The Food and Drug Administration (the “FDA”) has approved a modification to the Mifepristone Risk Evaluation and Mitigation Strategy (“REMS”) Program, increasing the accessibility of mifepristone for patients with a prescription. [1], [2] 

Continue Reading FDA Approval Mifepristone REMS Program Modification Expands Patient Access to Abortion Care

I was struck on the first day of the 41st Annual J.P. Morgan Healthcare Conference by Sanjay Doddamani (CEO of UpStream Healthcare) saying that “Health is a state of independence.” A simple statement, but a very profound and interesting lens through which to view the Day One Medicare Advantage-focused company presentations. Perhaps it struck a chord in me because, in a flurry of presentations today touting patient net promoter scores (NPS), that simple statement brings to mind the feelings associated with dignity, respect, self-reliance and, perhaps most importantly, choice – concepts that are hard to quantify into a neat NPS number but which we all recognize and understand. Good health indeed does allow us the chance to be independent, while poor health, economic insufficiency and/or aging can force us into dependence, burden and obligation. I don’t have to take a scientific poll to determine which you personally would prefer.

Continue Reading Day 1 Notes from the 41st Annual J.P. Morgan Healthcare Conference

The New Year energizes us to plan for success in the coming months. To increase the odds of meeting your business goals, we suggest taking a quick inventory of legal risks and brainstorming corrective actions for 2023. While important, legal risks may not seem urgent until a related problem impacts your business (i.e., you are subject to litigation, a business dispute erupts over unclear contract terms, an insurer or Medicare Administrative Contractor notifies you of billing/coding problems, or an employee makes a claim). Once present, legal risks can take a significant amount of time, expense, and energy to resolve that could be spent elsewhere in your business. We recommend taking a few minutes today to ask yourself the following questions:

Continue Reading Are You Ready for 2023? Here’s a Quick Checklist to Reduce Legal Risks in the New Year

The abortion debate continues in America after the Supreme Court decision in Dobbs v. Jackson and the midterm elections on November 8th. Following our first post in this series, there have been a number of noteworthy developments* that occurred over the past month including several significant events at both federal and state levels as well as recent activity by registered voters during the midterms to protect access to reproductive care.

Continue Reading Part 2: An Update on the Federal and State E-Roe-sion or P-Roe-tection of Abortion Rights

On Friday, August 26, 2022, the Department of Health and Human Services’ Centers for Medicare and Medicaid Services (“CMS”), the Department of Labor’s Employee Benefits Security Administration and the Department of Treasury’s Internal Revenue Service (the “Departments”) published a final rule updating key regulations pertaining to the No Surprises Act (the “Final Rule”). The Final Rule changes requirements promulgated through prior interim final rules[i] to conform with two rulings by the U.S. District Court for the Eastern District of Texas.[ii] The Final Rule addresses specific disclosure requirements for group health plans and health insurance issuers related to the Qualified Payment Amount (“QPA”) for out-of-network (“OON”) services and sets forth the factors and information which certified Federal Independent Dispute Resolution (“IDR”) entities must consider in arbitrating disputes for OON services or items.

Continue Reading Final Rule Changes No Surprises Act Requirements

On January 13, 2022, the United States Supreme Court upheld the Centers for Medicare & Medicaid Services (“CMS”) Interim Final Rule (the “Rule”) in a 5-4 decision, staying the preliminary injunctions issued for 24 states by the District Courts for the Eastern District of Missouri and the Western District of Louisiana.  Therefore, the CMS vaccine mandate is in full effect for all states except Texas, which was not part of the cases before the Court.  The Rule requires nearly all workers at Medicare- and Medicaid-certified facilities—whether medical personnel, volunteers, janitorial staff, or even contractors who service the facilities—to be fully vaccinated against COVID-19 unless they qualify for a medical or religious exemption.

Continue Reading U.S. Supreme Court Lifts Preliminary Injunctions on Healthcare Worker Vaccine Mandate

The ABA Washington Health Law Summit is the premier legal conference focusing on health law policy and, as a result, offers insight into current and future major policy issues.  But, as always at this conference, there are the issues selected by the conference chairs and formally on the agenda – and then there are issues experienced practitioners can identify by reading between the lines.  Both are addressed below.

Continue Reading Health Law Policy Heading Into 2022 At The ABA Health Law Summit

This post originally appeared as an article in the Los Angeles Daily Journal on October 29, 2021.

As of January 1, 2022, patients will no longer be at risk for one of the most detested practices in healthcare: surprise out-of-network bills.

Continue Reading Relief from Surprise Bills – Congress Passes the No Surprises Act What Providers and Insurers Need to Know

According to a Centers for Medicare and Medicaid Services (“CMS”) study reported in Health Affairs on March 24, 2020, national health care spending reached $3.81 trillion in 2019 and is projected to increase to $4.01 trillion by the end of 2020.  CMS also projects that by 2028, health care spending will reach $6.19 trillion, and will account for 19.7% of GDP, up from 17.7% in 2018.
Continue Reading Venture Capital And Private Equity Investors Take Note: Primary Care May Be The Next Behavioral Health

On Friday, President Trump announced four executive orders directed at decreasing prescription drug prices by ordering certain actions by the Department of Health and Human Services (“HHS”).  One order – which has received the most negative reaction from the pharmaceutical industry – would create a “most-favored nation” policy to limit the price Medicare Part B pays for certain drugs to the lowest price paid in another Organization for Economic Cooperation and Development country.  The White House did not release the text of this order on Friday and stated that it would not take effect until August 24, or at all if pharmaceutical companies can offer an alternative proposal to substantially reduce drug prices or if Congress acts.
Continue Reading A Shot Across the Bow of the Pharmaceutical Industry: President Trump Issues a Quartet of Executive Orders on Drug Pricing that Might Eventually (OR NEVER?) Take Effect

While traditionally healthcare businesses have tended to look to patent protection, it would behoove them to also think about trade secret protection to protect their valuable inventions.  Given the financial strains on businesses from the COVID-19 pandemic, some businesses may find trade secret protection a cost-efficient alternative to the patent process. Trade secret enforcement also potentially can yield hundreds of millions, sometimes even over a billion, dollars for the trade secret holder.[1] Further, patent protection is not always available.[2]
Continue Reading Admonition To Members Of The Healthcare Industry: Don’t Give Trade Secret Protection The Short Shrift!