Health Policy Report

The Week in Review

While most lawmakers were out of town for a Memorial Day district work period, House Republicans continued to block unanimous consent (UC) of a bipartisan $19.1 billion disaster relief bill during last week’s informal “pro forma” sessions. Rep. John Rose (R-TN) joined fellow conservatives Reps. Chip Roy (R-TN) and Thomas Massie (R-KY) in objecting to a voice vote on the measure over concerns about the deficit and the bill’s lack of border security funding. Democratic leadership plans to consider the bill under suspension of the rules, with a final roll call vote expected on later this evening.

Meanwhile, the Trump administration gave Congress a 30-day notice yesterday of its intent to send lawmakers implementing legislation for a vote on the United States-Mexico-Canada Agreement (USMCA). The statement of administrative action indicates that President Donald Trump plans to push for votes on the North American Free Trade Agreement (NAFTA) replacement before the August recess. However, House Speaker Nancy Pelosi (D-CA) and Ways and Means Chairman Richard Neal (D-MA) said that the notification would not impact their efforts to negotiate changes to the agreement — specifically on provisions pertaining to drug exclusivity, labor standards, and environment protection — with U.S. Trade Representative Robert Lighthizer.

The Week Ahead

Lawmakers will return to Washington this afternoon for a busy June legislative session. In the House, Democratic leadership plans to bring fiscal year (FY) 2020 appropriations bills to the floor starting on the week of June 12. Majority Leader Steny Hoyer (D-MD) stated that the lower chamber will look to clear each one of the spending bills prior to the Independence Day district work period. Today, the House will consider the disaster relief bill and a measure H.R. 2940 that would extend funding for the Temporary Assistance for Needy Families (TANF) program through September 30, 2019.

While the House has mapped out its plan for FY 2020 appropriations, the Senate’s timeline to address these spending measures remains unclear. In the meantime, Senators are expected to continue clearing their presidential nominations queue while Majority Leader Mitch McConnell (R-KY) tees up consideration of several key presidential nominees, including Andrew Saul to be Commissioner of Social Security, Heath Tarbert to be Chairman of the Commodity Futures Trading Commission (CFTC), and Susan Combs to be an Assistant Secretary of the Interior.

Drug Pricing Reform Gains Traction in Congress 

As the countdown to the August recess begins, Congress and the Administration are moving into a new phase of their efforts to reform prescription drug policy. Over the past several weeks, congressional committees have been pushing out bipartisan draft legislation to address drug prices, scheduling and holding hearings and markups, and starting to advance legislation through regular order. The release of draft legislation in both chambers marks a new phase in the process of prescription drug pricing discussions, as credible proposals — including a proposal to cap out-of-pocket costs in Medicare Part D — are now in writing and potential avenues to implementing them begin to take shape. The Part D proposal, introduced by the bipartisan leaders of the House Ways & Means and Energy & Commerce committees, is also paired with a proposal to increase insurance plan payments in the catastrophic phase. Meanwhile, in the upper chamber, Senate Health, Education, Labor, and Pensions (HELP) Committee leaders recently released their first drug pricing measure, which adopts new restrictions on PBMs along with a slate of House-passed transparency measures.

While bipartisan talks in Congress are accelerating, negotiations between House Speaker Nancy Pelosi (D-CA) and President Trump have broken down around the President’s frustration with House Democrats’ investigations. The two sides were supposedly negotiating on strategies to reduce drug costs in Medicare, including by exploring new tools for the federal government to negotiate Part D prices. Instead, given this lapse in top-level negotiations, it’s become increasingly likely that any drug pricing deal will need to be palatable to both House Democrats and Senate Republicans, and the bipartisan House legislation on Part D benefit design reflects that reality. Between drug competition measures, transparency and reporting requirements, Medicare benefit design, and surprise billing, the House and Senate have plenty of common ground. And even if the White House takes a back seat in negotiations, Congress stands poised to force their hand.

With respect to timing, the months of June and July are expected to be pivotal. In the Senate, the Finance and HELP Committees have teased hearings on healthcare legislation for mid- to late-June. Staff-level negotiations in the Finance Committee are progressing and have reportedly yielded an agreement on the framework of a deal. The HELP Committee is working on additional legislation — including potential reforms to the 340B program — which may be included in its markup. On the House side, meanwhile, Speaker Pelosi will continue developing her “binding arbitration” legislation, which could be unveiled at any time, and the leaders of the Energy & Commerce and Ways & Means Committees are gathering feedback on their draft legislation prior to formally introducing a bill. Following feedback and hearings, some of the proposals could be merged into a larger vehicle (potentially including other health “extenders”). While a drug pricing-focused package may hinge on the timing and outcome of a deal between congressional leaders and the White House, final passage around the end of the fiscal year (Sept. 30) is the most likely timeline.

HHS Task Force Releases Report on Pain Management

Last Thursday, the Inter-Agency Pain Management Task Force released its report to Congress and the public detailing its recommendations to advance patient-centered care for pain and decrease opioid use for most populations. The report was largely unchanged from the draft it released in late December 2018, with the Task Force approving it following a period of public comment. The Task Force’s report will serve to drive the next round of conversations on pain management.

