The Inflation Reduction Act (IRA) will allow Medicare to negotiate prescription drug prices, starting with a limited set of therapies in 2026. But while some aspects of the law are clear, some uncertainties around others exist. Biopharma companies need to start preparing as much as they can for some of the challenging situations that may arise, recommends one industry expert.

Josh Schimmer, an analyst at Evercore ISI, pointed out during a Nov. 17 webinar hosted by his company that the IRA has “many, many moving parts, some of which are…really quirky, some of which seem a little unsustainable in terms of the dynamic that they might have. It’s going to impact so many companies in this industry sooner or later; some might be spared. But those are probably going to be smaller companies. So the bigger you are, the more likely you are at some point to have to face the IRA.”

In an executive order released Oct. 14, the Biden administration directed the CMS Center for Medicare and Medicaid Innovation (CMMI) to “to consider additional actions to further drive down prescription drug costs,” building on the Medicare drug price negotiation stipulations of the Inflation Reduction Act (IRA). D.C. insiders tell AIS Health, a division of MMIT, that CMMI could pull old policy proposals off the shelf when it works to “test new ways of paying for Medicare services that improve the quality of care while lowering costs,” as the administration puts it.

The executive order isn’t specific about what policies the White House would prefer CMMI look into. However, the administration will know the possibilities fairly soon: CMMI will have 90 days to develop recommendations. Per a White House fact sheet, the final product will be “a formal report outlining any plans to use the Innovation Center’s authorities to lower drug costs and promote access to innovative drug therapies for Medicare beneficiaries.”

The median launch price of oncology drugs increased by over 8,000% between 2008 and 2021, according to a new report compiled by the office of Rep. Katie Porter (D-Calif.), from $2,115 to $180,087. The report, which draws mainly on data from the FDA's Center for Drug Evaluation and Research (CDER), calls for reforms to the FDA approval process and Medicare’s market access rules in order to curb or unwind launch price growth, which have made oncology drugs unaffordable for many critically ill patients.

The report calls for reforms to launch price regulations, some of which could be implemented under existing FDA authority. It also examines how launch pricing dynamics may change as the federal government prepares to implement Medicare drug price negotiation — part of this year’s blockbuster Inflation Reduction Act — which will begin in 2026. The report observes that “some health policy experts project that recently enacted reforms could even apply upward pressure on launch prices,” as pharmaceutical manufacturers seek to recoup revenue that Medicare price negotiation may tamp down.

In an executive order released Oct. 14, the Biden administration directed the CMS Center for Medicare and Medicaid Innovation (CMMI) to “to consider additional actions to further drive down prescription drug costs,” building on the Medicare drug price negotiation stipulations of the Inflation Reduction Act (IRA). D.C. insiders tell AIS Health, a division of MMIT, that CMMI could pull old policy proposals off the shelf when it works to “test new ways of paying for Medicare services that improve the quality of care while lowering costs,” as the administration puts it.

The executive order isn’t specific about what policies the White House would prefer CMMI look into. However, the administration will know the possibilities fairly soon: CMMI will have 90 days to develop recommendations. Per a White House fact sheet, the final product will be “a formal report outlining any plans to use the Innovation Center’s authorities to lower drug costs and promote access to innovative drug therapies for Medicare beneficiaries.”

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.”

Only 9% of Medicare beneficiaries who sign up for a stand-alone Prescription Drug Plan (PDP) in 2023 will be in contracts rated 4 stars or higher, compared to 42% in the 2022 plan year, CMS recently estimated based on current enrollment figures. The average star rating for stand-alone PDP plans declined to 3.25 in 2023 from 3.70 in 2022, with only two PDP contracts receiving a 5-star rating. The change in distribution is largely due to adjustments in measure scores, and “the unusual circumstance of nearly all contracts qualifying for the regulatory adjustment for extreme and uncontrollable circumstances” driven by the pandemic, which led to higher than normal 2022 Star Ratings distributions, CMS explained in a fact sheet accompanying the release of the 2023 Star Ratings.

Only 9% of Medicare beneficiaries who sign up for a stand-alone Prescription Drug Plan (PDP) in 2023 will be in contracts rated 4 stars or higher, compared to 42% in the 2022 plan year, CMS recently estimated based on current enrollment figures. The average star rating for stand-alone PDP plans declined to 3.25 in 2023 from 3.70 in 2022, with only two PDP contracts receiving a 5-star rating. The change in distribution is largely due to adjustments in measure scores, and “the unusual circumstance of nearly all contracts qualifying for the regulatory adjustment for extreme and uncontrollable circumstances” driven by the pandemic, which led to higher than normal 2022 Star Ratings distributions, CMS explained in a fact sheet accompanying the release of the 2023 Star Ratings.

Now that Medicare can negotiate the price of prescription drugs it purchases, the Biden administration needs to figure out how it will hash out deals with drugmakers. Experts tell AIS Health, a division of MMIT, that implementation of the long-sought negotiation program will come with plenty of challenges and pitfalls.

The administration will have to issue new regulations, hire hundreds of staff, determine which drug prices will be negotiated first and design the criteria that will select drugs for negotiation in the future.

Now that Medicare can negotiate the price of prescription drugs it purchases, the Biden administration needs to figure out how it will hash out deals with drugmakers. Experts tell AIS Health, a division of MMIT, that implementation of the long-sought negotiation program will come with plenty of challenges and pitfalls.

The administration will have to issue new regulations, hire hundreds of staff, determine which drug prices will be negotiated first and design the criteria that will select drugs for negotiation in the future.

While an unprecedented number of Medicare Advantage Prescription Drug plans earned a 5-star rating for 2022 largely because of flexibilities granted during the COVID-19 public health emergency, Blue Cross & Blue Shield of Rhode Island (BCBSRI) credits a performance-based pharmacist intervention model with dramatically improving its drug-related scores and contributing to a 5-star summary rating for both of its contracts.

For 2022, CMS allowed plans to use the better of the two years’ rating (2021 or 2022) for most measures because all contracts qualified for the “extreme and uncontrollable circumstances policy.” Plans will not have that flexibility for the 2023 star ratings due out this fall.