IHA Daily Briefing: July 9

Monday, July 9, 2018

340B Drug Pricing Program Hearing July 11
CMS Puts Risk Adjustments On Hold
Upcoming Webinars Explore CMS CoPs

340B Drug Pricing Program Hearing July 11
Late last week, in advance of a July 11 hearing on “Opportunities to Improve the 340B Drug Pricing Program,” the U.S. House Committee on Energy and Commerce Subcommittee on Health released more than a dozen bills and drafts of legislation related to the program.

A hearing webpage features details on the following legislation:

  • H.R. 2889, Closing Loopholes for Orphan Drugs Act
  • H.R. 4392, To provide that the provision of the Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs final regulation
  • H.R. 4710, 340B Protecting Access for the Underserved and Safety-Net Entities (340B PAUSE) Act
  • H.R. 5598, 340B Optimization Act
  • H.R. 6071, Stretching Entity Resources for Vulnerable (SERV) Communities Act
  • H.R. 6240, To amend the Public Health Service Act to provide for certain user fees under the 340B drug discount program
  • H.R. 6273, To amend the Public Health Service Act to ensure appropriate care by certain 340B covered entities for victims of sexual assault, and for other purposes
  • H.R. __, Protecting Safety-Net 340B Hospitals Act
  • H.R. __, Bettering Operations and Oversight through Senate-process Transparency (BOOST) in 340B Act
  • H.R. __, To amend the Public Health Service Act to define the term patient for purposes of the 340B drug discount program
  • H.R. __, To require the Secretary of Health and Human Services to implement the Government Accountability Office recommendations
  • H.R. __, To amend the Public Health Service Act to require under the 340B drug discount program reports by covered entities
  • H.R. __, To amend the Public Health Service Act to require the Secretary of Health and Human Services to conduct audits
  • H.R. __, To amend the Public Health Service Act to require certain covered entities under the 340B drug discount program
  • H.R. __, To amend the Public Health Service Act to allow the Secretary of Health and Human Services to prescribe regulation

According to an AHA summary, the bills would: “Void recent outpatient prospective payment system changes in the payment amount for certain drugs and biologicals purchased under the 340B program (H.R. 4392); limit the orphan drug exclusion under the program (H.R. 2889); establish a moratorium on the registration of certain new 340B hospitals and associated sites (H.R. 4710); require certain disproportionate share hospitals under the 340B program to submit reports on low-income use of outpatient hospital services (H.R. 5598); clarify the intent of the program and enhance program integrity (H.R. 6071); and provide for certain user fees under the program (H.R. 6240).”


CMS Puts Risk Adjustments On Hold
On Saturday, the Centers for Medicare & Medicaid Services (CMS) issued a press release announcing that it has put risk adjusted collections and payments, as part of the Affordable Care Act (ACA), on hold until pending litigation has been resolved. A February ruling by the U.S. District Court for the District of New Mexico invalidated using the statewide average premium by CMS in the risk adjustment transfer formula established under the ACA, for the 2014 – 2018 benefit years, pending further explanation of CMS’ reasons for operating the program in a budget neutral manner in those years.

The January ruling by the U.S. District Court for the District of Massachusetts, ruled that CMS had acted within its authority to utilize the U.S. Dept. of Health and Human Services-operated risk adjustment methodology based on the statewide average premium.

The government moved the New Mexico district court to reconsider its decision, and CMS is currently awaiting the court’s ruling. CMS is seeking a quick resolution to the legal issues raised and will inform stakeholders of any update to the status of collections or payments at an appropriate future date. The calculated risk adjustment transfer amounts for the 2017 benefit year are $10.4 billion, which includes transfers across catastrophic, small group, and individual non-catastrophic risk pools.


Upcoming Webinars Explore CMS CoPs
Is your hospital prepared for a surprise visit from a Centers for Medicare & Medicaid Services (CMS) surveyor? To make sure the answer is "yes," take part in the upcoming sessions of IHA's CMS Hospital Conditions of Participation (CoPs) Made Easy webinar series.

On July 12 from 12 to 2 p.m., Nursing and Pharmacy will focus on challenging standards, interpretive guidelines, proposed changes, and compliance strategies related to the Nursing and Pharmaceutical Services CoPs chapters.

On July 17 from 12 to 2 p.m., Utilization Review, Quality, Radiology and Other CoPs will review recent regulatory changes and requirements related to:

  • Hospital quality assessment and performance improvement programs;
  • Radiological services;
  • Laboratory services and the look back program;
  • Food and dietetic services;
  • Utilization review;
  • Outpatient observation; and
  • Physical environment and maintenance.

For more information about the agenda, faculty and registration, click here. IHA's series concludes on July 26 with Infection Control, Discharge, Surgery and Other CoPs.