Legal, Legislative Quest to Expand Off-Label Part D Coverage Continues

[Rich66]

Legal, Legislative Quest to Expand Off-Label Part D Coverage Continues

The Pink Sheet Daily. 2009 Apr 27, G Twachtman

The Medicare Rights Center is continuing a lawsuit seeking to expand coverage for off-label indications under the Medicare Part D prescription drug benefit after helping a beneficiary gain coverage of a drug to treat ovarian cancer.
The case involves two plaintiffs - Judith Layzer and Ray Fischer - who are trying to secure Part D coverage for off-label indications that have peer-reviewed journal backing but are not listed in any of the recognized compendia.
In the case of Judith Layzer, she was trying to secure Part D coverage of Merck Serono's fertility drug Cetrotide (cetrorelix acetate) to treat and limit her ovarian cancer.
The off-label indication was covered by her insurance company prior to Part D's implementation. However, the Medicare Modernization Act, under which Part D was formed, prohibited coverage for drugs not listed in compendia, and when Layzer switched to Part D, coverage for Cetrotide was denied.
She ultimately received a positive coverage resolution April 20 from a Part D review board because changes under the Medicare Improvements for Patients and Providers Act opened the door for Part D coverage of off-label drugs used to treat cancer based on peer-reviewed literature.
"It was a very methodical, evidence-based decision ... which is really what we've been asking for," Paul Precht, director of policy and communication for the Medicare Rights Center, said in an interview. "That is very encouraging that they did this, so MIPPA is working as it was intended to."
Co-plaintiff Ray Fischer is still fighting to get coverage of Tercica's Increlex (mecasermin [rDNA origin] injection). The drug is indicated for IGF-1 deficiency treatment for short stature, but Fischer uses it in the off-label treatment of his myotonic muscular dystrophy type 2. Unlike Layzer's situation, Fischer is not being treated for cancer, so rules that prevent off-label coverage when no compendia listings are available come into play.
The original case was filed by the Medicare Rights Center on behalf of Layzer on Nov. 26, 2007, in the U.S. District Court for the Southern District of New York. An amended filing on Dec. 17, 2007, added Fischer to the case. Even though her coverage issue has been settled, Layzer remains a part of the case in hopes of getting coverage made retroactive to the beginning of the Part D benefit.
A decision has not yet been rendered, but if it came out in favor of Layzer and Fischer, "that would be a great victory ... for all folks under Part D," Precht said.
Seeking A Legislative Fix
The Medicare Rights Center is not just focusing on the courts to gain greater access to off-label uses under Part D.
"We are still pushing, through the lawsuit as well as on the legislative front, to get that same type of case-by-case review for non-cancer drugs," Precht said.
To that end, the coming legislative activity surrounding health care reform could present the perfect opportunity to loosen off-label coverage restrictions, and the Medicare Rights Center is pushing for inclusion.
"That's our hope," Precht said. "There seems to be some appetite for at least technical changes to Part D that deal with how it works. This would fall into that."
He added that the idea of extending the off-label coverage rules to non-cancer drugs is slowly getting traction.
"Generally speaking, the more we talk to people with a clinical background, the more receptive folks are because they understand how nuanced and individualized these decisions can be and believe that actually looking towards the original source of the material ... is the better way of making a decision," he said.