Monday, December 10, 2018

Very Brief Blog: SUPPORT Act is Federal Legislation Affecting Lab Sales Practices to All Payers

In October 2018, Congress passed the SUPPORT Act, an omnibus opioid abuse legislative package.  An "11th hour" addition, Section 8122, could affect lab practices to all payers, not just Medicare and Medicaid.   Practices include compensation for blood draws, on-site phlebotomists, sales force compensation, etc.
  • Legislation here (Section 8122).
  • Covered in Dark Report, December 3, 2018 (subscription)
  • Open-access discussion at Epstein Becker Green, here.
  • Open-access discussion at Mintz law firm, here.
  • Memo on the ACLA website from Alston & Bird, November 26, 2018, here.
  • Letter from ACLA to HHS re: anti-kickback improvements; letter mentions Section 8122.  Here.
  • Washington Post here.  
At a glance, to me, I would have thought the law applied to relationships between opioid treatment centers and tox labs serving opioid treatment centers.  But it applies to opioid treatment centers OR labs, regardless of whom the lab is dealing with.

(According to Dark Report, p. 9, this is scope is "open to debate" in view of the legislative history and intent, or, "applies to all laboratories and to all services.")   Everyone agrees it's a criminal provision.


The law develops out of an earlier bill, HR6878, Eliminating Kickbacks in Recovery Act, EKRA, but the SUPPORT Section 8122 is not exactly the same.


Pop Quiz.

What is LEIE?  The HHS OIG list of excluded individuals and entities.  When was it last updated?  Today!     How many entities are on it?  70,847.  How many are entities (clinics, pharmacies, DME suppliers)? 3087.  How many are people?  67,760.  How many are labs?  45.  How many are hospice owners/employees?  35.  Related to infusion centers?  40.  Government employees related to the Health Resources Services Administration (HRSA/HHS)?  3.  Government employee of Substance Abuse and Mental Health Administration?  1.

By the way, if you want someone's name, address, and birthday, without breaking into Target's computers, they're here.  Youngest birthday seems to be April 29, 1990 (28).  There appear to be a couple dozen earlier than 1910, predominantly classed general practitioners.