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GOP LAWMAKERS: EUROPE, CANADA ‘FREE RIDING’ ON US DRUG INNOVATION

More than two dozen House Republicans last week called on President Donald Trump to leverage upcoming trade negotiations to stop other nations from “free riding” on U.S. pharmaceutical innovations.

In a letter to Trump, Rep. Sean Duffy, R-Wis., wrote that foreign government price controls, market access barriers and theft of intellectual property undermine U.S. companies and place an unfair burden on American patients. The letter, which was signed by 27 House Republicans, singled out Germany, France, Japan, Australia and Canada as countries whose policies effectively force U.S. patients to shoulder a disproportionate share of research and development costs.



The White House Council of Economic Advisors last week met with pharmaceutical industry stakeholders to solicit recommendations on policies the Trump administration could pursue to pressure other countries to bear more of the drug-development costs.

Meanwhile, an announcement by President Trump on proposals to lower prescription drug prices has been pushed back until at least Friday. The announcement is expected to include a mix of initiatives already untaken – like speeding the Food and Drug Administration (FDA) approval of generic medicines – with calls for other changes, including payment pilot projects. White House aides have said the announcement is not expected to include sweeping initiatives adverse to the pharmaceutical industry that could be implemented unilaterally by the administration. Most major overhauls – for example, removing the ban on Health and Human Services (HHS) negotiating prices directly for drugs in Medicare Part D plans – would require congressional approval.

But the announcement is likely to call for removing anti-competitive barriers as well as creating payment reforms that could upend current reimbursement practices. New Centers for Medicare and Medicaid Services (CMS) payment demonstration projects are also expected to be included in the announcement, though with voluntary industry participation and a narrow scope.

NEW 340B LEGISLATION AIMS TO BOOST HOSPITAL TRANSPARENCY

New legislation introduced in the House before Congress went on recess last month would require hospitals participating in the 340B prescription drug discount program to disclose low-income utilization rates for outpatient services as well as for inpatient services in both the main hospital and so-called child sites.

Introduced by Rep. Buddy Carter, R-Ga., the legislation has been endorsed by stakeholders that are lobbying for changes to the 340B program, including the pharma trade association BIO and physician groups like the U.S. Oncology Network. Carter is a pharmacist and a member of the House Energy and Commerce Committee, which has been pushing 340B reforms.

Meanwhile, the Senate Committee on Health, Education, Labor and Pensions (HELP) announced that on May 15 it will hold a second hearing on the 340B program. Scheduled witnesses include Ann Maxwell, an assistant inspector general at HHS, and Debra Draper, the director of the healthcare team at the Government Accountability Office.

AZAR TO TESTIFY BEFORE SENATE APPROPRIATIONS PANEL 

HHS Secretary Alex Azar will be on Capitol Hill this week to testify before a Senate committee on his department’s fiscal 2019 budget.

Azar will testify Thursday before the Senate Appropriations Subcommittee on Labor, Health and Human Services, and Education.

The White House earlier this year proposed $68 billion for HHS for fiscal 2019, which begins Oct. 1. In addition to his department’s budget, Azar also is likely to be questioned about the Trump administration’s efforts to reduce prescription drug prices.

HOUSE, SENATE CONTINUE FOCUS ON OPIOID BILLS, INVESTIGATIONS 

Executives from leading national pharmaceutical distributors will testify before a House investigations subcommittee this week as Congress continues to focus on the opioid crisis.

The House Energy and Commerce investigations subcommittee on Tuesday will continue its probe of the opioid epidemic in West Virginia, which the panel has been examining for more than a year. The hearing will feature five senior executives of drug distributors, including McKesson, AmerisourceBergen and Cardinal Health.

The House Judiciary Committee will hold a hearing Tuesday on challenges posed by the opioid crisis, and a House Education and the Workforce subcommittee will hold a hearing Tuesday on the impact of the opioid crisis on federal employees.

Meanwhile, before Congress adjourned in late April for a weeklong recess, healthcare committees in the House and Senate approved sweeping, mostly bipartisan measures aimed at curbing the national epidemic. The House Energy and Commerce Health Subcommittee last month approved 57 separate opioid-related bills, including adding a pain assessment as part of the Welcome to Medicare initial examination for seniors. The full committee will hold two days of votes on the various proposals beginning Wednesday and again May 17.

