United States: Capitol Hill Healthcare Update - September 4, 2018

Last Updated: September 10 2018
Article by Christian B. Jones

This week's "Capitol Hill Healthcare Update" includes the latest on Congress reconvening after a summer break and facing near-term deadlines on government funding, including for healthcare agencies and programs; whether Congress will approve opioids legislation before the November elections; an unlikely alliance of Senate Democrats and the Trump administration on requiring drug manufacturers to include prices in their ads; and more.


Lawmakers returning to Capitol Hill today begin a monthlong sprint to approve fiscal 2019 funding – including for healthcare agencies and programs – with the hopes of avoiding a politically calamitous government shutdown only weeks before the November midterm elections.

Congressional leaders will meet with President Trump at the White House this week to plot strategy. Adding to the sense of urgency: Government funding expires in 26 days, and the House is scheduled to be in session for only 11 days in September. The Senate will be in session for 16 days, but the partisan fight over the nomination of Brett Kavanaugh to the Supreme Court could make reaching bipartisan consensus on the budget more difficult.

The Senate last week overwhelmingly approved a combined budget bill that included funding for HHS, but the House hasn't voted on its version yet. Any fiscal 2019 appropriations bill not enacted before Oct. 1 would require Congress and President Donald Trump to agree to extend current-year funding likely into December – or that portion of the government would shut down.

Although Trump has warned he would close the government if Congress doesn't approve funding for a U.S.-Mexico border wall, GOP leaders say his threats are most likely targeted to post-election spending negotiations in December. Republicans on the Hill believe – or at least hope – they have persuaded Trump that an October shutdown would distract voters from a potential victory on Kavanaugh and jeopardize GOP election prospects in November.


Senate Majority Leader Mitch McConnell, R-Ky., said advancing bipartisan legislation to crack down on opioid abuse, expand access to treatment and incentivize alternative pain treatments will be among the Senate's top priorities in September.

Senators had hoped to vote on a compromise bill in August but were unable to reach consensus on several provisions, including limiting opioid prescriptions to three days. McConnell said Republicans have agreed on the package and are waiting for Democrats to signal their support before scheduling a vote on the bill – perhaps as soon as this week.

HELP Committee Chairman Lamar Alexander, R-Tenn., is spearheading the drive to finalize the legislation, which is expected to authorize at least $500 million annually for state grants, spur development of nonaddictive painkillers, strengthen coordination between FDA and customs officials to stop cross-border drug shipments, and give the U.S. Postal Service new tools to block mail delivery of fentanyl and other illicit drugs.

The House approved a sweeping opioid measure in June, including changes to Medicare and Medicaid reimbursement rules that would allow for coverage of inpatient drug rehab services and non-opioid pain management drugs.

Congress would have to race to reconcile the separate House and Senate bills this month before the House adjourns, which could be before Oct. 1.


FDA Commissioner Scott Gottlieb is likely to testify this month before the Senate HELP Committee on how his agency is leveraging new laws like 21st Century Cures and new funding to speed drug approvals.

Gottlieb had been scheduled to testify last week, but the hearing was canceled as the Senate adjourned for the Labor Day holiday.

Committee aides say they expect to reschedule the hearing with Gottlieb for later this month.


The Senate last month approved $1 million for HHS to develop regulations that would require pharmaceutical manufacturers to include pricing information in consumer advertising, but it's not clear if the funding will remain in the final bill.

Senate Democratic Whip Dick Durbin, D-Ill., and Judiciary Committee Chairman Chuck Grassley, R-Iowa, pushed the language as an amendment to the fiscal 2019 HHS funding bill.

"PhRMA hates this amendment like the devil hates holy water," Durbin said.

The trade associations PhRMA and BIO opposed the amendment, saying consumers have different costs for out-of-pocket expenses depending on their insurance plans. List prices for prescription drugs vary depending on discounts, rebates and negotiations by insurers, according to the trade groups, which also raised First Amendment concerns.

The Durbin-Grassley provision still has to win approval in the House, and the House version of the HHS spending bill doesn't include similar language on consumer advertising. But HHS Secretary Alex Azar – who previously boasted the idea – weighed in directly with senators in favor of the amendment, and the administration is likely to advocate that it be included in the final bill, too.

