Obviously things are continuing to move quickly around the country with states taking action to pre-empt local or even federal guidelines as is the case in New York State. As always, I am providing breaking news with facts not opinions. Today I am providing 2-stories from other authors for your review and consideration. The sharing of this content has in no way repurposed or disseminated the content and there is no intent to violate copyright law. Proper sourcing and credit is provided to the author(s).

I have bold typed and underlined the aspects of the articles that I would like to draw your attention to as these are significant. Please feel free to let me know if you have questions or concerns.

What appears to be a more stringent and strict requirement for vaccination of healthcare professionals has hit New York State. The Mandate for Vaccines is group healthcare facilities, which now overrides New York City “Testing-Out Option”.

“All individuals affiliated with general hospitals and nursing homes who engage in activities at those facilities such that if they were infected with COVID-19, they could potentially expose other personnel, patients or residents to the disease, must receive their first dose of the COVID-19 vaccine by September 27, 2021. Affiliated individuals at various other types of group healthcare entities must meet an October 7, 2021 for their first dose of the vaccine, with very limited exemptions.

The Emergency Regulations imposing this mandate by the New York State Department of Health (“DOH”) represent one of the latest efforts to mitigate and prevent the spread of COVID-19. The Emergency Regulations are premised on the view that within healthcare settings, unvaccinated personnel pose an unacceptably high risk of both acquiring COVID-19 and transmitting the disease to colleagues, vulnerable patients and residents, thereby exacerbating the risk of complications and staffing shortages.

Who is Covered and Who is Not

For the purposes of the Emergency Regulations, covered entities include:

• • any facility or institution included in the definition of “hospital” in section 2801 of the Public Health Law, including but not limited to general hospitals, nursing homes, and diagnostic and treatment centers;
  • any agency established pursuant to Article 36 of the Public Health Law, including but not limited to certified home health agencies, long term home health care programs, acquired immune deficiency syndrome (AIDS) home care programs, licensed home care service agencies, and limited licensed home care service agencies;
  • hospices as defined in section 4002 of the Public Health Law; and
  • adult care facility under the Department’s regulatory authority, as set forth in Article 7 of the Social Services Law.

Notably, the vaccine mandate carries broad coverage of all persons even affiliated with covered entities, and this will include many non-employees, contractors, staffing agency employees, and other individuals who work for entities that have a relationship with the covered entity.

No Testing-Out Option

Earlier last month, New York City had announced that employees at city-run healthcare facilities would be required to submit proof of vaccination or in the alternative, have the ability to “opt out”, and submit to weekly COVID-19 testing and provide proof of a negative test. In consideration of the new state mandate and Emergency Regulations, New York City’s regulations appear to be outdated, and the “opt out” testing alternative to vaccination will no longer be allowed.

Only Medical Exemptions Allowed

Unlike other regulations and guidance published at the federal level regarding the COVID-19 vaccine, the only permissible exception to the vaccine requirement is for those requiring a medical accommodation. Entities must only consider this exemption if an individual has been certified by a licensed physician or certified nurse practitioner as having a pre-existing condition that makes immunization with COVID-19 vaccine detrimental to the health of the covered person. Entities must document the nature and duration of the medical exemption, and if it is subsequently found that the vaccine is no longer detrimental to the person’s health, the person must then be fully vaccinated. The Emergency Regulations permit no exemption based on religious beliefs or practice. Ultimately, covered entities are permitted to terminate covered personnel who are not fully vaccinated and do not have a valid medical exemption, if they are unable to ensure individuals are not engaged in patient/resident care or expose other personnel.

Other Record Keeping Obligations

Covered entities must appropriately document that covered personnel are fully vaccinated against COVID-19, and document the review and determinations made on requests for medical exemptions and any reasonable accommodations. Covered entities must also have processes in place to ensure compliance with the mandate and may be asked to make those documents available to the DOH. In addition, the DOH may request covered entities to report the number and percentage of those vaccinated against COVID-19, and those who have been granted medical exemption or reasonable accommodations.”

Source: Levy Employment Law LLC – Alexandra Lapes and Tracey I. Levy

“CMS issued several rules, actions and plans in the last two months, including updates on the surprise billing rule, outpatient service reimbursement and vaccine mandates for healthcare workers.

Here’s a breakdown of 11 of these actions, beginning with the most recent:

1. 1. CMS wants to nix a rule introduced by former President Donald Trump’s administration that would add Medicare coverage for medical devices that the FDA designates as “breakthrough” technologies.
   2. CMS issued proposed rules Sept. 10 that unveiled details of the process of enforcing surprise billing protections and added disclosure requirements for health plans and providers of air ambulance services.
   3. CMS will reprocess calendar year 2019 claims for outpatient services provided at excepted off-campus, provider-based departments because of an appeals court ruling on site-neutral payments, the agency said Sept. 9. The agency will begin automatically reprocessing the claims by Nov. 1. The excepted off-campus, provider-based departments will be paid at the same rate as nonexcepted departments.
   4. CMS awarded $452 million to 13 states through reinsurance waivers to support affordable coverage. States will receive between $2.5 million and $139 million, depending on the size and scope of their reinsurance programs.
   5. CMS will require COVID-19 vaccines for healthcare workers at Medicare- and Medicaid-participating hospitals and other healthcare settings. The requirement will affect more than 17 million healthcare workers and applies to hospitals, dialysis facilities, ambulatory surgical settings and home health agencies. CMS also said Aug. 18 that nursing homes must have staff vaccinated against COVID-19.
   6. CMS issued new Medicaid and Children’s Health Insurance Program guidance Aug. 30 to increase COVID-19 vaccination and testing. The guidance aims to expand the settings where COVID-19 testing is covered, including in schools.
   7. CMS on Aug. 24 increased the amount Medicare will pay providers administering the COVID-19 vaccine to multiple patients in their homes. Under the new policy, providers are eligible to receive up to five times the typical payment when they administer COVID-19 doses to multiple Medicare beneficiaries on the same day at one location. This could mean an increase of up to $35 per vaccination.
   8. CMS on Aug. 20 said it will delay enforcement of the insurance price transparency rule by six months, according to recent guidance from the agency. While the Transparency in Coverage final rule is set to take effect Jan. 1, CMS will delay enforcement of key parts of the rule until July 1 to give health plans more time to comply.
   9. CMS encouraged all Medicare Advantage organizations and Medicare-Medicaid plans to waive or relax certain prior authorization requirements amid the COVID-19 surge. In an Aug. 20 letter, CMS asked these health plans to relax the requirements to facilitate the transfer of patients from acute-care hospitals to post-acute and other clinically appropriate settings.
   10. CMS doubled the time states will have to determine Medicaid enrollees’ eligibility status after the federal public health emergency ends. In an Aug. 13. letter to state health officials, CMS extended the deadline for states to complete pending eligibility and enrollment actions by up to 12 months after the public health emergency concludes.
   11. CMS confirmed in mid-August that it has refrained from levying a financial penalty against providers who haven’t complied with its price transparency rule. CMS said it began sending warning letters to hospitals not in compliance with the regulation in April. It has sent about 165 warning letters by mid-July. Hospitals have 90 days to address the violations before CMS decides whether additional compliance actions are necessary”.

Source: Becker’s Healthcare: A breakdown of 11 recent CMS actions (beckershospitalreview.com)

By Sean M. Weiss, Partner, Vice President, and Chief Compliance Officer

Sean M. Weiss is a Partner and Chief Compliance Officer for DoctorsManagement, LLC. Sean provides strategic litigation defense services and a host of regulatory compliance services for clients nationally.

Learn more about Sean’s expertise at www.thecomplianceguy.com.

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