AMARILLO, TX – On January 25, 2022, the Occupational Safety and Health Administration (OSHA) formally withdrew its November 5, 2021 Emergency Temporary Standard (ETS). The ETS contained mandatory vaccination or mandatory testing requirements for all employers with more than 100 employees.

CMS Interim Final Rule Overview: On Thursday, November 4, 2021, CMS issued its IFR regarding mandatory COVID-19 vaccinations. The IFR applies to 21 types of providers and suppliers. The IFR broadly applies to all “staff” at the relevant facilities. Originally, the IFR required all staff at the relevant facilities to receive the first vaccination dose by December 5, 2021, and the second dose by January 4, 2022.

Previous Injunction Covering Half the Country – Missouri and Louisiana Rulings: On Monday, November 29, 2021, a federal district court judge in the Eastern District of Missouri issued a preliminary injunction enjoining CMS from enforcing the IFR in 10 states. The next day, on Tuesday, November 30, 2021, a federal district court judge in the Western District of Louisiana issued a purported nationwide preliminary injunction restraining CMS from enforcing the IFR in any state–even though only 14 states had challenged the IFR in the Louisiana court.

CMS December 2, 2021, Memorandum: On December 2, 2021, in recognition of the court rulings previously discussed, CMS issued a memorandum acknowledging its plan to suspend enforcement of the IFR and all surveying related to compliance with the IFR. In the text of the memorandum, CMS stated it “remains confident in its authority to protect the health and safety of patients in facilities certified by Medicare and Medicaid programs.”

Previous Injunction Covering Half the Country – Fifth Circuit Ruling: On December 15, 2021, the Fifth Circuit Court of Appeals (the federal court governing Texas, Louisiana, and Mississippi) partially granted the government’s request to stay the injunction issued by the Louisiana district court. Instead of applying nationwide, the Fifth Circuit changed the scope of the temporary injunction to apply only to the 14 states that challenged the IFR before the Louisiana court:

• Alabama, Arizona, Georgia, Idaho, Indiana, Kentucky, Louisiana, Mississippi, Montana, Ohio, Oklahoma, South Carolina, Utah, and West Virginia.

Previous Injunction Covering Half the Country – Fifth Circuit and Texas Rulings
On the same date, December 15, 2021, a federal district court in Texas granted a preliminary injunction applicable to Texas. Therefore, until January 13, 2022, due to the three orders from the federal district courts in Missouri, Louisiana, and Texas, CMS was barred from enforcing the IFR or taking steps to implement the IFR in 25 states: Alabama, Alaska, Arizona, Arkansas, Georgia, Idaho, Indiana, Iowa, Kansas, Kentucky, Louisiana, Mississippi, Missouri, Montana, Nebraska, New Hampshire, North Dakota, Ohio, Oklahoma, South Carolina, South Dakota, Texas, Utah, West Virginia and Wyoming.

Previous Injunction Covering Half the Country
Even though the CMS IFR was enjoined from enforcement in half the country, CMS could still take steps to implement and enforce the IFR in the remaining 25 states and Washington D.C., which included: California, Colorado, Connecticut, Delaware, Florida, Hawaii, Illinois, Maine, Maryland, Massachusetts, Michigan, Minnesota, Nevada, New Jersey, New Mexico, New York, North Carolina, Oregon, Pennsylvania, Rhode Island, Tennessee, Vermont, Virginia, Washington, Washington D.C. and Wisconsin.

