Author: Neal N. Peterson

Neal regularly advises clients regarding compliance with laws specific to the health industry, such as state licensure requirements and corporate practice of medicine statutes and regulations. Neal's experience includes representing clients who are both payers and providers of health care, such as health insurers, HMOs, management services organizations, integrated delivery systems, accountable care organizations, hospitals, multi-specialty physician groups, pharmacies, nursing homes and assisted living facilities.

New Proposal to Remove Disincentives to Living Organ Donation

On December 20, 2019, the Department of Health and Human Services (“DHHS”) issued a notice of proposed rulemaking (the “Proposal”) that removes financial barriers to organ donation by expanding the scope of reimbursable expenses paid through the Health Resources and Services Administration’s Reimbursement of Travel and Subsistence Expenses Incurred toward Living Organ Donation program (the...

New Disclosure Requirements to be Phased-In to CMS Enrollment and Revalidation Process

On September 5, 2019, the Centers for Medicare & Medicaid Services (“CMS”) issued a final rule (“Final Rule”) effective November 4, 2019, which increases disclosure requirements for the provider and supplier enrollment and revalidation process. The Final Rule is aimed at increasing the information provided to CMS in enrollment and revalidation to identify fraud, waste,...

Minnesota Enacts New Assisted Living Facility Law

On May 22, 2019, Minnesota Governor Tim Walz signed a significant new assisted living licensure bill into law. Previously in Minnesota, assisted living facilities were required to register with the Minnesota Department of Health (the “Department”) but were not subject to facility licensure. The new law requires assisted living facilities to be licensed, with special...

CMS Continues Expansion of Supplemental Benefits in Medicare Advantage Plans

Last week, the Centers for Medicare and Medicaid Services (“CMS”) announced increased flexibility for Medicare Advantage health insurance plans to offer supplemental benefits (those benefits not covered under Medicare Parts A or B). Beginning in 2020, Medicare Advantage plans may offer chronically ill enrollees supplemental benefits that are not necessarily health-related but are reasonably expected...

CMS Proposed Rule to Require Drug Pricing Transparency

On October 18, 2018, the Centers for Medicare and Medicaid Services (“CMS”) proposed a new rule (“Proposal”) that would require direct-to-consumer (“DTC”) television advertisements of prescription drugs paid for by Medicare or Medicaid to include the drug’s wholesale acquisition cost (“List Price”). The Proposal comes as part of the current administration’s promise and attempt to...

Calls for Modernizing the Stark Law Continue; CMS Seeks Public Input on Stark Law Reforms

Many regulatory and legislative calls for modernizing the federal physician self-referral law (or “Stark Law”) in light of the move to value-based payment under Medicare have been made in recent months.  Most recently, a hearing on “Modernizing the Stark Law to Ensure the Successful Transition from Volume to Value in the Medicare Program” took place...

CMS Expands Health Related Supplemental Benefits in Medicare Advantage Plans

Last month, the Centers for Medicare and Medicaid Services (“CMS”) announced new flexibility in what Medicare Advantage plans may cover as “supplemental health care benefits.” The announcement was part of CMS’ release of Calendar Year 2019 Medicare Advantage and Part D Rate Announcement and Call Letter. The Medicare Managed Care Manual (Chapter 4, Section 30.1)...

FDA Commissioner Announces Plans to Streamline Approval Process for Headline-Grabbing Products

Last week, Dr. Scott Gottlieb, Commissioner of the FDA, touched on two issues that have frequented headlines in the past two years. First, in remarks made on November 28, 2017, Commissioner Gottlieb expanded on plans to finalize guidance related to complex generic drugs, a broader issue that received specialized focus during coverage of EpiPen’s price...