Health and Human Services officials have clarified ways that drug manufacturers can continue to provide free medications to needy patients, even if those patients are enrolled in Medicare Part D prescription coverage.
HHS Inspector General Daniel Levinson clarifed his position on Tuesday, April 19, 2006 that there are “lawful avenues” for pharmaceutical companies to give financial assistance to needy Medicare patients.
Critical to such programs are:
- No Medicare payment is sought for free drugs.
- Assistance is based solely on financial need.
- There is a methodology for assistance that does not take into account the patient’s choice of a Medicare Part D drug plan.
In January 2006, HHS provided guidance to pharmaceutical companies and patient assistance programs to ensure that the programs operated legally and did not pressure any patient to take a particular drug.
There has been confusion over whether patients could be required to drop out of Part D in order to receive drug assistance or help with co-pays. In addition, some pharmaceutical company patient assistance programs have required that patients enroll in Part D. However, patients do not need to drop out of Part D or be compelled to enroll to meet federal requirements.
Pharmaceutical companies can help with Medicare Part D co-pays as long as there is no company pressure to persuade a patient to use a particular drug. Many companies are turning to not-for-profit organizations to provide counseling and financial help with co-pays through unrestricted grant programs to those organizations.
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