Health Industry Washington Watch

Updates by Reed Smith on U.S. legislative & regulatory developments affecting the health care industry

As part of the Trump Administration’s fall regulatory agenda, the Department of Health and Human Services (HHS) emphasizes its commitment to “reducing and streamlining its regulations and improving the transparency, flexibility, and accountability of its regulatory processes.”  One of the specific deregulatory initiatives noted is a future proposed rule to remove outdated Medicare and Medicaid conditions of participation for long-term care providers. Other top regulatory priorities in the HHS Statement of Regulatory Priorities for
In an effort to “modernize the Medicare program and bring the latest technologies and innovations to Medicare beneficiaries,” CMS has announced revisions to the local coverage determination (LCD) process.  Specifically, under authority provided in the 21st Century Cures Act and taking into account stakeholder feedback, CMS has issued Program Integrity Manual (PIM) changes intended to promote transparency, clarity, and consistency in the development of LCDs.  As provided in the 21st Century Cures Act, CMS is…
The Centers for Medicare & Medicaid Services (CMS) has announced that 1,299 entities have signed agreements to participate in the Administration’s new Bundled Payments for Care Improvement (BPCI) Advanced episode payment model, which runs from October 1, 2018 through December 31, 2023.  According to CMS, BPCI Advanced participants include 1,547 Medicare providers and suppliers (832 acute hospitals and 715 physician groups) in 49 states plus Washington, DC and Puerto Rico. BPCI Advanced will test whether…
The Centers for Medicare & Medicaid Services (CMS) has proposed revising its rules governing the process Medicare beneficiaries, providers, and suppliers use to appeal adverse determinations regarding claims for Medicare Part A and Part B benefits or determinations for Part D prescription drug coverage.  According to CMS, the revisions “would help streamline the appeals process and reduce administrative burden on providers, suppliers, beneficiaries, and appeal adjudicators.” Among other things, the proposed rule would: Allow appellants…
The Centers for Medicare & Medicaid Services (CMS) is holding a Town Hall Meeting on December 4, 2018 to discuss fiscal year (FY) 2020 applications for add-on payments for new medical services and technologies under the Medicare inpatient prospective payment system (IPPS).  Interested parties will have an opportunity to present recommendations and data regarding whether pending applications meet the substantial clinical improvement criterion. The deadline to submit agenda items and register to present at the…
The Centers for Medicare & Medicaid Services (CMS) has provided additional guidance on a hospital price transparency policy that goes into effect January 1, 2019.  By that date, hospitals must make available a list of their current standard charges via the internet in a machine readable format and update this information at least annually, or more often as appropriate.  This could be in the form of the chargemaster itself or another form of the hospital’s…
The Department of Health and Human Services (HHS) has just announced annual inflation-related increases to civil monetary penalties (CMPs) in its regulations, including those promulgated by the Office of Inspector General, the Centers for Medicare & Medicaid Services, and the Food and Drug Administration.  Specifically, pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, HHS is applying a 1.02041 inflation “multiplier” (i.e., a 2.041% increase) to CMPs assessed on or…
The House of Representatives approved two “gag clause” bills on September 25, 2018 that would prevent insurers from restricting pharmacies from informing consumers about lower cost, out-of-pocket prices for their prescriptions.  The bills were approved by the Senate earlier this month, and are now cleared for the President’s signature. Specifically, S 2553, the Know the Lowest Price Act of 2018, would prohibit a Medicare Part D or Medicare Advantage prescription drug plan from restricting…
HHS Deputy Secretary Hargan has announced the creation of the “Deputy Secretary’s Innovation and Investment Summit” (DSIIS), which will provide a forum “to discuss the innovation and investment landscape within the healthcare sector, emerging opportunities, and the government’s role in facilitating more investment and accelerated innovation.”  The DSIIS will involve quarterly meetings between healthcare innovation and investment professionals and HHS personnel focusing on “emerging innovation opportunities and whether government policies are accelerating or…
CMS has issued a proposed rule intended streamline the Medicare and Medicaid regulatory burden on numerous types of providers and suppliers.  CMS generally classifies the proposals as falling into the following categories:  (1) those that simplify and streamline processes, (2) those that reduce the frequency of activities and revise timelines, and (3) those that address obsolete, duplicative, or unnecessary requirements.  CMS estimates that its proposal would result in total annual savings of about $1.1 billion,…