CMS Enforcement for 25 Applicable States and Washington D.C.
On December 28, 2021, CMS issued guidance for the IFR for the 25 states (and Washington D.C.) where the IFR was not currently enjoined by litigation. For clarity, those states include California, Colorado, Connecticut, Delaware, Florida, Hawaii, Illinois, Maine, Maryland, Massachusetts, Michigan, Minnesota, Nevada, New Jersey, New Mexico, New York, North Carolina, Oregon, Pennsylvania, Rhode Island, Tennessee, Vermont, Virginia, Washington, and Wisconsin. The first compliance deadline identified by CMS in this guidance was January 27, 2022. On or before January 27, 2022, the facilities subject to CMS’s December 28 guidance must have demonstrated that they have developed and implemented policies and procedures for ensuring that:

• all facility staff are vaccinated for COVID-19; and
• 100% of the staff have received at least one dose of the COVID-19 vaccine
  (or have a pending request for or have been granted a qualifying exemption or have been identified as having a temporary delay as recommended by
  the CDC).

As of January 27, 2022, if less than 100% of the staff have received at least one dose of the COVID-19 vaccine (or have a pending request for or have been granted a qualifying exemption or have been identified as having a temporary delay as recommended by the CDC), the facility was non-compliant and will receive a notice of non-compliance. A facility that is above 80% and has a plan to achieve a 100% staff vaccination rate within 60 days would not be subject to additional enforcement action except in limited circumstances. In addition, on or before February 28, 2022, the facilities subject to CMS’s December 28 guidance must demonstrate that they have developed and implemented policies and procedures for ensuring that 100% of the staff have received the necessary doses to complete the vaccine series (i.e., one dose of a single-dose vaccine or all doses of a multiple-dose vaccine series) or have been granted a qualifying exemption or have been identified as having a temporary delay as recommended by the CDC.

As of February 28, 2022, if less than 100% of the staff have received the necessary doses to complete the vaccine series (i.e., one dose of a single-dose vaccine or all doses of a multiple-dose vaccine series) or have been granted a qualifying exemption or have been identified as having a temporary delay as recommended by the CDC), the facility is non-compliant. A facility that is above 90% and has a plan to achieve a 100% staff vaccination rate within 30 days would not be subject to additional enforcement action except in limited circumstances. On or before March 28, 2022, the facilities subject to CMS’s December 28 guidance that have not met the 100% standard may be subject to enforcement actions depending on the severity of the deficiency and the type of facility.

CMS Compliance Surveys for 25 Applicable States and Washington D.C.

For the facilities subject to CMS’s December 28 guidance, surveys for compliance as part of initial certification, standard recertification or reaccreditation, and complaint surveys began on January 27, 2022.

CMS IFR Reinstated Nationwide – Supreme Court Ruling
On January 13, 2022, the Supreme Court reinstated the CMS IFR nationwide. This resulted in CMS being able to enforce the IFR and take steps to implement the IFR in 24 states where the IFR was previously enjoined. For clarity, those states include Alabama, Alaska, Arizona, Arkansas, Georgia, Idaho, Indiana, Iowa, Kansas, Kentucky, Louisiana, Mississippi, Missouri, Montana, Nebraska, New Hampshire, North Dakota, Ohio, Oklahoma, South Carolina, South Dakota, Utah, West Virginia, and Wyoming. Note that the CMS IFR was reinstated for enforcement nationwide. It was not a final ruling on the lawfulness of the CMS IFR. After additional litigation concerning the Texas ruling, the CMS IFR was also reinstated in Texas. On January 13, 2022, CMS issued a statement regarding the Supreme Court ruling. In its statement, CMS said, “health care providers subject to the [IFR] in the . . . [states] covered by this decision will now need to establish plans and procedures to ensure their staff are vaccinated and to have their employees receive at least the first dose of a COVID-19 vaccine. Today’s decision does not affect compliance timelines for providers in the District of Columbia … and the 25 states” subject to the December 28 guidance.

CMS Enforcement for Remaining States
Since January 13, 2022, CMS has issued two additional memorandums for enforcement of the IFR in the remainder of the country. The enforcement guidelines mimic the language quoted above. For the 24 states previously subject to the Missouri and Louisiana Rulings, the enforcement deadlines are February 14, 2022; March 15, 2022; and April 14, 2022. Enforcement is in the same three-step process previously described. For Texas, the enforcement deadlines are February 20, 2021; March 21, 2022; and April 20, 2022. Enforcement is in the same three-step process previously described.

