United States: Capitol Hill Healthcare Update - May 20, 2019

Below is this week's "Capitol Hill Healthcare Update," which is posted on Mondays when Congress is in session. Note that because Congress will be in recess for the Memorial Day holiday, the next "Capitol Hill Healthcare Update" will be posted on June 3.

LAWMAKERS QUESTION DEMOCRATS' STRATEGY ON DRUG PRICING

House Democrats last week combined bipartisan bills designed to lower drug prices with controversial legislation related to the Affordable Care Act, prompting Democratic and Republican lawmakers to question whether party leaders are committed to bipartisan solutions to control drug costs.

By combining the two issues in one bill, the legislation won House approval but on a near-party line vote. Republicans accused Democrats of being more interested in politics than consensus on lowering drug prices.

Even some Democrats questioned their leaders' strategy and raised fresh doubt about whether House Speaker Nancy Pelosi, D-Calif., would be willing to forge a bipartisan agreement on drug prices that would allow President Donald Trump to claim at least a partial victory ahead of his re-election campaign in 2020.

The drug-pricing provisions in the bill represent incremental approaches to lowering drug costs. But House Democrats' sweeping plans to address the issue – allowing Medicare to negotiate prices and threatening to invalidate manufacturers' patents – are unlikely to win congressional approval.

Meanwhile, bipartisan discussions on drug pricing initiatives continue in the Senate, where the Finance Committee is planning a mid-June vote on a package being developed by Chairman Chuck Grassley, R-Iowa, and ranking Democrat Sen. Ron Wyden, D-Ore. The committee is discussing provisions like those that passed the House as well as addressing prices for drugs administered in physicians' offices and capping out-of-pocket costs for Medicare Part D beneficiaries. Because of the scope of that potential bill, committee staff caution that the timing for a vote could slip to July.

Senate HELP Committee Chairman Lamar Alexander, R-Tenn., is also working on similar legislation, including on broader health spending, that could be released as soon as this week. He he hopes to hold a hearing and committee vote on the bill in June.

HOUSE BILL WOULD PRESERVE DME REIMBURSEMENTS IN RURAL AREAS

Bipartisan legislation introduced in the House last week aims to preserve access to durable medical equipment (DME) in rural communities by blocking reimbursement cuts.

Introduced by Reps. Cathy McMorris Rodgers, R-Wash., and Dave Loebsack, D-Iowa, the bill would delay reductions of DME payments in rural areas and would shield oxygen concentrators from competitive bidding.

The Centers for Medicare & Medicaid Services in 2016 released a final rule on national price adjustments for specific DME, leading to reductions in Medicare reimbursements by 50 percent on average.

CONGRESS FAST-TRACKS ACTION ON SURPRISE MEDICAL BILLING

A group of six bipartisan senators introduced legislation last week to protect patients against unexpected medical bills, and two House lawmakers will testify at a hearing Tuesday on the need to address the issue.

The Senate bill, a product of nearly yearlong negotiations, would require patients to pay only the in-network cost-sharing amount required by their health plan for emergency services, even if they were treated at an out-of-network facility or by an out-of-network provider.

The bill was introduced by Sens. Bill Cassidy, R-La.; Michael Bennet, D-Colo.; Todd Young, R-Ind.; and Maggie Hassan, D-N.H.

In the House, Energy and Commerce Chairman Frank Pallone, D-N.J., and ranking Republican Rep. Greg Walden, R-Ore., last week circulated draft legislation that would require hospitals and physicians to alert patients when they're likely to be treated by an out-of-network provider. Not included in the Pallone-Walden draft: how to handle emergency helicopter and other medical transport issues that are among the principal surprise billing complaints.

A key flashpoint is how to resolve disputes. Physicians are advocating for binding arbitration, which Cassidy had previously praised but the White House has rejected. Under Cassidy's bill, payment disputes would be handled by an independent dispute resolution entity certified by the departments of Labor and Health and Human Services.

Meanwhile, Reps. Jaime Herrera Beutler, R-Wash., and Katie Porter, D-Calif., will testify Tuesday before the House Ways and Means Health Subcommittee on unexpected medical bills. Other witnesses include James Gelfand of the ERISA Industry Committee, Tom Nickels of the American Hospital Association, Jeanette Thornton of America's Health Insurance Plans and Dr. Bobby Mukkamala of the American Medical Association.

President Donald Trump last week called on Congress to address surprise medical bills, and key congressional leaders quickly pledged to address the issue.

SENATE PANEL TO FOCUS ON USE OF TECHNOLOGY TO MAINTAIN HEALTH

The Senate Aging Committee will hold a hearing Wednesday on how technology can help maintain the health of older Americans.

