Message from the CPC Chair
As we informed you last week, on June 27, CMS issued an interim final rule on the CAP program entitled “Competitive Acquisition of Outpatient Drugs and Biologicals Under Part B.” What follows are some initial details about the CAP rule:

Drugs included in the CAP: The CAP will go into effect nationwide January 1, 2006, for one broad category of commonly prescribed drugs. Most oncology drugs, including supportive care drugs, are included. Among the drugs that will NOT be included in the CAP are the following: 1) Drugs that do not have permanent J-codes, 2) Leuprolide (Lupron), 3) Opiates and other controlled substances, 4) IVIG, and 5) A few orphan drugs, including oprelvekin (Neumega), alemtuzumab (CamPath), aldesleukin (Proleukin), arsenic trioxide, and denileukin diftitox (Ontak). 

Physicians who have agreed to participate in the CAP may purchase drugs that are not covered in the CAP and bill Medicare. CMS will publish a list of approved CAP vendors, as well as the specific NDC codes for the drugs the vendors will provide, on its website by October 1.

Vendor selection: The 5 lowest bidders among qualified bidders will be selected as CAP vendors. As the program will be implemented on a nationwide basis, vendors will be required to hold licenses in all 50 states.

Participation in CAP: Physicians will be able to elect into the CAP on an annual basis between October 1 and November 15. If one or more physicians in a group practice elect into the CAP, then every physician must elect in.

Ordering drugs: A practice may place drug orders by telephone, with a follow-up order in writing required. Drug orders must include: 1) The order date, 2) Beneficiary’s name and contact information, 3) Physician’s identifying information, 4) Drug name, 5) Strength, 6) Quantity ordered, 7) Dose, 8) Frequency/instructions, 9) Anticipated date of administration, 10) Beneficiary’s Medicare information, 11) Supplemental insurance information, 12) Medicaid information (if applicable), 13) Beneficiary date of birth, height/weight, ICD-9 code, allergies, and gender.

Supply of drugs: Vendors will be required to ship drugs to physician practices within 2 business days from the time the drug is ordered. Drugs that are needed by the practice in an emergency will be delivered within 1 business day. The physician can use his/her own stock and be resupplied by the vendor in cases where “the physician’s clinical judgment requires immediate treatment of the patient” and certain other requirements are met.

Unused and wasted drugs: State laws and regulations, as well as manufacturer requirements, will determine how unused drugs should be handled. The vendor would be responsible for the cost of the wasted or unused drug.

Vendor liability: If a physician orders a drug and the vendor thinks Medicare may not cover it, the vendor may issue the patient an advance beneficiary notice (ABN), asking the patient to agree to pay for the drug if Medicare does not cover it.  However, the vendor must dispense the drug even if the patient refuses to sign and the vendor would then be at financial risk if the claim were denied.

Appealing denied claims: Vendors can appeal denied drug claims.

Collection of patient coinsurance: Vendors can refuse to dispense additional drugs through the end of the calendar year to patients who have not paid their coinsurance within certain time limits.

Other vendor issues: CAP vendors must ship drugs unopened. There is no formulary permitted.  The vendor is required to offer only one drug per J-code, and the NDC number for that drug must be disclosed during the annual physician election period.

ASCO is continuing to analyze the rule and will follow up with more information for you in the coming days.The rule is open for public comment until September 6.You may submit comments to CMS electronically at www.cms.hhs.gov/regulations/ecomments.Please contact ASCO's Cancer Policy & Clinical Affairs Department at -703-299-1050 or publicpolicy@asco.org with any questions.


Register for ASCO’s Legislative Conference
The proposed fee schedule for Medicare is typically released in July, making ASCO’s Legislative Conference on July 26 and 27 a timely opportunity for ASCO members to interact and share information about delivering quality cancer care with key policymakers in Washington.

This premier event includes a day of “Inside the Beltway” issue briefings with commentary and perspective from Members of Congress, the Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS).Additionally, a reception on Capitol Hill will offer attendees an excellent opportunity to talk to Members of Congress and their staff about issues, including the new fee schedule, implementation of MMA, reimbursement challenges, and access to quality cancer care.

Confirmed speakers for the Legislative Conference include:

• Mark McClellan, MD, PhD, Administrator of CMS
  
• Lester Crawford, DVM, PhD, Acting Commissioner of the FDA
  
• Andrew C. von Eschenbach, MD, Director of the NCI
  
• Rep. Ralph Hall (R-TX), Member of the Energy and Commerce Committee
  
• Rep. Nathan Deal (R-GA), Chairman, Energy and Commerce Subcommittee on Health

ASCO’s voice is important collectively, however your voice individually has significant impact as well, particularly with your home state Members of Congress.We hope you can take advantage of this conference and share your opinion with policy leaders during this important time.For more information or to register for the conference please contact ASCO’s Cancer Policy & Clinical Affairs Department at 703-519-1413 or online.


Quality Care Issues
Pay for Performance Legislation in Senate
The Senate Finance Committee is planning to introduce pay for performance legislation that would link reimbursement to high-quality performance measures. The bill initially provides payment incentives for quality reporting and then links reimbursement to hitting quality targets for healthcare providers. The bill also calls on CMS to form a new standard-setting body that would develop measures for quality and efficiency. The Finance Committee released a summary of the pending legislation. ASCO will be providing feedback to the Committee and will continue to keep you informed as to the status of this legislation.

In addition, CMS Administrator Mark McClellan, MD, sent a letter to the House Ways and Means Committee on CMS’s plans to promote pay for performance programs for Medicare providers. The letter details some of the quality indicators being developed and how these would be reported, to foster innovative ideas and approaches to improve patient health care.


News and Notes
Journal of Oncology Practice – Second Issue
ASCO’s new Journal of Oncology Practice (JOP) made its official debut at the Annual Meeting in May.The second issue comes out in July and should be arriving in your mailbox soon.Articles in the July issue address electronic health records and practice management systems, among other topics. You can view current and past issues of JOP at: www.jopasco.org.

Grassroots Advocacy Network
Many of you already participate in the legislative process by writing or calling your Member of Congress, visiting your legislators in Washington, and encouraging your peers to communicate to Congress. Through the Grassroots Advocacy Network, we can work together to communicate more effectively on Capitol Hill about the issues that are most important to the cancer community. Joining the network is easy. Please visit www.asco.org/grassroots_survey to sign up.

ASCO’s Reimbursement Hotline
If you need help with the new coding changes or the demonstration project, please contact ASCO’s Coding and Reimbursement Hotline at 703-299-1054 or by email at practice@asco.org.