As soon as Friday, Congress is expected to pass Medicare prescription drug price reforms as part of the Inflation Reduction Act (IRA). The reforms are less ambitious than previous versions of drug pricing legislation considered by the current Congress, but various experts and health care stakeholders are mounting vehement arguments about the reforms’ ultimate impact on prices.

Under the bill, HHS would be able to negotiate the price of a gradually increasing number of drugs starting in 2026, when 10 drugs will be eligible for negotiation. The bill would also limit out-of-pocket drug costs for Medicare Advantage and Part D beneficiaries to $2,000 per year, and repeal the so-called rebate rule in Medicare Part D. In addition, the proposal would bar Medicare Part B and Part D drug prices from growing faster than inflation. In a summary of the late version of the reconciliation bill, Senate Democrats estimated that the drug pricing reform program would save $288 billion over 10 years.

CMS at press time unveiled substantive changes to its Medicare Parts C and D enrollee grievances, organization/coverage determinations and appeals guidance. Effective immediately, the Aug. 3 memo from the Medicare Enrollment and Appeals Group contained numerous redlined edits to the guidance for Medicare Advantage organizations, Prescription Drug Plans, Cost plans, Medicare-Medicaid Plans and Programs of All-Inclusive Care for the Elderly. These included guidance on ensuring that enrollees with limited English proficiency have the same level of access to plan representatives and information regarding initial determinations, appeals, and grievances as those who are proficient in English; new specifications regarding plan delivery of notifications; detailed procedures when an initial determination request is withdrawn; and a clarification that a non-contracted provider who has furnished a service to an enrollee may request that an organization determination be reconsidered by the plan.

Suddenly, the U.S. Senate may be about to pass a drug price reform package and extend enhanced individual marketplace subsidies through 2025. West Virginia centrist Democrat Joe Manchin — who has almost singlehandedly held up progress on the Biden administration’s agenda — in recent days reached a deal with Senate Majority Leader Chuck Schumer of New York to move on the administration’s top health care priorities, along with climate change mitigation and tax reforms, in a bill that the upper chamber may pass through budget reconciliation before its annual summer break.

Democrats are once again seeking to pass drug pricing reform with a new proposal published earlier this month. While the bill is similar to previous ones, most notably with having Medicare conduct drug price negotiations, it also offers some changes from past efforts, including not basing those drug prices on an international reference model. Still, many pharma stakeholders expressed disappointment over aspects of the bill, and while its odds of passing have slightly improved more recently, industry experts are somewhat divided on the bill’s chance of approval.

The newest proposal was released on July 6 after negotiations with Sen. Joe Manchin (D-W.Va.), who squelched earlier administration attempts at drug pricing reform.

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%.

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].”

After four years, the Enhanced Medication Therapy Management (MTM) Model still has not generated any net savings to the Medicare program. Through the five-year model that started in January 2017, model participants tested a variety of interventions to improve Part D beneficiaries’ medication use. Despite efforts by some sponsors to alter their interventions, there continued to be no statistically significant impacts on Medicare Parts A and B expenditures for the overall enrollee population in model-participating plans, observed the Fourth Evaluation Report released by the CMS Innovation Center last month. Findings from subgroup analyses suggested that enrollees eligible for the low-income subsidy and enrollees with medically complex profiles did not benefit more from the model compared to the overall enrollee population, while the program saw decreases in inpatient expenditures and admissions related to the Ambulatory Care Sensitive Conditions for both the medically complex subgroup and the all-enrollee cohort, according to the report prepared by Acumen.

At a time when the federal government is clamping down on pharmacy benefit managers and seeking ways to lower prescription drug prices, a recently unsealed whistleblower complaint details how one of the three largest PBMs allegedly drove up costs for Medicare Part D beneficiaries and the federal government. In a lawsuit that CVS Health Corp. intends to fight, the False Claims Act complaint accuses the parent company of colluding with its “supposedly firewalled” entities — the SilverScript Part D subsidiary, PBM CVS Caremark and CVS pharmacies — of striking secret rebate agreements with the drug makers that required SilverScript to block substitution on its formularies of generic drugs in favor of costlier brand-name alternatives.

The U.S. Dept. of Justice chose not to intervene in the second amended complaint, which was filed in the U.S. District Court for the Eastern District of Pennsylvania in March and recently obtained by Stat. The suit was filed by relator Alexandra Miller, who worked for CVS Health for 19 years. According to Miller’s LinkedIn profile, she most recently served as senior director of Medicare Part D operations and is now senior director of member and provider experiences for Oscar Health.

Researchers from the USC Leonard D. Schaeffer Center for Health Policy & Economics are pushing for more transparency in the pharmaceutical supply chain and policy changes in the generic drug sector. Their recommendations, published in a white paper on May 31, were based on their findings that PBMs and health insurers cost patients, employers and the federal government billions of dollars per year in the generic drug market.

Karen Van Nuys, Ph.D., one of the paper’s authors and executive director of the Center’s Value of Life Sciences Innovation Project, tells AIS Health, a division of MMIT, that she recommends changes in the way pharmacies set their cash prices as well as in some formularies that favor branded drugs over generics and so-called spread pricing, where PBMs reimburse pharmacies one price, charge health plans a higher price and pocket the difference.

Judicious enhancements to supplemental benefits was the common theme as Medicare Advantage organizations prepared their bids for 2023, according to actuaries who recently helped sponsors submit bids that were due on June 6. The benefit changes come as plans considered potential bonus payment losses in 2024 and other possible drivers of increased costs next year.

“The signature trend of this year was carrying forward a lot of the innovative benefits that we’ve seen take hold over the past few years,” remarks Tim Murray, principal with Wakely, an HMA company. These include “wallet” benefits such as over-the-counter card allowances and flexible “choose your own adventure” benefits often involving healthy food and/or groceries, he observes.