Medicare Advantage Rx Drug

Medicare Will Select 10 Drugs for Price Negotiation by Sept. 1

HHS set important deadlines for Medicare drug price negotiation on Jan. 11: Biden administration officials said that the first 10 drugs selected for negotiation will be announced on Sept. 1 of this year, and the maximum fair price for those drugs will be revealed on the same day in 2024. Those prices will go into effect at the start of 2026. HHS also released more information about the process it designed to select drugs and negotiate prices, which will include public comment periods and official consultations with stakeholders including manufacturers, insurers and providers.

HHS has a “plan to voluntarily solicit public comments on key elements of the program,” said CMS Administrator Chiquita Brooks-LaSure during a press conference call. “Input from our partners is essential to effectively and expeditiously implementing the Medicare drug pricing negotiation authority. We are committed to engaging with our partners through our timeline to maximize transparency, predictability and collaboration.”


FDA Approves Alzheimer’s Agent Leqembi Shortly After Release of Congressional Aduhelm Report

Less than two years after the FDA approved the first treatment for Alzheimer’s that was aimed at targeting the underlying disease process, it has approved a second similar agent. Payers are likely to cover the drug, one industry expert says, but they almost certainly will try to place restrictions on their coverage.

On Jan. 6, the FDA gave accelerated approval to Eisai Co., Ltd. and Biogen Inc.’s Leqembi (lecanemab-irmb) for the treatment of Alzheimer’s disease in people with mild cognitive impairment or mild dementia stage of disease. People must have confirmed presence of amyloid beta pathology before starting treatment. The agency gave the humanized immunoglobulin gamma 1 monoclonal antibody fast track, priority review and breakthrough therapy designations.


Express Scripts, Optum Add Humira Biosimilars to 2023 Formularies

As multiple biosimilars to AbbVie’s Humira (adalimumab) are set to hit the market in 2023, two of the largest pharmacy benefit managers (PBMs) in recent weeks made favorable coverage decisions for the soon-to-debut drugs. The FDA has approved seven Humira biosimilars so far, with Amgen’s Amjevita set to launch first, in January 2023. Bloomberg on Nov. 15 reported Optum Rx will cover up to three of the new biosimilars on the same tier as Humira on its 2023 formularies, while Cigna Corp.’s Express Scripts on Dec. 5 said it will cover the biosimilars as preferred products on its “largest formularies.” The PBM said it will “continue to evaluate all biosimilar products to Humira….and will provide updates related to specific changes as available.” Combined, the two PBMs and their corresponding payer units cover nearly 15 million people on their Medicare formularies, according to data from MMIT Analytics (MMIT is the parent company of AIS Health). Most people (86%) covered under Medicare formularies have access to Humira on the specialty tier, with utilization management restrictions such as step therapy and prior authorization.


PDP Star Ratings Dip Amid End of Pandemic-Era Adjustments

When it comes to Star Ratings for Medicare plans, 2023 represented a return to the status quo after CMS stopped making adjustments related to the COVID-19 public health emergency that had largely inflated plans’ performance. Stand-alone Prescription Drug Plans (PDPs) were no exception to that trend, but they also continued a phenomenon seen in prior years where their overall scores trailed that of the more comprehensive Medicare Advantage-Prescription Drug (MA-PD) plans.

“In general, the PDP Star Ratings are somewhat lower than the average rating for MA contracts,” observes Shelly Brandel, a principal and consulting actuary at Milliman. That tends to happen every year, she adds, “so I think directionally the PDP Star Ratings have moved pretty similarly to MA Star Ratings [for 2023], but at a lower level.”


News Briefs: CMS to Hire “Small Army” of Drug Pricing Staff

After Michelle McMurray-Heath, M.D., resigned from her position as president and CEO of the Biotechnology Innovation Organization, the major industry trade group said on Oct. 11 that Rachel King, co-founder and former CEO of GlycoMimetics, Inc., agreed to serve in those roles on an interim basis while BIO searches for a permanent successor. Before her departure, McMurray-Heath was on leave following disagreements with some board members over whether BIO should engage on social issues not directly connected to health care policy, which the molecular immunologist opposed, The Wall Street Journal reported. Her exit also comes in the wake of Congress’ passage of major drug pricing reforms as part of the Inflation Reduction Act, representing a rare defeat for the powerful pharma lobby.


