ACCC Submits Comments to CMS About FDG-PET Coverage

The Association of Community Cancer Centers (ACCC) has requested that the Centers for Medicare and Medicaid Services (CMS) end the prospective data collection requirements as a condition of coverage for positron emission tomography (PET) with the 2-[F-18] Fluro-D-Glucose (FDG) radioisotope across all oncologic indications except for monitoring response to treatment.

“CMS should transition from conditional coverage of FDG-PET to unconditional coverage such that physicians can continue to ascertain the potential that this procedure could have on improving patient care,” according to ACCC’s May 9, 2008, letter. ACCC believes that CMS should cover PET because of the procedure’s demonstrated value in informing physician treatment decisions.

ACCC urges CMS to end the data collection requirements for diagnosis, staging, and restaging/suspected reoccurrence for PET scans across all cancer types. By eliminating the prospective data collection requirement, CMS will reduce the administrative burdens of CED on this important diagnostic tool and create greater certainty for our members who fight cancer on a daily basis.

Furthermore, ACCC recommends that CMS and the National Oncologic PET Registry (NOPR) Working Group continue collecting data for the coverage of PET for treatment monitoring.

 Click here to read ACCC's comment letter to CMS.

Posted 5/09/2008

Oncology Pharmacist Ernest R. Anderson, Jr., Takes Helm as ACCC President

Ernest R. Anderson, Jr., MS, RPh, became President of the Association of Community Cancer Centers (ACCC) at its 34th Annual Meeting on April 4, 2008. He is director of pharmacy at the Lahey Clinic in Burlington, Mass., as well as the Lahey Clinic North in Peabody. Mr. Anderson is also associate clinical professor of pharmacy at Northeastern University College of Pharmacy and Allied Health Professions and adjunct associate professor of pharmacy at Massachusetts College of Pharmacy and Health Sciences in Boston.

"I am honored to serve as President of the Association of Community Cancer Centers," said Mr. Anderson. "Our common goal and calling is to provide excellent and effective care to our patients. To that end, we must help ensure that all patients with cancer can access breakthrough treatments if we are to truly increase cure rates, improve quality of life, and assure happiness and satisfaction of patients."

Mr. Anderson is the first pharmacist to serve as ACCC President and was the first pharmacist on ACCC’s Board of Directors. Working with the Association's Executive Director, he helped create the Oncology Pharmacy Education Network (OPEN)—a network for oncology pharmacists to share experiences, business models, and successes. An advisory committee was created within OPEN, with Mr. Anderson as its chair.

During his term as President, Mr. Anderson will continue to encourage greater involvement in the Association by oncology pharmacists. In addition, he will promote the value of leadership skills among all ACCC members. "Leadership starts with valuing the people you work with every day—believing in their potential until they see it themselves. We need to ignite the fire of worth and potential in others. This will encourage all caregivers to provide the best for their patients."

Posted 4/07/2008

ACCC Releases Revised Cancer Program Guidelines, New Survivorship Section

ACCC has released its "Cancer Program Guidelines 2008" to assist cancer programs that want to develop and/or maintain a comprehensive interdisciplinary program that meets the needs of cancer patients and their families. These guidelines were developed to reflect the optimal components for a cancer program.

ACCC’s "Cancer Program Guidelines 2008" includes a new “Survivorship Services” section that encourages cancer programs to make available information and services specific to survivorship issues to cancer patients and their families. Cancer survivorship—a key component of comprehensive care—is a key ACCC focus.

Survivorship is defined as the experience of living with, through, and beyond cancer for both patients and the people in their lives who are impacted by the diagnosis. It comprises the physical, psychological, emotional, social, spiritual, and economic aspects of life that may be influenced by cancer at any time from diagnosis through treatment and all remaining years of life. Survivorship has figured prominently in ACCC’s two annual national meetings. A soon-to-be published survivorship supplement in Oncology Issues as well as publication and distribution of ACCC’s “Cancer Program Guidelines 2008” are part of this year’s Presidential Grant, sponsored by AstraZeneca, LP, and Abraxis Oncology.