The Senate HELP Committee last month approved its bipartisan package supported by Chairman Lamar Alexander, R-Tenn., and Sen. Patty Murray, D-Wash., the panel’s top Democrat. Alexander said the bill includes 40 provisions from 38 different senators, including measures that would seek to stop illegal fentanyl importation, reduce inappropriate prescribing and accelerate research on nonaddictive pain medicines.

LAWMAKERS WANT TRUMP TO DROP MEDICAL DEVICES FROM CHINA TARIFFS

Two House lawmakers are circulating a draft letter calling on the Trump administration to remove nearly $3 billion in medical technology products from its proposed Chinese tariff list.

Reps. Erik Paulsen, R-Minn., and Scott Peters, D-Calif., drafted the letter to U.S. Trade Representative Robert Lighthizer, which they hope to deliver by the end of the week. The lawmakers say including medical devices on the tariff list was misplaced because the United States and China enjoy a nearly balanced trade relationship in medical technology products. They also warned that China could retaliate not only by creating tariffs on U.S. medical devices but also by instituting new regulatory and payment barriers that could delay or prevent timely market access.

U.S. medtech firms sell $4.7 billion annually to China, while medical device imports from China total $5 billion. All U.S. exports of medical devices last year totaled $52 billion, creating a $1 billion worldwide trade surplus.

Paulsen and Peters said that because China imports about 70 percent of its medical devices, it would be counterproductive for the United States to impose tariffs and jeopardize American access to the $25 billion Chinese market for medical technology.

PATIENT GROUP TO HOLD HILL BRIEFING ON STEP THERAPY LEGISLATION 

The Crohn’s &amp; Colitis Foundation will hold a briefing Thursday on Capitol Hill to promote bipartisan legislation that would regulate insurers’ step therapy protocols by giving doctors greater say in the treatments they prescribe for their patients.

The briefing is aimed at congressional healthcare staff. The Crohn’s &amp; Colitis Foundation says step therapy represents an access barrier for patients suffering from Crohn’s disease, ulcerative colitis and other inflammatory bowel diseases.

Introduced in April by Reps. Brad Wenstrup, R-Ohio, and Raul Ruiz, D-Calif., the legislation would require health plans to establish a clear process under which physicians could request exceptions to step therapy protocols and require plans to respond in a timely manner to physician requests. The bill would affect only employer-sponsored health plans governed under federal law and would not pre-empt state laws – though several states have enacted similar legislation in recent years.

Wenstrup is a former podiatric surgeon, and Ruiz is a former emergency room physician. Their bill has 56 House co-sponsors.

HOUSE PANEL TO HOLD HEARING ON MEDICARE ADVANTAGE 

The House Ways and Means Health Subcommittee on Tuesday will hold a hearing to evaluate the state of the Medicare Advantage program.

Subcommittee Chairman Peter Roskam, R-Ill., said the hearing will focus on plan operations, quality measurements and challenges faced by emerging insurers.

Witnesses include Karoline Mortensen, an associate professor at the University of Miami Business School; Andrew Toy, chief technology officer of Clover Health, a San Francisco-based startup that leverages data analysis and preventive care to improve insurance options for seniors; Daphne Klausner, senior vice president of Independence Blue Cross; and Jack Hoadley, an analyst at Georgetown University’s Health Policy Institute.

SENATE PANEL OKs CHILDREN’S HOSPITAL GME REAUTHORIZATION 

The Senate HELP Committee last month unanimously voted to renew for five years federal funding for the Children’s Hospital Graduate Medical Education (CHGME) program.

Introduced by Sens. Johnny Isakson, R-Ga., and Bob Casey, D-Pa., the legislation aims to ensure that more than 50 free-standing children’s hospitals nationwide can train general pediatricians and pediatric specialists. More than 7,000 physicians receive training annually under the CHGME program.

Similar legislation was introduced in the House this spring by Energy and Commerce Health Subcommittee Chairman Michael Burgess, R-Texas, and Rep. Gene Green, D-Texas, the top Democrat on the subcommittee.

