Washington Watch for May 2018
Carter L. Alleman, J.D.
Energy and Commerce Health Subcommittee Considers 60+ Opioid Bills
The House Energy and Commerce Health Subcommittee has advanced 57 bills focused on combating the opioid crisis.
Not all measures were passed with bipartisan support, and Democratic members voiced concern that the committee was moving too quickly on too many bills that had not yet been fully vetted by staff, stakeholders, and the appropriate agencies. Republican leadership responded that many of the bills were left in discussion draft form to continue work on getting the technical details correct.
Thirty-five bills were passed by voice vote, 13 were passed en-bloc, and nine bills passed by individual roll call vote. Subcommittee Chairman Michael Burgess (R-Texas) adjourned the hearing without considering six bills that were originally included in the markup notice.
Full committee markup of the bills is expected to take place within the next several weeks. Chairman Greg Walden (R-Ore.) has repeatedly stated that he hopes the House will take up the opioid legislation by Memorial Day weekend. During the markup, the subcommittee also advanced legislation to reauthorize the Animal Drug User Fee Act (ADUFA) and the Animal Generic Drug User Fee Act (AGDUFA).
Opioid Declaration Renewed
The Trump Administration has renewed the public health emergency declaration for the opioid crisis, effective April 24. The opioid epidemic was first declared a national public health emergency in October. The 90-day designation was renewed again in January. The declaration gives federal agencies the authority to more quickly hire treatment specialists and reallocate resources to respond to the crisis.
Antibiotic Use Increases Worldwide
A new report from the National Academy of Sciences reveals that human use of antibiotics rose by 39 percent worldwide between 2000 and 2015. The increase was driven by antibiotic use in low-income and middle-income countries, in part due to population growth in those areas. Consumption of antibiotics in high-income countries slightly decreased during the time period of the analysis.
Ways and Means Convenes Second Red Tape Roundtable
House Ways and Means Health Subcommittee Chairman Peter Roskam (R-Ill.) convened the second in a series of roundtables for the Medicare Red Tape Relief Project last week. During the first roundtable discussion, lawmakers spoke with physicians about the regulatory burden of the Medicare program. This time, hospitals were invited to discuss with the subcommittee how current Medicare regulations are hindering their ability to improve care for beneficiaries.
Panelists spoke about the impact of regulations on rural and underserved communities, as well as the promise of telehealth to improve care for this population. The conversation also touched on the restrictions surrounding physician-owned hospitals.
President Signs Executive Order on Safety Net Programs
President Trump has signed an executive order telling the U.S. Department of Health and Human Services (HHS) and other federal agencies to increase state flexibility to create or strengthen work requirements in safety net programs, including Medicaid. The order also orders agencies to conduct a review of existing regulations to ensure people receiving public assistance are being pushed into employment programs. The order aims to restore “independence and dignity to millions of Americans.” Steven Wagner, Acting Assistant Secretary of HHS’ Administration for Children and Families, has stated that HHS will announce new policy guidance and research in the coming months.
Rescission Package Announced
The Trump Administration has decided to request no more than $25 billion in its forthcoming rescission package, according to Rep. Tom Cole (R-Okla.), Chairman of the House Appropriations Labor/HHS Subcommittee. This is less than the amount originally anticipated since package of cuts to fall in the range of $30 to $60 billion. While some of the funding will be pulled from the most recent omnibus spending deal, the White House is also expected to rescind unspent funding from prior years. The package could be just the first of several claw backs to come from the Trump administration this year and is expected to be released after lawmakers return from a week-long recess on May 7. Office of Management and Budget (OMB) Director Mick Mulvaney hopes the House will vote on the proposal before July.
HELP Advances Opioid Crisis Package
The Senate Health, Education, Labor, and Pensions (HELP) Committee unanimously advanced S. 2680, the Opioid Crisis Response Act of 2018 last week. The legislation includes more than 40 bipartisan proposals from 38 different senators. The bill reauthorizes a grant program to increase access to addiction treatment created by the 21st Century Cures Act for an additional three years and makes changes to the funding formula to prioritize states most affected by the opioid epidemic.
The legislation also creates new grants for the establishment of comprehensive opioid recovery centers to provide medication-assisted treatment (MAT) and related services and will allow the National Institutes of Health (NIH) additional flexibility in conducting opioid-related research. The bill will also make it easier for providers to prescribe smaller packs of painkillers for limited duration and includes provisions to increase detection of illegal drugs at the border. During the markup, Chairman Lamar Alexander (R-Tenn.) stated his hopes that the bill will be considered by the full Senate this summer.
HELP to Consider Maternal Mortality Measure Next Month
The Senate Health, Education, Labor, and Pensions (HELP) Committee plans to vote on a bipartisan bill next month to address the nation’s increasing maternal mortality rate, according to Ranking Member Patty Murray (D-Wash.). The Committee will mark up the Maternal Health Accountability Act (S. 1112) sponsored by Sens. Shelley Moore Capito (R-W. Va.) and Heidi Heitkamp (D-N.D.) to support state efforts to track and investigate pregnancy-related deaths and prevent future deaths from occurring. It is not clear when the Energy and Commerce Committee will consider the House version of the bill (H.R. 1318), sponsored by Rep. Jaime Herrera Beutler (R-Wash.).
