POLICY

A Big Medicare Shift

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in the 2021-2022 policy and technical rule are perhaps less disruptive, but still certainly signal some major policy shifts from CMS and have a number of implications for managed care pharmacies,” said Ross Margulies, JD, MPH, an attorney with Foley Hoag LLP in Washington, D.C., during an AMCP webinar this spring.

Here are some changes that are part of the May final rule or are expected as part of a rule later this year that pharmacists should be aware of, Mr. Margulies said:

Changes to Star Ratings. CMS proposed an increase in the impact that patient experience and access measures have on a Medicare Advantage and Part D plan’s Star Rating, a system that helps beneficiaries and caregivers compare the quality of health and drug plans being offered. CMS would increase the calculated weight of patient experience and complaints in determining a Part D plan’s Star Rating from a 2 to a 4, making the beneficiary-reported experience in a Part D plan worth more in future years. “Despite a large number of commenters not being supportive of this proposal, CMS argued this move is in support of its goal of ‘listening to the voice of the patient to identify opportunities to improve care delivery,’” Mr. Margulies said. The May final rule stated that this measure will be enacted by Jan. 1, 2021.

Establishing pharmacy perform

ance standards. CMS has proposed new reporting requirements in which Part D plan sponsors will need to disclose the measures they use to evaluate pharmacy performance in their network agreements. The agency plans to report this information publicly to increase transparency related to the process and to inform industry about efforts to develop a set of standard performance measures. Going forward, Mr. Margulies said, Part D plan sponsors may be limited in their ability to develop their own pharmacy performance measures and, instead, will have to use a set of predefined measures developed by a group such as the Pharmacy Quality Alliance. Although not in the May final rule, this provision is expected to be addressed in a separate final rule to be published later in 2020, he said.

Implementing a Beneficiary RealTime Benefit Tool (RTBT). CMS proposes to require Part D plans to implement an RTBT by Jan. 1, 2022, through which beneficiaries can view real-time formulary and benefit information, including their share of costs of a recommended drug and its alternatives. Plans also would be allowed to offer nominal gifts to enrollees to encourage them to use the tool. Previously, CMS had required plans to support an RTBT for prescribers as of Jan. 1, 2021, to supply prescribers with information on

Capping Out-of-Pocket Insulin Costs for Medicare

CMS is capping out-of-pocket insulin costs for Medicare benefor Medicare bene- ficiaries at $35 per month as of Jan. 1, 2021. The cap applies to . The cap applies to both pen and vial dosage forms for rapid-acting, short-acting, acting, short-acting, intermediate-acting and long-acting insulin. It will extend n. It will extend from the beginning of the year and through the Part D h the Part D coverage gap. Participation by Medicare Part D preart D prescription drug and Medicare Advantage (MA) plans MA) plans with prescription drug coverage has been robust. More robust. More than 1,750 stand-alone Medicare Part D and MA pred MA prescription drug plans will offer the lower insulin copays ulin copays through the Part D Senior Savings Model for the 2021 or the 2021 plan year. (To familiarize yourself with this new innovanew innovation model, visit bit.ly/3cPTVQ3.)

The change to insulin copays in 2021 for benefir beneficiaries in participating plans will cover “all common common forms of insulin,” CMS Administrator Seema Verma ma Verma said during a recent press conference. “If it goes well, t goes well, we’ll extend that to other drugs. We’re starting with arting with insulin, but depending on the progress of this, we will this, we will consider offering this flexibility to manufacturers and cturers and plans with other drugs. We think that this creates a founcreates a foundation and a platform to fix ... some of the problems that problems that we have in the Part D plans. It’s time for that program at program to be updated. A lot of the provisions just don’t work don’t work anymore, and it’s standing in the way of free-marree-market competition and negotiation that can lower lower prices for seniors.” —Bonnie Kirschenbaumm cost-sharing for formulary drugs and any necessary prior authorizations or utilization management strategies. The new RTBT also is expected to be addressed in a later 2020 final rule, Mr. Margulies said.

Permitting a Second Preferred Spe

cialty Tier. All drugs that fall in a Part D plan’s specialty tier (with the highest cost drugs) have the same level of cost sharing for enrollees: $670 per month. CMS proposes to allow plans to establish a second specialty tier with lower costsharing drugs, with the agency setting standards for the maximum cost share for each tier. Sponsors could determine which drugs would fit which tiers. “This proposal probably got the most news after it came out, likely due to the implications for negotiations between plans, pharmacy benefit managers and manufacturers,” Mr. Margulies said, noting that this proposal also likely will be addressed in the rule expected later in 2020.

SUPPORT Act Implementation.

The proposed rule would implement several provisions of the federal Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment ( SUPPORT) Act signed in 2018. They include a potential requirement for Part D plan sponsors to start drug management programs by Jan. 1, 2022, for beneficiaries at risk for abuse or misuse of frequently abused drugs. Such programs place beneficiaries at risk for abuse into programs, limiting them to one or a small number of pharmacies to discourage inappropriate pharmacy shopping. These programs historically have been voluntary, and are used by about 80% of plans, Mr. Margulies said. Additional measures propose to modify the definition of a potentially at-risk

Changes to Medicare’s Star Rating system are ‘in support of its goal of “listening to the voice of the patient to identify opportunities to improve care delivery.”’

—Ross Margulies, JD, MPH

beneficiary to include a Part D-eligible

individual who has a history of opioidrelated overdose through a recent claim, and to automatically forward to the independent review entity information about an enrollee appealing their enrollment in a drug management program. Furthermore, it requires implementation of a provision requiring Part D plans to suspend payments to pharmacies for reasons such as credible allegations of fraud.

Second Specialty Tier Could Have Benefits

CMS has been focused on addressing high drug prices, high out-of-pocket insulin costs (sidebar) and drug price transparency, so suggesting an RTBT for beneficiaries was not surprising, said Carrie Monks, the session moderator and director of regulatory affairs for AMCP. d The second specialty tier proposal was T more surprising, she said, but if finalized, m it has the potential to reduce prescripit tion drug costs in the Medicare program ti by allowing the design of Part D drug b formularies “that are even more effective fo at recommending the most appropriate a drug choice for patients, while limiting d out-of-pocket costs. o

“We do expect that CMS will issue Part 2 of this final rule later this year, though 2 when it will be published is unknown at w this time,” Ms. Monks added. “The focus th on the COVID-19 public health emergeno cy is vital and likely appropriately redic recting some agency attention. However, re Medicare Advantage and Part D M plans do need final guidance on the provisions not finalized in Part 1 of the rule to prepare for future plan years.”

For an overview of the final rule on Parts C and D, see the Federal Register at go.aws/3cWgSkU. —Karen Blum