Both bills would authorize up to $330 million annually, but separate congressional votes would be required each year to appropriate those funds.

KEY DEMOCRAT WANTS LONG-TERM CARE BENEFIT IN MEDICARE

The Democrat who would lead a key healthcare committee if Democrats win control of the House in November wants to create a new Medicare benefit covering long-term care.

Under the proposal by Rep. Frank Pallone, D-N.J., the top Democrat on the Energy and Commerce Committee, Medicare would cover the costs of long-term residential care, adult day programs, home health aides and assistance provided by family caregivers. The plan also would reduce the amount family members must spend down to qualify for Medicaid, which unlike Medicare does provide a long-term care benefit.

Pallone’s proposal is a “discussion draft” that hasn’t yet been formally introduced as legislation in the House. He asked stakeholders to review his proposal and submit comments by June 15.

The congressman didn’t say how much his bill would cost – but it’s likely in the tens of billions of dollars. Pallone said long-term care in his home state of New Jersey can cost more than $65,000 annually per senior.

HOUSE BILL WOULD INJECT $5.2 BILLION FOR VETERANS’ PRIVATE CARE

The House Veterans’ Affairs Committee on Tuesday is expected to vote on legislation that would bolster veterans’ private healthcare options.

The bill, introduced by committee Chairman Phil Roe, R-Tenn., would authorize $5.2 billion outside of Congress’ annual appropriations process. Roe said mandatory funding for the Veterans Choice Program – which allows veterans to see physicians outside of VA healthcare facilities – was necessary after veterans officials said the program would run out of money next month.

President Trump last week via tweet said reforming the choice program was “vital,” and he called on Congress to act before Memorial Day. Senate Veterans Affairs Committee Chairman Johnny Isakson, R-Ga., praised Roe’s bill, saying it includes multiple bipartisan provisions.

SENATOR PROBES AIR AMBULANCE AND INSURER BALANCE BILLING

Sen. Claire McCaskill, D-Mo., sent letters last week to nine air ambulance providers and insurance companies over billing practices that she says leave patients with tens of thousands of dollars in uninsured costs.

McCaskill said air ambulance services are important, particularly for patients in rural communities, but that at $30,000 or more per transport, the costs can be unaffordable. She said insurance coverage is spotty because some insurers and air ambulance providers can’t agree on terms for reimbursement.

In letters to health insurers Aetna Inc., Anthem Inc., Blue Cross Blue Shield of Kansas City, Cigna Corp., Humana Inc. and UnitedHealth Group, as well as air ambulance companies Air Evac Lifeteam, Air Methods and LifeFlight Eagle, McCaskill requested documents and posed questions to better understand industry practices. She requested responses by May 21.

KEY HOUSE CONSERVATIVE BACKS MEDICAL MARIJUANA BILL

The chairman of the House Judiciary Committee announced last week that he supports bipartisan legislation that would allow federal researchers to study medical uses of cannabis.

Committee Chairman Bob Goodlatte, R-Va., confirmed he’s co-sponsoring the legislation, which would require the Department of Justice to assess the supply of research-grade cannabis and ensure that at least three federally approved manufacturers produce enough marijuana for federal researchers to conduct studies.

The bill – which gained 26 other co-sponsors before Congress adjourned last month – also would allow universities and other institutions that receive federal funding to study cannabis without risk of losing that funding.

SENATE COMMITTEE TO HOLD HEARING ON INSULIN ACCESS 

The Senate Special Committee on Aging will hold a hearing Tuesday on insulin access and affordability.

Witnesses include Dr. William Cefalu, chief medical officer at the American Diabetes Association; Dr. Jeremy Green, a professor of medicine at the Johns Hopkins School of Medicine; Paul Grant, a father whose son has type 1 diabetes; and Lois Ondik, a retiree.

Committee Chairwoman Susan Collins, R-Maine, also is a founder of the Senate Diabetes Caucus. She has long advocated for more Medicare coverage for patch pumps and other therapies to aid insulin-dependent Medicare beneficiaries.

Capitol Hill Healthcare Update