Click here to view ACCC’s "Cancer Program Guidelines 2008".

Posted 4/07/2008

Welcome to ACCC's 2008-2009 Board of Trustees

At ACCC's recent Annual National Meeting, new officers and trustees assumed leadership. Welcome to all!

• President: Ernest R. Anderson, Jr., MS, RPh
• President-Elect: Luana R. Lamkin, RN, MPH
• Treasurer: Al B. Benson III, MD, FACP
• Secretary: Thomas L. Whitaker, MD, FACP
• Past-President: Richard B. Reiling, MD, FACS

Trustees
Connie T. Bollin, MBA, RN; Gabriella Collins, RN, MS, OCN; Becky L. DeKay, MBA; Steven L. D'Amato, RPh, BCOP; Thomas A. Gallo, MS; Anna M. Hensley, MBA, RT(T); George Kovach, MD: Diane M. Otte, RN, MS, OCN; Alan S. Weinstein, MD, FACP.

Posted 4/07/2008

CMS Releases ASP Second Quarter 2008 Data

The Centers for Medicare & Medicaid Services (CMS) has posted a file on its website that contains the payment amounts that will be used to pay for Part B covered drugs for the second quarter of 2008. Comparing the second quarter 2008 payment amounts with the previous quarter reveals that for the most part average drug prices in the market remain stable. Overall, average payment amounts across the top physician administered drugs are unchanged and average payment amounts across all drugs decreased by less than 1 percent. Preliminary 2007 data for the top physician administered drugs suggest that overall utilization of these drugs appears to have increased compared with 2006 levels.

CMS notes that for most of the higher volume drugs (39 out of the top 50), the payment amounts changed 2 percent or less. Overall, the payment amounts for 30 of the top 50 drugs increased, while 3 remained the same. In general, among the top drugs with a decrease, there are a number of competitive market factors at work – multiple manufacturers, alternative therapies, new products, recent generic entrants, or market shifts to lower priced products.

 Click here to download the second quarter ASP data.

Posted 3/24/2008

ACCC Welcomes Genzyme to its ECC

ACCC is pleased to welcome Genzyme Corp. to its Emerging Companies Council (ECC). With many established products and services helping patients in nearly 90 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. Among its oncology-related products and services are:

• Campath® (alemtuzumab for injection) is a humanized monoclonal antibody indicated in the United States for the treatment of B-cell chronic lymphocytic leukemia (B-CLL) in patients who have been treated with alkylating agents and have failed fludarabine therapy.
• Clolar® (clofarabine) is the first new leukemia treatment approved specifically for children in more than a decade. ALL is the most common form of pediatric leukemia and children who do not respond to initial therapy, or relapse, have a very poor survival prognosis.
• Thyrogen® (thyrotropin alfa for injection) is an adjunctive diagnostic used in follow-up screenings of cancer patients with well-differentiated thyroid cancer who have had their thyroid glands removed.
• Cancer Genetics services in diagnosis and monitoring of leukemias and lymphoproliferative disorders.

ACCC's EEC is designed to provide companies with access to up-to-the-minute news and insight into cancer care issues not available through any other professional association. EEC members receive a variety of benefits, including recognition through the ACCC network and better visibility with the nationwide cancer care community.

 Click here to find out more about the products and services that Genzyme Corp. offers.

Posted 3/24/2008

FDA Approves Treanda for CLL Patients

Cephalon, Inc. announced March 20 that the U.S. Food and Drug Administration (FDA) has approved Treanda (bendamustine hydrochloride) for Injection for the treatment of patients with chronic lymphocytic leukemia (CLL). The Treanda application as a CLL treatment received priority review from the FDA and was approved within six months of the September 2007 submission. Cephalon anticipates that TREANDA will be available to physicians and patients as a CLL treatment in the United States in April 2008.

