The Affordable Care Act authorized the Department of Health and Human Services (HHS) to require a physician, dentist or other healthcare provider to be enrolled in the Medicare program before they can issue a prescription covered by Medicare Part D.

Regulations implementing this requirement were first issued by HHS in 2014 and scheduled to go into effect June 1, 2015, with an enforcement delay until December 1, 2015.  Under the regulations, HHS required all providers to either formally enroll in, or officially opt out of, the Medicare program in order to issue a covered prescription to a Medicare Part D beneficiary.

These regulations will have the greatest impact on healthcare providers, such as dentists, whose services are generally not covered under Medicare but who may still issue prescriptions to Medicare beneficiaries.  These providers have historically neither formally enrolled in nor opted out of the Medicare program, because they never provided services which were eligible for Medicare reimbursement.

The provider community objected that these regulations would create an undue burden on providers who had never been subject to Medicare enrollment requirements and would limit beneficiaries’ access to needed pharmaceuticals. For example, a prescription for a painkiller or antibiotic issued to a patient by a dentist would no longer be covered if the dentist had not met these new enrollment requirements.  The patient would have to pay for the full cost of the drug and, if they could not afford to so, might not receive needed pharmaceutical care.

In response, HHS released revised regulations on May 6, 2015.  These revisions include a delayed effective date of January 1, 2016.  In addition, Medicare Part D plans must now provide provisional coverage of the a drug prescribed by a provider who does not meet the enrollment/opt out requirements.  The provider will then have up to 3 months to either enroll or formally opt out of Medicare, allowing the prescription to be covered back to the original date.

Providers who have not yet enrolled in or opted out of Medicare have four options to consider:

1. Take no action.  The provider can still issue prescriptions – but Medicare Part D beneficiaries will be required to pay the full cost of the prescription or find an alternate provider.
2. Enroll as a Medicare provider.  Dentists and other healthcare professionals are eligible for Medicare enrollment, even if they never provide Medicare-covered services.
3. Enroll in Medicare as an ordering/referring provider (ORP).  This is a limited enrollment category.  An ORP is allowed to order Medicare-reimbursable services, including prescriptions, but is not eligible for Medicare reimbursement for any services they provide directly.
4. Opt out of Medicare.  Providers can formally opt out of Medicare by filing an affidavit with the appropriate Medicare contractor.

Each option has pros and cons that should be weighed carefully before a decision is made.