A proposed HHS regulation on drug pricing transparency is under review at the White House's Office of Management and Budget. It's not known when that rule may be finalized, but it is believed to deal with consumer ads.


The Republican majority on the House Energy and Commerce Committee last month sent letters to nine contract pharmacies that participate in the 340B prescription drug program, seeking information on industry practices and pharmacies' financial stake in the program.

During a nearly three-year review of the 340B program, the committee earlier this year released a report finding that despite the program's rapid growth, it lacks robust government oversight, meaningful reporting requirements and reliable data.

The letters were written by committee Chairman Greg Walden, R-Ore., Health Subcommittee Chairman Michael Burgess, R-Texas, and Oversight and Investigations Subcommittee Chairman Gregg Harper, R-Miss.


Two former physicians now serving in the House say CMS should prevent managed care plans from using "onerous and often unnecessary prior authorization requirements" to effectively stifle patient access in Medicare Advantage plans.

Reps. Phil Roe, R-Tenn., and Ami Bera, D-Calif., are calling on CMS to issue guidance on Medicare Advantage plans' use of prior authorization. The lawmakers say the guidance would help remove access barriers for Medicare beneficiaries, about one-third of whom are in Medicare Advantage plans.

Roe and Bera plan to send the letter to CMS later this month. Roe, who is chairman of the Veterans Affairs Committee, is a former obstetrician, and Bera is a former physician.


Sen. Tammy Baldwin, D-Wis., introduced a resolution that would block a Trump administration plan to extend the use of short-term health insurance plans, which feature lower premiums but scaled-down coverage.

HHS last month finalized regulations authorizing the sale and renewal of the plans from three months to up to three years. The plans could be available as soon as this fall in states that authorize them.

The administration said the plans will aid consumers facing high premiums and limited options in the individual insurance market. "Millions of Americans who are between jobs and who pay for their own insurance will welcome this extended option for lower-cost, short-term, renewable policies," said Senate HELP Committee Chairman Lamar Alexander.

Congressional Democrats say the plans are less expensive only because they don't have to comply with the Affordable Care Act's requirements on pre-existing conditions, essential health benefits and prescription drug coverage.

Baldwin's measure would block implementation of the HHS regulation under the Congressional Review Act, which is the procedural tool Republicans used last year to overturn multiple Obama administration environmental and labor regulations. Baldwin, who is seeking re-election in November, said she has sufficient support to force a vote before the Senate adjourns this fall.


The House Energy and Commerce Health Subcommittee on Wednesday will hold a hearing on draft legislation that would overturn "pharmacy gag clauses."

The bill, which is a discussion draft, aims to ban private group and individual health plans as well as Medicare from restricting a pharmacy's ability to inform customers about lower-cost, out-of-pocket prices for prescriptions. Currently, pharmacists who disobey these clauses in contracts with pharmacy benefit managers can face penalties.

The Senate HELP Committee in July approved bipartisan legislation backed by Sen. Susan Collins, R-Maine, that would prohibit these restrictions. The House panel isn't considering companion legislation to Collins' bill, introduced by Rep. Lloyd Doggett, D-Texas. Instead, the subcommittee is seeking to develop its own legislation.

During the Senate committee vote, Collins called gag clauses "an egregious tool" some insurers use to conceal prescription drug prices from patients at the pharmacy. HHS Secretary Alex Azar told the Senate committee earlier this summer that the contract provisions were "unconscionable."


The House Energy and Commerce Health Subcommittee on Wednesday will hold a hearing on bipartisan legislation that aims to coordinate care under Medicaid for children with complex medical conditions.

Introduced by Reps. Joe Barton, R-Texas, and Kathy Castor, D-Fla., the legislation would allow states to participate in national children's hospital networks, effectively allowing kids living in one state to be treated by pediatric providers in other states. The bill wouldn't mandate that states participate, but would allow them to opt in to the networks, which could coordinate services among home, primary, ambulatory, acute and post-acute care providers.

