United States: Capitol Hill Healthcare Update – July 17, 2018

HOUSE PANEL TO EXAMINE POTENTIAL CHANGES TO STARK LAW

Senior Health and Human Services (HHS) officials are scheduled to testify this week before a House subcommittee examining whether laws governing physician self-referral are an impediment to coordinated care.

HHS Deputy Secretary Eric Hargan and Deputy General Counsel Kelly Cleary are scheduled to testify Tuesday before the House Ways and Means Health Subcommittee.

Subcommittee Chairman Peter Roskam (R-Ill.) has said the physician self-referral law, or "Stark Law," impedes value-based reforms that reward better outcomes and higher-value care.

DEMOCRATS CITE HEALTHCARE AS REASON TO BLOCK KAVANAUGH

Senate Democrats are leveraging healthcare policy to try to unite the party in opposition to President Donald Trump's nominee to replace retiring Supreme Court Justice Anthony Kennedy.

Democratic leader Chuck Schumer (D-N.Y.) says confirming Brett Kavanaugh would give the Supreme Court a majority to erode the Affordable Care Act's protections for people with pre-existing conditions.

"We Democrats believe the No. 1 issue in America is healthcare," Schumer said. Sen. Patty Murray (D-Wash.), the top Democrat on the HELP Committee, said voting to confirm Kavanaugh "is a vote to end protections for patients with pre-existing conditions."

Senate hearings on Kavanaugh could come as early as August – with a confirmation vote held after Labor Day – before the new court session begins in early October. The Republicans' Senate majority is a slim 51-49, and Sen. John McCain (R-Ariz.) may not be able to vote, as he is being treated for brain cancer. Still, GOP leaders are initially confident all of their members will support Kavanaugh and that they will gain support from several Democrats seeking re-election in November in states that Trump won in 2016.

KEY DEMOCRAT PANS TRUMP'S DEAL WITH PFIZER ON DRUG PRICES

The top Democrat on the Senate Finance Committee last week questioned whether President Trump and Pfizer had engaged in "secret, sweetheart arrangements" to temporarily delay the company's price increases across its drug portfolio.

Sen. Ron Wyden (D-Ore.) wrote letters to HHS Secretary Alex Azar and Pfizer CEO Ian Read demanding details on the company's plans to delay for several months its planned price increases.

"Like many pronouncements coming out of the administration, the president's agreement with Pfizer is long on theatrics and short on real and sustainable relief for patients being mugged at the pharmacy counter," Wyden wrote to Azar.

In a phone call last week with Azar and Read, the president pressured Pfizer to back away from scheduled price increases. The company agreed to hold off until the end of the year or when the administration implements its blueprint to lower drug prices, which is under development at HHS.

HOUSE BILL BOOSTS HHS BUDGET; DRUG PRICE STUDY WINS APPROVAL

The House Appropriations Committee last week approved a fiscal 2019 spending bill that would boost funding for HHS, the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) but trim administrative expenses for the Centers for Medicare and Medicaid Services (CMS).

Under the House bill, HHS would receive $89.2 billion, a $1.1 billion increase over fiscal 2018 and $2.4 billion more than President Trump had requested.

The committee also narrowly approved an amendment by Rep. Marcy Kaptur (D-Ohio) that calls on CMS to issue a report on price changes of prescription drugs since 2008. Kaptur's amendment calls for a study of prices net of rebates for the 10 most frequently prescribed drugs and the 10 highest-cost drugs in Medicare Part D, Medicaid and veterans' healthcare. Four committee Republicans backed the amendment while another GOP lawmaker was absent, allowing Kaptur's language to win approval with a vote of 26-25.

The Senate Appropriations Committee last month approved its version of the bill that funds HHS and also the departments of Education and Labor. Next up are floor votes in each chamber as lawmakers race to approve appropriations bills before the beginning of fiscal 2019 on Oct. 1. But because of the calendar as well as policy differences and election-year challenges, it's more likely Congress will vote to temporarily extend current-year funding for HHS and federal health programs.

COMMITTEES TO EXAMINE HEALTH COSTS AND MEDICARE FRAUD

House and Senate committees this week will hold hearings on healthcare spending and Medicare fraud.

The Senate HELP Committee on Tuesday will hold its second in a series of hearings on how to reduce healthcare costs.

"We're going to look at how to prevent unnecessary spending, such as when a patient has a hip replacement at a hospital instead of a lower-cost outpatient clinic or when a patient receives an MRI when an X-ray would have been fine," Chairman Lamar Alexander (R-Tenn.) said.

Scheduled witnesses include Dr. Jeff Balser, CEO of Vanderbilt University Medical Center; Dr. Steven Safyer, CEO of Montefiore Health System in New York; David Lansky, CEO of Pacific Business Group on Health in California; and Dr. Brent James, a clinical professor at Stanford University's School of Medicine.

The House Energy and Commerce Subcommittee on Oversight and Investigations will hold a hearing Tuesday to examine state laws and policies that improve the transparency of healthcare costs for consumers.

