Below is this week’s “Capitol Hill Healthcare Update,” which is posted on Mondays when Congress is in session. Included this week is an update on congressional efforts to finish opioids response legislation; efforts by pharmaceutical manufacturers to change discounts they are required to provide Medicare beneficiaries in the Part D donut hole; the status of funding for HHS and the rest of the government; pending House votes on pharmacy “gag clauses”; and more.


Congressional staff spent the weekend negotiating details of what’s expected to be the final version of opioids response legislation that the House would vote on this week and the Senate would consider early next month.

The final text – which could be released as soon as today – would draw on provisions of an opioids bill the Senate overwhelmingly approved last week and similar legislation the House passed in June.

Republican House leaders want to adjourn as soon as fiscal 2019 spending bills are in place to allow vulnerable GOP lawmakers to return to their respective districts to campaign for re-election. That could happen as soon as the end of this week – which is driving lawmakers to quickly complete the opioids bill.

The final legislation is expected to include key provisions of each chamber’s bills, including blocking mail shipments via the U.S. Postal Service of fentanyl and synthetic opioids and allowing the FDA to require opioids to be prescribed in shorter durations rather than month-long supplies. The bill also is expected to expand access to medication-assisted treatment, include new research funding to develop nonaddictive painkillers and expand telehealth coverage for treatment options.

Negotiators were trying to resolve sticking points between the two bills, including whether to allow Medicaid reimbursement for inpatient drug rehabilitation services and whether to allow providers to share patients’ substance abuse treatment records.


The House this week is expected to give final congressional approval to a mammoth spending bill that includes full-year funding for HHS, federal health programs and medical research.

If the House passes the bill this week, it would mark the first time in a decade that Congress has approved yearlong HHS funding before the start of the federal fiscal year.

The sweeping spending package includes labor, health and education programs and is paired with Pentagon funding, covering almost 70 percent of government discretionary spending for fiscal 2019. The bill also includes stopgap funding through Dec. 7 covering any separate appropriations bill not approved by the Oct. 1 start of the fiscal year.

The Senate approved the bill last week.

President Donald Trump has threatened to veto spending bills not to his liking, but Republican leaders are confident Trump would not risk a government shutdown so close to the November elections.

Under the agreement, HHS’ budget would rise to $90.5 billion, $2.3 billion more than the current fiscal year, according to a summary released by the House Appropriations Committee. NIH would receive a $2 billion increase — to $39 billion. The additional funding would target oncology and Alzheimer’s research.

The CDC would receive $7.9 billion for programs to protect against health threats such as pandemics and biological threats, and $2 billion for biomedical research, acquisition of medical supplies and vaccines, and hospital preparedness grants. Federal programs that help fight, treat and stop substance abuse, and those that support access to mental health services, would receive $6.7 billion.


Final legislation to address the opioids epidemic that is likely to be unveiled this week is not expected to include changes to the coverage gap in the Medicare Part D prescription drug program that had been sought by pharmaceutical manufacturers.

Republican House leaders had been pushing to correct a Congressional Budget Office (CBO) fiscal forecast that led lawmakers in February to vote to increase from 50 percent to 70 percent the discount manufacturers provide for brand-name drugs in Part D donut hole. That change actually reduced costs for insurers offering Part D plans and pharmacy benefit managers.

Sen. Ron Wyden, D-Ore.

Some lawmakers had wanted to couple language lowering the industry’s donut hole contribution to 63 percent, with separate legislation to prevent manufacturers from delaying generic drug companies’ access to drugs protected by FDA’s REMS safety program. That REMS language would lower federal healthcare spending by $3.3 billion over a decade, according to a CBO analysis.

But disagreements among House and Senate Republicans and the White House plus opposition from leading Democrats stalled the effort. Even though the February vote was caused by a CBO miscalculation, Democrats on Capitol Hill were unwilling to make the change even in return for the REMS legislation they had long sought.

Sen. Ron Wyden, D-Ore., the ranking Democrat on the Finance Committee, said Republicans’ effort to aid “price-gouging pharmaceutical manufacturers” in the opioids response bill was “unconscionable.”


The House Energy and Commerce Health Subcommittee on Thursday is scheduled to hold a hearing on bipartisan legislation to increase surveillance of state data collection on maternal mortality.

The legislation, by Reps. Jaime Herrera Beutler, R-Wash., and Diana DeGette, D-Colo., aims to help state agencies collect data around maternal mortality, identify groups of women with disproportionately high rates of maternal mortality, and understand how disparities in maternal care, health risks and health outcomes impact mortality.

Scheduled witnesses include Charles Johnson, the founder of 4Kira4Moms; Stacey Stewart, president of the March of Dimes; and Dr. Hal Lawrence, III, CEO of the American College of Obstetricians and Gynecologists.


Sen. Susan Collins, R-Maine

Legislative solutions to address prescription drug prices typically have stalled because of partisan differences, but Congress is speeding passage of measures that would allow pharmacists to tell patients that paying for certain drugs with cash could be less expensive than their insurance copay.

The Senate last week approved 98-2 legislation by Sen. Susan Collins, R-Maine, to prohibit the so-called pharmacy gag clauses in employer-provided plans. The Senate earlier this month overwhelmingly approved legislation by Sen. Debbie Stabenow, D-Mich., that would ban the gag clauses in Medicare and Medicare Advantage plans.

The House on Tuesday is scheduled to vote on both bills under fast-track procedures typically reserved for noncontroversial legislation.


House Ways and Means Committee Chairman Kevin Brady, R-Texas, last week praised CMS for proposing a rule that would cut red tape and reduce regulatory and administrative burdens for Medicare providers.

CMS wants to eliminate dozens of paperwork requirements for physicians and hospitals, with the goal of allowing providers to spend more time with patients.

Brady and Ways and Means Health Subcommittee Chairman Peter Roskam, R-Ill., had called on CMS to take steps to reduce providers’ administrative burdens.

Reducing paperwork is about “getting Washington out of the way so our providers can focus on delivering high-quality and affordable care for patients, especially those in rural areas with limited access to care,” Brady said.


The House on Tuesday is scheduled to vote on bipartisan legislation that would reauthorize health emergency programs, including research on vaccines and antibiotics for drug-resistant bacteria that could be needed during public health emergencies.

Rep. Anna Eshoo, D-Calif.

Introduced by Reps. Susan Brooks, R-Ind., and Anna Eshoo, D-Calif., the legislation would renew for five years key preparedness and response programs within the Pandemic and All-Hazards Preparedness Act.

It also would authorize funding to develop medical countermeasures for pandemic influenza and emerging infectious diseases within the Biomedical Advanced Research and Development Authority.

The Senate has similar legislation by Sen. Richard Burr, R-N.C., that has not been considered.