Health Policy Report

The Week in Review

President Donald Trump signed a $19.1 billion disaster relief bill a months-long delay over issues related Puerto Rico and border security. The bill passed under suspension of the rules early last week after House conservatives blocked the bill from being passed during pro forma sessions over the Memorial Day district work period. The lower chamber also cleared another key suspension bill, H.R. 2940, that would extend funding for the Temporary Assistance for Needy Families (TANF) program through September 30, 2019.

Additionally, House Democrats took action on addressing the immigration status of millions of young adult immigrants. House lawmakers passed a measure of (H.R. 6) that would provide permanent status and a pathway to citizenship for eligible young adult immigrants protected under the Deferred Action for Childhood Arrivals (DACA) program, as well as for temporary U.S. residents protected under the Temporary Protected Status (TPS) and Deferred Enforced Departure (DED) programs. The bill is likely dead-on-arrival in the GOP-controlled Senate, as the White House has issued a formal veto threat on the legislation. 

In the upper chamber, senators resumed consideration of several key presidential nominees. Last week, the Senate approved the nominations of 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.

The Week Ahead

House lawmakers will kick off a busy legislative work week later this afternoon as the House begins full consideration of fiscal year (FY) 2020 spending bills. The lower chamber take up the first “minibus” package (summary; amendments) for FY 2020, containing five appropriations bills. The five spending bills included in the first minibus include: Labor-Health and Human Services-Education (text; report), Energy and Water Development (text; report), Legislative Branch (text; report), Defense (text; report), State-Foreign Operations (text; report).

In the upper chamber, a timeline for FY 2020 appropriations remains unclear as Senators lack a bipartisan agreement on funding levels to start markups. In the meantime, the Senate will resume consideration of presidential nominees. A full list of pending nominations up for consideration is available here.

Grassley Floats Drug Pricing Reforms in Interview

As staff-level negotiations continue over a Senate Finance Committee drug pricing package, Chairman Chuck Grassley (R-IA) floated several key reforms at an event last week hosted by Axios. While several of the policies that Chairman Grassley cited reflect bipartisan priorities, others, such as expanding the ‘rebate rule’ to the commercial market, have been met with resistance from Democrats.

Similar to a discussion draft released recently by House committee leaders, Chairman Grassley suggested reforming the Medicare Part D catastrophic benefit to establish an out-of-pocket cap for beneficiaries, increase insurer responsibility (currently 15 percent), and reduce federal government responsibility (currently 80 percent). Importantly, Chairman Grassley also signaled an openness to requiring drug manufacturers to accept some liability in the catastrophic phase. “We want to take away that incentive [to get beneficiaries through the donut hole] by having the insurance companies and the pharmaceuticals pay a greater part of the cost,” he said. Discussing misaligned incentives in prescription drug policy, Chairman Grassley singled out the ASP+6% payment to physicians under Medicare Part B. He explained that the current model encourages doctors to prescribe higher-cost medications to increase their own reimbursement. Notably, reforming physician payments for Medicare Part B drugs appeared to be an area of consensus during a series of Finance Committee hearings earlier this year.

Chairman Grassley also made a clear call for expanding the Trump Administration’s proposed rule that would require prescription drug rebates to be passed directly to consumers into the commercial market. Given the limits of the Administration’s authority, however, he suggested that “it seems to me that it’s our job to make [their proposal] more encompassing.” Additionally, he acknowledged the need to provide states with flexibility in how they pay for “gene therapies and other life-saving drugs,” suggesting that “it would be as simple as spreading out that payment over a long period of time.” For example, he said that spreading out payments over five years could help make those drugs available for low-income individuals.

A long-time transparency advocate, Chairman Grassley suggested the need for increased transparency into both manufacturer pricing and in how rebate dollars flow through pharmacy benefit managers (PBMs). Lastly, Chairman Grassley emphasized that there is overwhelming support in the Senate Judiciary Committee and various House panels for banning so-called “pay-for-delay” agreements and advancing the CREATES Act — both of which string to increase generic competition. These measures should be considered “low-hanging fruit,” he remarked.

