Our colleagues at ML Strategies have provided their Health Care Weekly Preview for the week of October 9, 2017.  This week’s preview discusses many topics, including the Trump administration’s roll back of the ACA’s mandate that employers cover birth control coverage. It also discusses Congess’ work on health extenders, CHIP, and the community health centers program, among other things. The preview also touches on MedPAC’s recommendation that CMS replace the Merit-based Incentive Payment System (MIPS) which the group believes is too much of a burden on physicians.

Thus far, 2016 has been a relatively quiet year for the 340B program at the federal level.  Neither Congress nor the Health Resource and Service Administration (HRSA) has shown an appetite to take on the issues plaguing the program.  In fact, late last month, the Department of Health and Human Services indicated that the program is likely to remain in its status quo until at least the end of the year.  In its regulatory agenda released May 2015, HRSA stated it will delay the release of its final 340B Program Omnibus Guidance to the end of 2016.  HRSA also indicated it will delay its 340B manufacturer civil monetary penalty rule and proposed administrative dispute resolution rule.

Although HRSA has not provided any further information for the reason of the delay, it does not come as a surprise.  When the D.C. District Court invalidated HRSA’s orphan drug “interpretive” rule in October 2015, we hypothesized that this may call into question HRSA’s willingness to proceed on the Proposed Guidance.  The fact is, a number of the provisions in the Proposed Guidance impose duties in the name of compliance that go beyond statutory requirements, and under the Court’s decision, such provisions may be unenforceable.  This delay may be the first step in HRSA’s decision to eventually pull the Proposed Guidance and spare itself the attacks. Continue Reading Delays in 340B Mega-Guidance and a Recap of the Latest 340B Updates

Written by:  Andrew J. Shin, Stephen M. Weiner, and Stephanie D. Willis

On September 16, 2014, the Centers for Medicare & Medicaid Services (CMS) announced key shared savings and losses results of Accountable Care Organizations (ACOs) that began participating in the Medicare Shared Savings Program (MSSP) or the Pioneer ACO Program (PACO) in 2012 and 2013.  Thus far, of the ACOs still participating in the MSSP or PACO at the time the data was collected:

  • Fifty-three out of the 204 ACOs generated shared savings totaling more than $300 million during their first performance year;
  • Nine out of the 34 ACOs participating in the Advanced Payment model option of the MSSP generated gross shared savings of $58.53 million, but over a third (34.5%) of that gross amount was generated by one ACO;
  • One ACO participating in the risk-sharing/shared-losses option (Track 2) of the MSSP generated losses of $9.97 million and will have to repay $3.96 million to CMS;
  • Two ACOs participating in Track 2 of the MSSP generated gross shared savings and will receive performance payments from CMS of nearly $17 million; and
  • During the second year of the PACO, 11 out of the 23 Pioneer ACOs earned $68 million in financial bonuses.

CMS provided a table with details about the gains and losses generated by the ACOs that will be updated as new information becomes available. Continue Reading CMS Releases MSSP and Pioneer ACO Data on Shared Savings and Losses – Where Do We Go From Here?