In a randomized, international, multicenter, open-label pivotal study of 301 treatment-naive patients with CLL, those who received Treanda had better clinical outcomes compared to patients treated with chlorambucil, an FDA-approved chemotherapy for patients with CLL. Specifically, Treanda patients had a significantly higher overall response (59 percent of patients responded to Treanda and 26 percent of patients responded to chlorambucil; p < 0.0001). Patients who received Treanda also had a higher complete response rate than those treated with chlorambucil (8 percent vs. <1 percent), which means that after treatment with Treanda, some patients had no signs of disease in their blood. Importantly, Treanda patients also had a significantly longer progression-free survival (18 months vs. 6 months; Hazard Ratio = 0.27; p < 0.0001), meaning the disease did not get worse for a significant period of time. The response to Treanda lasted longer (duration of response) than in patients who received chlorambucil (19 months vs. 7 months). The most common adverse events in the trial were myelosuppression, fever, nausea, and vomiting.

The American Cancer Society estimates that more than 15,000 new cases of this rare disease will be diagnosed in the United States this year.

Posted 3/21/2008

ACCC Garners Support for Legislation to Return Hospital Outpatient Drug Reimbursement to ASP +6 Percent

ACCC has begun meeting with members of the U.S. Senate Finance Committee to garner support for legislation that would set hospital outpatient drug reimbursement at average sales price (ASP) +6 percent, which is the same level as the physician office setting. Currently, the hospital outpatient department is paid at ASP +5 percent and is planned to go to ASP +3 percent in 2009. The legislation would also limit the amount the drug packing threshold could be raised each year equal to the hospital market basket increase of that year. ACCC is hoping that this legislation, which is budget neutral (will not require any new money), will be included in a larger Medicare package we expect to be passed by the end of June 2008.

Prior to its meetings, ACCC sought support from national organizations and hospitals in certain areas of the country to sign on to a coalition letter in support of the legislation. To date, over 30 groups have signed on to theletter.

To view the letter, click here.

If your organization is interested in signing on to the letter, please contact Matt Farber at mfarber@accc-cancer.org.

Posted 3/11/2008

APC Panel Meets, Makes Recommendations to CMS

On March 6-7, 2008, the Ambulatory Payment Classification (APC) Panel met to discuss issues facing the hospital outpatient department. On March 7 ACCC and other pharmacy stakeholders testified before the panel on issues relating to drug and pharmacy reimbursement. The stakeholders presented data showing that when all HCPCS-coded drugs are accounted for, the reimbursement level is ASP +12.6 percent, not the ASP +3 percent that CMS has been proposing for 2009. (CMS calculations exclude packaged drugs.) The panel made a recommendation to CMS to further study the data that the group presented at the meeting and develop information in time for 2009 rulemaking. The panel also agreed that ASP +3 percent is untenable in 2009.

Finally, on the drug reimbursement front, the panel also recommended that CMS should limit the increase of the packing threshold for drugs equal to inflation rounded to the nearest $5. Over the past two years, the threshold has been increased by $5 a year. ACCC is pleased that the panel made these recommendations to CMS. ACCC will continue to work with CMS to implement these recommendations.

The APC Panel is charged with discussing such issues as drug reimbursement levels, drug administration, radiation procedures, and packaging and bundling. The Panel hears testimony from CMS and the public, and then makes recommendations to CMS for future rule changes. ACCC has testified at numerous APC Panel meetings in the past and plans to continue to do so going forward.

Posted 3/11/2008

ACCC Supports NCCN Compendium and DrugPoints

ACCC has written a letter to CMS in support of the NCCN Drugs & Biologics Compendium and DrugPoints for their inclusion in the list of approved compendia by CMS. Starting this year, groups had been invited to submit applications to have compendia included in the list of those approved by CMS for coverage. The application process was from Jan. 15 to Feb. 15, 2008, and the public had 30 days to comment. CMS is reviewing the public comments and will announce any additions to the approved list within 90 days of the end of the public comment letter.

To view ACCC's support letter, click here.

