Health Policy Report

The Week in Review

Both chambers were able to clear significant items off their to-do list before breaking for a brief recess this week. For the Senate, that work entailed confirming Mike Pompeo as Secretary of State, which was finalized on Thursday by a 57-42 margin. The former congressman and Central Intelligence Agency (CIA) Director faced some skepticism from both sides of the aisle before being confirmed by a relatively comfortable margin. He will be facing a busy period as the State Department ramps up for talks with North Korea and the rumored American withdrawal from the nuclear deal with Iran.

In the House, lawmakers worked through Friday to advance a reauthorization (H.R. 4) of the Federal Aviation Administration (FAA), which was eventually cleared on a strong bipartisan vote of 393-13. The measure would reauthorize the aviation regulator through the 2023 fiscal year and include disaster-related provisions that would alter Federal Emergency Management Administration (FEMA) policy to give the agency more flexibility in providing grants for infrastructure construction used to mitigate future natural disasters. The House also saw the election of its newest member, Republican Debbie Lasko, who won a special election in Arizona’s heavily-Republican 8^th congressional district on Tuesday.

Last week also saw French President Emmanuel Macron visit Washington, with the charismatic French leader being greeted by a state dinner on Tuesday before addressing Congress on Wednesday. Macron — a young moderate and reportedly one of President Trump’s closest foreign counterparts — pushed back against the global populist upsurge, urging for multilateralism to address issues ranging from terrorism to climate change to Iran’s nuclear program.

Finally, President Trump’s nominee to run the Department of Veterans Affairs, White House physician Ronny Jackson, was forced to withdraw last week after allegations emerged on his workplace management and alleged problems with drunkenness on the job. Jackson — who already faced a steep climb to be confirmed given his relative lack of experience in management — weathered two days of speculation, but ultimately chose to withdraw his name from consideration Thursday morning. President Trump initially backed his character, while offering a tepid endorsement of his nomination to be VA Secretary in a press conference after allegations emerged on Tuesday. However, Trump subsequently and repeatedly blasted Montana Senator Jon Tester (D-MT), whom he blamed for the nominee’s failure.

The Week Ahead

Both chambers will be out of session on a weeklong recess and will return to Washington Monday, May 7. 

E&C Health Subcommittee Approves 56 Opioid Bills, ADUFA

The House Energy and Commerce Health Subcommittee has approved almost five dozen bills to address the opioid crisis, despite concerns from the panel’s top Democrats that the process may be moving too quickly. In largely bipartisan fashion, the Subcommittee approved 56 of the 63 opioid bills that were slated for consideration at the marathon markup, keeping the full Committee on track to advance legislation to the House floor no later than Memorial Day. Seven of the bills noticed for the markup were not considered, including a few Democratic-backed Medicaid bills — a source of additional frustration for the members of the minority. Subcommittee Chairman Michael Burgess (R-TX) indicated that a full Committee markup is likely to happen in “several weeks.”

The wide-ranging package of opioid bills is relatively modest in scope, and the individual bills have  generally focused on expanding access to substance abuse treatment, building up the provider workforce, and encouraging the use of non-opioid pain treatments. Other measures approved at the markup would encourage the use of telehealth to treat opioid use disorder, incentivize Medicare beneficiary education and pain assessment, incentivize the development of non-opioid alternatives, foster provider education for clinical outliers, and more. Ultimately, 35 measures passed by voice votes, 13 passed en bloc, and 9 passed by individual roll call votes. While almost all of the bills considered were focused on stemming the tide of opioid abuse, the Animal Drug User Fee Act (ADUFA) also passed by a voice vote. While most of the bills taken up during yesterday’s markup passed with broad bipartisan support, Democrats did vote against two bills designed to increase reimbursement for non-opioid alternatives to treat pain.

Despite the ambitious timeline laid out by GOP leaders, Democrats on the panel expressed concern that “we’re putting quantity over quality,” as characterized by Ranking Member Gene Green (D-TX). The Subcommittee’s top Democrat was joined by several of his counterparts in expressing disapproval for the “hasty” process by which the Subcommittee was approving opioid legislation, and cautioned that the bills need to be adequately vetted prior to a full committee markup. Other Democrats expressed concern that the time frame for passing these bills through the Subcommittee was rushed and lacked the time to allow the Congressional Budget Office (CBO) and other stakeholders to appropriately analyze and vet the bills.

