How Will Proposed Medicare Part D Changes Affect Specialty Pharmacies?

The Centers for Medicare & Medicaid Services (CMS) recently proposed a rule that aims to ensure Medicare beneficiaries have access to a wider variety of more affordable drugs, while also combatting the opioid epidemic, according to a press release.

The Trump administration has previously advocated for lowering drug prices; however, it has yet to approve legislation that addresses the issue. In line with the goals of the Trump administration, CMS plans to eliminate hurdles that stand in the way of lower cost options for Medicare beneficiaries, according to the release.

Under the policy, the CMS will provide increased flexibility for changes to prescription drug formularies when generic drugs are launched. The changes will encourage generic adoption when clinically appropriate, but protect access to branded drugs for beneficiaries who require those therapies, according to the release.

The CMS said this change will promote flexibility to switch to lower cost therapies and pass potential savings to beneficiaries, according to the release. In an email, the National Association of Specialty Pharmacy (NASP) said this change highlights CMS’ recognition that some plans may prefer more costly drugs, which shifts costs to beneficiaries.

Another part of the plan to lower drug costs is the implementation of a rule that treats biosimilars similarly to generic drugs in terms of out-of-pocket costs. This change aims to improve access to low-cost, effective alternatives for beneficiaries.

Additionally, the proposed rule includes a Request for Information for manufacturer discounts and the price paid at the pharmacy, which shows that these costs are not currently reflected at the point of sale, according to the NASP.

The CMS is asking for comments on whether this plan would increase cost savings for patients, how the changes may best be implemented, and how this would affect stakeholders and taxpayers, according to the release.

The rule would also give beneficiaries the ability to fill prescriptions at a wider range of pharmacies. The revision to the pharmacy participation rules aim to promote local pharmacy participation in Part D, while allowing patients to access various pharmacy delivery services.

The NASP said these changes show that the CMS recognizes the impact of direct and indirect remuneration fees and how these fees are for plan profit and do not help beneficiaries, but instead accelerate them into catastrophic coverage, according to the email.

These policy changes show that the CMS understands that price concessions are currently not reflected at the pharmacy counter and occur as clawback fees. The agency aims to remedy this problem by revising the definition of negotiated price, which will be a significant focus of the NASP’s comments to the CMS.

Additionally, the NASP’s comments will also focus on pharmacy reimbursement, any willing pharmacy laws, cost increases, and accreditation, according to the email.