WH Budget to be Released Today, Expected to Include Drug Pricing Provisions

The fiscal year (FY) 2019 budget process is set to begin today, when the President is scheduled to release the White House budget. According to some reports, the budget will take into account the recent changes to the overall discretionary caps, per the recent passage of the Bipartisan Budget Act of 2018. The President’s budget request is expected to include a number of proposals aimed at lowering prescription drug costs for Medicare and Medicaid beneficiaries. The measure would reportedly allow seniors enrolled in Medicare Part D to share in rebates that drug companies pay to insurers and pharmacy benefit managers for the individual drugs that they purchase at the pharmacy and would also expand Medicare’s catastrophic drug benefit. In Medicare Part B, U.S. Department of Health and Human Services (HHS) Secretary Alex Azar wants to modify the payment rate for newly launched, physician-administered drugs. He is also looking at potential changes to the 340B drug discount program and to the 180-day exclusivity period for the first generic manufacturer to challenge a particular brand patent. Additionally, the budget will request that Congress grant HHS authority to allow five state Medicaid programs to try and negotiate lower drug costs, including through formulary utilization. It will also ask for a revision of Medicaid’s definition of generic and over-the-counter (OTC) drugs.

February 21 Event: Thought Leaders, Experts Converge on Washington to Address Unsustainable Rise in Health Care Costs

On February 21 leaders from every sector of health care will convene at the West Health Healthcare Costs Innovation Summit to generate new ideas, innovations and practical policy prescriptions that will change the trajectory of the cost of healthcare in America. “Taking Bold Action and Creating Accountability to Solve Our Nation’s Healthcare Costs Crisis,” will include keynotes Steve Forbes, Chairman and Editor-in-Chief of Forbes Media; Sanjay Gupta, MD, Chief Medical Correspondent, CNN; and Andy Slavitt, Former Acting Administrator for the Centers for Medicare and Medicaid Services. Andy Slavitt will focus on the urgent need to solve the cost crisis so that health care can become more accessible and more affordable for all Americans. For more information and to register for this free public event, visit hcidc.org.

Sanders Requests Opioid Hearing with Pharma CEOs

Sen. Bernie Sanders (I-Vt.) sent a letter this week to the Chairman of the Health, Education, Labor, and Pensions (HELP) Committee Sen. Lamar Alexander (R-Tenn.) requesting that the committee hold a hearing to examine the role of pharmaceutical companies in exacerbating the nation’s opioid epidemic. Citing the precedent of a 1994 hearing in the House of Representatives that consisted of witnesses from the country’s largest tobacco companies, Sanders argued that the hearing would shine a light on the pharmaceutical industry that could lead to similar improvements in public health oversight. Sanders also notes that he plans to introduce legislation “to prohibit marketing and illegal distribution practices with respect to opioids, create public accountability for these companies and the CEOs, and require companies to reimburse the economic impact of their products.”

President Picks White House Staffer for Drug Czar Job

This week, the Trump Administration announced their intention to nominate current White House Deputy Chief of Staff Jim Carroll to be the Director of the Office of National Drug Control Policy (ONDCP), a position commonly referred to as the “Drug Czar.” Carroll has served in his current role in the West Wing for three months, and previously worked in the U.S. Treasury and Justice Departments, and as a private-sector attorney. The Administration’s first nominee for the Drug Czar position, Pennsylvania Congressman Tom Marino, withdrew himself from consideration after it was reported that he sponsored legislation making it easier for drug companies to distribute opioids throughout the country. The Administration officially named Carroll as the deputy director of the drug office on Friday, where he will serve as Acting Director during his confirmation process in the Senate.

NIH/Opioid Research Legislation Introduced

On Thursday, a bipartisan group of Senators from the Health, Education, Labor, and Pensions (HELP) Committee jointly introduced legislation that would provide more flexible authority at the National Institutes of Health (NIH) to advance research needed to combat the nation’s opioid epidemic. The Advancing Cutting-Edge (ACE) Research Act (S. 2406) was introduced by committee Chairman Lamar Alexander (R-Tenn.), Ranking Member Patty Murray (D-Wash.), Sen. Todd Young (R-Ind.), and Sen. Maggie Hassan (D-N.H.). The bill gives the Director of the NIH, Dr. Francis Collins, authority to approve projects using other transaction authority for cutting-edge research, with the goal of increasing scientific understanding and leading to ways to prevent, treat, diagnose and cure disease. This authority includes support for research that is urgently required to respond to public health threats such as the opioid crisis, including the science to develop a non-addictive opioid painkiller. The legislation builds on investments in NIH research from the 21st Century Cures Act (P.L 114-225) and the Comprehensive Addiction and Recovery Act (P.L. 114-198).

Right-to-Try Gains Traction, Hits Roadblocks

Following President Trump’s endorsement of right-to-try legislation during his January 30th State of the Union Address, the bill (S. 204) has gained the attention of leadership from the House of Representatives. The bill’s bicameral sponsors, Sen. Ron Johnson (R-Wis.), Rep. Andy Biggs (R-Ariz.), and Rep. Brian Fitzpatrick (R-Pa.) recently met with Speaker of the House Paul Ryan (R-Wis.), House Majority Leader Kevin McCarthy (R-Cal.), and House Energy and Commerce Committee Chairman Rep. Greg Walden (R-Ore.) to discuss the bill. The legislation would prevent the government from blocking access to drugs that have only undergone preliminary testing in humans.

While the House leadership has received a letter of support signed by more than 40 House Members, the proposal is facing pushback from several stakeholder groups. On Tuesday, a letter signed by 38 patient advocacy groups urged bipartisan House leaders to oppose the legislation if it is brought to the House floor. The groups argue that this approach is not likely to increase access to experimental therapies for patients in need, and would likely do more harm than good. They note that the bill would remove the Food and Drug Administration (FDA) from the process of facilitating increased access to unapproved medicines, which currently approves 99.7 percent of expanded access requests. They also argue that denials generally come from drug companies.

The bill was passed by unanimous consent in the Senate last year, and House leadership have reportedly expressed private support to the bill’s sponsors, but the House Energy and Commerce Committee has continued to work on their own right-to-try proposal. While many in the House want the bill to receive an immediate floor vote, the sponsors have stated their commitment to moving the bill through the process of regular order. This would allow for committee hearings and amendments before the bill is voted on by the entire chamber. FDA Administrator Scott Gottlieb, MD, who has raised concerns on the bill regarding the scope of who would qualify for experimental drugs, said that the agency is committed to finding a solution that works on behalf of patients and has provided technical assistance to multiple proposals that are currently being considered on Capitol Hill.

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