Free Drug Samples to Patients Come with Restrictions

December 1, 2014

At present, the question of providing free, or reduced costs drugs to patients, is a multifaceted problem which defies easy solutions.

The availability of pharmaceutical free samples has declined in recent years, along with the number of detailers who deliver them. According to a 2012 American Medical News report, "[p]harmaceutical companies have slashed their sales rep force by about 30 percent from a high of 105,000 five years ago, according to industry figures. And as the number of detailers has fallen, so, too, has another hallmark of pharmaceutical marketing: drug samples."

Part of the reason, according to the report, is the loss of valuable patent protection for many higher-priced drugs. "In 2011, the world's best-selling drug, Pfizer's Lipitor (atorvastatin), went off patent; as did Eli Lilly's antipsychotic Zyprexa (olanzapine). In 2012, patents expired for the clot-buster Plavix (clopidogrel), made by Bristol-Myers Squibb and Sanofi-Aventis, AstraZeneca's anti-psychotic Seroquel (quetiapine), and Takeda's diabetes drug Actos (pioglitazone)."

This industry pullback may provide an opening for those who have long-questioned the safety and validity of free-sample programs. The problem was described by the Institute on Medicine as a Profession (IMAP) in a 2013 publication:

"Ostensibly, samples can be used to benefit low-income patients who would otherwise struggle to afford a particular drug. In practice, however, low-income and uninsured patients are less likely to receive samples than high-income patients and patients with insurance. Furthermore, samples often never reach patients at all, and are instead used by physicians or hospital staff or their relatives. Patients who do receive samples may discontinue treatment entirely if they are not able to afford the medication once the sample supply runs out."

One solution suggested by IMAP: Deliver free samples to a pharmacy, not the physician's office. While pharmacies may be better-equipped and properly trained to prevent diversion, it is hard to justify creating a new public expectation that pharmacies should provide free alternatives to paying for the very products a pharmacy sells.

Another solution might be the replacement of free samples with "voucher" programs. Prescription assistance programs (PAPs) have been in place for many years. Many are charitable in nature and often specific to a particular disease, such as cancer as reflected in this index.

Others PAPs are more narrowly drawn to a particular product or service.

More recently, voucher programs have been created for patients with prescription drug plans. The PAP pays the patient's coinsurance or copayment, which means the drugs are provided at no cost to the patient. While copayment vouchers can frustrate the very purpose of coinsurance provisions, insurance plans are not free from complicity. Prescription drug plans are notorious for designing benefits and patient copayments in such a way as to discourage if not punish the patient for certain purchases. Disfavored purchases of drugs may carry a much higher copayment or coinsurance amount. All of this is designed to increase the out-of-pocket portion paid by the patient, to the point that the patient cannot afford the disfavored service.

In May 2014, HHS' Office of the Inspector General (OIG) issued a bulletin, "Supplemental Special Advisory Bulletin: Independent Charity Patient Assistance Programs," 79 FR 31120 addressing Medicare Part D and PAPs under a federal anti-kickback statute analysis.

Specifically, the OIG stated that drug benefit PAPs could violate the statute, because the waiver of copayments could be designed to steer patients to pharmacies willing to forgive the patient's obligation. The OIG stated that illegality often depends upon the "structure, sponsorship, and funding" of the PAP in Medicare and Medicaid cases. The OIG takes the position that a Medicare or Medicaid PAP should be a bona fide charity; the PAP should not be so narrowly drawn that it amounts to nothing more than a conduit for the payment of the patient's responsible portion by the provider; the PAP should not be limited to certain products or a subset of products; and the PAP must determine eligibility according to a reasonable, verifiable, and uniform measure of financial need that is applied in a consistent manner.

Concerns multiply in states which permit physician ownership in pharmacies participating in voucher programs for private pay insurance plans. At present, the question of providing free, or reduced costs drugs, is a multifaceted problem which defies easy solutions.