Health Policy Report

September 24, 2018

The Week in Review

While House lawmakers left Washington for a district work week, the Senate reconvened last week for a brief legislative session. The upper chamber cleared a highly anticipated package of bills to address the nation’s opioid crisis — the Opioid Crisis Response Act (H.R. 6) — setting up a conference with the House to iron out the final details of the response legislation. The Senate also continued work on the FY 2019 appropriations process with final passage of the Defense-Labor-HHS-Education conference report.

The Week Ahead

The Senate will reconvene today (Monday) and turn its attention to its presidential nominations queue. As of now, Senators are expected to consider the nominations of Jackie Walcott to be a Representative of the United States to the International Atomic Energy Agency (IAEA) and Peter Feldman to be Commissioner of the Consumer Product Safety Commission (CPSC).

Congressional lawmakers are also nearing a compromise on a bill that would reauthorize the Federal Aviation Administration (FAA). While discussions are still ongoing, news reports suggest that the House could tentatively vote on both a short-term extension, as well as the long-term reauthorization deal this week in hopes of keeping the FAA funded past the September 30th government funding deadline. The short-term, two-week extension is designed to give the Senate more time to approve the multi-year reauthorization deal after it passes the lower chamber.

Meanwhile, the House will return from its week-long recess on Tuesday as lawmakers aim to keep the government funded beyond the September 30th deadline. The House will vote on the minibus package containing Defense-Labor, Health and Human Services, Education (Labor-HHS) FY 2019 funding bills (H.R. 6157) (bill textconference reportsummary). The Defense-Labor-HHS package will also serve as the vehicle for a continuing resolution (CR) through December 7th — allowing Congress to avert a shutdown and punt decisions on controversial issues until after the mid-term elections.

Additionally, House lawmakers are also expected to consider a bill (H.R. 3798) next week that would amend the Affordable Care Act’s (ACA) employer mandate to adjust the definition of “full-time employees” from a 30-hour threshold up to a 40-hour threshold. Previous versions of the bill stalled in the House during the 113th and 114th Congresses. The lower chamber is also scheduled to vote on a trio of "Tax Reform 2.0" bills that passed out of Committee last week, including: (1) The Family Savings Act (text; summary); The Protecting Family and Small Business Tax Cuts Act (text; summary); and (3) The American Innovation Act (text; summary). 

The House may also consider the Opioid Crisis Response Act (H.R. 6) this week, as lawmakers look to notch one final legislative accomplishment before the midterm elections. The package — comprised of dozens of bipartisan proposals intended to strengthen enforcement activities as well as prevention efforts and services for those affected by substance use disorders — overwhelmingly passed the Senate last Monday, and bicameral staff-level negotiations on a conference version have continued throughout the weekend. Committee sources have indicated that negotiations over most of the bill’s major provisions have been resolved, and that the bill could be released as soon as this evening.

Senate Approves $855.1 Billion Spending Package for HHS, Other Agencies

Last week, the Senate overwhelmingly passed a bipartisan “minibus” package for the Defense-Labor, Health and Human Services, Education (Labor-HHS) fiscal year 2019 funding bills (H.R. 6157) on a vote of 93-7 (conference report; explanatory statement; summary). The Defense-Labor-HHS package also served as the vehicle for a continuing resolution (CR) to fund outstanding appropriations bills through December 7th, allowing Congress to avert a shutdown and punt decisions on controversial issues until after the midterm elections. The House is expected to vote on the spending package when Members return to Washington this week and send the measure to President Trump’s desk before the end of the fiscal year on September 30. It’s widely expected that the measure will pass.

The funding bill provides approximately $90.5 billion in discretionary funding for the Department of Health and Human Services, a $2.3 billion increase above the comparable FY2018 level. In addition, the bill includes $711 million for activities authorized by the 21st Century Cures Act. The opioid-related proposals have remained a high priority throughout the appropriations process, with funding to address opioid abuse cutting across several agencies and programs. Overall, lawmakers approved approximately $3.8 billion, an increase of over $206 million, for these activities. Additionally, the bill includes $1.9 billion for the Substance Abuse Block Grant through the Substance Abuse and Mental Health Administration (SAMHSA).

Senate Passes Sweeping Legislation Addressing Opioid Epidemic

The Senate overwhelmingly approved a bill last Monday to address the opioid epidemic in a 99 to 1 vote. The Opioid Crisis Response Act (H.R. 6) contains dozens of bipartisan proposals intended to strengthen enforcement activities as well as prevention efforts and services for those affected by substance use disorders, particularly opioid addiction. House staff and leadership continue to work towards an agreement for floor consideration, and aims to pass the bill under suspension rules by the time the lower chamber adjourns next week. Sen. Mike Lee (R-UT) cast the only vote in opposition to the bill in the upper chamber.

Earlier this month, Senate leaders appeared to have reached an agreement on an opioids package which merged the wide-ranging bills separately advanced by the Finance, Judiciary, Commerce, and Health, Education, Labor and Pensions (HELP) committees (section-by-section). Senate leaders hit a brief snag last week when Democrats objected to new grant program language they said was too narrowly drafted. Senate Republicans agreed to revise the language to expand the universe of potential grantees, thereby paving the way for the chamber to advance the bill. The Senate considered a substitute amendment (S. Amdt. #4013) to the version passed in the House last June. Bicameral staff-level negotiations that started weeks ago, and have recently intensified and stalled a score of the bill. The chambers still need to resolve some of the thorniest policy differences around issues such as the privacy rules governing a patient’s medical record when it contains information about substance use disorder.

