNs will play a valuable role in caring for the long-term care patient and reducing costly and unnecessary hospital admissions.

Florida’s new law requires that APRNs have at least 3,000 hours of experience and completion of graduate courses in pharmacology and differential diagnosis to be qualified to autonomously provide services in family medicine, general pediatrics, and/or general internal medicine. Likewise, the new law requires pharmacists to enter into collaborative agreements with physicians before the pharmacist is qualified to treat chronic conditions including asthma, arthritis, and obesity and also to test for and treat patients for minor, uncomplicated acute conditions including influenza, strep throat, lice, ringworm, and athlete’s foot. Accordingly, only subsets of Florida’s 20,175 licensed APRNs and 20,510 licensed pharmacists will benefit from the new law. It is likely that many of those APRNs and pharmacists that are otherwise qualified to expand their practices will decide not to do so because of factors including professional liability costs.

Proponents of the new legislation believe it will improve the timeliness and access to medical care by giving Floridians more options for treatment. For example, Floridians living in rural areas, where they are often underserved, will now have improved access to healthcare in their own communities. Proponents make good points because some experts estimate that by 2030 Florida will have a shortage of 4,671 primary care providers (“PCPs”) unless something is done. Those opposed argue that the new laws authorize pharmacists, which are generally not formally trained in medical diagnoses, to practice medicine. The opposition is also concerned that there will be a dangerous expansion in APRNs’ scope of practice where they will be challenged to properly diagnose and treat life-threatening conditions.

The Florida Medical Association, which represents physicians, opposes the new laws because they allow individuals without sufficient training to practice medicine. In contrast to that position many individual physicians are optimistic about expanded practice because they believe it will allow patients to obtain medical care from more and different sources which in turn will allow physicians to concentrate on the more serious and chronic medical conditions.

Dr. Steven D. Brownlee is a health law attorney with Williams Parker. He focuses on assisting healthcare and senior living providers with their operational and regulatory matters, including professional licensing, compliance planning, Medicare/Medicaid issues and appeals, DEA issues, and provider contracting. Prior to practicing law, Steven practiced medicine and medical management consulting. He can be reached at sbrownlee@williamsparker.com or (941) 552-2567.