Scheduled witnesses include Jaime King, professor at the University of California Hastings College of the Law; Michael Chernew, professor of healthcare policy at Harvard Medical School; and Kavita Patel, associate chief medical officer at Johns Hopkins Medicine.

Finally, the House Ways and Means Oversight Subcommittee will hold a hearing Tuesday on Medicare fraud, including how CMS identifies and manages fraud risk in Medicare.

HOUSE COMMITTEE OKs HEALTH TAX BILLS

The House Ways and Means Committee last week approved a series of healthcare-related tax bills, including several that would expand health savings accounts.

The committee also approved delaying the Affordable Care Act's so-called Cadillac tax on high-cost health plans until 2023.

Other approved bills included expanding the number of authorized Health Savings Account (HAS) medical expenses to include over-the-counter products and gym memberships; expanding access to HSAs to seniors still in the workforce; and increasing HSA contribution limits by allowing both spouses to contribute so-called catch-up contributions.

BIPARTISAN BILL WOULD CREATE NEW EXCLUSIVITY TO SPUR ANTIBIOTIC RESEARCH

Bipartisan legislation introduced in the House would encourage pharmaceutical manufacturers to research new antibiotics by giving companies an additional year of exclusivity.

Introduced by Reps. John Shimkus (R-Ill.) and Tony Cardenas (D-Calif.), the legislation also would allow that exclusivity to be transferred to other drugs or sold to other drugmakers. That conveyable exclusivity would be extremely valuable to manufacturers but needed to spur companies to invest the money needed to restock the antibiotic pipeline to treat multidrug-resistant pathogens, the lawmakers say.

Shimkus and Cardenas are both members of the Energy and Commerce Subcommittee on Health.

The bill would create a Committee on Critical Need Antimicrobials, whose membership would be comprised of officials from HHS, the Food and Drug Administration (FDA), CDC and Biomedical Advanced Research and Development Authority (BARDA) as well as physician specialists. That committee would develop a list of critical need antimicrobial priorities, taking into account infections for which there are an unmet medical need and multidrug resistance. Companies that manufacture antibiotics targeting the committee's priorities would be eligible for the added conveyable exclusivity.

Novartis announced last week that it was shutting down its antibacterial and antiviral research operations in California, joining AstraZeneca and Allergan as major drug manufacturers to recently exit the space.

HOUSE PANEL APPROVES SERIES OF HEALTHCARE BILLS

The House Energy and Commerce Committee last week approved more than a dozen healthcare bills that panel Chairman Greg Walden (R-Ore.) said will soon be scheduled for votes in the full House.

The bills received mostly bipartisan support, including reauthorizing nursing workforce development programs that focus on recruitment, retention and advanced education of skilled nurses; directing HHS to award grants to improve the training of health professionals in palliative care; and renewing existing programs that support loan repayment and provider training experiences in primary care, dentistry, rural or underserved areas, and community-based settings.

The committee also approved reauthorizing for five years the Children's Hospital Graduate Medical Education Program.

SENATE DEMOCRATS INTRODUCE BILL CAPPING DRUG CO-PAYS

Sen. Elizabeth Warren (D-Mass.) last week introduced legislation that would place a monthly cap on out-of-pocket prescription drug costs.

The legislation would limit out-of-pocket costs at $250 for individuals and $500 for families. The limit would apply to all group insurance plans and individual plans, including those governed currently under state law.

Joining Warren in co-sponsoring her bill was Sen. Ron Wyden (D-Ore.), the top Democrat on the Finance Committee. Companion legislation was introduced in the House by Rep. Jacky Rosen (D-Nev.).

HOUSE FORMS NEW SUBCOMMITTEE ON VA HEALTH TECH

The House Veterans' Affairs Committee last week announced the creation of a subcommittee that will examine the troubled $16 billion project to overhaul the Department of Veterans Affairs' electronic health record system.

Rep. Jim Banks (R-Ind.) will serve as chairman of the Subcommittee on Technology Modernization. Banks is a veteran, but he has no healthcare or information technology background. Banks does serve on the House Armed Services oversight and investigations subcommittee, which has oversight of the Pentagon's new electronic health records system.

The VA has agreed to a multibillion-dollar contract to implement the electronic health records system, which not only requires interoperability between the VA and Defense Department but also data sharing between VA physicians and non-VA providers.

HOSPITAL GROUP HOLDS HILL BRIEFING ON CYBER THREATS

The American Hospital Association is hosting a briefing for congressional staff today on cybersecurity threats facing the healthcare sector.

John Riggi, AHA senior adviser for cybersecurity and risk, will review the threat landscape and how hospitals and health systems are responding.

The House Energy and Commerce Committee in April announced it was seeking industry feedback on legacy health technology's susceptibility to cyber challenges. Chairman Greg Walden (R-Ore.) said the use of legacy medical technologies, which are generally less protected from cyber threats than their modern counterparts, continues to be a root cause of many cyber incidents in the health sector.

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