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New Vaccine Requirement for Select CMS-Participating Facilities

On November 4, 2021, the Centers for Medicare and Medicaid (“CMS”) released a new rule requiring certain healthcare facilities to implement policies requiring employees to be vaccinated against COVID-19. It does not matter if a staff member does not perform patient treatment services, they must still be vaccinated if an employee of an applicable facility.

Particularly, staff at these facilities should be given at least the first dose of an accepted vaccine within 30 days of November 5, 2021. Phase 2 will require staff to have their second dose within 60 days of November 5, 2021. Acceptable vaccines include, and at this time are limited to, Pfizer, Moderna, and Johnson & Johnson.

Applicable Facilities

The new requirement does not apply to all facilities that provide healthcare services, but rather only those facilities that are regulated by CMS as one of the following:

  • Ambulatory surgical centers;
  • Hospices;
  • Programs of all-inclusive care for the elderly;
  • Hospitals;
  • Long-term care facilities;
  • Psychiatric residential treatment facilities;
  • Intermediate care facilities for individuals with intellectual disabilities;
  • Home health agencies;
  • Comprehensive outpatient rehabilitation facilities;
  • Critical access hospitals;
  • Clinics (rehabilitation agencies, and public health agencies as providers of outpatient physical therapy and speech language pathology services);
  • Community mental health centers;
  • Home infusion therapy suppliers;
  • Rural health clinics/federally qualified health centers; and
  • End-stage renal disease facilities.

While a facility may render some of the services listed above, that does not necessarily mean that a facility is required to comply with the rule. For example, if a facility provides care for psychiatric patients, the rule still may not apply if the facility is not regulated by CMS as a psychiatric residential treatment facility.

Additionally, while many facilities identify as “clinics,” the rule states that there are only approximately 5,000 clinics who are Medicare and Medicaid-certified rural health clinics and federally qualified health centers. Therefore, without this qualification, the rule will not apply.

However, facilities who are not required to comply with this new rule should note that their facility may still need to follow the OSHA COVID-19 Employer Emergency Temporary Standard, which requires employers with more than 100 employees to be vaccinated, or undergo regular testing, among other requirements. For more information, read this client alert by BMD Healthcare Litigation Member Stephen Matasich. 

Staff Exemptions

Staff who work full-time remotely do not need to be vaccinated under the new rule.

However, staff members are still able to seek either bona-fide religious or medical exemptions to exclude them from the vaccine requirement. For those that are given an exemption, the facilities must ensure that reasonable accommodations are given to the employee, while still minimizing the risk of the spread of COVID-19. CMS refers to the Equal Employment Opportunity Commission’s (“EEOC”) website for further guidance on this topic.

Compliance/Discipline

Those facilities who do not comply with the new rule within the specified timeframe will be subject to civil monetary penalties, denial of payment, and, in extreme circumstances, exclusion from Medicare and Medicaid. CMS plans to oversee facilities through state surveyors, and has noted that interpretive guidelines outlining how surveyors will determine compliance will be published in the future. However, CMS has already stated that reviewing records of staff vaccinations, staff interviews, and review of facility vaccine policies and procedures are among some of the procedures that will be used to detect noncompliance.

Questions

If you have any further questions about the new rule or are unsure of whether it is applicable to your facility, please contact Labor + Employment Partner Bryan Meek at bmeek@bmdllc.com (330.253.5586) or Healthcare and Hospital Law Member Amanda Waesch at alwaesch@bmdllc.com (330.253.9185).

Bryan and Amanda will be hosting an informative webinar on Wednesday, November 17 at 2 PM ET to discuss who the new rule applies to, and if so, what steps should be taken to comply. Click here for more information and registration.

New York, Kansas, Massachusetts, and Delaware Become the latest States to Adopt Full Practice Authority for Nurse Practitioners

While the COVID-19 pandemic certainly created many obstacles and hardships, it also created many opportunities to try doing things differently. This can be seen in the instant rise of remote work opportunities, telehealth visits, and virtual meetings. Many States took the challenges of the pandemic and turned them into an opportunity to adjust the regulations governing licensed professionals, including for advanced practice registered nurses (APRNs).

Explosive Growth in Pot of Gold Opportunity for Bank (and Other) Cannabis Lenders Driving Erosion of the Barriers

Our original article on bank lending to the cannabis industry anticipated that the convergence of interest between banks and the cannabis industry would draw more and larger banks to the industry. Banks were awash in liquidity with limited deployment options, while bankable cannabis businesses had rapidly growing needs for more and lower cost credit. Since then, the pot of gold opportunity for banks to lend into the cannabis industry has grown exponentially due to a combination of market constraints on equity causing a dramatic shift to debt and the ever-increasing capital needs of one of the country’s fastest growing industries. At the same time, hurdles to entry of new banks are being systematically cleared as the yellow brick road to the cannabis industry’s access to the financial markets is being paved, brick by brick, by the progressively increasing number and size of banks that are now entering the market.

2021 EEOC Charge Statistics: Retaliation & Impact of Remote Work

The U.S. Equal Employment Opportunity Commission (EEOC) released its detailed information on workplace discrimination charges it received in 2021. Unsurprisingly, for the second year in a row, the total number of charges decreased as COVID-19 either shut down workplaces or disconnected employees from each other. In 2021, the agency received a total of approximately 61,000 workplace discrimination charges - the fewest in 25 years by a wide margin. For reference, the agency received over 67,000 charges in 2020, and averaged almost 90,000 charges per year over the previous 10 years.

Ohio’s Managed Care Overhaul Delayed – New Implementation Timeline

At the direction of Governor Mike DeWine, the Ohio Department of Medicaid (ODM) launched the Medicaid Managed Care Procurement process in 2019. ODM’s stated vision for the procurement was to focus on people and not just the business of managed care. This is the first structural change to Ohio’s managed care system since the Centers for Medicare & Medicaid Services' (CMS) approval of Ohio’s Medicaid program in 2005. Initially, all of the new managed care programs were supposed to be implemented starting on July 1, 2022. However, ODM Director Maureen Corcoran recently confirmed that this date will be pushed back for several managed care-related programs.

Laboratory Specimen Collection Arrangements with Contract Hospitals - OIG Advisory Opinion 22-09

On April 28, 2022, the Department of Health and Human Services, Office of Inspector General (“OIG”) published an Advisory Opinion[1] in which it evaluated a proposed arrangement where a network of clinical laboratories (the “Requestor”) would compensate hospitals (each a “Contract Hospital”) for specimen collection, processing, and handling services (“Collection Services”) for laboratory tests furnished by the Requestor (the “Proposed Arrangement”). The OIG concluded that the Proposed Arrangement would generate prohibited remuneration under the federal Anti-Kickback Statute (“AKS”) if the requisite intent were present. This is due to both the possibility that the proposed per-patient-encounter fee would be used to induce or reward referrals to Requestor and the associated risk of improperly steering patients to Requestor.