Author Archives: Steven D. Brownlee

Steven D. Brownlee

About Steven D. Brownlee

Steven is a health law attorney focused on assisting healthcare providers with their operational and regulatory matters. In particular, he has extensive experience working with physicians, physician groups, senior living facilities, home health agencies, and related healthcare employees throughout Florida. In addition to his JD, he holds and MD and MBA. He can be reached at sbrownlee@williamsparker.com or (941) 552-2567.

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

The Expansion in Telehealth through the CARES Act

The recently enacted Coronavirus Aid, Relief, and Economic Security (“CARES”) Act strongly supports the use of telehealth, removes barriers to its use, and undeniably acknowledges that access to telehealth is fundamental in defeating the COVID-19 pandemic. Telehealth is a powerful technology that enables patients geographically separated from healthcare providers to more easily access health care and speed up diagnosis and treatment. Telehealth is especially valuable in light of the highly contagious nature of COVID-19 because telehealth limits the risk of person-to-person exposure, thus thwarting the spread of the viral disease. The CARES Act will help America’s healthcare providers to migrate their patients to virtual care platforms which reduce exposure to COVID-19. The Act contains provisions which will expand the use of telehealth services both during the current COVID-19 pandemic (“emergency period”) and beyond with respect to Medicare beneficiaries, veterans, rural care, hospice care and home health services, and individuals with Health Savings Accounts (“HSA”).

CARES Act telehealth provisions build on the initial Medicare Telehealth Waiver authorized by Congress earlier in March 2020 by removing the requirement that a provider must have seen the patient within the last three years. This allows Medicare beneficiaries to more easily access care when and where they need it during the COVID-19 pandemic. This will enable beneficiaries to access telehealth, including in their home, from a broader range of providers, and will thereby reduce potential exposure to and spread of COVID-19. The CARES Act requires the U.S. Department of Health & Human Services to issue clarifying guidance encouraging the use of telecommunications systems, including remote patient monitoring, to furnish home health services consistent with the beneficiary care plan during the emergency period. During the emergency period, qualified hospice providers can use telehealth technologies to fulfill Medicare’s face-to-face recertification requirement.

Veterans Administration (“VA”) facilities will receive $14.4 billion in funding for the provision of healthcare services through telehealth as well as for the purchase of medical equipment and supplies, testing kits, and personal protective equipment. Included in that funding is $2.15 billion, which is dedicated to the VA’s information technology to support increased telework, telehealth, and call center capabilities to deliver healthcare services directly related to coronavirus and mitigate the risk of virus transmission including the purchasing of devices, as well as enhanced system bandwidth and support. Also authorized under the CARES Act is the VA’s expansion of mental health services delivered via telehealth and authorization for VA to enter into short-term agreements with telecommunication companies to provide veterans with temporary broadband services.

The CARES Act permits individuals with HSAs that are insured through high-deductible health plans to use telehealth services without the need to first reach a deductible. This provision should allow patients who may have the COVID-19 virus to obtain medical consultation from home and thus protect other patients and caregivers from potential exposure. However, this is a temporary provision that will expire on December 21, 2021.

The Health Resources and Services Administration will receive $180 million to assist Federally Qualified Health Centers (“FQHC”) and Rural Health Clinics (“RHC”) in providing telehealth services. During the emergency period, FQHCs and RHCs may serve as “distant sites” (i.e., the location of the healthcare provider) for telehealth consultations. Thus, FQHCs and RHCs can furnish telehealth services to Medicare beneficiaries in their home, and Medicare will provide reimbursement for these such services.

Steven D. Brownlee
sbrownlee@williamsparker.com
(941) 552-2567

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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.