House Democrats Comment on Part B Demonstration

A group of nine moderate Democratic members of the House of Representatives have written to the Centers for Medicare and Medicaid Services (CMS) to express their concerns with the proposed Medicare Part B drug demonstration. The letter identifies the scope of the demonstration and the lack of stakeholder input as key issues the agency should address, as well as the short timeframe to implement and educate Medicare beneficiaries about the demo. “We believe that this demonstration should in no way undermine or diminish the health of Medicare beneficiaries or limit the ability of clinicians to appropriately prescribe the best therapies, including personalized medicine, for these patients,” the lawmakers write. The letter was signed by Reps. Kyrsten Sinema (D-Ariz.), Ami Bera (D-Calif.), Brad Ashford (D-Neb.), Joyce Beatty (D-Ohio), Suzan DelBene (D-Wash.), Grace Meng (D-N.Y.), Scott Peters (D-Calif.), Collin Peterson (D-Minn.) and David Scott (D-Ga.). CMS has yet to say when the final version of the demonstration will be released.

Employers Take Steps to Avoid the Cadillac Tax

Approximately 12 percent of companies say they have begun taking steps to avoid triggering the excise tax on highpriced health insurance plans – known as the “Cadillac tax” – according to the annual employer benefits survey by the Kaiser Family Foundation and the Health Research and Educational Trust. The Cadillac tax does not go into effect until 2020, but employers have already started shifting more costs to employees, dropping more expensive health plans, or choosing plans with fewer providers in order to avoid the penalty. Two-thirds of companies say that they have conducted an analysis to see whether their health insurance plans would be subject to the 40 percent tax on the most generous benefit options. The tax was originally scheduled to go into effect in 2018, but was delayed for two years due to widespread
opposition from many stakeholders and members of Congress.

Epi-Pen Controversy Continues

The House Committee on Oversight and Government Reform will question the CEO of Mylan, maker of EpiPens, during a hearing this week examining the recent price hikes for the epinephrine auto-injector. Dr. Doug Throckmorton, Deputy Center Director for Regulatory Programs at the Food and Drug Administration (FDA) will also testify. Democratic committee members Peter Welch (D-Vt.) and Tammy Duckworth (D-Ill.) recently wrote to Chairman Jason Chaffetz (R-Utah) requesting a hearing on prescription price increases in light of the EpiPen controversy to assess “the root cause of skyrocketing prescription drug prices as well as possible solutions.” While Democrats have appeared more interested in larger policies to reduce the cost of drugs across the pharmaceutical industry, such as allowing Medicare to negotiate drug prices, Republicans have focused on how to increase competition in the market, such as through speeding the FDA’s approval process for generic drugs. Fifteen Republican members of the House Energy and Commerce Committee have written to the U.S. Department of Health and Human Services’ (HHS) Office of the Inspector General (OIG) requesting an investigation into the oversight of the Medicaid Drug Rebate Program. The program, which is overseen by the Centers for Medicare and Medicaid Services (CMS), classifies the EpiPen as a generic rather than a brand drug, resulting in Mylan being subject to significantly lower rebate obligations. Meanwhile, Sen. Chuck Grassley (R-Iowa) has expressed disappointment in Mylan’s response to his questions about their decision to increase the cost of EpiPens from $100 to more than $500 since acquiring the product in 2007. The Senator characterized the seven-page letter as incomplete, and he promised to continue his search for more adequate details.

Biden Announces New Moonshot Activities

Vice President Biden announced a series of new initiatives last week as a part of the cancer moonshot initiative. The Food and Drug Administration (FDA) will take steps to encourage innovative clinical trial designs, including convening four workshops on the topic. The first workshop will be held this month and will focus on cardiovascular toxicity in oncology clinical trials. The aim is to produce better results from clinical research at an accelerated pace and lower cost. In concert with the announcement, the U.S. Department of Health and Human Services (HHS) also released a final rule requiring researchers to publish a summary of their results from trials conducted on new drugs and medical devices on ClinicalTrials.gov. The National Institutes of Health (NIH) will also begin working to improve the usability of
the government database on clinical trials.

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