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Pre-2019 Requirement: Mandatory Medicare Enrollment for Part D Prescribers
- Before January 1, 2019, prescribers of Part D drugs were required to be enrolled in Medicare or have formally opted out in order for a Part D plan to cover the drug.
- This rule was finalized in 2015 (CMS-4159-F) and was meant to ensure that only verified, credentialed providers could prescribe drugs under Medicare.
- CMS delayed enforcement multiple times due to pushback from provider groups, concerns about patient access, and logistical challenges.
What Changed in 2019?
- CMS reversed course and eliminated the mandatory Medicare enrollment requirement for Part D prescribers in the 2019 Medicare Advantage and Part D Final Rule (CMS-4182-F).
- Instead of requiring enrollment, CMS implemented a "preclusion list" mechanism:
- Prescribers do not have to enroll in Medicare.
- However, they must have an active and valid NPI.
- Prescribers on the preclusion list (e.g., those who were revoked from Medicare, excluded by the OIG, or found guilty of fraudulent prescribing) are blocked from prescribing under Part D.
Why Did CMS Make This Change?
Concerns About Provider Burden:
- Many prescribers, especially those who did not typically see Medicare patients, objected to the enrollment requirement.
- Examples: Pediatricians, psychiatrists, and urgent care providers who occasionally prescribed for Medicare beneficiaries but had no reason to enroll in Medicare.
Patient Access Issues:
- The enrollment requirement led to prescription rejections, especially in specialties where providers were less likely to enroll (e.g., behavioral health, addiction medicine).
- Patients faced delays in obtaining medications when their prescriber was not enrolled.
Administrative Complexity:
- The enrollment process added bureaucratic overhead, creating backlogs at CMS and delaying access to medications.
- The system relied on Medicare Administrative Contractors (MACs), which had difficulty keeping up with enforcement.
Alternative Oversight via the Preclusion List:
- CMS argued that maintaining a "bad actor" preclusion list would be a more effective way to prevent fraud, waste, and abuse.
- They claimed that enrollment did not add meaningful protections beyond existing fraud detection mechanisms.
Was the Change Controversial?
Yes, but mostly among regulatory and compliance stakeholders.
Supporters:
- Medical groups, pharmacists, and patient advocates largely supported the change, citing improved access to medications and reduced administrative burden for prescribers.
- Behavioral health and addiction medicine specialists particularly welcomed the decision.
Critics:
- Some compliance and fraud prevention experts worried that eliminating the enrollment requirement might make it easier for unscrupulous prescribers to exploit Medicare.
- Certain policymakers argued that requiring prescriber enrollment added an extra layer of vetting, which the preclusion list might not fully replace.
Pharmacists & PBMs:
- Some Part D plan sponsors and pharmacy benefit managers (PBMs) were initially concerned about how they would verify prescriber eligibility without the enrollment requirement.
- However, once CMS clarified that an NPI is still required and that plans must check the preclusion list, these concerns largely faded.
Key Takeaways from the 2019 Change
- Before 2019: Prescribers had to be enrolled in Medicare or opted out for a Part D drug to be covered.
- After 2019: Prescribers do NOT have to enroll, but they must have:
- A valid, active NPI.
- No inclusion on the CMS preclusion list.
- Impact:
- Reduced burden on prescribers.
- Improved access to medications.
- Potential concerns about fraud oversight.
Would you like more details on how the preclusion list is managed or any specific examples of prescriber access issues that led to the rule change?