Committee Chairwoman Susan Collins, R-Maine, said the hearing will spotlight how access to technology is a key driver of senior citizens' quality of life.

Witnesses include Joseph Coughlin, director of the Massachusetts Institute of Technology's AgeLab; Cara McCarty of the Cooper Hewitt Smithsonian Design Museum; Brenda Gallant, a registered nurse and executive director of the Maine Long-Term Care Ombudsman Program; and Robert Mecca of Life and Independence for Today.

HOUSE BILL WOULD ALLOW STATE TORT CLAIMS AGAINST MEDICAL DEVICES

Legislation introduced in the House last week would overturn a decade-old Supreme Court decision and permit state-based product liability lawsuits against manufacturers of medical devices approved under the Food and Drug Administration's (FDA) most stringent review process.

The Supreme Court ruled 8-1 in 2008 that state tort claims could not challenge the safety or efficacy of devices marketed consistent with their premarket approval by the FDA. The Class III medical devices that undergo the FDA's premarket approval include technology such as carotid stents, drug-coated balloons and implantable defibrillators.

Rep. Rosa DeLauro, D-Conn., introduced legislation to overturn the court decision and permit personal injury lawyers to initiate litigation in state courts. The bill was co-sponsored by Rep. Brian Fitzpatrick, R-Pa.

The effect of the legislation would be to overturn the 1976 federal law that pre-empted state laws and established the FDA as the arbiter of safety and oversight of medical devices.

Democrats in 2009 introduced similar legislation but did not push for its enactment – despite deep majorities in Congress and President Barack Obama in the White House. Rep. Frank Pallone, D-N.J., who introduced the 2009 bill, is now chairman of the Energy and Commerce Committee, which has jurisdiction over the FDA.

Even if Democrats advance the bill in the House, it's not likely to be considered in the Republican-controlled Senate.

SINGLE-PAYER HEALTH SYSTEM SUBJECT OF HEARING

An official with the Congressional Budget Office (CBO) will headline a hearing this week on replacing private and employer-provided insurance with single-payer coverage, which is gaining traction among some Democratic presidential candidates.

Mark Hadley, the deputy director of the CBO, will testify at the House Budget Committee hearing. Other witnesses include Jessica Banthin, the deputy assistant director for health, retirement and long-term analysis at the CBO, and Jeffrey Kling, an associate director for economic analysis at the CBO.

Sen. Bernie Sanders, I-Vt., introduced Medicare for All legislation, which also won the backing of his fellow presidential contenders Sens. Cory Booker, D-N.J.; Kirsten Gillibrand, D-N.Y.; Kamala Harris, D-Calif.; and Elizabeth Warren, D-Mass.

Rep. Pramila Jayapal, D-Wash., introduced the House version of the single-payer bill, which has been co-sponsored by 108 Democrats.

BIPARTISAN DRUG PRICING BILLS FOCUS OF HOUSE HEARING

Officials from the national trade associations representing brand-name prescription drug manufacturers and pharmacy benefit managers (PBMs) are scheduled witnesses at a House hearing this week that will examine drug pricing legislation.

The Energy and Commerce Health Subcommittee hearing will review seven bills, including legislation by Reps. Jan Schakowsky, D-Ill., and Francis Rooney, R-Fla., that would require drug manufacturers to publicly report to the Department of Health and Human Services any price increase of 10 percent or more during a 12-month period or 25 percent or more during a 36-month period.

The subcommittee will also examine similar legislation by Reps. Steven Horsford, D-Nev., and Tom Reed, R-N.Y., requiring drugmakers to publicly justify price increases.

The panel will review legislation by Reps. Abigail Spanberger, D-Va., and Jodey Arrington, R-Texas, that would require PBMs to disclose the amount of rebates, discounts and price concessions they negotiate with drug manufacturers.

Other legislation to be reviewed would expand Sunshine Act reporting to include drug and medical device samples provided to physicians and teaching hospitals, legislation that would eliminate copayment requirements for generic drugs for Medicare Part D beneficiaries who also receive low-income subsidies, legislation that would require manufacturers to report average sales price data for drugs covered under Medicare Part B and legislation that would require the Federal Trade Commission to conduct a study on the state of competition in the drug supply chain.

Scheduled witnesses include Lisa Joldersma of the Pharmaceutical Research and Manufacturers of America, Kristin Bass of the Pharmaceutical Care Management Association, Madelaine Feldman of the Alliance of Specialty Medicine, Frederick Isasi of Families USA, Mark Miller of Arnold Ventures and Douglas Holtz-Eakin of the American Action Forum.

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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