Medicare drug choices called too restrictive

Washington -- Medicare drug formulary guidelines commissioned by the federal government still omit some therapies that physicians deem vital to their patients, and doctors' groups worry that drug plans could decide against covering the medicines as a result.

The recommendations, which the U.S. Pharmacopeial Convention released to Medicare officials last month, contain the same total number of unique drug therapeutic categories and pharmacological classes as a proposed model that USP unveiled in August 2004.

The group does not list any actual medicines by name, but insurers that cover two drugs in each category or class will receive less regulatory scrutiny when it comes time for the Centers for Medicare & Medicaid Services to approve plans' offerings.

The advisory panel modified some of the details of its original proposal, but not to the extent called for by some physician groups and patients' advocates. The American Medical Association is still reviewing the final USP product.

Specialty medical groups remain concerned that the regulatory safe harbor offered by CMS will allow plans to deny coverage for drugs needed by beneficiaries with certain conditions.

Doctors treating Medicare seniors with osteoporosis, for instance, might encounter plans that will not cover bisphosphonates, calcium-regulating hormones or other key bone disease agents. If CMS gives its blessing to such plans, millions of seniors could forgo the treatments and put themselves at risk for serious injury, said C. Conrad Johnston Jr., MD, an endocrinologist in Indianapolis.

"Most of these drugs are probably $700 to $900 a year," said Dr. Johnston, who serves on the board of the National Osteoporosis Foundation.

"We know that many of the people already having fractures are not being treated, and most of them are in Medicare when they start having fractures. So it could be a big problem for that population."

Practices that rely on therapies that recently came through the pipeline could be particularly affected by USP's decision not to undertake a major expansion of its drug category listing. "For people with dementia, it's some of the newer drugs that may not be covered, and that's a concern," said Stephen McConnell, vice president for policy at the Alzheimer's Assn.

The formulary guidelines call for plans to cover several classes of antidepressants, for instance, but do not establish separate classes for selective serotonin reuptake inhibitors or selective norepinephrine reuptake inhibitors. Therefore, a plan could avoid triggering more rigorous CMS scrutiny in one of the antidepressant classes after covering only two kinds of tricyclics, an older generation drug.

An attempt at compromise

USP did not turn a complete deaf ear to physician complaints about its original proposal.

In response to calls from the AMA and others for more categories and classes, the advisory group included a list of 118 "formulary key drug types" separate from the main guidelines. The addendum breaks down some of the official categories and classes into more specific subclasses. Nonsteroidal anti-inflammatories and COX-2 inhibitors, for instance, are listed as the two key types of the non-opioid analgesic class.

The new listing, which corresponds to some of the drugs prescribed most often by physicians, could prompt drug plans to cover some of these excluded medicines when they develop final Medicare formularies of their own, USP stated.

In addition to enforcing the two-drug safe harbor policy for categories and classes, CMS should question a drug plan if its proposed formulary does not contain at least one of each key medication type, USP said. By asking a plan to justify any such exclusion, "CMS can help ensure that a formulary is comprehensive and will not substantially discourage enrollment of eligible beneficiaries," the group stated.

The panel also heeded the specific requests of some physician specialties when it modified the original proposal. The pharmacologic classes in the final draft, for instance, now include proton pump inhibitors, histamine blocking agents, protectants and irritable bowel syndrome agents. Gastroenterologists and others had warned that Medicare beneficiaries with ulcers or IBS would find no covered alternatives for such vital drugs.

With USP's completion of its primary commission, the physician community now turns to CMS to see how the agency will implement the final recommendations. As of press time, federal officials had not yet released final drug benefit regulations that are expected to incorporate the model formulary and outline the extent to which the government will scrutinize plans that adhere to the guidelines.

Physician specialty groups report that they have received no definite indication as to whether Medicare regulators will follow USP's advice on the separate list of formulary key drug types. Unless CMS responds with strong language calling for the inclusion of at least one of each drug type, plans might not see any reason to cover some of the newer, most commonly prescribed drugs.

"In the Medicare program, there's a need for a rational, national standardization, whether it's for the prescription drug benefit, CPT coding, reimbursement policy or whatever," said Douglas E. Henley, MD, executive vice president of the American Academy of Family Physicians. "Allowing plans to have great flexibility on covering some of these important medications would be a cause for concern, and we would hope that CMS would ... give more national guidance to the various plans so that there's a greater degree of standardization."

While not weighing in on the key drug type debate, CMS Administrator Mark McClellan, MD, PhD, continued to insist that seniors will receive adequate coverage for their needed medicines.

Pharmaceutical benefit managers, the entities with the task of administering the drug benefit starting in 2006, said flexibility is needed for plans to control costs and keep the program affordable for both seniors and the federal government. The Pharmaceutical Care Management Assn., which represents PBMs, issued a statement saying that the managers would be able to accomplish this goal.

"While more expansive than what is typically found in the commercial marketplace, USP's model Medicare formulary guidelines preserve the ability of PBMs to develop formularies that reflect those found in the commercial market," the group stated.