United States: Capitol Hill Healthcare Update - October 2, 2017

Alexander, Murray Seek Health Law Stabilization Agreement

With congressional Republicans' efforts to repeal the Affordable Care Act (ACA) on hold at least for now, the bipartisan leaders of the Senate HELP Committee are seeking to rekindle their work to shore up the health law's troubled individual marketplace.

Committee Chairman Lamar Alexander (R-Tenn.) said he hoped to be able to announce an agreement as soon as this week with the top panel Democrat, Sen. Patty Murray (D-Wash.). The senators have been discussing a deal that would include locking in cost-sharing payments to insurers while granting states flexibility to try to lower consumers' insurance costs.

Even if the two senators reach an agreement, it is not clear it would have sufficient bipartisan support to receive the needed 60 votes in the Senate or win approval in the more conservative House.

Alexander and Murray halted their negotiations last month while Senate Republicans struggled and ultimately failed to gain votes for their latest ACA replacement legislation by Sens. Lindsey Graham (R-S.C.) and Bill Cassidy (R-La.).

Republicans Hope to Revive ACA Repeal Efforts Later

Like the victim of the Black Plague in "Monty Python and the Holy Grail," congressional Republicans' efforts to replace the ACA are not quite dead.

Despite two failed Senate attempts in July and last month, some Republicans say they want the option to try again.

The GOP's previous efforts at repealing the ACA have been with special legislation called "reconciliation," which prevents a Senate filibuster and allows the bill to be approved with 50 Senate votes instead of the usual 60. But the reconciliation bill Republicans had been using in recent months expired September 30, the end of the 2017 federal fiscal year.

To authorize a new reconciliation bill, Congress needs to approve a separate fiscal 2018 budget resolution. Republicans appear on track to do that in the coming weeks. While the GOP had planned to use that reconciliation legislation as a vehicle for tax reform, it could be expanded to make room for tax reform and ACA repeal.

A more likely scenario is that Congress keeps the fiscal 2018 reconciliation legislation for taxes and instead targets next spring, when lawmakers would begin consideration of the fiscal 2019 budget, for an ACA reconciliation bill.

Still, whichever timeline Republicans use, it is not clear the intra-party divisions that have undermined the GOP's efforts thus far will be any more successful in the future. Indeed, the Republican candidate currently expected to win a special Senate election in Alabama says he would have opposed the ACA repeal bill backed by GOP leaders last month.

Verma, Gottlieb Seen as Leading Candidates for HHS

Two Trump administration healthcare leaders who have already been through Senate confirmation are among the leading contenders to replace the former Secretary of the U.S. Department of Health and Human Services (HHS) Tom Price, who resigned on Friday.

Before becoming administrator of the Centers for Medicare & Medicaid Services (CMS) in March, Seema Verma advised several states on their Medicaid expansion plans, including Indiana, where she worked with then-Gov. Mike Pence. She also has been active on Capitol Hill as an administration liaison lobbying congressional Republicans to repeal the ACA.

Scott Gottlieb held several federal healthcare positions prior to becoming FDA commissioner in May. A physician, Gottlieb earlier served as the FDA's deputy commissioner and as a senior advisor to a previous FDA commissioner, and separately as a senior advisor to a previous CMS administrator.

Although both Verma and Gottlieb are only months into their current jobs, each are known quantities who have recently been confirmed by the Senate, giving both an advantage over other potential candidates.

The White House has not announced a timeline for choosing Price's successor.

House, Senate Committees to Vote on CHIP Renewal This Week

Two congressional committees are slated to vote this week on separate legislation to extend the Children's Health Insurance Program (CHIP).

Federal funding for CHIP expired Saturday, the start of the 2018 federal fiscal year. But most states say they have money to operate the program well into next year.

The House Energy and Commerce Committee and the Senate Finance Committee will meet separately Wednesday to consider different versions of the CHIP renewal bills.

The bipartisan leadership of the Senate panel – Sens. Orrin Hatch (R-Utah) and Ron Wyden (D-Ore.) – last month announced they had reached an agreement on a five-year CHIP renewal. Their bill also would wind down an ACA funding boost over three years – a formula that won widespread praise from providers.

House committee staff worked this weekend on the scope of their as-yet-unreleased bill, including how long to renew the program, how to phase down the higher federal match and what other healthcare funding will be trimmed to offset CHIP funding. Reauthorization of a federal program for community health centers, which provide care for about 24 million people in medically underserved areas, is expected to be included in the House CHIP bill.

Senate Democrats Demand Allergan-Tribe Probe

Four Senate Democrats are calling on the Judiciary Committee to investigate Allergan's attempt to block the review of some of its drug patents by selling them to a Native American tribe in New York.

The senators criticized the "blatantly anti-competitive attempt" to sell the patents to the Saint Regis Mohawk Tribe, saying the deal raises significant patent law and anti-competitive implications that the committee should address.

The letter was written to committee Chairman Charles Grassley (R-Iowa) by Sens. Maggie Hassan (D-N.H.), Sherrod Brown (D-Ohio), Robert Casey (D-Pa.), and Richard Blumenthal (D-Conn.).

Mylan had initiated a Patent and Trademark Office (PTO) administrative challenge to Allergan's Restasis eye drug, which earned $1.5 billion last year. But Allergan then sold the Restasis patent to the tribe for a one-time payment of $13.8 million and $15 million annually in royalties in return for exclusive licensing. The tribe last month called on PTO to dismiss the Mylan challenge, saying its sovereign status effectively shields it from the agency's jurisdiction.

Gottlieb to Testify at 'Right-to-Try' Hearing

The House Energy and Commerce Health Subcommittee on Tuesday will hold a hearing on proposals that would give terminally ill patients wider access to prescription drugs and medical devices that have not yet won FDA approval.

Among the scheduled witnesses is FDA Commissioner Scott Gottlieb, who sounded caution in limited comments earlier this year on loosening the agency's expanded access program with so-called "right-to-try" legislation. By contrast, Vice President Pence earlier this year publicly endorsed the legislative effort.

The subcommittee announced it will consider two similar bills: House legislation that would grant wider access to drugs and devices, and Senate-approved legislation that would only apply to drugs. The House bill, introduced by Rep. Morgan Griffith (R-Va.), would permit access to treatments beyond existing compassionate use programs – even for drugs and devices that have not completed a clinical trial. The more narrowly tailored bill, introduced by Sen. Ron Johnson (R-Wis.), would only apply to prescription drugs.

Senate Opioid Hearing to Feature Top HHS Officials

Leading healthcare officials from the federal government will testify Thursday at a Senate HELP Committee hearing about Washington's response to the opioid crisis.

The committee will review implementation of last year's Comprehensive Addiction and Recovery Act, which authorizes $181 million to support opioid prevention and treatment programs. The panel will discuss implementation of the 21st Century Cures Act, which included $1 billion in grants to states to combat opioid abuse.

Witnesses at the hearing include FDA Commissioner Scott Gottlieb, NIH Director Francis Collins, CDC Director Brenda Fitzgerald and Elinore McCance-Katz, an assistant secretary at the Substance Abuse and Mental Health Services Administration.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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