Off-Label Drugs Prescribed to Medicare Part D Plan Members


Young Law Group is investigating pharmacies that are submitting false statements and claims to Medicare Part D plans for reimbursement for “off-label” prescriptions that are not for a “medically accepted indication.”

Under Medicare Part D, a drug has a medically accepted indication only if the indication has been approved by the FDA, or if the indication is supported by one of the following compendia:

  1. American Hospital Formulary Service Drug Information
  2. United States Pharmacopoeia-Drug Information
  3. the DRUGDEX Information System.

Medicare Part D (“Part D”) is a federally funded prescription drug benefit program available to Medicare participants who voluntarily enroll. The Medicare Part D program is administered by the Centers for Medicare and Medicaid Services (“CMS”) and provides drug coverage to Part D enrollee beneficiaries through private Part D Plans (“PDP”) offered and administered by private PDP sponsors authorized by CMS.

Beneficiaries enroll in a PDP of their choice and pay premiums to their PDP sponsors. PDP coverage is limited by certain deductibles, co-payments, and benefit caps and beneficiaries have their prescriptions filled at private pharmacies, which are generally within a PDP’s contract network. Pharmacies submit their PDP bills for payment by the PDP sponsor, or the PDP sponsor’s subcontractor, which pays the prescription costs not paid directly by the beneficiary.

CMS ultimately reimburses the PDP sponsor for varying portions of the prescription costs.

Young Law Group is looking into and for specialty pharmacies that provide services to long-term care facilities (“LTCFs”), such as nursing homes. Under federal regulations, specialty pharmacies may act as a “consulting pharmacy” by providing “consulting pharmacy services” to LTCFs. The specialty pharmacies may also act as a “dispensing pharmacy” by filling prescriptions for LTCF residents.

In both its roles as “consulting” and “dispensing” pharmacy, the specialty pharmacies acquire specific knowledge of the Part D beneficiaries’ medical records and drug regimens and know whether the drugs are being dispensed ” for a “medically accepted indication” or for a non-approved off-label use. If the specialty pharmacies dispense drugs for an off-label use and seek Medicare Part D reimbursement for that drug, the False Claims Act maybe violated.

If you know or have information concerning specialty pharmacies that seek reimbursement for drugs that were dispensed off-label to Medicare Part D members, please call Eric Young at the Young Law Group at (800) 590-4116 or email to for a free confidential consultation.