Senate HELP Committee Advances Opioid Legislation, OTC Reform, CHGME

The Senate Health, Education, Labor, and Pensions (HELP) Committee held a markup this week to consider a 40-bill opioid package — the Opioid Crisis Response Act of 2018 (S. 2680) — as well as other health care measures including an over-the-counter drug reform bill (S. 2315) and a reauthorization of children’s hospital graduate medical education (CHGME) (S. 2597). The opioid package passed unanimously, and Chairman Lamar Alexander (R-TN) said he hopes to merge the opioid package with proposals from other Senate committees and reach an agreement with Senate Leaders Mitch McConnell (R-KY) and Chuck Schumer (D-NY) to bring the package to the floor by this summer. The Committee cleared several amendments by unanimous consent, including changes to enhance a practitioner’s ability to provide medication-assisted treatment (MAT) for opioid use disorders (OUD), grants to hospitals relating to alternatives to opioid pain management, and greater access to peer recovery support for OUD sufferers.

The Committee, along party lines, rejected a proposal to boost funding for the National Health Service Corps to build up the behavioral care workforce in underserved areas. Another proposal from Sen. Chris Murphy (D-CT) to increase the Labor Department's authority to enforce federal parity laws also failed on a party-line vote. Though the Committee's bill advanced unanimously, some progressive lawmakers said it didn't go far enough to get the opioid crisis under control, with Sens. Bernie Sanders (I-VT) and Elizabeth Warren (D-MA) calling for additional funding. The Committee also advanced via a 22-1 vote an over-the-counter drug reform measure which would accelerate FDA approvals of new products or changes to approved ones by updating monographs that lay out the dosage, formulation and labeling information drugmakers must follow without going through the rulemaking process.

CMS Proposes Overhaul of Meaningful Use Program and Hospital Price Transparency

Last Tuesday, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule updating Medicare payment policies and rates under the Inpatient Prospective Payment System (IPPS) and the Long-Term Care Hospital (LTCH) Prospective Payment System (PPS). The nearly 1,900 page proposed rule contains significant changes to CMS’ Electronic Health Record (EHR) Incentive Program, now the “Promoting Interoperability” program. CMS states that the collection of proposed changes will “further advance the agency’s priority of creating a patient-driven healthcare system by achieving greater price transparency and interoperability – essential components of value-based care – while also significantly reducing the burden for hospitals so they can operate with better flexibility and patients have the information they need to become active healthcare consumers.”

This represents another step in CMS’ efforts to improve the transparency of charges, which the Administration hopes will ultimately empower patients and drive competition, lower prices and improve quality in the Medicare program as well as the broader health insurance marketplace. CMS also seeks to make significant changes to the Medicare and Medicaid Meaningful Use program, starting with rebranding it the “Promoting Interoperability” program. CMS identifies several areas where it is specifically seeking comment in order to operationalize its proposals. The comment deadline is June 25, 2018.

CMS Announces Medicare Data Roll-out, Previews Medicaid Efforts

The Centers for Medicare & Services (CMS) Administrator Seema Verma discussed the agency’s new Data Driven Patient Care Strategy during remarks at the annual Health Datapalooza conference in Washington, D.C last week. The three pillars of the Data Driven Patient Care Strategy are: putting patients first, making more data available, and taking an “API-approach” to exchanging data with CMS partners in a timely, secure manner. CMS’ materials acknowledge potential concerns about privacy and security of data, saying “strict privacy and security requirements to protect patient data are put in place from the beginning and play a prominent role in all decisions.” Last week’s announcement is part of the CMS and White House patient data collaboration, known as MyHealthEData.

CMS released an outline of its broader strategy which affirms and provides additional insight on its planned actions around patient empowerment and data transparency. Ultimately, the policy changes and related actions will allow the Administration to demonstrate whether providing patients and researchers with claims and encounter data will enhance efficiency, improve quality and reduce costs across healthcare systems. In her prepared remarks at the Health Datapalooza, the Administrator delivered a strong message to industry, saying the agency “is not backing down” on the requirement that providers use the most current version of Certified EHR Technology by 2019. She also floated the potentially controversial idea CMS is considering to require providers to share health data with patients as a condition of participation in Medicare, which represents a significant shift in the drive for interoperability.

Researchers are eager to access the vast amount of Medicare Advantage encounter data, and the resulting analyses could shed new light on patient experiences and value in the context of the Medicare Advantage program. Federal policymakers and stakeholders have also been eager for more widespread access to standardized Medicaid and CHIP data, and CMS hinted at work underway here. These efforts are likely to cause some level of tension with state agencies due to the disparate reporting systems and challenges that have historically plagued the program.