Over the last couple of weeks, a great deal has been written about the steps hospitals should take as they begin to provide elective procedures again as the COVID-19 outbreak slowly subsides in some parts of the US. Lurking in the shadow of this issue is the question of what steps medical practices and outpatient clinics (“Medical Practices”) should take as they begin the process of returning to normal operations.
As I am sure you know, the U.S. Department of Health and Human Services (HHS) began distributing approximately $50 billion in Provider Relief Funds provided under the CARES Act between April 10 and April 17. The initial distribution of Provider Relief Funds (consisting of approximately $30 billion) was distributed among healthcare providers based on their “proportionate share of Medicare fee-for-service reimbursement for 2019”. For example, a provider with $15 million of Medicare FFS revenue in 2019 and $22 million in net patient revenue for 2018 would have received approximately $930,000 of Provider Relief Funds in the initial distribution: ($15,000,000/$484,000,000,000 (Total Medicare FFS Revenue for 2019) x $30,000,000,000).
On April 19, 2020, the Centers for Medicare and Medicaid Services (“CMS”) provided its initial guidance to hospitals and other healthcare facilities (collectively, “Hospitals”) as they begin to consider the timing for re-commencing normal operations as the COVID-19 outbreak begins to subside in some parts of the United States (the “Re-Opening Recommendations”). In a sense, the Re-Opening Recommendations are the bookend to the guidance CMS provided on March 18, 2020 recommending that Hospitals discontinue the provision of non-emergent and elective medical services and treatments during the COVID-19 outbreak. In each case, the guidance provided by CMS is neither legally mandated nor enforceable. Instead, the guidance merely provides a framework or frame of reference for use by Hospitals as they consider these decisions.
One of the most heavily-debated legal and ethical issues to arise during the current COVID-19 outbreak is what methodology a hospital should use to allocate ventilators when the number of patients who need a ventilator exceeds the hospital’s supply of ventilators. Even more heavily discussed is whether a hospital should disconnect a patient from a ventilator against the wishes of the patient and his/her family in order to use that ventilator for another patient with a statistically greater chance of survival.
During times of national or local crisis, people often look to the pillars of their communities, local employers, charities and other publicly-supported institutions, to provide much needed resources and stability. In many rural communities, the local hospital fits into all three categories being one of the largest (if not they largest) local employer, charity and publicly-supported institution in the community (other than the local government). As a result, people often look to hospitals during times of crisis, not just for healthcare services but also for the other resources needed in their lives (e.g., food, housing, financial assistance, etc.).
With the potential of scarce resources resulting from the COVID-19 virus, rural hospitals should consider taking immediate action to establish or reconstitute a hospital ethics committee. Although relatively common in large urban hospitals, in our experience ethics committees are relatively rare in rural hospitals. In rural settings, “typical” ethics issues such as end-of-life decisions are often resolved through informal interactions among patients, families, physicians, and administration. However, the COVID-19 pandemic is likely to (if it has not already) raise not-so-typical issues for hospitals that will require a more structured approach. It is likely that hospitals will face issues never before considered about how to ethically apportion scarce resources such as masks, gowns, respirators, ICU beds, and ventilators.
On March 30, 2020, Alex M. Azar II, the Secretary of the Department of Health and Human Services, under the authority given to him under Section 1135(b) of the Social Security Act (42 U.S.C. §1320b-5), issued a series of waivers of the Stark Law (42 U.S.C. §1395nn). Unlike the case-by-case waivers of the Stark Law that Secretary Azar previously gave the Centers for Medicare and Medicaid Services (“CMS”) authority to issue to individual designated health services providers based on their specific request, the Stark Law waivers issued by the Secretary on March 30 apply to all designated health services providers. As a result, these Stark Law waivers are referred to as blanket waivers.
A Missouri federal court granted a motion to dismiss this week in a case against a provider and medical record processing company. In the case, a patient alleged that a “search and retrieval” fee imposed in response to a patients request for access to medical records violated the Missouri Merchandizing Practices Act. In dismissing the claim, the court only addressed Missouri law as the allegations did not involve alleged violations of HIPAA. The outcome in this Missouri case is similar to the outcome in an unrelated Tennessee case against the same medical records company that was dismissed earlier this summer. The Tennessee case alleged multiple violations of Tennessee law relating to the fees imposed for access to medical records, using HIPAA as the standard for medical records fees. In dismissing the case, the Tennessee court found that neither HIPAA nor Tennessee law provide a private cause of action for excessive medical record fees. The Tennessee case is pending appeal.
Effective Thursday, April 26, the Missouri Board of Registration for the Healing Arts (MBHA) and the Missouri Board of Nursing (MBN) loosened the regulatory requirements which dictate the maximum distance between the location at which an Advance Practice Registered Nurse (APRN) practices and the location at which his/her collaborating physician practices.
Effective March 1, 2018, the Missouri Department of Social Services (“MDSS”) – Mo HealthNet Division (“Mo HealthNet”) began working collaboratively with the Missouri Department of Mental Health and the Missouri Department of Health and Senior Services to enhance the Mo HealthNet Opioid Prescription Intervention (“OPI”) Program.