The Honorable Mark B. McClellan
Administrator
Centers for Medicare and Medicaid Services
Department of Health and Human Services
Attention CMS-4068-P
PO Box 8014
Baltimore, MD 21244-8014
Dear Dr. McClellan:
On behalf of the 93,700 members of the American Academy of Family Physicians, I am pleased to offer our comments on the CMS “Strategy for Affordable Access to Comprehensive Drug Coverage” – Guidelines for Reviewing Prescription Drug Formularies and Procedures.
The Academy also commented on the Medicare Program; Medicare Prescription Drug Benefit; Proposed Rule, CMS-4068-P, as well as the model drug formulary guidelines created by the United States Pharmacopeia (USP) as required by section 1860D-4(b)(3)(C)(ii) of the law. Our primary goal in those comments and our ambition in this letter are to ensure that the guidance provides sufficient flexibility for physicians to prescribe effective, safe and affordable medications to their Medicare patients. We agree with the comment in the guidance that the new drug program is a landmark change to Medicare, and that beneficiaries must have access to covered drugs that are medically necessary for their condition. Our comments follow the order that they are discussed in the guidance document.
Guiding Principles for CMS Formulary and Benefit Review Strategy.
The structure of the health plan drug formulary is one of the most critical elements within the regulation since coverage is essentially meaningless if a patient is unable to access his or her necessary medication. Absent access to the medication, a patient would be forced to go without the drug; switch to another, potentially ineffective product, or ask his or her physician to go through a burdensome process to win approval for health plan coverage. We agree with the statement made in the guidance that “a formulary must consist of drugs that will provide patients with a clinically appropriate medication for the course of treatment established by the physician.”
A. P&T Committee Review
We support the section in the guidance stating that a P&T Committee is a forum for an evidence-based formulary review. Requiring P&T panels to base decisions on research and studies cannot be emphasized too strongly: the Academy is firmly in support of evidence-based clinical decision-making. However, we believe there is a paucity of evidence-based research (particularly regarding generic drugs or drugs that are not being currently promoted because they are available in generic form).
Consequently, we have supported Section 1013 of the Medicare Modernization Act, which calls for the Agency for Healthcare Research and Quality (AHRQ) to conduct research on comparative clinical effectiveness, and which Congress funded at $15 million for FY 2004. As family physicians, we believe that physicians need more objective, reliable data so that we can determine the best treatment decisions for our patients. In fact, in our comments on the rule, we suggested adding language to the regulation mandating that P&T committees seek out available comparative clinical effectiveness research to emphasize the importance of this issue. While this field is still developing, we think it is appropriate that the ultimate regulations begin to focus attention on this subject.
Membership
Regarding membership on the P&T committees, while we support the inclusion of different specialists on the P&T committees, we believe family physicians should be included on the majority of the panels since they write more prescriptions than any other specialty. In addition, we believe that P&T panel members who are making decisions about the inclusion of various medications must be as unbiased as possible. Consequently, we support the section in the guidance that states at least one P&T committee practicing pharmacist and one practicing physician be independent and free of conflict with respect to the sponsor and plan. We also believe that the P&T committee decision should be binding.
Formulary Management
The guidance states that the P & T committee must review formularies for clinical appropriateness, and the practices and policies for formulary management activities such as prior authorization, step therapies, generic substitutions and other drug utilization activities that affect access.
The Academy's policy, Principles for the Development and Management of Patient-Centered Formularies, incorporates our understanding that health plans will use various cost management tools. Specifically, the policy states, "The AAFP recognizes the role of appropriately designed restrictive formularies used by providers of pharmacy benefits and third party insurers which have the goal of optimizing clinical outcomes while minimizing overall health care costs."
We are opposed to cost saving measures such as prior authorization procedures and step therapy. In our view, it does not make sense from a clinical perspective to require a physician to receive approval to prescribe a drug he or she believes is appropriate for a patient. Moreover, it is not only illogical, but could be even harmful to force a patient to try out -- step through -- various medications before he or she can be prescribed and be covered for the one that is the most effective. In addition, to use a specific example, there is new evidence that ACE inhibitors prevent kidney damage in hypertensives whereas diuretics do not, although both drugs can control blood pressure. Finally, step therapy ignores the new evidence that patients can be genetically tested for efficacy of some drugs, a scenario that is likely to become more prominent in the future.
Viewed over the long-term, requiring patients to take a series of drugs that may not work, or may even worsen his or her condition, is more costly to the health care system. While the reason for step therapy is ostensibly to save money, costs will increase in the form of uncontrolled illness. However, of utmost importance is the personal harm that could be inflicted on the patient in terms of poor quality health care. As advocates for our patients, we oppose step therapy requirements.
