United States: Capitol Hill Healthcare Update – May 6, 2019

Below is this week's "Capitol Hill Healthcare Update," which is posted on Mondays when Congress is in session.


During a White House meeting last week on infrastructure policy, President Donald Trump, House Speaker Nancy Pelosi, D-Calif., and Sen. Democratic Leader Chuck Schumer, D-N.Y., agreed to meet in the future to discuss drug pricing legislation.

A date for that meeting hasn't been finalized, but Democrats aren't waiting to move bills on drug prices.

House Democrats are teeing up legislation that would make it easier for generic drug manufacturers to gain access to brand-name drugs protected under the FDA's high-risk safety program. Legislation ending "pay-for-delay" patent settlements also has been approved by a key healthcare committee.

Two narrow, rifle-shot drug bills are scheduled for votes this week. More are likely to be scheduled later this month, including requiring pharmaceutical manufacturers to justify price increases. Future anti-industry measures may be paired with legislation to bolster the Affordable Care Act's individual markets or provisions to strengthen projections for individuals with preexisting conditions. Those bills would force Republicans to choose between backing the ACA or siding with the pharma industry.

But Democrats haven't yet advanced their most far-reaching – and controversial – legislation: allowing Medicare to negotiate prices directly with drug manufacturers or threatening to take away pharma's patent protections.

Trump, too, has outlined proposals strongly opposed by the pharmaceutical industry, including tying Medicare reimbursement for certain drugs administered in the physician's office to an average of prices paid in foreign countries where the governments set drug prices.

Democrats themselves are trying to find party-wide consensus on whether to pursue their more hardline provisions or seek a potential middle ground that could produce an agreement with the White House, such as backing away from Medicare negotiation on drug prices in favor of binding arbitration.

One White House official who has been involved in discussions with Congress said it was doubtful the administration would support binding arbitration. The administration examined arbitration as a potential policy solution in surprise medical billing but quickly rejected it.


The Senate Judiciary Committee will hold a hearing Tuesday on pharmaceutical manufacturers' patents and their role in drug prices.

Scheduled witnesses include Joshua Barker, director of the South Carolina Department of Health and Human Services; David Mitchell, president of Patients for Affordable Drugs; James Stansel, executive vice president of PhRMA; Michael Carrier, professor at Rutgers Law School; and David Olsen, associate professor at Boston College School of Law.

Sen. John Cornyn, R-Texas, plans to introduce legislation that would authorize the Federal Trade Commission to block pharmaceutical manufacturers from creating "patent thickets," or a series of patents to extend a drug's exclusivity.

Cornyn is a member of the Judiciary Committee.


The House Appropriations Committee is scheduled to vote Wednesday on a proposed $99 billion budget for HHS.

Under the Democrats' bill, HHS' overall budget would increase by nearly $8.5 billion. NIH would see $3.2 billion for HIV/AIDS research and $2.4 billion for Alzheimer's disease research.

CMS would receive $4 billion for administrative activities, an increase of $315 million. The FDA's budget is funded in the separate agriculture appropriations bill as well as by industry user fees.

The bill won approval last week in an appropriations subcommittee, though most panel Republicans oppose the measure and are likely to vote against in the full committee.


The Senate Finance Committee on Wednesday will examine the way Medicare rewards doctors for value over volume two years after implementation of an overhaul of physician payments.

Scheduled witnesses include Dr. Barbara McAneny, president of the American Medical Association; Dr. John Cullen, president of the American Academy of Family Physicians; Dr. Scott Hines, director of the American Medical Group Association; and Matthew Fiedler, a fellow at the Brookings Institution.

Passed by Congress in 2015, the Medicare Access and CHIP Reauthorization Act created a new payment framework and established a pay-for-performance program that focuses on quality, value and accountability.


The House Energy and Commerce Health Subcommittee will hold a hearing Tuesday on the pharmaceutical supply chain.

The subcommittee hasn't announced witnesses as of Monday morning, but look for officials from brand and generic drug manufacturers, insurers, hospitals, pharmacists and other providers.

"This hearing will get to the root causes of high prescription drug costs, how prices are set, and how each stakeholder can lower prices so that Americans can afford the care they need," according to a statement from full committee Chairman Frank Pallone, D-N.J., and subcommittee Chairwoman Anna Eshoo, D-Calif.


The House is scheduled to vote Thursday on legislation that would block a Trump administration rulemaking designed to increase states' flexibility to waive certain Affordable Care Act requirements.

The so-called Section 1332 waivers permit states to seek federal approval for testing innovative coverage options. The Trump administration last year issued new guidance designed to incentivize more states to pursue the waivers, saying the ACA is failing and the flexibility will help to bolster law's marketplace.

