CMS offers plan for doctor-dispensed drug option

Washington -- Medicare regulators have a plan designed to cut out the legwork when it comes to obtaining physician-administered drugs, but some doctors are finding that the alternative might be more trouble than it's worth.

The competitive acquisition program will allow participating physicians to obtain chemotherapy treatments and other injectable drugs covered under Medicare Part B directly from one of five vendors that the government chooses through a bidding process.

If doctors decide to join the program, which will launch in January 2006, they would no longer need to pay for all of these drugs up-front and then bill Medicare and their patients to be reimbursed.

Centers for Medicare & Medicaid Services officials late last month released more details about the initiative, which will cover 181 drugs. Those medications represent more than 85% of the dollars Medicare spends on physician-injectable drugs.

CMS Administrator Mark McClellan, MD, PhD, said that competitive acquisition will be an attractive option for practices that spend too much money and energy trying to find the best prices for these medications on their own.

"The program frees physicians from the administrative work of purchasing and procuring drugs in their offices so that they can focus more time and resources on providing the best treatments for their patients," Dr. McClellan said.

Doctors would need to bill Medicare only for the cost of administering the drugs themselves.

Although physician groups praised CMS for developing the alternative, they continue to worry that such promises are accompanied by serious doubts as to whether the untested program will better serve both doctors and patients.

Organizations such as the American Medical Association and the American Society of Clinical Oncology issued comments to CMS earlier this year calling for greater physician flexibility and patient protections, but the calls went largely unheeded by the agency in issuing the June rule.

For example, requirements that each medication order to a vendor be accompanied by a unique prescription number and by detailed information about the patient receiving the drug could be a significant headache for some practices that are not accustomed to collecting that information, AMA Executive Vice President and CEO Michael D. Maves, MD, wrote in his letter to CMS.

Rather than track each purchase, many doctors simply buy the drugs in bulk and maintain the stock until patients require the medications.

"We have been advised by some of the medical specialty organizations that physicians currently do not maintain [such] inventory records, and the additional work involved would appear to be substantial," Dr. Maves stated.

CMS rejected the Association's call to reduce the list of required patient information and to give doctors more time to file their drug administration claims.

Oncologists, one group of specialists the new program will especially affect, are concerned about the additional responsibilities that they would need to take on if they chose to participate, said Deborah Kamen, RN, PhD, senior director of cancer policy and clinical affairs at ASCO.

"When you create a system like this -- the additional reviews that have to take place, the tracking, the identification of individual patient information -- all of that represents more of an administrative burden, and physicians will not react well to that," she said.

Patients also might lose out if their doctors join the competitive acquisition program, Dr. Maves said. Because the drug vendor -- not the physician -- will collect any required coinsurance from beneficiaries, doctors no longer will be able to waive payments for low-income patients.

CMS will let vendors issue notices to patients warning that Medicare might not pay for their expensive drugs if it is determined that they are not covered after the fact, Dr. Kamen said.

That, combined with the firms' ability to cut off patients that do not make their co-payments, could make some seniors reluctant to seek out the medications that they need, she said.

An open door for physicians

A few of the oncology groups that ASCO surveyed said they would be interested in considering the competitive acquisition alternative. These practices tend to be small or solo practices that spend an inordinate amount of time and energy to procure their Part B drugs, Dr. Kamen said.

But many others remain reluctant to abandon a system that, while perceived as flawed, has nevertheless resulted in doctors' ability to serve their patients adequately, she said.

"A lot of practices have established mechanisms for obtaining chemotherapy drugs because of the sensitivity of these drugs and the issues of stability and the importance of a chain of custody," Dr. Kamen said. "A lot of people feel that they are comfortable with the process that they have, and they're concerned about using a system that they have not tested before."

Responding to these concerns, Medicare officials agreed to issue last month's interim final rule on the competitive acquisition program, or CAP. Doctors and other stakeholders now have until Sept. 6 to submit additional comments and requests for changes. The regulation could be modified further after CMS considers those comments.

At the end of the debate, however, each practice will have to make its own decision about whether to participate in the new program in 2006 or beyond, the agency said. CMS will hold an annual election period for the next year from the beginning of October through the middle of November.

"A physician is free to a significant extent to design his or her practice so that the additional burden of participating under the CAP is as small as possible," Dr. McClellan wrote in the regulation. "CAP is a voluntary program, so if a physician finds it more burdensome, then he or she is under no obligation to participate."