February 26, Dear Administrator Tavenner:

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1 February 26, 2014 Marilyn Tavenner Administrator Centers for Medicare and Medicaid Services Department of Health and Human Services Mail Stop 314G 200 Independence Avenue, S.W. Washington, DC Re: CMS-4159-P: Medicare Program; Contract Year 2015 Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs; Proposed Rule; 79 FR 1918 (January 10, 2014) Dear Administrator Tavenner: I am contacting you on behalf of the nearly 13,000 members of the American Academy of Dermatology Association (AADA) to share our comments responding to the Contract Year 2015 Medicare Advantage and Part D proposed rule published in the Federal Register on January 10, The AADA is committed to excellence in medical and surgical treatment of skin disease; advocating high standards in clinical practice, education, and research in dermatology and dermatopathology; and supporting and enhancing patient care to reduce the burden of disease. The AADA appreciates the opportunity to provide comments to the Centers for Medicare and Medicaid Services (CMS) on this proposed rule and hopes CMS will take the AADA s concerns and recommendations into consideration when crafting the final rule and formulating future policy. Medicare Part D We acknowledge CMS tremendous effort in crafting the first major proposed revision of Medicare Part D regulations in years, and we recognize the agency s laudable goal of saving $144 million a year with these measures between 2015 and The AADA, however, believes the proposed regulations would deprive

2 beneficiaries of vital medications, adversely impacting their health. Accordingly, the AADA urges CMS to reconsider finalizing the proposed rules as written. Required Medicare Participation for Part D Prescribers CMS is proposing to require that physicians and non-physician practitioners who write prescriptions for covered Part D drugs must enroll in Medicare for their prescriptions to be covered under Part D by January 1, A prescriber must either be enrolled in the Medicare fee for service (FFS) program or have a valid opt-out affidavit on file. Drugs prescribed by non-enrolled providers will only be covered if the physician follows established opt-out procedures, which include filing an affidavit listing their National Provider Identifier (NPI) with a Medicare Administrative Contractor (MAC). The AADA is concerned that these proposed regulations would adversely impact physician access for Medicare beneficiaries. Under the proposed rules, CMS will not cover prescriptions for beneficiaries who pay for Medicare Part D if they receive those prescriptions from physicians not participating in Medicare. Accordingly, beneficiaries will have to see physicians who participate in Medicare. Unfortunately the number of physicians who participate in Medicare has continued to drop because of low reimbursement rates and administrative burden. Some patients will be forced to change providers. As more Medicare beneficiaries are forced to see a smaller pool of physicians, access to care will become more limited. Moreover, the AADA does not believe that this provision will result in enhancing the quality of care afforded to beneficiaries. We believe the benefit to CMS of having greater control over who writes the prescriptions can be achieved by other means that are less onerous for physicians, and do not impede patients access to beneficial medications. Authority To Revoke Medicare Enrollment for Abusive Prescribing Practices The AADA is concerned that the proposed rule would permit revocation of Medicare enrollment if CMS determines that the physician has a pattern or practice of prescribing Part D drugs that is abusive and represents a threat to the health and safety of Medicare beneficiaries or otherwise fails to meet Medicare requirements. In the proposed rule, abusive prescribing practices and patterns are delineated through a list of criteria which afford CMS considerable subjectivity in reaching a revocation decision. Under the proposed rules, it is clear that CMS--not the physician or beneficiary will determine what constitutes excessive prescribing. We fear this could discourage physicians from prescribing new medications that may be critically beneficial to patients out of fear of prosecution. While the intent of this provision may be curbing potential opioid or acetaminophen overutilization, the language of this provision is much broader and could include almost any prescription medication. Flagging methodologies that focus on prescription number 2

