The final U.S. Medicare physician fee schedule (MFPS) for calendar year 2021 included a much sought-after boost in rates paid to physicians for evaluation & management (E&M) services, but the requirements for budget neutrality have dinged other rates. Those offsets drew the ire of physician specialty societies and drew the attention of a number of senators, who penned a Dec. 4 letter to the Senate leadership urging that legislation be undertaken to temporarily override the budget neutrality requirement. The 46 senators who signed onto the letter made a bipartisan argument that the offsets would be problematic in ordinary times, and that any such cuts imposed during the pandemic would be even more a hazard to the continuity of many medical practices, and thus jeopardize access for Medicare beneficiaries. The cuts are slated to go into force Jan. 1, and Congress has one obvious legislative vehicle for such an override, the budget agreement needed to sustain government operations past Dec. 11.

USPTO finalizes SAS rule

The U.S. Patent and Trademark Office (USPTO) finalized a rule it proposed in May in response to the Supreme Court’s 2018 decision in SAS Institute Inc. v. Iancu. Besides requiring the Patent Trial and Appeal Board (PTAB) to hear all challenged claims and asserted grounds of unpatentability when it institutes an inter partes review, the rule “eliminates the presumption that a genuine issue of material fact is viewed in the light most favorable to the petitioner for purposes of deciding whether to institute a review,” the USPTO said. It also revises PTAB rules so they conform to the current standard practice of providing for automatic sur-replies.

U.S. senators press case for permanent telehealth

Telehealth has been expanded considerably for Medicare beneficiaries in the U.S., but roughly half the U.S. Senate is prodding the other denizens of Capitol Hill to make those changes permanent. Sen. Jean Shaheen (D-N.H.) said in a Dec. 7 press release that leaders in both parties and both chambers have been encouraged to promote passage of the CONNECT for Health Act of 2019, thanks in large part to the feedback from patients and health care professionals about the benefits of telehealth as experienced during the COVID-19 pandemic. The pandemic-driven, temporary easing of restrictions on telehealth should be made permanent to eliminate issues related to the patient’s site and originating sites of telehealth services. The associated Dec. 4 letter does not, however, mention the associated budget scoring for any such expansion, one of the concerns voiced regarding a broader set of telehealth benefits.

CMS no fan of national coverage policy for Allomap

The U.S. Centers for Medicare & Medicaid Services (CMS) indicated it will not adopt national coverage policy for the Allomap molecular test for detection of heart transplant rejection even though the agency received the initial request to non-cover the test seven years ago. In the absence of a national coverage determination (NCD), Medicare administrative contractors would continue to make local coverage determinations for their respective districts. The CMS proposal suggests the agency agrees with the requestor that the test lacks sufficient sensitivity to perform the indicated use. Another issue seen in connection with a national coverage policy is the low volume of cases in which such a test might be deployed. CMS recently proposed to revert to MAC adjudication of coverage for artificial hearts as well, another move driven by a low volume of associated claims. The agency expects to post the final NCD Jan. 14, 2021. The Allomap is manufactured by Care Dx, of Brisbane, Calif.

TGA posts guidance for class I tests

Australia’s Therapeutic Goods Administration (TGA) posted a guidance for the use of declarations of conformity for class I in vitro diagnostics and other class I devices for inclusion in the Australian Register of Therapeutic Goods (ARTG). Also within the scope of the guidance are class I non-sterile, non-measuring medical devices, as well as class I procedure packs. Among the requirements for any such products are technical documentation, such as diagrams and drawings of the device, and documentation for post-market surveillance and reporting systems. This first iteration of this guidance is already in force, TGA indicated.

Marburg MCMs protected under PREP

Exercising his authority under the U.S. Public Readiness and Emergency Preparedness (PREP) Act, HHS Secretary Alex Azar issued a declaration providing liability immunity to certain individuals and entities against any claim of loss related to the manufacture, distribution, administration or use of medical countermeasures (MCMs) against marburgvirus or Marburg disease. MCMs covered under the declaration include drugs, vaccines, diagnostics and devices used to treat, diagnose, cure, prevent or mitigate Marburg disease or the transmission of marburgviruses. Also included are devices used in administering an MCM and all the components of the product, as well as countermeasures for adverse effects of the MCMs. In making the declaration, Azar said he has determined that Marburg disease and marburgviruses are a credible risk and may, in the future, constitute a public health emergency. The declaration is intended to encourage the development of MCMs targeting the deadly virus.