United States: Capitol Hill Healthcare Update - April 29, 2019

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


Congress reconvenes today after a two-week spring recess, with lawmakers in both parties continuing their focus on prescription drug prices.

House and Senate committees are planning a series of hearings and votes on drug pricing legislation, beginning Tuesday and going through at least June. The issue is also on the agenda at a White House meeting Tuesday with House Speaker Nancy Pelosi, D-Calif., Senate Minority Leader Chuck Schumer, D-N.Y., and President Donald Trump.

Senate Finance Committee Chairman Chuck Grassley, R-Iowa, said he's working with the panel's top Democrat, Sen. Ron Wyden, D-Ore., on bipartisan drug pricing legislation that he hopes to introduce by mid-June.

Senate HELP Committee Chairman Lamar Alexander, R-Tenn., said his committee will take action this summer on a series of bills designed to reduce healthcare costs. Alexander said he favors extending the Trump administration's proposed regulation requiring negotiated rebates in Medicare Part D plans to be extended to commercial plans. The senator said he hoped to approve several measures that are under his committee's jurisdiction this summer, combine them with legislation approved by Grassley's committee and have the package ready for consideration by the full Senate.

In the House, Majority Leader Steny Hoyer, D-Md., said votes on drug pricing bills could be scheduled for next month. Those bills – already approved by the Ways and Means Committee and the Energy and Commerce Committee – include requiring drug manufacturers to publicly justify price increases and launch prices, requiring HHS to disclose rebates negotiated by pharmacy benefits managers and ending "pay-for-delay" patent settlements that critics say block generic competition.

While those bills are mostly bipartisan and in some cases noncontroversial, House Democrats have introduced more sweeping proposals to lower drug prices, such as permitting HHS to negotiate with manufacturers over prices and using the threat of invalidating manufacturers' patents to force price concessions.

It's still not clear whether those more sweeping bills will gain traction in Congress or become candidates for a potential agreement with Trump, who in his 2016 campaign championed similar initiatives.

Democrats are still working to develop a partywide consensus on how far to push legislatively on drug prices. While Trump seems to be a willing partner in overhauling drug prices, the overall divisive political environment makes a large-scale deal problematic. That environment is expected to become only more toxic as the 2020 presidential campaign draws near and House Democrats accelerate their oversight of Trump.

Still, both the House and Senate are on a trajectory to vote on drug pricing legislation before the monthlong summer recess begins Aug. 1.


The House Rules Committee will hold a hearing Tuesday on congressional Democrats' "Medicare for All" legislation – a sweeping measure that would replace private and employer-provided insurance with single-payer coverage.

Introduced by Rep. Pramila Jayapal, D-Wash., the bill has been endorsed by most of the nearly two dozen Democratic presidential candidates. One of those contenders, Sen. Bernie Sanders, I-Vt., is the author of the Senate version of the bill.

The House Budget Committee is likely to hold its own hearing in May on single-payer coverage. The Congressional Budget Office this week is expected to release its fiscal analysis of the measure. Nongovernment forecasters say creating a universal, government-run health program would cost $32 trillion over 10 years.

Currently, 108 House Democrats are co-sponsoring Jayapal's bill. No Republican is supporting it.

The issue is splitting Democrats on Capitol Hill, with some lawmakers saying Medicare for All is unachievable, pointing to its staggering price tag and impact on private and employer-provided health coverage. House Energy and Commerce Committee Chairman Frank Pallone, D-N.J., says Medicare for All is politically unattainable.

Other Democrats, including Sen. Sherrod Brown, D-Ohio, are proposing what they say is a middle ground: Americans should have the option of joining Medicare before they retire in a system that would run in parallel with today's group health insurance and Affordable Care Act marketplace.


The Senate HELP Committee on May 7 will hold its second hearing in as many months 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.


The House Judiciary Committee is scheduled to vote Tuesday on four drug pricing bills, including bipartisan legislation that would allow generic manufacturers to gain quicker access to high-risk drugs and biologics protected by an FDA safety program.

Introduced by Rep. David Cicilline, D-R.I., the legislation aims to allow generic drug companies to gain quicker access to treatments approved under the FDA's risk evaluation and mitigation systems safety protocol. It also would allow civil suits against drugmakers that refuse to provide enough samples for bioequivalence testing of a generic version of a brand-name drug. Several House Republicans are co-sponsoring the bill. Identical legislation has been introduced in the Senate by Sen. Pat Leahy, D-Vt.

The committee also is scheduled to vote on a House version of bipartisan Senate legislation that would end "pay-for-delay" patent settlements that critics say block generic drug competition. The Senate bill was introduced in January by Sen. Amy Klobuchar, D-Minn., and Senate Finance Committee Chairman Chuck Grassley, R-Iowa.


The head of Congress' independent advisory board on Medicare will testify Tuesday at a House subcommittee hearing on drug pricing in the Part B and Part D programs.

James Mathews, the executive director of the Medicare Payment Advisory Commission, will be the sole witness before the Energy and Commerce Health Subcommittee. The panel is not expected to consider specific legislation but instead will examine recent commission recommendations, such as capping Part D enrollees' out-of-pocket spending by eliminating cost sharing above the out-of-pocket threshold.

Medicare prescription drug coverage includes 60 million seniors and people with disabilities. In 2016, drugs covered under Part B and Part D accounted for almost 20 percent of all Medicare spending, or $129 billion.


Bipartisan legislation introduced in the House would require employer-sponsored health plans that utilize step therapy protocols to create exceptions for patients when medically necessary.

Introduced by Reps. Raul Ruiz, D-Calif., and Brad Wenstrup, R-Ohio, the bill mirrors legislation recently enacted in more than 20 states.

Ruiz is a former emergency room doctor and serves on the Energy and Commerce Committee, which has jurisdiction over the FDA and Medicare Part D. Wenstrup is a former podiatrist who serves on the Ways and Means Committee, which has jurisdiction over CMS and Medicare Part A.

The lawmakers say insurance companies are increasingly requiring patients to try other drugs in the same therapeutic class before approving coverage for the drug prescribed by a physician. Those step therapy protocols can ignore patients' medical histories, such as whether they have already tried certain drugs under a different insurance plan or they have medical conditions that might interfere with a certain drug's effect.

The bill wouldn't prohibit step therapy. Instead, it would allow doctors to challenge a step therapy requirement and force insurers to adopt a standardized process for those appeals.


A House appropriations subcommittee will vote Tuesday on the fiscal 2020 budget for HHS, an early start for one of Congress' most contentious spending bills.

In addition to HHS, the appropriations bill also includes funding for the departments of Labor and Education, and it totaled $177 billion in the current fiscal year.

President Donald Trump last month proposed $87.1 billion for HHS for the fiscal year that begins Oct. 1. That's $7 billion less than the White House asked for last year. The House spending bill for HHS, which is scheduled to be released this afternoon, is likely to be more than $90 billion.

Although HHS officials said Trump's budget would lower insurance and prescription drugs costs, Democrats on the committee called it "cruel" for proposing to reduce NIH's budget by nearly $5 billion, including reducing funding for research on cancer, Alzheimer's disease and infectious diseases as well as cuts to mandatory health programs such as Medicaid.

Before the budget can be adopted, House Democrats and Senate Republicans will need to agree on final language before the new fiscal year starts this fall. Without an agreement, lawmakers may need to approve a stopgap budget bill that would extend current-year funding.

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