Posted 3/11/2008

Ixempra™(ixabepilone) Assigned C-Code

The Centers for Medicare & Medicaid Services (CMS) has assigned a specific C-code to Ixempra (ixabepilone) effective dates of service January 1, 2008: C9240. Billing for Ixempra should be done by total dose, in 1-mg billing units.

Posted 2/28/2008

Association of Community Cancer Centers Launches Internet Resource to Provide Oncology Continuing Education

The Association of Community Cancer Centers (ACCC) is proud to announce the launch of the ACCC Continuing Education (CE) Blackboard, an Internet resource devoted to on-line oncology education. ACCC members will have easy access to a variety of timely oncology education programs from premier CE providers. Click here to visit.

"ACCC's CE Blackboard is now available on the Association's award-winning website accc-cancer.org. This valuable resource provides links to multidisciplinary continuing education credits at no charge to ACCC’s 15,000-plus oncology professional members," said LuAnne Bankert, ACCC’s senior director of meetings and programs.

Meniscus Educational Institute (MEI) will be the first medical education company to provide ACCC members with oncology education programs on the ACCC CE Blackboard. ACCC and MEI, a triple-accredited medical education company, have entered into an innovative collaboration that combines the strength of MEI’s expertise in oncology CE with the reach of ACCC, whose 670 member institutions/oncology practices treat 60 percent of all new cancer patients in the United States each year.

Founded in 1982, MEI collaborates with healthcare communities, foundations, and organizations to connect physicians, nurses, and pharmacists to state-of-the-art information about clinically relevant professional practice issues, making learning more meaningful. MEI consistently provides high-quality, cost-effective continuing education activities designed to help clinicians improve patient care.

ACCC encourages other CE providers to list their programs and courses on the CE Blackboard.

Any links to non-ACCC information are provided as a courtesy. They do not constitute an endorsement of the linked materials by ACCC. The information presented reflects the views of the faculty/authors of the medical education organization(s) only and are not those of ACCC.

Posted 2/1/2008

Bayer Withdraws Current Liquid Formulation of Leukine

Bayer Healthcare Pharmaceuticals and the Food and Drug Administration (FDA) have informed healthcare professionals of the market withdrawal of the current liquid formulation of Leukine, a growth factor that helps fight infection and disease in appropriate patients by enhancing immune cell function. The product was withdrawn because of an upward trend in spontaneous reports of adverse reactions, including syncope, which are temporally correlated with a change in the formulation of liquid Leukine to include edetate disodium (EDTA). The upward trend in adverse reaction reporting rates has not been observed with the use of lyophilized Leukine. Healthcare professionals should immediately stop using liquid Leukine and return unused vials to the manufacturer.

Click here to read more.

Posted 1/24/2008

CMS Releases Transmittals on ESAs Coverage and Payment

On January 16, 2008, the Centers for Medicare and Medicare Services (CMS) released three transmittals relating to coverage and payment for erythropoiesis stimulating agents (ESAs).

Transmittal 1412 (link www.cms.hhs.gov/transmittals/downloads/R1412CP.pdf) “Reporting of Hematocrit or Hemoglobin Levels on All Claims for the Administration of Erythropoiesis Stimulating Agents (ESAs), Implementation of New Modifiers for Non-ESRD Indications, and Reporting of Hematocrit Levels on all Non-ESRD, Non-ESA Claims Requesting Payment for Anti-Anemia Drugs.”

This transmittal includes information on three new HCPCS modifiers on claims for ESAs, and makes effective a statutory requirement that all claims submitted for ESAs include reporting of hematocrit/hemoglobin.

Transmittal 1413. (link www.cms.hhs.gov/transmittals/downloads/R1413CP.pdf) “Erythropoiesis Stimulating Agents (ESAs) in Cancer and Related Neoplastic Conditions,” which includes instructions to carriers on implementing the July 30, 2007 NCD on ESAs in cancer.