We realize that large increases in the cost of prescription drugs have made generic drugs an appealing option for our patients. And, because of the nature of family medicine, we want to respond to the needs of our patients’ limited resources. Nevertheless, the Academy continues to oppose mandatory generic substitution as an unwarranted intrusion into the practice of medicine.
The guidance states that formulary therapeutic categories and classes may be changed only at the beginning of each plan year or when new drugs or new drug therapeutic uses appear. The AAFP’s statement, Principles for the Development and Management of Patient-Centered Formularies, indicates specifically that “formularies must be ‘stable’ since frequent changes create confusion and frustration for patient and physicians leading to non-compliance, adverse reactions, increased costs and erosion of patients’ confidence.”
While we understand the agency’s desire to allow plans to make changes to take advantage of new therapeutic uses and newly approved drugs, on the whole, we believe that drug formulary lists should be changed as little as possible to prevent disruption of a patient’s health care. As a result, we recommend that changes be done no more than annually. We also suggest that periodic evaluation and analysis be done no more frequently than once every 12 months.
Formulary Exceptions
The guidance on formulary exceptions does not contain much information except to state that P&T committees must establish protocols and procedures. As a result, we would like to reiterate our concern that the exceptions process in the proposed rule is far too burdensome. The section requires health plans to establish a process for formulary exceptions. Formulary use is defined under the proposed rule as including dose restrictions that cause a drug not to be covered for the number of doses prescribed, or a step therapy requirement that causes a drug not to be covered until the requirements of the sponsor’s coverage policy are met.
Under the draft regulation, plans may require a written certification from the physician that the preferred drug on the formulary is not as effective as the requested drug, or that it may have adverse effects for the patient, or both. Information may include enrollee name; group or contract number; subscriber number; patient history; primary diagnosis related to drug; reasons why the preferred drug is not acceptable; justification for why the drug is needed; and any other information reasonably necessary to evaluate the medical necessity of the request.
While we understand health plans’ desire to save money, and we are sensitive to the need to strike the appropriate balance between cost and quality, the recommended procedures as written not only second guess the physician, but interfere with the practice of medicine.
B. Formulary List Review
The guidance states that “plans can choose to adopt a classification system that is consistent with the USP’s drug categories and classes or may use other classification systems” and that “plans using the USP classification system will satisfy a safe harbor and thus CMS will approve their formulary classification system.”
Since the guidance builds on the USP framework, and the USP has not yet released a revised draft or final classification system, we will reiterate the comments we provided to the USP. Specifically, as proposed, the model guidelines establish three subdivisions: therapeutic category; pharmacologic class; and recommended subdivisions. Under the proposed regulation, health plan formularies must include at least two drugs within each therapeutic category and class (unless only one drug is in a category or class).
Our primary concern is that the classes are too general to include all appropriate drugs that physicians may wish to prescribe to their patients. Specifically, the recommended subdivisions include several generations of drugs that have different mechanisms for action, different indications and are suitable for various individuals. In general, our recommendation to the USP is that the “recommended subdivisions” become separate classes.
Simply stated, while the recommended subdivisions may include a list of four drugs, the health plan will be required to offer only two. And, if a physician wishes to prescribe one of the remaining drugs that are not on the formulary, even though it is included in the subdivision, he or she will be required to go through a burdensome exceptions process. Otherwise, the patient will be unable to receive the medication except by paying the full price.
Finally, the USP model guidelines include both old and new drugs and drugs that are appropriate for different patients under the assumption that they are interchangeable for treating various diseases. The result of this classification is that plans will be permitted to exclude many types of medications that are a necessary part of physicians’ treatment regimens for acute and chronic illnesses. As a result, we recommend that the USP expand the list of 146 therapeutic categories and classes. We offer the following example of well-known antidepressants as evidence that the current classification model is not workable.
Under the antidepressants, pharmacologic class 16, “reuptake Inhibitors,” recommended subdivisions include SNRIs, SSRIs and tricyclics. Under the model guideline and under the proposed regulation, health plans would be required to offer only two drugs from the above three subdivisions. And, since tricylics are older and less expensive, health plans could potentially cover only two of these early generation antidepressants. As a result, our elderly patients would be unable to obtain the newer and generally safer medications. We ask USP to make each of these three subdivisions separate classes.
C. Review of Benefit Management Tools that Affect Access
Appeals, Exceptions and Grievances
It is difficult to provide much comment on the guidance regarding these issues since the section is so brief. As physicians who want our patients receive the appropriate medication, we hope that none of us need to utilize these systems. Our belief is that if the drug formularies and overall program are constructed carefully, Medicare beneficiaries will get the drugs they need in an efficient manner. That said, we believe that these processes are overly burdensome as currently structured.
We appreciate the opportunity to provide comment on the draft guidance. We urge you to modify the document as suggested to fulfill the intent of Congress to create a program guaranteeing beneficiaries access to the drugs they need.
Sincerely,
Douglas E. Henley, MD
Executive Vice President