3 or variance from the general physician population do not work in all cases because prescribing is individualized and tied to the patient s specific needs. Also, it is common for various physicians to treat very different patient populations. Such variation in patient populations actually justifies different prescribing patterns. The proposed rule changes the traditional paradigm by moving away from deferring to physician judgment toward overriding the decision of whether a drug is medically necessary. This enhanced emphasis on discovering fraud impedes important doctor-patient relationships by discouraging lawful beneficial prescribing practices. We question whether CMS multi-faceted approach to discovering and enforcing improper prescription practices would balance both patient safety and the need for proper medication. Accordingly, we urge CMS to reconsider finalizing these provisions. We do not believe that providing CMS the authority to revoke such prescriber s Medicare enrollment would help protect beneficiaries and the Medicare Trust Fund from fraud, waste, and abuse. Instead, we believe it will disrupt and impede on-going continuity of care. We are gravely concerned that the possibility of revocation of Medicare enrollment based on a subjective determination regarding appropriate use--is excessive. Impact of Medicare Program Exclusion We believe that it is critical to have clarity and objectivity in CMS exclusion determination and are concerned over the ambiguity in the proposed rule. Exclusion from the Medicare program can have serious consequences on a health care provider far beyond the ability to prescribe Part D drugs to Medicare beneficiaries. These consequences may include termination for cause from all state Medicaid programs, loss of state professional licenses in other states and jurisdictions, loss of hospital, ambulatory surgery center (ASC) and nursing home clinical privileges and other farreaching consequences. The proposed rule also allows CMS to request and collect information directly from pharmacy benefit managers, pharmacies, and other entities that contract with Part D sponsors in order to better detect fraud, and increases CMS ability to collect identified Medicare overpayments from Medicare Advantage (MA) plans and Part D sponsors. We are concerned that physicians will face a far greater likelihood of audits, which can unduly burden and negatively impact a physician s practice even when the audit finding is ultimately determined to have no merit. Six Protected Classes/Formulary The proposed rules would limit the drugs that would be covered under Medicare Part D. Currently all plan formularies must include substantially all drugs within six drug categories: (i) antineoplastics, (ii) anticonvulsants, (iii) antiretrovirals, (iv) antipsychotics, 3

4 (v) antidepressants, and (vi) immunosuppressants. This policy, known as the six protected classes policy, has been in effect since the inception of Part D. Starting in 2015, CMS would no longer require antidepressants and immunosuppressant drugs to be covered under the plan. The proposed rules would cut down the list of protected drug classes vital drugs for which insurers cannot impose restrictions on use. In the proposed rule, CMS laid out its new criteria that CMS will use to identify drug categories or classes of clinical concern from the existing categories and identify drug categories or classes that meet the proposed criteria, as well as exceptions that permit plan sponsors to exclude certain Part D drugs within an identified drug category or class from their formularies. These criteria are: Failure to receive the drug would result in the patient s hospitalization, disability or death within 7 days (the timeframe for the current exceptions and appeals process); and Medications in that class are not interchangeable. The AADA questions CMS dismantling of the six protected classes policy and advocates for preserving open access to all FDA-approved medications. The proposed rule marks a change from Medicare focusing its efforts on making medications accessible to beneficiaries to focusing on tracking down fraudulent providers. We are concerned that this proposal opens the door for insurers to require that patients receive prior approval--thereby impeding access of beneficiaries to beneficial medications. We urge CMS to maintain a more patient-centric approach and recommend that CMS maintain the six protected classes. Conclusion The AADA appreciates the opportunity to provide comments on the Contract Year 2015 Medicare Advantage and Part D proposed rule. We look forward to additional opportunities to comment on these issues and to provide feedback that may help guide policy development. Please contact Richard Martin, JD, Assistant Director, Regulatory Policy, at (202) or RMartin@aad.org if you require clarification on any of the points or would like more information. Sincerely, Dirk M. Elston, MD, FAAD President, American Academy of Dermatology Association 4

5 CC: Lisa A. Garner, MD, FAAD, Vice President Brett M. Coldiron, MD, FAAD, President-Elect Suzanne Olbricht, MD, FAAD, Secretary-Treasurer Marta Jane VanBeek, MD, MPH, FAAD, Chair, Council on Government Affairs, Health Policy, and Practice Elaine Weiss, JD, Executive Director and CEO 5