Proposed Tariffs May Impact Price of Drugs, Devices
An increasing number of health care stakeholders are concerned that the President’s proposed tariffs on products from China could result in significant increases in cost for dozens of drugs and medical devices. The Administration has proposed a 25 percent tariff on a list of Chinese-manufactured goods that includes supplies used to manufacture drugs and devices. Products like insulin, antidepressants, and epinephrine could be affected. Some of these drugs are already in short supply, and others have been criticized for recent increases in price. Additionally, one estimate indicates that 12 percent of medical devices imported into the U.S. come from China, and that the proposed tariffs could cost the medical device industry up to $1.5 billion each year. It is still unclear whether the tariffs will be enacted or are a negotiating tactic.
GAO Releases Report on Medicare Data Security
The Government Accountability Office (GAO) has released a new report calling for increased oversight by CMS over the data security of beneficiary information. The report was initially requested by the House Energy and Commerce Committee. Although CMS has an oversight program in place for Medicare Administrative Contractor (MAC) data, it does not have a similar program to monitor the security of Medicare beneficiary data used by researchers and qualified entities. The GAO recommends that the agency issue additional guidance on required security controls and more routinely track its oversight efforts.
Surgeon General Issues Public Health Advisory on Naloxone
Surgeon General Jerome Adams has issued a public health advisory urging increased access to naloxone. The public health advisory reads as follows: “I, Surgeon General of the United States Public Health Service, VADM Jerome Adams, am emphasizing the importance of the overdose-reversing drug naloxone. For patients currently taking high doses of opioids as prescribed for pain, individuals misusing prescription opioids, individuals using illicit opioids such as heroin or fentanyl, health care practitioners, family and friends of people who have an opioid use disorder, and community members who come into contact with people at risk for opioid overdose, knowing how to use naloxone and keeping it within reach can save a life.”
DOJ Looks to Join Opioid Settlement
The U.S. Department of Justice (DOJ) is requesting permission to join settlement talks as a “friend of the court” in lawsuits filed against manufacturers and distributors of opioids by state and local governments seeking to recoup the costs stemming from the tide of opioid addiction and overdoses. This role would allow the DOJ to help determine non- monetary remedies for the opioid epidemic and indicates that the federal government does not have plans to join the more than 400 lawsuits consolidated against opioid makers. U.S. District Judge Dan Polster of Cleveland has expressed hope that both sides will negotiate a deal this year to address current pharmaceutical business practices and the roots of the opioid crisis.
Retirements and Resignations from Congress
- House Speaker Paul Ryan (R-Wis.) has announced that he will not seek re-election in the November midterms. He will serve the remainder of his term and retire from Congress
- Rep. Elizabeth Esty (D-Conn.) has announced that she will not run for reelection in the upcoming November midterms. Esty currently serves on the House Committee on Veterans’ Affairs.
- Rep. Blake Farenthold (R-Texas) also announced his immediate resignation from Congress. Farenthold was a member of the Oversight and Government Reform Committee and the Judiciary Committee.
- Rep. Patrick Meehan (R-Pa.) announced on Friday that he would resign from Congress, effective immediately.
- Rep. Charlie Dent (R-Pa.), a member of the House Appropriations Committee, announced plans to resign from Congress in the coming weeks, noting that his last day on the job would be sometime in May.
- Rep. Ryan Costello (R-Pa.) has announced that he will not be seeking reelection in the upcoming November midterms. Costello currently serves as a member of the House Energy and Commerce Committee.
Key House Committee Considers Legislation to Allow Electronic Prior Authorization
The House of Representatives Energy and Commerce Health Subcommittee held a hearing this week on a variety of legislative proposals, including the Standardizing Electronic Prior Authorization for Safe Prescribing Act, H.R. 4841. This bipartisan legislation would allow for electronic prior authorization (PA) under Medicare Part D and allow for the creation of technical standards for the electronic transmission of PA.
CMS Finalizes 2019 Opioid Overutilization Policies
Earlier this month, the Centers for Medicare & Medicaid Services (CMS) published its 2019 Rate Announcement and Call Letter, finalizing policy and payment updates to the Medicare Part D prescription drug benefit program. In the call letter, CMS adopted an opioid medication supply limitation policy for patients who have not been prescribed opioids in the last 60 days or longer.
Beginning in 2019, Medicare Part D insurers must limit initial short- and long-acting opioid prescriptions for the treatment of acute pain in opioid-naïve patients to no more than a seven-day supply. CMS directs Part D insurers to implement real-time safety alerts in pharmacy systems at the point-of-sale (POS) of opioid prescriptions, during which time the insurer may deny coverage for the medication. Prescribers and pharmacists will be allowed to appeal denials and submit clinical documentation to Part D insurers to support coverage of the opioid medication. CMS will not apply this coverage limitation to Medicare beneficiaries who are being treated for cancer-related pain; are receiving hospice, palliative, or end-of-life care; or are residents of a long-term care facility.
CMS also finalized a policy to allow Part D insurers to limit coverage of opioid prescriptions for at-risk beneficiaries to certain prescribers and pharmacies. CMS instructs insurers to integrate the agency’s Overutilization Monitoring System, which retrospectively identifies beneficiaries obtaining high levels of opioids from multiple prescribers and pharmacies, into case management processes in order to track opioid overuse. Under this policy, insurers have the flexibility to restrict the number of prescribers and pharmacies from which a patient may receive opioid medications and may deny coverage for medications at the POS if the patient exceeds the set prescriber and/or pharmacy count.