CMS’s final rule on prescription drug prices & transparency

May 21, 2019

The Centers for Medicare and Medicaid services has announced its finalized improvements to Medicare Advantage and Medicare Part D, which the agency says will provide seniors with medical and prescription drug coverage through competing private insurance plans. CMS says the final rule will also ensure that patients have greater transparency into the cost of prescription drugs, allowing them to compare options and demand value from pharmaceutical companies.

“They are significant steps toward a Medicare program, a drug pricing marketplace, and a healthcare system where the patient is at the center and in control,” said Health and Human Services Secretary Alex Azar.

In the same announcement, CMS Administrator Seema Verma added that the “rule requires Part D plans to adopt tools that provide clinicians with information that they can discuss with patients on out-of-pocket costs for prescription drugs at the time a prescription is written. This effort builds on new requirements for hospitals to disclose chargemaster prices and other agency initiatives to promote price transparency.”

After an implementation period, CMS says Part D plans will be required to provide access to such a tool that is integrated into clinicians’ electronic prescribing or electronic health records (EHR) systems, although some plans are already offering these tools. But the new policy will require all plans to provide clinicians with access to price information for different prescription drugs. Getting more information on out-of-pocket costs for prescription drugs to patients and their clinicians early in the process is critical, CMS stared, so that patients don’t encounter “surprises at the pharmacy counter.”

After an implementation period, CMS says the rule will also require the Explanation of Benefits document that Part D enrollees receive each month to include information on drug price increases and lower-cost therapeutic alternatives. As a result of these changes, patients and their clinicians will be able to find high-value options, which the agency hopes will also increase patient adherence and improve health outcomes.

Further, CMS is codifying a policy that enables beneficiaries to select a Medicare Advantage plan that negotiates prices for physician-administered medicines when beneficiaries are first starting the treatment. Many physician-administered medicines are biologics, which very expensive, so CMS says this action should foster innovation in biosimilars in order to drive competition in the market for physician-administered drugs.

The rule also prohibits “gag clauses,” which keep pharmacists from telling patients about lower-cost ways to obtain prescription drugs, which the agency says complement a series of other changes towards including a final rule issued by CMS last week to require pharmaceutical companies to disclose the list price of prescription drugs in direct-to-consumer television advertisements.

“Although CMS is not implementing this policy for 2020, the agency appreciates the over 4,000 comments that were received on this issue,” sated the agency. Furthermore, CMS proposed facilitating negotiations for discounts for drugs in Part D’s “protected” therapeutic classes. The agency says it appreciates the feedback received on this issue and has chosen not to finalize the proposed changes to its protected classes policy at this time, but rather is codifying existing policy. However, it says prescription drug companies are offering seniors in Medicare substantially smaller discounts for protected class drugs than are offered in the commercial market and will continue to address the problem.