Download AUA, Alliance of Specialty Medicine Comments on 2015 Policy and

 Centers for Medicare and Medicaid Services Department of Health and Human Services Attn: CMS-­‐4159-­‐P P.O. Box 8013 Baltimore, Md. 21244-­‐8013 Re: Medicare Program; Contract Year 2015 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefits Programs; Proposed Rule Dear Administrator Tavenner: The undersigned medical specialty societies write to express concerns with your proposed rule that would modify aspects of the Medicare Advantage and Part D prescription drug program to the detriment of beneficiaries. We describe our specific concerns in the paragraphs below. Eliminating Protected Access to Certain Drug Classes CMS is proposing to eliminate protected access for three of the six protected classes of drugs – immunosuppressants, anti-­‐depressants, and possibly anti-­‐psychotics – for Part D beneficiaries. CMS believes that by removing protected class status for these drug classes, Medicare and its beneficiaries would realize savings, as plans would have more leverage to negotiate drug prices. CMS further believes its proposal would address potential overutilization, misuse, or abuse in these drug classes. We are deeply concerned with CMS’ proposal. While our members do not typically prescribe medications in the aforementioned drug classes, we are concerned that CMS’ proposal foreshadows the agency’s intent to eliminate other protected drug classes, such as antineoplastics, in the future. In addition to treating cancer, specialty physicians used antineoplastics to treat a wide range of chronic conditions, such as Crohn’s disease and rheumatoid arthritis, among others. We are concerned that CMS’ proposed criteria for how it would determine whether a drug class should have protected status could lead to the elimination of protected status for antineoplastics, which we would vigorously oppose. Given these concerns, we urge CMS to withdrawal this proposal until it has engaged the physician community through pre-­‐rulemaking activities to develop a more rational and clinically-­‐sound proposal that does not harm beneficiaries by limiting the range of therapies available to them in certain drug classes. Implementing Enrollment Requirements and Criteria for Determining Improper Prescribing Practices CMS proposes that physicians and eligible professionals (EP) must be enrolled in the Medicare program or have a valid opt-­‐out on file with the local Medicare Administrative Contractors (MAC) in order to prescribe drugs covered under Part D. The enrollment deadline would be January 1, 2015. In addition, CMS is proposing a number of criteria to determine improper prescribing practices, which would ultimately be used to revoke a provider’s Medicare enrollment. Among the grounds for revocation include a pattern or practice that is determined to be abusive and represents a threat to the beneficiary’s health and safety or fails to meet certain newly proposed requirements, which would consider, among other criteria, the following: • Whether there are diagnoses to support the indications for which the drugs were prescribed; • Whether there are any instances where the necessary evaluation of the patient for whom the drug was prescribed could not have occurred; • Whether the physician or eligible professional has prescribed controlled substances in excessive dosages that are linked to patient overdoses; • The number and type(s) of disciplinary actions taken against the physician or eligible professional by the licensing body or medical board for the state or states in which he or she practices, and the reason(s) for the action(s); • Whether the physician or eligible professional has any history of “final adverse actions”; • The number and type(s) of malpractice suits that have been filed against the physician or EP related to prescribing that have resulted in a final judgment against the physician or EP or in which the physician or EP has paid a settlement to the plaintiff(s); In determining whether a physician or EP has a pattern or practice of prescribing that fails to meet Medicare requirements, CMS would consider the following factors, among other things, including whether the physician or EP: • Has a pattern or practice of prescribing drugs for indications that were not medically accepted—
that is for indications neither approved by the FDA nor medically accepted under the law, and whether there is evidence that the physician or EP acted in reckless disregard for the health and safety of the patient. The Alliance is deeply committed to patient safety and safe prescribing practices; however, we believe that CMS’ proposal is duplicative of current safety mechanisms and tramples on the long history of states regulating the licensure process thereby adding yet another layer of bureaucracy and administrative costs to the program. The proposed requirement that physicians must be enrolled in Medicare suggests that state licensure is no longer sufficient on its own. The proposal would limit a physician’s ability to prescribe medications that, under current regulations, they are lawfully permitted to prescribe. We can appreciate that pharmacies should be enrolled, given they would be receiving reimbursements from the program and its administrators, directly. We are also concerned that some specialties will be unfairly targeted and prevented from legitimate prescribing. What may be considered excessive prescribing for the general population could be clinically appropriate given a patients individual circumstances, particularly in pain management and palliative care. In addition, many “off-­‐label” uses are clinically appropriate and represent the standard of care. CMS is also inappropriately suggesting that the existence of a medical liability lawsuit is somehow equivalent to liability without regard for the outcome of the lawsuit. This is offensive to our legal system and regulatory processes. Not only that, but CMS is proposing to implement this provision in the context of a lack of meaningful tort reform and would thereby inappropriately deny some physicians from prescribing when there is no evidence or finding of medical liability. There are too many ways in which physicians could be named in a medical liability suit, regardless of whether there is any evidence of negligence, and many liability insurers settle cases with little to no merit. 2
Finally, CMS’ ongoing challenges with the Provider Enrollment Chain and Ownership System (PECOS) and related databases and enrollment processes could result in the denial of important prescriptions for beneficiaries. While CMS is working to address these issues, it does not seem prudent to link beneficiary access to Part D drugs with physician enrollment in the Medicare program. Given the aforementioned concerns, we urge the agency to withdrawal its proposals. ***** We are strongly opposed to CMS’ proposals and disagree with CMS that this policy is in the best interest of Medicare beneficiaries. With some of these proposals, we believe CMS has stepped outside its statutory authority and into regulating the practice of medicine. Therefore, we urge the agency to withdraw its proposals. We further request that CMS work with the medical community through pre-­‐
rulemaking activities, such as listening sessions, town halls, and the issuance of requests for information (RFI), to better inform any future proposals that would address the agency’s concerns. Thank you for considering our comments. Should you have any questions, please contact Robert S. Jasak, Esq., at [email protected], or Emily L. Graham, RHIA, CCS-­‐P, at [email protected]. Sincerely, American Association of Neurological Surgeons American College of Mohs Surgery American Gastroenterological Association American Society of Echocardiography American Society of Plastic Surgeons American Urological Association Coalition of State Rheumatology Organizations Congress of Neurological Surgeons North American Spine Society 3