CMS proposes delaying drugmaker rule days after PhRMA sues
The lawsuit also casts blame on health plans and pharmacy benefit managers that allegedly "siphon the benefits" meant for consumers.
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The Centers for Medicare and Medicaid Services has proposed to delay a rule requiring drugmakers to report their multiple best prices, including discounts offered to consumers, under Medicaid's drug rebate program.
The value-based purchasing arrangement rule came out under the Trump Administration. CMS had proposed establishing minimum standards in Medicaid state drug utilization review to support value-based purchasing for drugs covered by Medicaid.
July 1, 2022 is the new date for drugmakers to report. Comments are being taken for 30 days.
The reason for the delay is to provide more time for CMS, states and manufacturers to make the complex system changes necessary to implement the new best price and value-based purchasing program given the COVID-19 public health emergency, the proposed rule said.
WHY THIS MATTERS
The proposed rule delay, released Wednesday, came out days after the Pharmaceutical Research and Manufacturers of America filed a civil lawsuit against the Department of Health and Human Services to prevent the rule from going forward.
CMS has reversed course and adopted a new regulation that treats the financial assistance manufacturers provide to patients as if such assistance were a price discount that manufacturers give to patients' health plans, according to the lawsuit filed May 21 in U.S. District Court. Drugmakers are being penalized for providing financial assistance to patients, PhRMA said.
CMS's final rule contradicts the law of the Medicaid rebate statute by improperly requiring manufacturers to treat the financial assistance as part of the price they offer to commercial health insurers, the lawsuit said.
The lawsuit also casts blame on health plans and pharmacy benefit managers for allegedly "siphoning the benefits" meant for consumers.
"Because manufacturer assistance helps patients overcome the rationing effect of high out-of-pocket costs, health plans have taken steps to blunt the beneficial effects of such assistance for patients," the lawsuit said. "Specifically, health plans have partnered with Pharmacy Benefits Managers – companies that manage prescription drug benefits on behalf of health insurers – to implement so-called 'accumulator adjustment programs.' Through these programs, health plans and PBMs unfairly siphon the benefits of manufacturer assistance from the patients for whom it is intended."
PhRMA wants the court to declare the Accumulator Rule invalid and to set it aside.
THE LARGER TREND
In December 2020, CMS released a final rule to advance efforts to support state flexibility to enter into innovative, value-based purchasing arrangements with drugmakers for new, and often costly therapies such as gene therapies.
The rule went into effect on March 1, except for certain instructions that were to be effective on January 1, 2022.
Twitter: @SusanJMorse
Email the writer: susan.morse@himssmedia.com