But Democrats say the waivers undermine key ACA protections, such as ensuring coverage for individuals with preexisting conditions, and would promote the sale of inadequate insurance coverage. The legislation, by Rep. Ann Kuster, D-N.H., would roll back that guidance.


Bipartisan legislation introduced in the House last week would create a separate Medicare benefit to cover complex wheelchairs and other adaptive equipment for people with severe medical needs.

Medicare considers complex rehabilitation equipment durable medical equipment (DME). But the competitive bidding reimbursement mechanism for one-size-fits-all DME doesn't account for the customized products needed for the rehabilitation needs of individuals with cerebral palsy, muscular dystrophy, multiple sclerosis or spinal cord injuries, according to the authors of the bill.

Introduced by Reps. Jim Sensenbrenner, R-Wis., and Brian Higgins, D-N.Y., the legislation would separate complex wheelchairs and other adaptive equipment from traditional DME.

The bill is supported by a host of patient advocacy groups, including the American Association for Homecare, the American Physical Therapy Association, the Brain Injury Association of America, the Christopher and Dana Reeve Foundation, and Easter Seals.


The House is scheduled to vote Wednesday on two bills that aim to speed generic drug manufacturers' access to patent information on brand-name drugs.

Introduced by Rep. Anna Eshoo, D-Calif., one bill would codify publication of patents for approved biological products in the FDA's "Purple Book," which lists biological products, including biosimilar and interchangeable biological products, licensed by the FDA under the Public Health Service Act.

The bill by Eshoo, who is chairwoman of the Energy and Commerce Health Subcommittee, also is backed by committee Republicans Reps. Greg Walden, R-Ore., and Michael Burgess, R-Texas.

A second bill, introduced by Rep. Robin Kelly, D-Ill., would ensure data are updated in the FDA's "Orange Book," which catalogs drugs approved based on safety and effectiveness. The legislation would require that manufacturers share complete and timely information with the FDA and ensure patents listed are relevant to the approved drug.


Healthcare costs in the United States are the most expensive in the world, and bipartisan legislation introduced in the Senate last week aims to trim one of the drivers for that spending: administrative costs.

Introduced by Sens. Tina Smith, D-Minn., and Bill Cassidy, R-La., the legislation would require HHS to propose a plan to reduce unnecessary costs and administrative burdens by 50 percent over the next decade and streamline administrative processes to reduce provider burdens and preserve the patient-provider relationship.

The bill also includes $200 million for state-based grants to curb administrative costs and earmarks $50 million in new grant funding to accelerate the adoption of electronic record-keeping and information exchange.


The House Oversight and Reform Committee will hold its second hearing in as many months on the Office of National Drug Control Policy (ONDCP), with Director Jim Carroll likely to come under fire from Democrats and defend the Trump administration's proposed drug-fighting budget.

The administration's fiscal 2020 budget proposes a record $34.6 billion to combat illegal drugs, including $6.6 billion for opioid abuse. But critics say transferring major ONDCP grant programs, such as the High Intensity Drug Trafficking Areas to the Justice Department and the Drug Free Communities to HHS, would deprioritize them.

Carroll testified in March, when committee Democrats criticized the administration for failing to offer a comprehensive drug control strategy.


The Senate HELP Committee on Tuesday will hold its second hearing on implementation of new interoperability rules for electronic health records.

Witnesses include Dr. Don Rucker, the head of HHS' Office of the National Coordinator for Health Information Technology, and Dr. Kate Goodrich, CMS' chief medical officer.

Committee Chairman Lamar Alexander, R-Tenn., has long been a proponent of the expanded use of electronic health records. The committee last month held a hearing on implementation of the electronic health information provisions included in the 21st Century Cures Act

Meanwhile, Alexander praised a new HHS draft rule that the senator said will improve the exchange of patient information across health networks.


Bipartisan legislation introduced in the Senate would which would protect access to bone marrow and cord blood transplants by aligning Medicare payment policies for hospitals that treat seniors with different types of blood cancers, such as leukemia, lymphoma and sickle cell disease.

Introduced by Sens. Richard Burr, R-N.C., and Debbie Stabenow, D-Mich., the bill would require that Medicare reimburse hospitals for the costs of searching for donors and acquiring cells and bone marrow separately from the cost of completing the life-saving transplants. Currently, Medicare does not cover the full costs of providing bone marrow or cord blood transplants to its recipients, forcing transplant centers nationwide to lose thousands of dollars on each Medicare beneficiary they treat.

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