Saturday, January 10, 2015

HHS Says Court Case Fighting the NCD on Amyloid PET Scans Isn't Valid; Defendants Fire Back


  • Three beneficiaries, supported by Lilly, filed for summary judgement against the CMS beta-amyloid NCD in September 2014.
  • CMS filed a lengthy motion to dsmiss in December 2014.
  • The plaintiffs filed a renewed request to invalidate the NCD and enjoin enforcement in January 2015.

Details after the break.

As was widely covered in some popular and trade press, in September, 2013, CMS issued the final version of a national coverage decision against coverage of beta-amyloid PET scan tracers.   The tracers can, however, be covered on a limited basis within CMS-approved trials (coverage with evidence development).

  • The amyloid PET scan NCD is here.  
  • Some representative press coverage is here.  
  • A general blog on the topic of evolving HHS policy for amyloid scans, by Dora Hughes in April 2014, is here.  
  • See also pp 10-11 at this link, here.

In September 2014, Lilly supported three patients in a lawsuit against HHS, asking the federal court to intervene.   The plaintiff's case is online here.  Press on the court filing in fall 2014 is here and here.

Three months later, on December 20, 2014, the government's response was released, available here.   In a 22 page argument, the government concludes that the plaintiffs failed to exhaust administrative remedies (e.g., reconsideration of the NCD and an appeal of the NCD to the CMS Department Appeals Board rather than a federal court; for the latter, here).

The government asks the judge to find that:

1.  The court lacks subject matter jurisdiction;
2.  Plaintiffs filed to exhaust administrative remedies;
3.  No complaint is stated upon which relief could be granted by the court;
4.  CMS actions did not violate the Social Security Act or the Administrative Procedures Act.

On January 26, 2015, the defendants, again supported by Lilly, filed a 53 page motion demanding that the court declare the NCD void and enjoin CMS against enforcing the NCD.   The filing is here.  A subscription trade journal, Gray Sheet, has coverage here.

Note - 

Another case was concurrently proceeding through federal court, and challenging whether CMS has the power to delegate coverage decision-making authority to its contractors (e.g. MACs) in the form of LCDs.  For more about that case, here.  This case survived initial motions to dismiss and reached oral argument 1Q2015.  But it was dismissed for lack of standing in May, 2015. (Here).