At the end of July, CMS approved two Section 1332 State Innovation Waivers submitted by Wisconsin and Maine for the purpose of establishing state reinsurance programs. There has been a flurry of 1332 waiver activity recently as states have sought to stabilize their individual insurance markets through reinsurance programs. Currently, Maryland and New Jersey have pending reinsurance applications before CMS. For more on the Wisconsin, Maine, and Maryland waivers, click here.

New Jersey’s request, which was submitted on July 2nd, 2018, is summarized below. Continue Reading New Jersey’s Pending 1332 Reinsurance Waiver

On Wednesday, August 8, CMS filed a proposed rule clearing the way for the federal government to continue making payments under the ACA’s risk adjustment program for the benefit year 2018.  The 2018 proposed rule is unsurprising.  It essentially mirrors the final rule CMS issued two weeks ago for benefit year 2017, including the same technical fix to the risk adjustment methodology meant to satisfy a decision handed down in February by a federal district court judge in New Mexico, who had ruled that the use of certain risk management formulas in the program was arbitrary and capricious.  Both the 2017 final rule (which will presumably allow CMS to make billions of dollars in risk adjustment payments to plans this fall for benefit year 2017) and the 2018 proposed rule (which is designed to allow payments for benefit year 2018, to be paid out during the fall of 2018) will still need to be approved by the district court before any risk adjustment payments can be made, meaning the future structure of the risk adjustment program is far from set in stone.  The New Mexico CO-OP which had challenged the risk adjustment methodology in the first place made clear in a filing on August 1 that it will continue to fight the risk adjustment methodology.  However, CMS’s decision to continue administering the risk adjustment program is noteworthy because it represents a stark reversal from the agency’s announcement in early June that the federal government would freeze the program in response to the district court ruling. Continue Reading CMS, In a Reversal, Announces Plans to Continue Funding Risk Adjustment Payments

States are increasingly looking for ways to improve stability in their individual insurance marketplaces. One way is through reinsurance programs – systems in which multiple insurance companies share risk by purchasing insurance policies from another party to limit the total loss the original insurer would experience in case of unusually high claims. To date, Alaska, Minnesota, and Oregon have established state reinsurance programs through Section 1332 State Innovation Waivers, according to the Kaiser Family Foundation. More are on the way.

Recently, there has been significant activity on using Section 1332 waivers to implement reinsurance programs. On July 29, 2018, CMS approved Wisconsin’s 1332 waiver request to implement a reinsurance program for years 2019 through 2023. On July 30, Maine’s waiver request to reinstate its reinsurance waiver was approved. Maryland and New Jersey also have pending reinsurance applications before CMS (Maryland being the most recent state to submit an application). Continue Reading Recent 1332 Waiver and Reinsurance Activity

In May, the Trump Administration announced its Blueprint to Lower Drug Prices and HHS Secretary Azar issued a Request for Information seeking comments from interested parties “to help shape future policy development and agency action” related to drug pricing issues.  Since that time, many industry commentators questioned whether any of the vague goals in the Blueprint would or could be turned into concrete action.

This month, the Trump Administration has attempted to answer that question through a variety of HHS and FDA initiatives.  Here’s what you need to know about drug pricing developments so far in July. Continue Reading Significant Drug Pricing Developments in July – Here’s What You Need To Know

It seems like every week, there are multiple new developments in the 340B program.  While it has just been a few weeks since my last 340B blog post, since that time we have had another Senate hearing, a new GAO Report, a new House hearing, and introduction of more than a dozen new bills in Congress.  But why, despite all these developments, does it feels like little has actually changed in the 340B world since January?  Continue Reading July 2018: Where Are We Now With 340B?

The government is focusing on opioids.  Whether it be program policies, enforcement, or legislation, combating the opioid epidemic continues to be a major focus for government officials.  It is also a major piece of the health care legislation moving in both the House and the Senate.

In the Senate, the Judiciary Committee advanced five bills relating to the opioid crisis, and the HELP Committee advanced the “Opioid Crisis Response Act of 2018,” which has over 40 measures relating to opioids. Most recently (6/12), the Senate Finance Committee unanimously approved the Helping To End Addiction And Lessen (HEAL) Substance Use Disorders Act Of 2018.  That Act includes the expansion of the Physician Payment Sunshine Act to include payments to mid-level providers, as we previously blogged about here.  Click here for a summary of all Senate bills.

On the House side, over the last two weeks, the House passed over 50 bills to combat the opioid crisis and have received bipartisan support. Additional opioid related bills have been introduced and passed out of committee. On June 20, the House voted and passed three additional opioid bills (HR 5925, HR 9797, and HR 6082). Two of these bills were considered controversial. H.R. 5797, The IMD CARE Act, repeals the Medicaid IMD exclusion for individuals with opioid use disorders. H.R. 6082, The Overdose Prevention and Patient Safety Act, amends 42 CFR Part 2 confidentiality protections pertaining to substance use disorder patient records.  Continue Reading Opioids Have Our Attention

A lot has happened since we last addressed new biosimilar developments in January 2018. In the intervening months, there have been many significant developments related to FDA’s implementation of an efficient regulatory program for biosimilar products and the abbreviated BLA (aBLA) review process. Today we’re going to recap some of what has transpired over the past 5 months in the biosimilars space in an attempt to get our readers caught up. Continue Reading Biosimilars in the Limelight – A Lot Has Happened Since January 2018

Many provisions of the Affordable Care Act (“ACA”) have been the subject of litigation over the last decade, with several high-profile Supreme Court cases including: NFIB v. Sebelius, King v. Burwell, and Burwell v. Hobby Lobby. One of the more overlooked topics of litigation has been the ACA’s “Risk Corridors” program. This has recently changed because a decision is anticipated in the consolidated appeal of two important risk corridors cases currently pending in a federal appeals court. Continue Reading Decision Expected Soon in Ongoing Risk Corridors Litigation