Transmittal 80. (link: www.cms.hhs.gov/transmittals/downloads/R80NCD.pdf) “Erythropoiesis Stimulating Agents (ESAs) in Cancer and Related Neoplastic Conditions,” which updates Medicare’s National Coverage Determinations Manual in regards to the July 30, 2007 NCD on ESAs in cancer.

Posted 1/16/2008

President Bush Cancels 10 Percent Medicare Physician Cut, Approves SCHIP Legislation

On Dec. 29 President George W. Bush signed into law legislation that increases Medicare and Medicaid payments to physicians and extends a U.S. children's health program. The measure signed is the Medicare, Medicaid, and State Children's Health Insurance Program (SCHIP) Extension Act of 2007. The legislation provides a six-month Medicare pay increase for physicians and extends funding for SCHIP through March 2009. The House and Senate had approved the measure by unanimous consent Dec. 19 and 18, respectively.

The law provides physicians a 0.5 percent payment increase through June 30, 2008, cancelling a 10.1 percent cut scheduled to take effect Jan. 1, 2008. Congress will have to address the issue again in mid-2008 to avoid yet another payment cut for physicians from taking effect July 1, 2008.

On Nov. 1, 2007, the Centers for Medicare & Medicaid Services (CMS) released the 2008 Physician Fee Schedule (PFS) final rule, which becomes effective Jan. 1, 2008. The conversion factor was set at $34.0682, a 10.1 percent reduction from the 2007 level of $37.8975. Congress has now reversed this reimbursement cut through legislation, as it has done in the past.

Posted 12/31/2007

House and Senate Keep 2008 Radioimmunotherapy Reimbursement Payment at 2007 Levels

New Medicare legislation passed by the House and Senate extends the 2007 reimbursement methodology for radiopharmaceuticals to June 2008. The Centers for Medicare and Medicaid Services called for new hospital outpatient reimbursement rates for 2008 for radiopharmaceuticals such as Zevalin and Bexxar below their acquisition costs. The drugs are used to fight relapsed non-Hodgkin's lymphoma, which for some patients can provide additional therapeutic options. The new Medicare legislation will maintain the current methodology for reimbursement of therapeutic radiopharmaceuticals for the first six months of 2008, giving the drugs' manufacturers and CMS time to seek a permanent reimbursement procedure that more accurately reflects hospital costs associated with the therapy.

The Association of Community Cancer Centers (ACCC) joined other advocacy groups, including the Lymphoma Research Foundation and the Leukemia and Lymphoma Society in calling on Congress to roll back these payment changes to radiopharmaceuticals. ACCC had urged its members to contact the Senate Finance Committee and other members of Congress to urge them to include a one-year freeze on Medicare payments for radioimmunotherapies that were changed in the final 2008 HOPPS Rule.

Posted 12/20/2007

CMS Outlines Plan to Link Hospital Pay With Performance on Quality Measures

The Centers for Medicare and Medicaid Services has issued a long-awaited report to Congress outlining how Medicare hospital payments could be linked to quality of care measures, but legislative action would be needed to implement any policy changes. The report on the Medicare Hospital Value-Based Purchasing (VBP) Program ties a "portion of hospital payment to quality," according to acting CMS Administrator Kerry N. Weems. He said the VBP Program is part of the agency's "ongoing initiative to transform Medicare from a payer of bills to a prudent purchaser" of health care for its beneficiaries. The VBP would improve upon a 2005 program that linked part of hospitals' payments to their reporting on a specific set of quality measures, according to the November 27 BNA Health Care Daily.

The plan essentially relies on reducing payments to hospitals by up to 5 percent, and allowing hospitals to "buy back" those funds by performing well on certain quality measures. Hospitals would receive incentive payments based on their performance on a specific set of measures under the VBP Program laid out by CMS. Those payments would be funded from a 2 percent to 5 percent reduction in hospitals' base diagnosis-related group (DRG) rate. Hospitals would receive scores both for "attainment," which would be compared with national thresholds and benchmarks, or "improvement," which would be compared with the hospitals' own performance in the previous 12-month baseline period, resulting in one Total Performance Score, according to the agency. That score would determine hospitals' percentage of incentive payments, the agency said.

