Capitol Hill Healthcare Update

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FDA NOMINATION HEARING DRIVES THE WEEK IN HEALTH POLICY

President Trump’s nominee to lead the Food and Drug Administration, Dr. Stephen Hahn, will appear Wednesday before the Senate Health, Education, Labor and Pensions Committee for a hearing on his nomination.

Hahn, an oncologist and chief medical executive at MD Anderson Cancer Center in Houston, is seen by lawmakers as a blank slate – he has a strong resume as a physician but scant policy experience. However, HELP Chairman Lamar Alexander, R-Tenn., announced he supports Hahn after meeting with the nominee Nov. 6. Meanwhile, Democrats are eager to replace current acting FDA Commissioner Brett Giroir because of concerns over his positions on social issues like abortion.

Still, Hahn is sure to face wide-ranging questions from lawmakers about the mission of the agency he hopes to lead. Senators are also likely to seek commitments from him to focus on certain policy issues.

Given Hahn’s lack of policy track record, senators will want details of his views on regulation of food, drugs and medical devices. Hahn can expect lawmakers to press him on ways the FDA can help to lower prescription drug costs while protecting medical innovation, including Trump’s efforts to allow drug importation. E-cigarettes will be a hot topic, as will cannabis regulation and efforts to stem opioid abuse.

PRESSURE FROM WHITE HOUSE ON DRUG PRICING

Despite bipartisan and bicameral interest, legislation to address prescription drug costs has faced continued delays as lawmakers await budget estimates and struggle with disagreements on policy specifics. President Donald Trump and his deputies are continuing to press the Hill for action.

According to reports from the Associated Press, Trump’s top domestic policy advisor, Joe Grogan, said recently the administration is continuing to press senators to support bipartisan legislation passed by the Finance Committee that would cap seniors’ out-of-pocket costs and require rebates from drugmakers if prices increase faster than inflation. But Grogan also acknowledged the “current complications” including policy disagreements – as well as impeachment consuming the political environment.

Health and Human Services Secretary Alex Azar and other officials have held multiple meetings with Republican lawmakers across the Hill to try to drive support for the Senate bill.

Yet broad legislation on the issue remains a long shot to reach Trump’s desk. Though Trump previously voiced support for direct government negotiation on drug prices, the administration does not support House Democrats’ bill to implement negotiation, currently scheduled for a vote next month.

The White House views Christmas as an effective deadline on getting drug pricing legislation done because the Senate could be consumed by impeachment considerations in January and even into February. Yet December’s legislative calendar will also be crowded by must-pass items, as lawmakers are set this week to pass a short-term government funding extension to Dec. 20.

Despite the administration’s pressure, most stakeholders are skeptical that lawmakers will be able to thread a needle this year with broad drug pricing legislation that can pass the Republican Senate and Democratic House.

HOUSE JUDICIARY PANEL TO TAKE UP DRUG PATENT BILLS

As hopes fade for passage of a large-scale drug pricing bill, lawmakers are moving forward with smaller-scale provisions addressing alleged abuses of the drug patent system. The House Judiciary Committee on Wednesday plans to take up two bills addressing drug patents.

Committee members Rep. Hank Johnson, D-Ga., and Martha Roby, R-Ala., sponsored the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act. The bill aims to address the so-called “patent dance” and speed the approval of lower-cost generic versions of complex biologic drugs.

Johnson, who chairs the Judiciary IP Subcommittee, said, “By streamlining and simplifying the patent litigation process, we hope to help boost an already robust biosimilar application process and help to expeditiously make these life-saving drugs affordable to every consumer.”

Rep. David Cicilline, D-R.I., recently introduced the Affordable Prescriptions for Patients Through Promoting Competition Act. Cicilline’s bill targets practices that he says drugmakers use to block competition.

Although the Federal Trade Commission already has authority to act against alleged anticompetitive tactics, lawmakers have proposed various legislative remedies to these alleged abuses. Drugmakers worry that legislation like Cicilline’s could open them to a wave of lawsuits and stifle research into new uses for their products to the benefit of patients.

FINANCE COMMITTEE TO HIGHLIGHT ALZHEIMER’S AWARENESS

The Senate Finance Committee on Wednesday will hold a hearing titled “Alzheimer’s Awareness: Barriers to Diagnosis, Treatment and Care Coordination.”

Witnesses for the hearing are Marc A. Cohen, gerontology professor at UMass Boston; Janet Tomcavage, chief nursing executive at Geisinger Health System in Pennsylvania; Jason Karlawish, professor of medicine, medical ethics and health policy, and neurology, and co-director of the Penn Memory Center at the University of Pennsylvania; and Lauren Kovach, an Alzheimer’s advocate from Michigan.

According to the Alzheimer’s Association, 5.6 million Americans currently live with Alzheimer’s disease. By 2050, that number is expected to increase to nearly 14 million, potentially costing the U.S. more than $1 trillion.

GOOGLE HEALTH DATA COLLECTION PARTNERSHIP CAUSES CONCERNS

Eyebrows are raised around Capitol Hill over reports from The Wall Street Journal last week that Google is collecting health data on millions of patients across the country.

“Project Nightingale” allows the tech giant to collect and analyze millions of patient records including lab results, doctor diagnoses, hospitalization records and other aspects of medical history. Google says it could help doctors predict patients’ needs and treat them more effectively.

Despite heavy scrutiny since the project was revealed last Monday, Google denies any wrongdoing or misuse of personal data and says Project Nightingale is HIPAA-compliant.

However, data privacy is already a hot topic in Congress, and lawmakers responded quickly. Sens. Lisa Murkowski, R-Alaska, and Amy Klobuchar, D-Minn., wrote to Health and Human Services Secretary Alex Azar encouraging the department to investigate the initiative. Separately, Sens. Bill Cassidy, M.D., R-La., and Jacky Rosen, D-Nev., responded by introducing legislation “to prevent data mining of Americans’ personal health data stored on wearable personal devices.”

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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