Democratic lawmakers are discussing a plan that would allow CMS to negotiate the price of certain medications and place a cap on Medicare beneficiaries’ out-of-pocket spending, an effort they hope could lead to the resuscitation of the drug pricing controls contained in the Build Back Better Act (BBBA). While those talks are far from a sure thing to pass, the Biden administration could institute policies to combat high drug prices that do not need congressional approval, according to health policy experts who participated in a Kaiser Family Foundation (KFF) webinar on May 23.
Rachel Sachs, an attorney and professor at the Washington University School of Law in St. Louis who spoke during the webinar, said the administration could particularly make an impact in federal insurance programs such as Medicare and Medicaid. One way could be via the approval of certain Section 1115 Medicaid waivers that states request. For instance, in Oregon’s Section 1115 renewal application in February, the state asked CMS for permission to exclude from its Medicaid formulary drugs approved under the FDA’s accelerated approval program that have “limited or inadequate evidence of clinical efficacy.”
Under a May 17 court decision striking down a CMS final rule slated to take effect in 2023, pharmaceutical manufacturers will not have to ensure that financial assistance provided to patients goes only to patients and not to payers under their copay accumulator and maximizer programs. However, the renewed attention to these programs could spur more states to take action of their own against them, industry experts tell AIS Health.
The Accumulator Rule (CMS-2482-F), published Dec. 31, 2020, could have resulted in patients facing increased out-of-pocket drug costs and pharma companies being held responsible for ensuring they know exactly where their assistance is going, industry experts tell AIS Health, a division of MMIT.
With the costs of treating cancer patients rising ever higher, payers and providers are increasingly turning to third-party pathways — or treatment protocols designed to provide the optimal therapy regimens — to improve outcomes and reduce excess costs. But not all pathways are created equal, and it’s crucial for oncology drug manufacturers to understand their nuances if they want to ensure their therapies are able to reach the most patients.
Those are the main takeaways from a recent “Meet the Expert” webinar from MMIT, AIS Health’s parent company. “It’s really key to get optimal placement of a brand on a pathway to ensure that patients can have access to these lifesaving therapies,” said Yana Faykina, senior consultant, advisory services at MMIT.
The House in March passed a bill that caps the out-of-pocket cost of insulin at $35 per month for Medicare Part D beneficiaries and for certain privately insured enrollees. A recent Kaiser Family Foundation analysis found that total out-of-pocket spending by Part D enrollees on insulin quadrupled between 2007 and 2019, reaching nearly $1 billion. If a $35 copay cap had been in place in 2019, Part D enrollees without low-income subsidies would have saved $14 per insulin prescription on average. Meanwhile, another study found that over one in four individual and small group enrollees paid more than an average of $35 per month out of pocket for insulin products in 2018. With a $35 cap, median monthly savings could reach $27 in the individual market and $19 in the small and large group markets.
Alvaro Bedoya’s confirmation as a commissioner of the Federal Trade Commission gave new hope to organizations urging the FTC to investigate PBMs. The Senate confirmed Bedoya, a Biden administration nominee, on May 11. Prior to Bedoya’s confirmation, an effort to investigate PBMs stalled when the agency’s existing four commissioners deadlocked along party lines in a Feb. 17 meeting over whether to start such a probe. Instead, the commission on Feb. 24 issued a public request for information (RFI) regarding “the ways that practices by large, vertically integrated Pharmacy Benefit Managers’ (PBMs) are affecting drug affordability and access.”
Meanwhile, Sens. Chuck Grassley (R-Iowa) and Maria Cantwell (D-Wash.) on May 24 introduced legislation that they said would empower the FTC “to increase drug pricing transparency and hold pharmacy benefit managers (PBMs) accountable for unfair and deceptive practices that drive up the costs of prescription drugs at the expense of consumers.” According to the two legislators, the Pharmacy Benefit Manager Transparency Act “would ban deceptive unfair pricing schemes; prohibit arbitrary claw backs of payments made to pharmacies; and require PBMs to report to the FTC how much money they make through spread pricing and pharmacy fees.”
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