Medicare

The most-favored-nation demonstration, which aims to lower drug prices, undermines price-competing biosimilars by subjecting them to international reference pricing, according to Coherus BioSciences, the maker of the biosimilar covered by the demonstration.

CMS backed away from its proposal to increase cuts to Part B pay for 340B drugs by an additional 6% in 2021, citing the COVID-19 public health emergency, and instead finalized its alternative proposal to continue paying hospitals for those drugs at the Average Sales Price minus 22.5% as part of the final 2021 hospital outpatient pay rule.

Rep. Ami Bera’s (D-CA) office hopes to get a two-year policy holding providers harmless from 2021 Medicare cuts that are linked to evaluation and management services pay wrapped into a year-end package.

The Federation of American Hospitals is urging President-elect Joe Biden and his transition team to institute a national COVID-19 mitigation and communications strategy as opposed to the current, splintered state-based approach; to gradually ease the end of COVID-19 waivers, rather than cutting them off at the end of the public health emergency; and to work with Congress to increase access to telehealth post-pandemic.

CMS on Friday (Nov. 20) finalized changes to Organ Procurement Organizations’ Medicare and Medicaid Conditions for Coverage, moving away from self-reported measures and setting up a 12-month review period during the organization’s four-year recertification cycle.

CMS plans to expand the non-emergency ambulance prior authorization demonstration across the country once the pandemic ends. In the meantime, the agency will continue the demonstration in states where it is already underway.

The incoming Biden administration is likely to rely on administrative actions for much of its health policy agenda but there is also a possibility some bipartisan bills could move forward, health policy experts from both parties said during recent post-election events.

If the Trump administration uses an interim final rule to put in place the president’s plan to base Medicare reimbursement on international drug prices, drug makers will surely sue, drug lobbyists say.

Regulatory work by the Trump HHS is continuing full speed in the aftermath of the election, with the surprise reappearance of a once-scrapped rule to ban Medicare drug rebates, finalization of the Medicaid managed care rule and the White House budget office’s recent clearance of FDA guidance and a Substance Abuse and Mental Health Services regulation.