There have also been credible reports that congressional leaders are considering including a change to the financing of drugs for beneficiaries in the Medicare Part D coverage gap, or “donut hole” as part of the opioids package. The measure — a top priority for branded pharmaceutical manufacturers — would reduce the share of drug costs that pharmaceutical companies must cover beginning in 2019 for beneficiaries in the donut hole from 70 percent to 63 percent, and policymakers propose to also include a version of the CREATES Act (H.R. 2212, S. 974) in exchange for the reduction in drugmakers’ share of costs for beneficiaries. The generic industry-backed CREATES Act, which would allow generic drug companies to sue branded drug manufacturers when they are allegedly abusing the Food and Drug Administration’s (FDA) Risk Evaluation and Mitigation Strategies (REMS), would save the federal government $3.3 billion over 10 years, according to a report released last week by the Congressional Budget Office. It’s unclear whether other drug industry offsets are being considered to cover the approximately $4 billion delta between the cost of the donut hole change and the CREATES Act savings.

House and Senate leaders are aiming to vote on a compromise measure before the end of September in order to send it to the President’s desk before November’s midterm elections.

Senate Approves Legislation Prohibiting ‘Gag Clauses’ in Private Insurance Plans

The Senate approved a bill (S. 2554) on a vote of 98-2 last Monday that prohibits “gag clauses” in insurance contracts preventing pharmacists from telling customers that they could save money by paying out-of-pocket rather than by using insurance. The Patient Right to Know Drug Prices Act — sponsored by Senators Susan Collins (R-ME), Claire McCaskill (D-MO), John Barrasso (R-WY), Debbie Stabenow (D-MI), and Bill Cassidy (R-LA) — would apply to all private insurance plans. This legislation expands on the gag clause ban passed by the Senate earlier this month (S. 2553), which applied to Medicare Part D and Medicare Advantage plans. A companion bill (H.R. 6143) has been introduced in the House.

Senator Mike Lee (R-UT) offered an amendment that would have limited the application of S. 2554 to self-insured group health plans, but the amendment was not adopted. S. 2554 also includes language to specifically include biosimilar pharmaceutical products under the Food and Drug Administration review clauses for abbreviated drug applications of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. With broad bipartisan support and scant opposition from industry stakeholders, it is increasingly likely that a ban on gag clauses will be enacted this year. Both S. 2553 and S. 2554 now await action in the House.

FDA Issues Final Opioid Analgesic REMS Guidance

The Food and Drug Administration (FDA) finalized guidance adding immediate release (IR) opioid painkillers to the Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) after determining that REMS is necessary for all outpatient opioid use. According to FDA Commissioner Scott Gottlieb, M.D., the guidance is designed to limit overall opioid dispensing, thereby limiting exposure to opioids and preventing addiction. The products added to REMS last week account for about 90 percent of all outpatient opioid prescriptions. The FDA concurrently released a new education blueprint for healthcare providers who treat patients for pain, a guide designed to increase awareness of proper pain treatment, the risks of certain treatments like opioid painkillers, how to manage patients who do require opioid painkillers, and the availability of alternative treatments.

Since 2012, manufacturers of extended-release and long-acting (ER/LA) opioid analgesics have been required to offer training to prescribers of those products. One approach drug companies took to meet this requirements was to provide unrestricted grants to accredited continuing education providers for the development of education courses for prescribers based on content outlined by the FDA. However, this guidance did not previously apply to IR opioid analgesic products intended for outpatient use.

To meet the requirements, drug manufacturers with products covered by the REMS program will provide unrestricted grants to develop educational programs on safe opioid treatments for healthcare providers using the new REMS Education Blueprint. The new educational programs are expected to be available to providers in March 2019, but are not mandatory. In addition to placing IR opioids in the REMS program, the FDA approved changes to safety labeling for all outpatient opioid analgesic products. The new requirements stipulate that labels include the availability of education for prescribers and other providers under REMS to better monitor and care for patients with pain. The FDA’s Opioid Policy Steering Committee is continuing to review whether the FDA should require some form of mandatory education regarding opioids to healthcare providers.

Bipartisan Group of Senators Unveil Bill to End Surprise Medical Bills

A bipartisan group of Senators last week announced draft legislation aimed at curbing surprise medical bills for patients. The group of members from the bipartisan Senate health care transparency working group — Sens. Bill Cassidy (R-LA), Michael Bennet (D-CO), Chuck Grassley (R-IA), Tom Carper (D-DE), Todd Young (R-IN), and Claire McCaskill (D-MO) — noted that the bill is intended to jumpstart discussions in Congress about how best to stop the use of balanced billing to charge patients for emergency treatment or treatment provided by an out-of-network provider at an in-network facility. The bill would prevent a health would prevent out-of-network providers from charging additional costs for emergency services or non-emergency services beyond the amount usually allowed under a patient’s insurance plan, and instead would hold the insurer responsible for the additional charges.

The draft legislation also proposes to require health care providers to give written notification to patients who receive emergency care at an out-of-network facility before any non-emergency follow-up appointments, in order to warn patients they will be subject to added costs. Additionally, the discussion draft would also instruct the Secretary of Health and Human Services to conduct a study and issue a public report that includes recommendations to Congress regarding the impact the bill would have on the prevalence of patient cost-sharing, patients’ access to care, and the quality of that care, among other things. Sen Cassidy noted that the lawmakers will continue to refine the discussion draft before formally introducing the bill in the 116th Congress.