United States: Capitol Hill Healthcare Update - June 2018

HOUSE OKs DOZENS OF OPIOID-RELATED BILLS; MORE VOTES SCHEDULED

The House last week approved 38 bills that lawmakers hope will stem the opioid epidemic, and it scheduled votes this week on at least a dozen more.

Most bills were noncontroversial, and others thought to be contentious – like giving the Postal Service more tools to track foreign mail shipments into the United States – easily won House approval.

House Republicans plan more votes on opioid bills this week. Then GOP leaders will package the individual bills into one comprehensive measure to send to the Senate.

Meanwhile, the Senate Finance Committee last week approved a combined package with 22 provisions that aim to crack down on opioid abuse and expand access to treatment. The bill would expand telehealth coverage, standardize electronic prior authorizations and remove Medicaid lifetime limits for substance abuse treatment.

EXPANDED 'SUNSHINE' REPORTING PROVISION WINS PANEL VOTE

The Senate Finance Committee last week approved expanding current physician payment reporting requirements for pharmaceutical and medical device manufacturers.

The payment reporting language was included as part of the committee's package of opioid-related measures – but the expanded reporting would apply to all industry payments, not just those related to opioid prescribing. Authored by Senate Judiciary Committee Chairman Chuck Grassley (R-Iowa), it would require drug and device companies to report payments made to nurse practitioners, physician assistants, clinical nurse specialists, certified registered nurse anesthetists and certified nurse midwives.

The committee did not approve a second provision that also would have expanded the 2010 Physician Payment Sunshine Act. Sen. Claire McCaskill (D-Mo.) had proposed capturing industry payments to professional medical societies; patient, consumer and disease-specific advocacy groups; co-pay and patient financial assistance groups; providers of continuing medical education; and entities that produce marketing materials and social media advertising.

McCaskill withdrew her amendment, but she and Grassley said they would work on adding McCaskill's language to the underlying bill before a Senate floor vote. The House's opioid package does not include an expansion of sunshine reporting.

HOUSE PANEL APPROVES HHS FUNDING BILL

A House appropriations subcommittee on Friday approved a fiscal 2019 spending bill that would boost funding for Health and Human Services (HHS), National Institutes of Health (NIH) and the Centers for Disease Control (CDC) but trim administrative expenses for Centers for Medicare & Medicaid Services (CMS).

HHS would receive $89.2 billion, a $1.1 billion increase over fiscal 2018 and $2.4 billion more than President Donald Trump had requested. Within that funding, the bill targets $38.3 billion for research initiatives at NIH, including $2.25 billion for Alzheimer's disease research, $400 million for the Cancer Moonshot research initiative, $429 million for the Brain Research through Application of Innovative Neurotechnologies (BRAIN) initiative, $130 million for research to develop a universal influenza vaccine and $528 million for research on antibiotic-resistant bacteria.

The legislation includes $7.6 billion for CDC, including $300 million to establish an Infectious Disease Rapid Response Reserve Fund, funding to track children and families affected by the Zika virus, and expanded grants to states for opioid tracking and deterrence.

The Health Resources and Services Administration (HRSA) would receive $6.5 billion, including $325 million, a $10 million increase, for the Children's Hospital Graduate Medical Education program.

CMS would receive $3.5 billion for administrative expenses, which is $168 million below current levels. The Biomedical Advanced Research and Development Authority would receive $587 million, Project BioShield would receive $780 million, and Hospital Preparedness Program grants would see a boost to $280 million.

House appropriators cut funding from the Office of the National Coordinator for Health Information Technology from $60 million to $42 million. The Agency for Healthcare Research and Quality would receive level funding of $334 million, but most functions would be merged into NIH.

The legislation moves to the full House Appropriations Committee, which hasn't yet scheduled a vote. The legislation includes spending not only for HHS and related healthcare agencies but also the departments of Labor and Education. As a result, the bill is a magnet for partisan policy battles like workforce issues and abortion, which in recent years have forced Congress to wrap its funding into larger stopgap budget bills.

SENATE PANEL TO HEAR FROM GAO, HHS ON MEDICAID FRAUD

The Senate committee that last month threatened to subpoena CMS chief Seema Verma to testify about Medicaid fraud will hold a hearing this week examining overpayments in the program.

The Senate Homeland Security and Government Affairs Committee had been seeking Verma's testimony since April on a Government Accountability Office (GAO) report that Medicaid alone accounts for one-quarter of all improper payments, which can include the wrong amount or payments to the wrong provider.