CMS Releases RFI on Continuing Patients Over Paperwork Initiative

The Centers for Medicare and Medicaid Services (CMS) released a Request for Information (RFI) last Thursday asking health care stakeholders how the administration could best continue its “Patients over Paperwork” initiative. The RFI on “Reducing Administrative Burden to Put Patients over Paperwork” requests patients and their families, the medical community, and other players in the health care industry to recommend fresh changes to rules, policies, and procedures that would shift more of clinicians’ time and health care system’s resources from regulated paperwork to quality care that improves patient health. CMS clarified that it is looking for “innovative ideas to relieve burden” not originally shared in 2017 when the initiative was launched.

CMS Administrator Seema Verma stated that the Patients over Paperwork initiative is still a top priority for the agency and said the administration would be “doubling down” on efforts to decrease health care costs by reducing administrative burden. She added that CMS was removing regulations that “didn’t add value,” to make room for those that do. CMS is seeking ideas on issues including the streamlining of CMS reporting requirements; easing prior authorization procedures; enabling of better data sharing; improving quality reporting; addressing overly burdensome policies for rural providers; and simplifying rules for beneficiaries dually enrolled in Medicare and Medicaid.

CMS also used the RFI to expand on how the agency has reduced burden through the Patients over Paperwork initiative to date. As of January 2019, CMS estimates that through regulatory reform alone, the health care system will save an estimated 40 million hours and $5.7 billion through 2021. The agency is asking that comments from stakeholders on how best to continue to Patients over Paperwork initiative be submitted by August 12, 2019.

Republican Senators Ask PhRMA for Drug Pricing Policy Solutions

Eight Republican Senators wrote to the Pharmaceutical Research and Manufacturers of America last week to ask for the organization’s best proposals to lower drug prices and increase transparency in the industry. The letter, released last Thursday, was led by Sen. Rick Scott (R-FL), and included signatures from Sens. Josh Hawley (R-MO), Marco Rubio (R-FL), Ron Johnson (R-WI), Mike Braun (R-IN), Kevin Cramer (R-ND), Cindy Hyde-Smith (R-MS), and Dan Sullivan (R-AK). The lawmakers explained they’re looking for “cooperation” from drug companies as they develop legislation to lower drug prices and asked how the trade association planned to address price disparities between the international and domestic markets. Sens. Scott and Hawley are sponsors of legislation that would prevent drug companies from charging higher prices in the United States than they do in other wealthy countries.

Inter-Agency Pain Task Force to Meet with CMS to Discuss Pain Management Tools

The Department of Health and Human Services (HHS) has announced it will be holding a virtual meeting with the Pain Management Best Practices Inter-Agency Task Force and Centers for Medicaid & Medicare Services (CMS) to discuss policy changes aimed at preventing and treating opioid addictions. The meeting will be held on Wednesday, June 12, 2019 from 5 p.m. to 6:30 p.m. and focus on Medicare and Medicaid payment and coverage policies for chronic and acute pain, service delivery models, access to therapies and medical devices, and other pain management tools. The SUPPORT Act requires that the Secretary of HHS collaborate with the Task Force to develop an action plan on recommendations for changes under Medicare and Medicaid to prevent opioid addiction and enhance access to Medication-Assisted Treatment by January 1, 2020.

This meeting follows the recent release of the Task Force’s report on acute and chronic pain management best practices. The report, issued May 30, highlighted the need to address the issues of stigma, risk assessment, and access to care for pain management. Careful planning, screening, and patient education regarding opioids, as well as setting clear goals around pain management were emphasized by the Task Force as important next steps. The meeting is expected to address the Task Force’s recommendations, specifically those related to reimbursement for pain management tools. The report encourages CMS and private payers to develop “appropriate reimbursement policies to allow for a multimodal approach to acute pain,” as well as implementing reimbursement for opioid and non-opioid management that is consistent with the time and resources required for patient education, safe evaluation, risk assessment, reevaluation, and integration of alternative, non-opioid modalities.