Hart Health Strategies provides a comprehensive policy briefing on a weekly basis. This in-depth health policy briefing is sent out at the beginning of each week. The health policy briefing recaps the previous week and previews the week ahead. It alerts clients to upcoming congressional hearings, newly introduced bills, regulatory announcements, and implementation activity related to the Patient Protection and Affordable Care Act (PPACA) and other health laws.


CBO Scores Repeal of Part B Demo

The Congressional Budget Office (CBO) estimates that blocking the proposed Medicare Part B Drug Payment Model would cost $395 million over the next decade. The model is an attempt by the Center for Medicare & Medicaid Innovation (CMMI) to lower payments for physician-administered drugs under the Medicare Part B program, which are projected to reach $18 billion in 2017. CBO’s new estimate is a score of H.R. 5122, introduced by Rep. Larry Bucshon (R-Ind.) earlier this year, that would stop implementation of the CMMI experiment. CBO projects that prohibiting the demonstration would result in lost savings of $1.1 billion through 2026, which would be offset in part by additional savings from CMMI’s replacement of the blocked demo with other projects – producing a net cost of $395 million. H.R. 5122 currently has 20
Republican and two Democratic cosponsors. The Centers for Medicare and Medicaid Services (CMS) has not announced when the final version of the demo will be released.

CMS Responds to EpiPen Concerns

In response to congressional inquiries, Centers for Medicare and Medicaid Services (CMS) Acting Administrator Andy Slavitt outlined that his agency spent nearly $1.3 billion on EpiPens over the last five years. Between 2011 and 2015, total Medicaid and Medicare Part D spending on EpiPens increased from $86.5 million to $486.8 million – a 463 percent increase. Slavitt’s letters to Sen. Ron Wyden (D-Ore.), Sen. Amy Klobuchar (D-Minn.), and Rep. Frank Pallone (D-N.J.) do not, however, offer any additional detail about when CMS became aware that EpiPens were misclassified as a generic drug, allowing its manufacturer Mylan to pay rebates of only 13 percent to the Medicaid program, rather than the 23.1 percent required for brand name drugs. Lawmakers are expected to press the agency for more details on EpiPen’s Medicaid Drug Rebate Program classification. Sen. Chuck Grassley’s (R-Iowa) office has already
performed an analysis of the above figures showing that the share of Mylan’s revenue from taxpayer dollars increased from 23.3 percent in 2011 to 53.4 percent in 2015. On Friday, it was announced that Mylan will pay $465 million in response to questions of misclassification, but without any finding of wrongdoing.

FDA Panel Recommends Increasing Naloxone Dose

A panel of independent advisors to the Food and Drug Administration (FDA) have recommended that the minimum acceptable dose for naloxone, the opioid overdose reversal treatment, be increased. By a 15-13 vote, the advisory committee recommended a higher starting naloxone dose due to the rising use of more potent opioids, such as the synthetic drug fentanyl. Data was cited showing that emergency responders must frequently administer multiple doses of naloxone to revive an overdose victim. They also cited cases of patients in rural areas who require a stronger dose during the time it takes to travel to the emergency room. The panel also voted 21-7 in favor of using the same minimum dosage for both adults and children, mostly to avoid the potential for confusion if multiple versions of the drug were available. While the FDA is not bound by advisory committee decisions, the agency often bases regulations on their views.

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