Dorsey Health Law Blog

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

Laura B. Morgan

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...

FDA Issues Guidance on Drug and Device Manufacturer Communications: Part II – Medical Product Communications that are Consistent with the FDA-Required Labeling

Alex Stoflet

On June 12, the FDA issued guidance that clarifies its recommendations for certain product communications made by medical product manufacturers, packers, and distributors (collectively “firms”). The guidance, “Medical Product Communications That Are Consistent With the FDA-Required Labeling” (the “Guidance”), explains the FDA’s views on firms’ communication of information that is not contained in the FDA-required...

FDA Issues Guidance on Drug and Device Manufacturer Communications: Part I – Health Care Economic Information and Unapproved Products/Use Communications with Payors

Alex Stoflet

On June 12, the FDA issued guidance that clarifies its recommendations for certain medical product communications. The guidance, “Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers” (the “Guidance”), provides answers to common questions about the communications between medical product manufactures, packers, and distributors (“firms”), and insurance companies,...

CMS Announces Rural Health Strategy

Aaron Mohr

Last week the Centers for Medicare & Medicaid Services (“CMS”) released its first Rural Health Strategy. The strategy is intended to improve the agency’s service to individuals living in rural areas. CMS’ Rural Health Council, created during the Obama Administration, developed the strategy by examining current rural-focused programs at CMS, reviewing the methods used by...

CMS Expands Health Related Supplemental Benefits in Medicare Advantage Plans

Aaron Mohr

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)...

President Trump Gives Speech on Prescription Drug Prices and Releases Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs

Nicole Burgmeier

On May 11, 2018, President Trump gave his long-awaited speech on his administration’s plan to lower prescription drug prices. In addition, the administration published its Blueprint to Lower Drug Prices and Reduce Out-of-Pocket costs. The blueprint can be found here.  The blueprint focuses on four areas for reform including strategies to: (1) improve competition; (2)...

Iowa Legislature Sends Bill Imposing Additional Requirements for Prescription Monitoring Program Reporting to Governor for Signature

Nicole Burgmeier

  Last week, with bipartisan support, both the Iowa House and Senate passed, unanimously, HF 2377   (“An Act Relating to the Regulation of Certain Substances, Including the Regulation of the Practice of Pharmacy, Providing Penalties, and Including Effective Date Provisions”). The bill is expected to be signed into law by the Governor in the coming days....

FDA Chief and HHS Secretary Cite Prescription Drug Prices as Top Priorities for Agencies; President Trump Scheduled to Speak on Issue on May 11, 2018.

Nicole Burgmeier

All eyes are on the federal government as top officials have recently signaled upcoming actions which could impact the prices of prescription drugs. In the past two weeks, leaders from both the FDA and HHS have made statements signaling that the agencies are focused on reducing prescription drug prices. In remarks at the Food and...

HIMMS, Chronic Care Management, and the Top 5 Overlooked Items

Shira Hauschen

Harnessing existing digital health solutions to improve chronic care management was a prominent topic at HIMMS this year (amongst many others, including AI and cybersecurity, both of which we will cover in upcoming blog posts). While this is not a new topic, it was particularly “buzzy” this year due to the ever-increasing number of large...