Medicare Part D

As PBMs Are Under Microscope, New Suit Accuses CVS of Generics-Blocking Scheme

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 Find Overspending in Generic Drug Market, Advocate for More Transparency

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.

Medicare Advantage Organizations Chase ‘Signature Trend’ of Offering Extra Benefits for 2023

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.

MedPAC Mulls Method of Reducing High-Cost Outlier Impact on Risk Scores

After its last two reports suggested comprehensive reforms to Medicare Advantage plan reimbursement, the Medicare Payment Advisory Commission (MedPAC) in its June report to Congress shifted its MA focus to one area in particular: the potential for high-cost patient outlier data to skew the calculation of risk scores that determine MA plans’ risk-adjusted pay.

Although the Hierarchical Condition Category (HCC) risk adjustment model is intended to produce scores that reflect the relative health status of a plan’s enrollees, fee-for-service (FFS) Medicare spending data that is used to calculate risk scores can include a small group of outliers whose annual costs are much higher than the average costs of patients with a given condition, explained MedPAC Executive Director Jim Mathews during a June 15 web briefing with members of the press.

Latest Audit Report Highlights Enforcement Activity Outside Program Audits

In CMS’s latest audit report, the agency confirms what an earlier AIS Health analysis of compliance notices indicated: the agency imposed approximately $1 million in civil money penalties (CMPs) based on 2021 referrals, and nearly half of that stemmed from one-third financial audit findings. CMS, meanwhile, cautioned the industry not to read too much into the latest audit results as they relate to 2020, when CMS audited a relatively small number of plans due to the COVID-19 public health emergency (PHE).

In the 2021 Part C and Part D Program Audit and Enforcement Report, published on June 7, CMS said it imposed 16 CMPs amounting to $1,043,953, or an average of $65,247 per CMP. Sponsors audited in 2021 covered 26% of enrollment.

Study: With High Prices, Rebate Revenue Is Growing for PBMs

New research published in JAMA Health Forum found that rebate revenue for PBMs grew between 2015 and 2019 — but that growing rebate revenue was not passed on to patients.

The research letter’s authors measured both prerebate and postrebate drug costs taken from medical loss ratio (MLR) filings made by plans to CMS. The research sample includes commercial insurance filings from small group, individual and large group health plans across “approximately 2,200 unique health plans” covering 70 million lives.

WellCare Kept PDP Enrollees Via ‘Conversational’ Outreach Pilot

A pilot with Drips’ trademarked “conversational texting” platform has helped WellCare significantly lower the percentage of Prescription Drug Plan policies that were being terminated due to nonpayment, according to a case study presented at the 13th Annual Medicare Market Innovations Forum, held May 11 and 12 in Phoenix.

Since WellCare was acquired by Centene Corp. in January 2020, the PDP team has been focused on “optimizing operational execution” and ensuring a positive member experience, said WellCare Senior Director of Prescription Drug Plans Talia Duany, who presented the case study with Drips. “When you’ve got 4.1 million members in an industry that’s shrinking — this year we saw the biggest [decline] in available PDP options, everyone’s moving into [Medicare Advantage] — having a robust member retention strategy” is critical.

CMS Finalizes MA Rule Provisions, Delays Pharmacy DIR Change

Just a month shy of the bid deadline for the 2023 plan year, CMS on April 29 finalized most provisions of a sweeping Medicare Advantage and Part D rule that was proposed in January. Those provisions included restoring detailed medical loss ratio (MLR) reporting requirements, requiring MA Special Needs Plans to incorporate certain questions on social risk factors into health risk assessments, and finalizing a pathway to allow for star ratings to reflect a Dual Eligible SNP’s local performance. But one Part D provision regarding pharmacy direct and indirect remuneration (DIR) was notably delayed, allowing plans, pharmacies and pharmacy benefit managers time to renegotiate pharmacy pacts.

“Generally speaking, the rule wasn’t surprising. CMS largely did what they proposed. I think the major concession that plans and PBMs were concerned about was the start date of the pharmacy DIR change, and they had that addressed. But by and large this rule was consistent with CMS’s goals of raising the bar for what it means to be a SNP and for reducing costs at point of sale for seniors” starting in 2024, says Tom Kornfield, senior consultant with Avalere.

Biosimilars Stand to Cut Costs for Medicare Part D and Beneficiaries, If Uptake Improves

New biologic drugs cost Medicare Part D and its beneficiaries almost $12 billion in 2019, but increased biosimilar uptake could cut spending significantly in coming years, according to a March report from HHS’s Office of the Inspector General (OIG). Specifically, the OIG report pointed to upcoming launches of Humira (in 2023) and Enbrel (in 2029) biosimilars as potential catalysts for change. The two biologics alone accounted for nearly half of 2019’s Part D spending. Studying 2019 Part D plan formularies, OIG found that biosimilar uptake for four select drug classes was limited due to lack of coverage, and formularies that did cover biosimilars did not encourage their use over the original reference products despite their lower cost. OIG advised CMS to encourage payers to place biosimilars on formulary, which the agency agreed with. As of the second quarter of 2022, most Medicare beneficiaries still have better access to the biologics OIG studied over their biosimilars, with the exception of Teva Pharmaceuticals’ Granix, a biosimilar to Amgen’s Neupogen, and Pfizer’s Retacrit, a biosimilar to Amgen’s Epogen and Johnson & Johnson’s Procrit. Granix holds covered or better status for 51% of Medicare beneficiaries, according to data from MMIT Analytics (MMIT is the parent company of AIS Health). Retacrit, meanwhile, holds 66% covered or better status.

Drug Price Controls Appear Central to Democratic Priorities

Democratic lawmakers are expected to make a strong push to revive a variety of drug pricing proposals, such as those that would grant CMS the ability to negotiate the price of certain drugs and place a cap on Medicare beneficiaries’ out-of-pocket spending.

House Majority Leader Chuck Schumer (D-N.Y.) has indicated he is targeting the current congressional work period that runs through Memorial Day as the time to make good on drug pricing plans that Democrats have long favored, noted Matt Kazan, managing director of policy with consultancy Avalere Health, during an April 27 webinar.

The convergence of several factors, including looming mid-term elections and the scheduled end of the COVID-19 public health emergency (PHE) could spur Democrats to make a last-ditch effort to resuscitate the Build Back Better Act (BBBA) and the drug pricing controls contained within it — especially since the end of the PHE could significantly impact Medicaid and Affordable Care Act (ACA) exchange enrollment.