Rick Merrill, CEO of Cook Children's Health Care System in Fort Worth, Texas, is scheduled to testify at the hearing. Merrill is also the chairman of the Children's Hospital Association board of trustees.

Similar legislation enjoys bipartisan support in the Senate and was introduced by Judiciary Committee Chairman Chuck Grassley, R-Iowa, and Sen. Michael Bennet, D-Colo.


The House Ways and Means Committee on Wednesday will vote on a series of mostly bipartisan healthcare bills, including one on how Medicare administrative contractors make local reimbursement decisions.

Introduced by Reps. Lynn Jenkins, R-Kan., and Ron Kind, D-Wis., the bill aims to provide transparency and consistency for providers by codifying requirements that Medicare administrative contractors must follow when making local coverage determinations. The transparency would include open meetings for stakeholders, timely feedback to public comments and a reconsideration process.

The committee is also scheduled to vote on legislation by Reps. Erik Paulsen, R-Minn., and Kind to codify existing regulations that ensure certain Medicare beneficiaries have time to make decisions about their Medicare coverage. Another bill, by Reps. Peter Roskam, R-Ill., and Earl Blumenauer, D-Ore., would create a three-year pilot program to test the use of smart-card technology in Medicare.


Top Republicans and Democrats on congressional committees that oversee the 340B prescription drug program "remain concerned" that the Health Resources and Services Administration has failed to issue rules that would update and clarify program requirements.

In a letter last week to HRSA's director of the Office of Pharmacy Affairs, the lawmakers wrote that the agency has regulatory authority to create an administrative process to resolve compliance disputes and levy penalties on prescription drug manufacturers that "knowingly and intentionally overcharge" for a 340B drug. The agency also has rulemaking power to define standards for calculating 340B prices.

"Unfortunately, HRSA has repeatedly delayed issuing rules and guidance regarding these important issues," wrote House Energy and Commerce Committee Chairman Greg Walden, R-Ore.; ranking Democrat, Rep. Frank Pallone, D-N.J.; Senate HELP Committee Chairman Lamar Alexander, R-Tenn.; and ranking Democrat, Sen. Patty Murray, D-Wash.


Republican leaders on a House committee last week sent letters to seven pharmacy benefit manager companies seeking information on their role in negotiating prescription drug benefits for employer-sponsored health plans, health maintenance organizations, Medicaid managed care plans and Medicare Part D drug plans.

Energy and Commerce Committee Chairman Greg Walden, R-Ore., asked companies how their work impacts the final drug prices paid by consumers and beneficiaries of federal programs like Medicare Part D. The seven-page letters included several dozen questions, including whether PBMs would pass along savings to consumers if drug manufacturers lowered list prices.

The letters, which requested responses by Sept. 30, were also signed by Health Subcommittee Chairman Michael Burgess, R-Texas, and Oversight and Investigations Subcommittee Chairman Gregg Harper, R-Miss.


The House Energy and Commerce Committee last week asked the Medicare Payment Advisory Commission to examine the degree to which hospital consolidation increases Medicare costs.

In a letter to MedPAC Chairman Dr. Francis Crosson, the committee said it wants to understand the impact consolidation has on Medicare beneficiaries and whether consolidation yields a benefit to patients.

The letter was written by committee Chairman Greg Walden, R-Ore., Health Subcommittee Chairman Michael Burgess, R-Texas, and Oversight and Investigations Subcommittee Chairman Gregg Harper, R-Miss.


The House Energy and Commerce Oversight and Investigations Subcommittee will hold a hearing Thursday on reports of abuse, neglect and substandard care at skilled nursing and other nursing facilities participating in Medicare and Medicaid.

Subcommittee Chairman Gregg Harper, R-Miss., said the hearing will review CMS' role of overseeing the facilities' safety as well as examine reports by the HHS inspector general and the Government Accountability Office (GAO).

Scheduled witnesses are Dr. Kate Goodrich, director of CMS' Center for Clinical Standards and Quality; Ruth Ann Dorrill of the HHS Inspector General Office; and John Dicken, director of healthcare at GAO.

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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