What Now? (CMS IFR)
One or more federal district courts may now determine whether the IFR is lawful. Should a federal district court find the IFR lawful, the IFR will remain enforceable pending appeal to a federal court of appeals and a final review of the lawfulness of the mandate by the United States Supreme Court. Should a federal district court find the IFR unlawful, the IFR may be stayed from enforcement (in one or more states or nationwide) pending appeal by CMS to a federal court of appeals and a final review of the lawfulness of the mandate by the United States Supreme Court.

What the CMS IFR Means for DME Suppliers
The CMS IFR mandates vaccinations for certain health care providers and suppliers that bill federal health care programs (“FHCPs”). DME suppliers are not covered by the CMS IFR … except when the supplier delivers equipment to, or furnishes services at, a facility that bills FHCPs. If a DME supplier delivers equipment to a facility (e.g., a SNF), it is likely that the facility will require the delivery person to be vaccinated. Even if the facility does not issue such a requirement, the CMS IFR will mandate that the delivery person be vaccinated. Subsequent to the CMS IFR and facility requirements, a DME supplier can establish its own vaccination policy. If it desires to do so, the supplier can mandate vaccinations unless an employee demonstrates:

• a bona fide religious belief, practice, or observance exempting the employee;
• a health condition that may be exacerbated by the vaccine or a medical condition preventing vaccination;
• a disability preventing vaccination; or
• an employee received a treatment (such as the monoclonal antibody treatment) entitling him/her to delay receipt of the vaccination; or
• Instead of mandating vaccines company-wide, the DME supplier may implement a mask/social distancing policy.

Jeffrey S. Baird, JD, is chairman of the Health Care Group at Brown & Fortunato, a law firm with a national health care practice based in Texas. He represents pharmacies, infusion companies, HME companies, manufacturers, and other health care providers throughout the United States. Mr. Baird is Board Certified in Health Law by the Texas Board of Legal Specialization and can be reached at (806) 345-6320 or [email protected].

AAHOMECARE’S EDUCATIONAL WEBINAR

Transitioning from Billing Assigned to Billing Non-Assigned

Presented by: Jeffrey S. Baird, Esq., Brown & Fortunato & Lisa K. Smith, Esq., Brown & Fortunato

Tuesday, February 22, 2022

1:30-2:30 p.m. CENTRAL TIME
Since its inception in the 1970s, the DME industry has been an “assignment” industry. A DME supplier would provide a product to a Medicare beneficiary, take assignment from the beneficiary, bill and collect from Medicare, and bill the beneficiary for the copayment. As a result of lower Medicare reimbursements, and in response to the willingness of aging Baby Boomers to pay cash for “Cadillac” products, an increasing number of DME suppliers are electing to become “non-participating” suppliers and are providing Medicare-covered items on a non-assigned basis. This means that the Medicare beneficiaries pay cash up front to the suppliers. This program will discuss the multiple issues arising out of transitioning from billing assigned to billing on a non-assigned basis, including the following: (i) What does it mean to bill non-assigned? (ii) If the supplier bills an item non-assigned, can the supplier set the price without limitation? (iii) Must the supplier submit a claim to Medicare so that the beneficiary can be reimbursed? (iv) Can the supplier sell a capped rental item for cash? (v) Does the supplier need to obtain documentation supporting medical necessity? (vi) Is the supplier at risk of having to repay Medicare and/or the beneficiary in the event of a subsequent audit?

Registration will soon be available for Transitioning from Billing Assigned to Billing Non-Assigned on Tuesday, February 22, 2022, 1:30-2:30 p.m. CT, with Jeffrey S. Baird, Esq., and Lisa, K. Smith, Esq., of  Brown & Fortunato.

Members:  $99
Non-Members:  $129