News & View: 12/1 - 12/7

December 8, 2020

PhRMA and the American Hospital Association (AHA) among the first to announce they will be filing a complaint against President Trump’s Most Favored Nation rule.

The rule, which will set prices of the top 50 separately reimbursable physician-administered Medicare Part B drugs to the lowest price from a comparable country, has received little to no support in the industry. It is likely more groups will follow PhRMA and AHA, as this rule is rushed through the typical regulatory process. To read the full article, click here.

CMS has removed the Part B drug payment measure from the Physician Fee Schedule rule.

The measure would streamline approvals by using the same billing codes for certain brand drugs as it does generics. The measure would have applied to 505(b)(2) drugs, but it is unclear how many would be affected. CMS decided to not finalize the proposed section in the rule in response to comments asking for more details and requests to delay the proposal. To read the CMS fact sheet, click here.

  • To read the full rule, click here.

CMS did not proceed with their initial proposal for additional 340B cuts in the Outpatient Prospective Payment System rule.

The proposed cut was to reduce the payment of 340B drugs from the average sale price (ASP) minus 22.5% to ASP minus 28.7%. The 2018 cut to ASP minus 22.5% was challenged by hospitals but was held up in federal appeals court. When CMS proposed an additional cut this year, Maureen Testoni of 340B Health argued that CMS was targeting safety net hospitals that are already under great strain from COVID-19.  To read the CMS factsheet, click here.

  • To read the full rule, click here.

Novo Nordisk is the most recent drug manufacturer to limit 340B discounts on their products.

The manufacturer will no longer give discounts at hospital contract pharmacies. When this policy goes into effect on January 1, 2021, Novo Nordisk will be the sixth large manufacturer to limit their 340B participation as 340B Health and members of Congress continue to urge HHS Secretary Azar to intervene. To read 340B Health’s statement, click here.

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