The report highlighted the need to address the issues of stigma, risk assessment, and access to care for pain management. The Task force emphasized careful planning, screening, and patient education regarding opioids, as well as setting clear goals around pain management. It also noted that Americans in many communities have access to only primary care providers, so those providers must receive education in best practices to be able to provide safe and effective pain management care. The Task Force also included a critique of the 2016 Centers for Disease Control (CDC) guideline on opioid prescription, noting that its adoption — and subsequent misinterpretation and misuse — had led to patient abandonment and forced tapers of opioid analgesics by patients with chronic pain. The report urges education about the intent of the guideline, emphasizing that the CDC and other stakeholders should take care to ensure that unintended consequences do not affect patients.

While the report is expected to drive policymakers’ discussions on pain management, there has been no indication that Congress will take up additional opioid legislation in the immediate future. With an existing push on healthcare and the looming consideration of Appropriations legislation, it is unclear if there is room for legislation in line with the recommendations in the Congressional schedule. Looking ahead, HHS will work to disseminate its recommendations to federal, state, and local agencies, and the agency is encouraging stakeholders who were engaged during the process of developing the report to now ensure that its message gets into the hands of those whom it would benefit. The agency’s immediate focus will be on educating public servants as well as community-based organizations and providers on the best practices outlined in the report.

CMS Releases Long-Awaited PACE Rule

The Centers for Medicare and Medicaid Services (CMS) finalized a rule last Tuesday to strengthen oversight, increase transparency, and clarify prescription drug requirements for the Programs of All-Inclusive Care for the Elderly (PACE). The proposed rule, which was promulgated in 2016, was largely supported by PACE providers in spite of some stakeholder opinion that its provisions were too onerous. Heeding those concerns, CMS did not finalize the entire rule, opting to jettison a proposal that would have required PACE organizations (POs) to monitor and audit their operations. However, the agency did finalize a provision clarifying that POs that offer qualifying prescription drug coverage must meet the same standards as Part D plans unless specifically receiving a waiver.

FDA Calls for Comment on Blister Packs for Opioids

The Food and Drug Administration (FDA) issued a request for comment last Thursday on whether to require certain immediate-release (IR) opioid analgesics to be packaged in fixed-quantity unit-of-use blister packs. The change, which would modify the agency’s Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS) framework, was authorized by Congress with the passage of last year’s SUPPORT Act. The FDA said it “anticipates that the widespread availability of fixed-quantity unit-of-use blister packaging could play a significant role in reducing overprescribing that leads to unused opioid analgesics without impairing access to opioid analgesics for patients who need them.”

In the notice, FDA cited data that shows that patients are often dispensed a much larger quantity of opioid painkillers than they actually use. This is particularly true for opioid-naïve patients receiving minor surgical procedures. As a remedy, FDA would require manufacturers to submit amendments to their REMS that would make 5-, 10-, and 15-count blister packages of certain opioids available. Additionally, FDA considers that fixed-quantity blister packs could “nudge” prescribers to carefully consider prescribed quantities. FDA notes that, with the solicitation of comments, it is still evaluating the list of products for which it would be appropriate to impose new packaging requirements and what packaging configurations should be available.

CMS Administrator Signals Intent to Advance States’ Capped Medicaid Funding Proposals

In an interview published last Friday in CQ Roll Call, Centers for Medicare and Medicaid Services (CMS) Administrator Seema Verma outlined her vision and potential policies for reshaping state Medicaid programs. The CMS Administrator touted her work to expedite states’ requests to update their Medicaid programs. She emphasized, however, that states remain too constrained in operating their programs, saying “If we move to… [a] different type of paradigm, we may see better results from the program in terms of the growth of the program, the costs of the program, and the quality of the program.” Administrator Verma teased some of the changes needed under this new paradigm, including additional “flexibilities,” less CMS “micromanagement,” and an optional block grant concept.

According to the Administrator, CMS receives many requests from states seeking to change how the federal government contributes funding to their programs. She also addressed some of the potential concern that states would be worse off with a lump sum federal Medicaid financing structure, saying that she recognizes a voluntary Medicaid block grant agreement with a state would need to include added flexibilities. Additionally, she signaled that the agency is exploring a more limited approach for such lump sum arrangements, contrasting her position with 2017 legislation that would have required a more comprehensive approach to the populations impacted by this type of reform. Lump-sum funding and flexibility could be balanced by accountability for population health outcomes, Administrator Verma said, although she did not elaborate on what the enforcement mechanisms would be.

One of the early Medicaid priorities under Administrator Verma’s leadership, the Medicaid Scorecard, would be integral for advancing her vision. While still in its infancy, the Medicaid Scorecard reports out certain performance and quality indicators and could evolve to include more robust health outcome measures over time. The tool could provide CMS with the data it would need to hold states accountable for a slate of health outcomes. In her interview, the Administrator also touched on another controversial topic – the federal match rate for partial Medicaid expansions. She noted that there is significant state interest in expanding Medicaid to individuals with income up to 100 percent of the poverty level instead of 138 percent. However, Administrator Verma cited several issues the administration is still working through, including whether they are legally permitted to approve such a state request and whether it would be fiscally prudent.