CMS-Sponsored Report Shows Medicare Advantage Members Encounter Significant Racial Disparities

Medicare Advantage members can experience markedly different outcomes in measures related to prescription drugs based on race and/or ethnicity that ultimately impact their overall quality of care, according to the CMS Office of Minority Health’s latest report on health disparities in MA. The report, “Disparities in Health Care in Medicare Advantage by Race, Ethnicity, and Sex,” was funded by CMS and conducted by RAND Health Care’s Quality Measurement and Improvement Program. The report authors studied both the 2021 Medicare Consumer Assessment of Healthcare Providers and Systems (CAHPS) survey and the 2021 Healthcare Effectiveness Data and Information Set (HEDIS), highlighting disparities in several clinical areas. In addition to the prescription drug measures illustrated in the graphics below, the report also covered other clinical care measures such as cancer screening rates and patient experience measures including the ease of getting medical appointments and customer service experiences.


As Audit Season Picks Up, CMS Is Scrutinizing Rx Access Issues

As Medicare Advantage plans and their providers operate under a new normal two-and-a-half years into the COVID-19 public health emergency (PHE), CMS is resuming its regular pace of auditing MA organizations as another program audit cycle gets underway, according to compliance experts. During a June 21 session of AHIP 2022, held in Las Vegas, panelists observed that CMS continues to be focused on ensuring seniors’ smooth access to prescription drugs and emphasized the importance of audit readiness.

CMS’s audit activity was limited during the previous cycle, especially in 2020, and its latest audit report reflected that. Released in June, the 2021 Part C and Part D Program Audit and Enforcement Report said CMS imposed 16 civil monetary penalties amounting to roughly $1 million and, between 2019 and 2021, it audited about 20% of currently active sponsors representing approximately 89% of Parts C and D enrollment — which is lower than CMS’s typical goal of 95%.


Plans Build Trust, Mine Data to Dash Medication Adherence Barriers

When it comes to medication adherence rates, disparities among racial and ethnic groups pose a common challenge to health plans. But leaders in the Medicare Advantage space are working to disrupt the status quo with patient-centric, data-driven solutions that are helping to bridge the gap.

A recent initiative at SCAN Health Plan, a not-for-profit insurer serving 270,000 MA members in Arizona, California and Nevada, sought to narrow the gap between member groups by engaging in a top-down endeavor that wrapped in multiple departments, from human resources to pharmacy. “Our goal was to improve adherence,” relays Romilla Batra, M.D., chief medical officer with SCAN, “and to reduce gaps among African American and Latinx [members].”


Plan Finder Update Leaves Out Detail on Supplemental Benefits

As CMS continues to seek ways to improve its consumer-facing tools for comparing Medicare coverage options, the agency last month unveiled a series of tweaks to the website and Medicare Plan Finder (MPF). The MPF in 2019 underwent a major makeover that reportedly cost the Trump administration $11 million but critics say fell short of fixing many of the issues highlighted in a July 2019 report from the Government Accountability Office. CMS has continued to make updates based on consumer feedback, but some industry experts suggest more detail around the supplemental benefits offered by Medicare Advantage plans would be useful.

“CMS is making easier to use and more helpful for people seeking to understand their Medicare coverage, which is an essential part of staying healthy,” said CMS Administrator Chiquita Brooks-LaSure in a May 18 press release. “We are committed to listening to the people we serve as we design and deliver new, personalized online resources and expanded customer support options for people with Medicare coverage and those who support them.”


Enforcement Actions Show Mounting CMPs from Financial Audits (with table: CMP Amounts Imposed on Medicare Advantage Insurers From February to April 2022)

Between February and April of this year, CMS imposed a total of nearly $1 million in civil monetary penalties (CMPs) on Medicare Advantage and Part D organizations for program violations uncovered during routine audits, including so-called “one-third financial audits.” While CMS has yet to release its annual report that provides a fuller picture of plan noncompliance, the latest round of CMP notices offers some important lessons for sponsors and flags a few potential areas of risk that they should be monitoring in their own operations, according to compliance experts.

Of the 15 CMP notices recently posted to the CMS Part C and Part D Enforcements Actions webpage, six resulted from 2021 program audits and eight were related to 2020 financial audits. Additionally, CMS imposed a fine on Anthem, Inc. for a Part D appeals violation stemming from a previously detected system migration issue that occurred in 2020.