Medicare’s Protected Classes of Drugs

By ASN Staff

CMS is proposing to give Medicare Part D and Medicare Advantage plans the option to limit coverage of drugs in six categories — known as the “protected classes” — in a bid to lower pharmaceutical costs. The agency posted a proposed rule in the Federal Register on Nov. 30, available for public comment through Jan. 25, that would give health plans the ability to exclude protected class drugs from medication prescription lists in certain instances. The changes are estimated to save the government about $1.9 billion over 10 years and save Medicare enrollees $692 million in cost sharing.

Regulatory changes proposed by CMS regarding access to protected-class drugs

  • Allows private insurance plans to exclude protected class single-source drugs from their formularies if the drugs’ prices increase beyond the rate of inflation.
  • Single-source drugs with minor advancement in formulation could be excluded regardless of whether older versions are still on the market.
  • Health plans could require physicians to get prior approval from Part D sponsors before prescribing protected class drugs.
  • Health plans could implement broader use of step therapy that requires patients to try the cheapest drug for treatment first before trying more expensive alteratives.

 

Sources: CMS, U.S. Pharmacopeia Model Guidelines, NIH, NIH RxClass Browser

Category:
Subcategory:
Author:
ASN Staff
Article Image:
Body:

CMS is proposing to give Medicare Part D and Medicare Advantage plans the option to limit coverage of drugs in six categories — known as the “protected classes” — in a bid to lower pharmaceutical costs. The agency posted a proposed rule in the Federal Register on Nov. 30, available for public comment through Jan. 25, that would give health plans the ability to exclude protected class drugs from medication prescription lists in certain instances. The changes are estimated to save the government about $1.9 billion over 10 years and save Medicare enrollees $692 million in cost sharing.

Regulatory changes proposed by CMS regarding access to protected-class drugs

  • Allows private insurance plans to exclude protected class single-source drugs from their formularies if the drugs’ prices increase beyond the rate of inflation.
  • Single-source drugs with minor advancement in formulation could be excluded regardless of whether older versions are still on the market.
  • Health plans could require physicians to get prior approval from Part D sponsors before prescribing protected class drugs.
  • Health plans could implement broader use of step therapy that requires patients to try the cheapest drug for treatment first before trying more expensive alteratives.

 

Sources: CMS, U.S. Pharmacopeia Model Guidelines, NIH, NIH RxClass Browser

Date:
Friday, December 21, 2018