Chairman Ron Johnson (R-Wis.) backed down from the threatened subpoena last month, saying he and the panel's top Democrat, Sen. Claire McCaskill (D-Mo.), would work cooperatively with Verma to understand what steps her agency was taking to crack down on fraud and improper payments.Testifying before the committee this week are Eugene Dodaro of GAO and Daniel Levinson, HHS' inspector general.

SENATE COMMITTEE APPROVES REMS DRUG BILL

The Senate Judiciary Committee last week approved legislation designed to make it easier for generic drug manufacturers to obtain samples of brand-name medicines that are part of an FDA-mandated safety program for high-risk drugs.

The committee vote, 16-5, sends the legislation to the full Senate for consideration. But the bill's fate is unclear.

It could be paired with legislation that addresses pharmaceutical manufacturers' concerns about recent changes to industry contributions related to the Medicare Part D donut hole. The bill also could find its way into opioid-related legislation as a pay-for.

Committee chairman Chuck Grassley (R-Iowa) said the bill – which would establish a pathway for generics to sue brand-name drug manufacturers to obtain samples – could save taxpayers $3.8 billion over 10 years.

Generics manufacturers say brand-name companies leverage FDA's risk evaluation and mitigation strategies safety program to block access to samples generics manufacturers need for bioequivalence testing. Brand-name companies with risk evaluation and mitigation strategy drugs say some generic manufacturers aren't equipped to handle high-risk drugs, which poses risk to patients.

SENATE PANEL TO HEAR FROM OFFICIAL WHO OVERSEES 340B PROGRAM

The director of the agency responsible for oversight of the 340B prescription drug discount program will testify this week at a Senate hearing.

Capt. Krista Pedley, the director of HRSA, will testify Tuesday before the Senate Health, Education, Labor and Pensions (HELP) Committee.

Pedley's agency has been criticized by committee chairman Lamar Alexander (R-Tenn.) for oversight failures, including not auditing hospitals participating in the program. HRSA's defenders say the agency is woefully underfunded; 22 full-time employees oversaw $16 billion in 340B program drug purchases in 2016.

Meanwhile, Rep. Doris Matsui (D-Calif.) last week introduced legislation that would clarify the intent of the 340B program by expressly allowing hospitals and covered entities to use program savings for other functions. Matsui serves on the House Energy and Commerce Health Subcommittee.

SENATE FACES DEADLINE THIS WEEK ON BILL RESCINDING 'UNUSED' CHIP FUNDING

The Senate faces a Friday procedural deadline to act on a $14.8 billion appropriations rescissions bill, eliminating previously approved but unused funding from the Children's Health Insurance Program and CMS' innovation center.

The House narrowly approved the bill earlier this month on a partisan vote. While some Senate Republican leadership staffers say the chamber is likely to vote on the bill this week, Senate Appropriations Committee Chairman Richard Shelby (R-Ala.) has been cool to the idea.

The bill targets previously approved but unused funding. Still, under budget scoring rules, it would reduce the deficit by only $1 billion.

The Senate has until Friday to approve the bill with a simple majority, less than the usual 60 votes required to approve most legislation.

SENATE HEARING TO FOCUS ON ALZHEIMER'S EARLY DETECTION

On Tuesday, the Senate Aging Committee will hold a hearing on the state of improving early detection of Alzheimer's as well as data collection regarding the disease.

Witnesses include Marcia Gay Harden, an Oscar-winning actress and family caregiver; Lisa McGuire, who runs CDC's Alzheimer's Disease and Healthy Aging Program; Teresa Osborne, secretary of the Pennsylvania Department of Aging; Gareth Howell, an associate professor at the Jackson Laboratory in Bar Harbor, Maine; and Cheryll Woods-Flowers, a family caregiver.

Headed by Sen. Susan Collins (R-Maine), the committee has held two previous hearings on Alzheimer's disease during this session of Congress.

HEALTHCARE COSTS FOCUS OF SENATE HEARING

On Wednesday, the Senate HELP Committee will hold a hearing on strategies to reduce healthcare costs.

Witnesses include Melinda Buntin of the Vanderbilt University School of Medicine and Dr. Ashish Jha, director of the Harvard Global Health Institute and professor of medicine at Harvard Medical School.

Other witnesses scheduled to testify are Niall Brennan, president of the Health Care Cost Institute, and Dr. Dave Hyman, a professor at the Georgetown University Law Center.

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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