Health Center Regulatory Issues

Regulatory Affairs: A Year in Review

NACHC’s Regulatory Affairs Department has seen a lot of action over the last year, with many important regulations and guidances released and the addition of new staff.  Below are some of our highlights from 2015:

  • We welcomed a new Director of Regulatory Affairs! As many of you know, Roger Schwartz, the former Director of the Regulatory Affairs Department retired at the beginning of the year and we welcomed Colleen Meiman on as the new Director.  She jumped right into the new role on Day One and, as you’ll see, we have kept her busy all year.  We are all glad to have her on board!
  • We redesigned the NACHC process for soliciting input on proposed regulations and guidances, such as:
    • expanding timeframes and opportunities for health centers and PCAs to suggest and respond to draft comments
    • creating a new webpage with information on the regulatory process, links to documents currently open for public comment, and links to NACHC comments to previous documents, searchable by topic area
  • We submitted formal comments to the Department of Health and Human Services (HHS) on a wide variety of policy areas, including:
    • The rules governing Medicaid Managed Care Plans: this is the first proposed rule on Medicaid Managed Care plans that CMS has released in years and covers policies guiding all areas of Medicaid Managed Care, including contract reviews and setting rates.
    • The mega-guidance on the 340B Drug Discount Program: this much anticipated guidance on the 340B program proposed to make major changes to the program in the agency’s first-ever guidance on the program,  including creating a new patient definition and other important program policies. We expect this “mega-guidance” to be finalized in the upcoming year.
    • The rules governing the Marketplaces in 2017: this is CMS’ annual guidance on the Marketplace Exchanges, which provides the policies that Exchanges and Qualified Health Plans must follow to participate in the Marketplaces, including issues such as essential community providers (ECPs), the role of Navigators and Certified Assistance Counselors, and network adequacy.
  • We have been working directly with the Administration to raise concerns about, and secure improvements, in:
    • changes to the HPSA scoring and Shortage Designation processes
    • the new format for the Medicare Cost Report, expected to be released in 2016
    • Medicaid payment approaches, including ensuring states are appropriately paying Medicaid PPS rates and the Medicaid wrap around
    • Addressing the 340B registration process to address the challenges and issues we have heard from health centers

It has been a busy, but important year in Regulatory Affairs and we expect 2016 to be just the same.  We thank you all for your time and attention in helping to formulate NACHC’s position on these rules and regulations and look forward to working with you in the New Year.   Happy Holidays! – Colleen and Susan