More information on the postponement of the CAP is at www.cms.hhs.gov/CompetitiveAcquisforBios
Medicare officials have pulled the plug at least temporarily on their Competitive Acquisition Program for Part B drugs, including some infused biologics.
The program was put on hold because of “contractual issues” with the successful vendor bidders for the 2009 cycle of the program. The Competitive Acquisition Program (CAP) will remain in effect until the end of this year, but after that, physicians who had participated in the program will have to go back to purchasing drugs using the average sales price (ASP) system. The CMS has not announced a time line for resuming the program.
The CAP was mandated by Congress under the 2003 Medicare Modernization Act. It was launched in July 2006 to give physicians an alternative to obtaining Part B infusion and injectable drugs through the ASP or “buy-and-bill” system.
The voluntary program took the purchase of these drugs out of the hands of physicians. Those physicians who enrolled no longer took on the financial risk of buying drugs up front and being reimbursed by the CMS later. Instead, they received drugs from an approved vendor who was selected by the CMS through a competitive bidding process. Under the program, physicians were paid only for the administration of the drug.
For 2008, nearly 5,000 physicians were enrolled in the CAP. The program included more than 200 drugs.
BioScrip Inc., an Elmsford, N.Y.-based specialty pharmaceutical health care organization, has been the only approved CAP vendor throughout the history of the program. The company announced over the summer that it would not sign a new contact with CMS for CAP because the terms of the contract presented an “unacceptable short- and long-term profit risk.”
For 2008, nearly 5,000 physicians were enrolled in the CAP. The program included more than 200 drugs.
As currently designed, the CAP is “totally untenable,” said Dr. Karen Kolba, a solo rheumatologist in Santa Maria, Calif., and a member of the American College of Rheumatology's Committee on Rheumatologic Care. The delay in the program will give the CMS time to consider changes that could encourage participation from rheumatologists, she said.
Dr. Kolba, who has not signed up for CAP, said the biggest problem with the program is the “all-or-nothing” requirement for ordering drugs. Once enrolled, physicians are not allowed to pick and choose what drugs they want to obtain through the CAP. If a drug they administer is available through the vendor, they must get it through the CAP. This is impractical for inexpensive, commonly used drugs such as cortisone injections, Dr. Kolba said, because CAP drugs must be ordered for specific patients and administered only to them. “It becomes something of an accounting nightmare,” she said.
Dr. R. Mack Harrell, an endocrinologist in Fort Lauderdale, Fla., said postponement of the CAP is likely to result in serious access problems for patients. Many endocrinologists rely on the CAP for expensive injectable drugs like thyrotropin alfa (Thyrogen), used to test for recurrence in thyroid cancer patients.
Without the CAP as a source of these drugs, Dr. Harrell said he fears that endocrinologists won't be able to provide these drugs in the office, forcing patients to go off their thyroid hormones for weeks at a time in order to undergo necessary testing.
Between now and the end of the year, physicians who are enrolled in the CAP must obtain drugs from BioScrip if the administration date for the drug is before Dec. 31, 2008. Any drugs that will be administered on or after Jan. 1, 2009, must be obtained through the regular ASP method.
If a physician has unused Part B drugs obtained through the CAP after Dec. 31, 2008, they are considered the property of the vendor and must be purchased through the ASP system or returned to BioScrip. They cannot be given to the physician by BioScrip.
As physicians return to the ASP method of procuring drugs in 2009, they will be responsible for collecting deductibles and coinsurance from Medicare beneficiaries and should not use the CAP modifiers (J1, J2, J3, and M2) on claims. The CMS is advising physicians to contact BioScrip to minimize the amount of unused drugs.
While the program is on hold, the CMS is asking physicians to provide feedback on the program. Agency officials are looking for information on the categories of drugs provided through the program, the distribution of areas that are served by the CAP, and any procedural changes that could make the program more attractive for vendors and physicians.