Health Policy Report

The Week in Review

Although it feels like a month ago, the first ever meeting between the active heads of state of North Korea and the United States occurred last Tuesday when President Trump and North Korean leader Kim Jong Un met for a summit in Singapore. The two leaders formalized the signing of a joint statement outlining the broad parameters of a future relationship between the two countries, largely mirroring previous agreements between North Korea and the international community and offering few details for denuclearization of the Korean peninsula. However, both leaders seemed pleased with the outcome of the meeting, with President Trump saying that the joint agreement was “tremendous” and that he expects the denuclearization process to start “virtually immediately.”

In Washington, the House passed nearly 40 bipartisan bills over the course of the week related to the opioid crisis — all but three of which were non-controversial — covering various issues including the support for appropriate prescribing practices and safe prescribing mechanisms, expanding access to prevention and treatment services, improving drug enforcement efforts, and providing additional support to families affected by the epidemic. Full details on those measures are provided in the roundup below.

Meanwhile, the Senate spent the week working on the FY19 National Defense Authorization Act (NDAA), but consideration of the massive Pentagon spending and policy bill will stretch into next week. One notable vote last week was the failure of an amendment to bolster the Committee on Foreign Investment in the United States (CFIUS), which was being championed by Sen. Pat Toomey (R-PA).

A significant result in the nation’s primary election season came last Tuesday when Rep. Mark Sanford (R-SC) — one of President Trump’s most outspoken Republican critics in Congress — was defeated by Trump-backed state representative Katie Arrington. In Virginia, state senator Jennifer Wexton earned a decisive victory in a crowded Democratic primary for the rights to face one of the House’s most vulnerable Republicans, Rep. Barbara Comstock (R-VA). Further complicating matters for Virginia Republicans is the primary win for Corey Stewart — whose sharp rhetoric on immigration and outspoken support for Confederate symbols sparked outrage during his 2017 campaign for governor — as the county board member is now set to face off against Sen. Tim Kaine (D-VA) this fall.

The Week Ahead

The House will continue its opioids blitz with the consideration of a major package that combines many of the bills considered at the committee level over the past few weeks. The new vehicle — dubbed the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act (H.R. 6) — is set for a hearing in the House Rules Committee on Monday, with floor consideration to follow later in the week. Two other opioids bills are also set for floor time, namely a bill that allows states to provide Medicaid services for individuals with opioid use disorders in institutions for mental diseases (H.R. 5797) and another measure aimed at protecting the confidentiality of substance use disorder patient records (H.R. 6082).

The lower chamber is also poised to contend with an ongoing immigration push as the House is set to vote on two immigration bills Thursday. A draft immigration bill that is being pitched as a compromise between the conservative and moderate wings of the Republican party is expected to come up for a floor vote, along with a conservative proposal authored by Judiciary Chairman Bob Goodlatte (R-VA).  The so-called compromise legislation would establish a special visa program that would protect young undocumented immigrants from deportation, provide billions of dollars for a wall along the U.S-Mexico border, and impose new limits on legal immigration. However, a path forward for the measures is unclear due to mixed signals from the White House and lack of Democratic support.

While the Senate pushed their work on the NDAA to next week, it aims to finish consideration of the mammoth Pentagon funding bill with a final roll call vote scheduled Monday evening. The upper chamber will then move to begin its appropriations work on the floor as Majority Leader Mitch McConnell has filed cloture on the motion to proceed on a “minibus” that combines the Energy/Water, Legislative Branch, and Military Construction-Veterans Affairs appropriations bills. A cloture vote on the motion to proceed to that measure could come as early as Monday night.

House Passes 38 Opioid Bills; More Controversial Measures on Tap for This Week

Last Friday, the House of Representatives approved one additional bill to conclude the first week of the chamber’s two-week push to pass legislation at curbing the nation’s opioid epidemic. Over the course of the week, the House passed nearly 40 bipartisan bills — all but three of which were non-controversial — covering various issues including supporting appropriate prescribing practices and facilitating safe prescribing mechanisms, expanding access to prevention and treatment services, improving drug enforcement efforts, and providing additional support to families affected by the epidemic.

In addition to considering the remaining non-controversial committee-passed measures, the House this week will turn its attention to the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act (H.R. 6) a bipartisan measure introduced by Ways and Means Committee Chairman Kevin Brady (R-TX), Ranking Member Richard Neal (D-MA), Energy and Commerce Committee Chairman Greg Walden (R-OR), and Ranking Member Frank Pallone (D-NJ). The bill consolidates most of the measures cleared by the chamber this past week and includes contentious language that would permanently increase the cap on prescribing buprenorphine and cement authority for nurse practitioners and physician assistants to continue to prescribe the drug. House leaders plan to use H.R. 6 as the vehicle to move comprehensive opioid legislation to the Senate.  

Notably, two key items have been left out of H.R. 6 — the IMD CARE Act (H.R. 5797), which addresses a portion of the Medicaid payment exclusion for inpatient services knowns as the Institutions of Mental Disease (IMD), and the Overdose Prevention and Patient Safety Act (H.R. 6082) — both of which remain controversial. Instead, the House plans to hold separate votes on the two bills, and will allow a limited number of amendments to each. H.R. 6082, which makes technical changes to its predecessor version (H.R. 5795), addresses the privacy rules established under 42 CFR Part 2 governing how information regarding a patients’ substance use disorder treatment history is shared. House leaders anticipate they will have the votes to pass both bills, and are working to solidify an approach for sending these to the Senate.

