December 31, 2021

Federal Court Halts Vaccine Mandate and Federal Regulatory Update

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Federal Court Halts Vaccine Mandate for Healthcare Workers

A federal judge in the District Court for the Eastern District of Missouri granted an injunction yesterday that temporarily halted the implementation of the federal COVID-19 vaccine mandate for healthcare workers.  The Court found, among other things, that the Centers for Medicare and Medicaid Services ("CMS") had no clear authority from Congress to enact the vaccine mandate for providers and that the mandate could lead to staffing shortages.  The Court's injunction, however, only applies to the ten states that sued to halt the mandate: Alaska, Arkansas, Iowa, Kansas, Missouri, Nebraska, New Hampshire, North Dakota, South Dakota, and Wyoming.

The Court's opinion can be found here.

Clarification On Financial Relationship

CMS issued its 2022 Physician Fee Schedule Final Rule on November 2, 2021 finalizing its regulations for the 2022 calendar year.  This final rule clarified certain points discussed in our September 22, 2021 blog post regarding the proposed rule. 

Specifically, the final rule provided clarification to identify unbroken chains of financial relationships under § 411.354(c)(2) that constitute "indirect compensation arrangements" to "ensure that a longstanding prohibition on certain per unit of service-based compensation formulas for determining charges for the rental of office space and equipment remains within the ambit of the law."  This final rule also added provisions to assist in identifying the individual unit to be analyzed under § 411.354(c)(2)(ii)(A)(2)(i) through (iv).  In addition, the final rule specifically addressed the "inadvertent omission" by CMS of the prohibition on per‑click payments for the lease of office space or equipment and the use of premises or equipment in indirect compensation arrangements, which CMS has flagged as being of serious risk for abuse.

The rule also finalized the proposed changes and clarifications to the Open Payments program set forth in the proposed rule.  Specifically, CMS finalized nine points with respect to the Open Payments program, which, in sum, are as follows:

  1. Adding a mandatory payment context field for records to teaching hospitals;  
  2. Adding the option to recertify annually even when no records are being reported;
  3. Disallowing record deletions without a substantiated reason;
  4. Updating the definition of ownership and investment interest;
  5. Adding a definition for a physician-owned distributorship as a subset of applicable manufacturers and group purchasing organizations, for the purposes of Open Payments program reporting only;
  6. Requiring reporting entities to update their contact information;
  7. Disallowing publications delays for general payment records;
  8. Clarifying the exception for short-term loans applies for 90 total days in a calendar year, regardless of whether the 90 days were consecutive; and
  9. Removing the option to submit and attest to general payment records with an "Ownership" Nature of Payment category. 

21st Century Cures Act Clarifications

On November 16, 2021, the Office of the National Coordinator for Health Information Technology ("ONC") released a blog post containing clarification on certain provisions of the 21st Century Cures Act.  In its post, the ONC specified that "[w]hen it comes to the information blocking provision and its intersection with other laws, we suggest keeping in mind how other laws align and interact with three main concepts set forth in the information blocking regulations: 1) ‘required by law,' 2) the definition of ‘interference,' and 3) information blocking ‘exceptions.'" 

The ONC explained that:

  1. The information blocking definition provided in the Cures Act did not include practices that were likely to interfere with, prevent, or materially discourage access, exchange, or use of electronic health information when the practice was "required by law." The ONC explained that its regulatory definition of information blocking substantially mirrors the statute, and the ONC currently interprets "required by law" to include federal and state statutes, regulations, court orders, and binding administrative decisions or settlements, such as (at the federal level) those from the Federal Trade Commission or the Equal Employment Opportunity Commission. 
  2. "Interference" in the form of delays that may be allowed, but that are not required by other laws, is not automatically exempted from implicating the information blocking definition.  As such, the ONC advised that practitioners should pay close attention to its practices with respect to delays in providing access to health information that were previously permitted under the law, but may now constitute information blocking. 
  3. There are eight exceptions under 45 CFR 171.202 and 45 CFR 171.201, known as the "Privacy" and "Preventing Harm" Exceptions, respectively.  The ONC advised practitioners to review these exceptions in light of other laws that may place preconditions on the permissibility of sharing health information or otherwise constituting interference. 

 Amendment to OIG Health Care Fraud Self-Disclosure Protocol

On November 8, 2021, the Department of Health and Human Services ("HHS") Office of Inspector General ("OIG") amended its health care fraud self-disclosure protocol ("SDP").  The specific changes of note are as follows:

  1. Increased the minimum amounts required to settle under the SDP to match new statutory minimum penalty amounts;
  2. Required SDP submissions to be made through HHS-OIG's web site;
  3. Added references to OIG's 2019 Grant and Contract Self-Disclosure Protocols;
  4. Clarified that CIA Reportable Events can be disclosed under the SDP;
  5. Clarified that DOJ sometimes settles SDP cases;
  6. Clarified that disclosers must include damages to each affected federal health care program and the sum of all damages; and
  7. Made technical changes to statistics, terminology, and background facts.

The OIG notes that the following items were left unchanged by the amendment:

  1. Timelines and content requirements;
  2. Methods for calculating damages; and
  3. Timely settlement with a lower multiplier and an exclusion release.

Health care organizations should be aware of these changes, as the SDP is an important tool for providers and organizations to voluntarily disclose any events of fraud before enforcement action is taken against them.  

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