Commissioner's Ruling - Patient Assistance Programs

Whereas, the Department recognizes that many patients are not able to obtain medications, including controlled substances, for their legitimate medical needs because they cannot afford to pay for prescription medications dispensed by a pharmacy; and

Whereas, Section 3319 of the Public Health Law prohibits the distribution of free samples of controlled substances, except to persons licensed pursuant to Title III of Article 33 of the Public Health Law to perform research, instructional activities or chemical analysis relating to controlled substances; and

Whereas, the Department has determined that pharmaceutical companies reimbursing pharmacies for supplies of controlled substances dispensed to patients who have presented company vouchers or coupons are violating Public Health Law Section 3319 because the reimbursement has the same effect as the company providing pharmacies with controlled substances at no cost; and

Whereas, the Department recognizes that many pharmaceutical companies have established Patient Assistance Programs to reimburse pharmacies for dispensing medications, including controlled substances, to patients who cannot afford to pay for their medications; and

Whereas, the Department has determined that Patient Assistance Programs are similar to public benefit programs when reimbursement is provided for medications dispensed to patients who have been determined to lack the resources to pay for such medications; and

Whereas, the Department finds that Patient Assistance Programs that are designed to help indigent patients address their medical needs, rather than as promotional tools, benefit the health, safety and welfare of the residents of the State of New York; and

Whereas, the Department finds that Public Health Law Section 3319 was not intended to prohibit public benefit programs or similar third party reimbursement programs from reimbursing pharmacies for the cost of prescription medications dispensed to patients who cannot otherwise afford to pay for them;

Now, therefore, pursuant to the authority contained in Public Health Law Section 3308(2), I hereby make the following ruling:

• A pharmaceutical company operating a Patient Assistance Program which reimburses pharmacies for the cost of dispensing controlled substances to patients who cannot afford to pay for prescribed medications is not in violation of the prohibition against the distribution of free samples, set forth in Public Health Law Section 3319, provided the Patient Assistance Program meets the following criteria:
  1. The Patient Assistance Program is designed to be a patient-specific assistance program, rather than a general promotion tool;
  2. The patient's physician or other practitioner authorized to prescribe a controlled substance, the pharmaceutical company or the pharmaceutical company's agent, and not the dispensing pharmacy, determines that a patient is eligible for participation in the Patient Assistance Program based upon financial need criteria developed by the pharmaceutical company;
  3. The program provides continuous coverage for the prescribed medication for as long as the patient's physician determines the medication is medically warranted and the patient meets the established financial eligibility criteria;
  4. The pharmacy pays the company for the drug in accordance with normal payment principles applicable to other medications;
  5. The patient can select any pharmacy to dispense the prescription; and
  6. The Patient Assistance Program is a voluntary program for all parties involved and is not limited to patients of physicians selected by the company.

Antonia C. Novello, M.D., M.P.H., Dr. P.H.
Commissioner of Health