As the House seeks to close out its work on the current slate of opioid legislation, the timing for Senate action may begin to crystalize. The Senate Finance Committee passed The Helping to End Addiction and Lessen (HEAL) Substance Use Disorders Act of 2018 this past week, which consolidates the 22 Senate draft bills released at the end of May and would further strengthen the Medicare, Medicaid and human services programs’ response to the opioid crisis. Senate committee leaders charged with devising an agreement on the scope of any measure for the full chamber’s consideration are still discussing viable options to move forward.

The midterm elections could complicate Congress’ effort to send legislation to the President in the near term. While largely united in the mission of advancing wide-ranging opioid legislation, Members of Congress will diverge in how they discuss the pending legislation in their home states and districts in the weeks ahead. Republicans will amplify their efforts to tout the bills as the next phase in their ongoing work to address the opioid epidemic. Meanwhile, Democrats are expected to support the measures, while also calling for more aggressive action and additional financial resources to combat the crisis.

House Labor-HHS Appropriations Panel Passes Spending Bill

The House Appropriations Committee has released a draft of their fiscal year (FY) 2019 Departments of Labor, Health and Human Services, Education (Labor-HHS) spending bill (summary), and the House Appropriations Labor-HHS Subcommittee swiftly approved the measure in at a markup Friday morning. The legislation outlines investments in medical research, public health, education, and other related agencies, and includes provisions to address various regulations.

The bill was approved by the Subcommittee this morning in a voice vote that broke along party lines. Democrats on the panel criticized the proposal for underfunding key programs and ignoring other pressing needs. That includes funding research on gun violence and allocating additional money to support services for migrant children separated from their parents and held in HHS-contracted facilities. Republicans touted a $1.25 billion funding increase for NIH — an increase that subcommittee Chairman Tom Cole (R-OK) said could yet grow. The legislation would set HHS’ budget overall at $89.2 billion, or $2.4 billion more than the White House requested.

While lawmakers held their most contentious amendments on Friday, the Subcommittee vote sets up what’s likely to be a far more contentious markup this week in front of the full House Appropriations Committee. There, lawmakers are expected to offer a slew of so-called “policy riders” targeting federal funding for programs like Title X family planning and ACA programs that the current bill proposes eliminating. The Labor-HHS funding bill is often one of the most contentious and usually among the last that Congress approves. The Senate’s top-line spending levels are $2 billion more than the House’s, meaning the spending levels in the bill are likely to change.

CMS Identifies Enhanced Medicaid Funding Opportunity to Address Opioid Epidemic

The Centers for Medicare and Medicaid Services (CMS) has released the agency’s Opioid Roadmap and two guidance documents to states intended to support Medicaid programs in combating the opioid epidemic. The Medicaid guidance is an outgrowth from recommendations of the President’s Opioid Commission.  In its Opioid Roadmap, CMS details the agency’s three-pronged approach to combating the opioid epidemic. The approach focuses on prevention of new cases of opioid use disorder (OUD), the treatment of patients who have already become dependent on or addicted to opioids, and the utilization of data from across the country to target prevention and treatment activities. The document also reviews certain ongoing initiatives and recent approvals.

In one of the Medicaid documents, Neonatal Abstinence Syndrome: A Critical Role for Medicaid in the Care of Infants, CMS writes that as the number of infants born with neonatal abstinence syndrome (NAS) continues to rise, states are exploring a broader array of NAS treatment settings. The guidance provides states with considerations and information related to designing approaches to cover treatment for infants born with NAS. CMS also describes Medicaid’s coverage requirements, reviews the parameters for post-partum mothers who may receive services in a residential setting subject to the Institution for Mental Diseases (IMD) coverage exclusion, and discusses instances where Medicaid may cover NAS treatment services provides to a non-Medicaid eligible mother.

CMS’ State Medicaid Director letter, Leveraging Medicaid Technology to Address the Opioid Crisis, advises states on available funding authorities to support a broad range of health information technology activities designed to address the opioid epidemic. The agency clarifies that the opportunities are available to all states, not just those that have an approved Section 1115 substance used disorder (SUD) demonstration program. 

FDA Guidances on Drug Manufacturer Communication Seek to Drive Value-Based Contracting

The Food and Drug Administration (FDA) has issued two final guidance documents which are intended to encourage competition by facilitating value-based contracting.  As detailed in a release from FDA Commissioner Scott Gottlieb, the respective guidance’s are intended to: (1) answer common questions about companies’ communications to payors, including insurance companies, formulary committees and similar entities; and (2) provide the FDA’s views on manufacturers’ communication of information that is not contained in the FDA-required labeling for their products, but that is consistent with that labeling. The documents were released ahead of Secretary Alex Azar’s appearance before the Senate Health, Education, Labor, and Pensions (HELP) Committee last week, and the Secretary cited the administration’s support for value-based contracting in the context of their broader initiative to address prescription drug costs.

The first guidance, entitled Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities—Questions and Answers, answers questions FDA has fielded from drug manufacturers regarding their communications with other pharmaceutical supply chain stakeholders. FDA explicitly states this is not intended to address the terms of contracts between firms and payors (such as value-based or risk-sharing arrangements).

The FDA seems to suggest that some firms may not be providing truthful communication of health care economic information (HCEI) to payors about approved/cleared medical products (including prescription drug and devices). With this guidance, the agency is seeking to ensure the information provided is truthful and non-misleading. FDA is also seeking to address a desire by payors to obtain information to inform their planning and coverage and reimbursement decisions in advance of the effective date of FDA’s approval decisions and information on unapproved uses of approved/cleared medical products. The guidance also provides a level-setting definition of HCEI under section 502(a) and describes several ways it can be presented.