As mandated by the Deficit Reduction Act (DRA) of 2005, the agency was instructed to submit the report in August, and to implement the plan beginning in fiscal year 2009. However, a statutory change is necessary to enact the VBP Program. The Senate could include the VBP provisions in a possible markup of a Medicare payment bill the week of Dec. 3, Weems said, or they could "roll it over to next year."

The report is available at the CMS website.

Posted 11/27/2007

FDA Approves Supplemental NDA for Nexavar

Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application for Nexavar® (sorafenib) tablets for the treatment of patients with unresectable hepatocellular carcinoma (HCC), or liver cancer. Nexavar, an oral anticancer drug, is the first approved systemic therapy for liver cancer.

HCC, the most common form of liver cancer, is responsible for about 90 percent of the primary malignant liver tumors in adults. About 19,000 cases of liver cancer are diagnosed yearly in the United States. Currently, the 5-year survival rate for liver cancer patients in the United States is 11 percent. In 2005 Nexavar became the first new treatment in more than a decade for advanced kidney cancer, and is currently approved in more than 60 countries for this indication.

Posted 11/27/2007

FDA Approves Tasigna for Philadelphia Chromosome Positive Chronic Myeloid Leukemia

The U.S. FDA has approved Tasigna (nilotinib) capsules for treatment of Philadelphia chromosome positive chronic myeloid leukemia (CML) in adult patients whose disease has progressed on or who cannot tolerate other therapies that included imatinib (Gleevec). Imatinib is approved for the treatment of new diagnosed patients with Philadelphia chromosome positive CML.

The FDA's approval of Tasigna includes a black box warning for possible life–threatening heart problems that may lead to an irregular heartbeat and possible sudden death.

CML accounts for 15 percent of all leukemias in adults. Approximately 4,500 new cases of CML will be diagnosed in 2007.

Tasigna is manufactured by Novartis Pharmaceuticals Corporation, East Hanover, N.J.

Posted 11/13/2007

Administration Payment Increases May Not Be Enough to Mitigate Cuts to Drug Payments in Final HOPPS Rule

On Nov. 1, 2007, the Centers for Medicare & Medicaid Services (CMS) released the 2008 Final Hospital Outpatient Prospective Payment System (HOPPS) rule. We are currently evaluating the rule and its impact for ACCC members. We will provide an in-depth analysis shortly, please check ACCC's website for updates. A summary of key highlights follows below.

Drug Payments. Despite recommendations from the Ambulatory Payment Classification (APC) Panel, ACCC, and other key stakeholders, CMS lowered payment for separately paid drugs without pass-through status to ASP+5 percent. Further, the agency states that it believes that adequate payment for drugs is ASP+3 percent; however, in 2008, CMS will provide a "transition" year with payment at ASP+5 percent. Drugs with pass-through status will continue to be reimbursed at ASP+6 percent. For all drugs and biologicals with average per day costs less than $60, CMS will package payment for the drug in with their administration payment. CMS will continue to make separate payment for anti-emetics, however. CMS has contracted with a company (RTI) to look at charge compression, and we may see proposals relating to this information in next year's rule making process.

Administration Payments. Although CMS had proposed to increase payment for all of these services by 1.6 percent to 12.2 percent, the final rule was not as positive for hospitals. Some administration payments increased slightly; other administration payments decreased. We are preparing a detailed look at these codes. CPT code 90768 (intravenous infusion, for therapy, prophylaxis, or diagnosis, concurrent infusion) will remain a packaged service–despite the APC Panel's recommendation to pay for this service separately.

Pharmacy Costs and Overhead. Once again, CMS did not accept the three-phase plan for reporting pharmacy overhead costs that was put forward by ACCC, the APC Panel, and other key stakeholders. In addition, the agency will not require hospitals to remove pharmacy overhead costs from drug acquisition costs and report these costs in an uncoded revenue code line.

Quality Measures. Similar to this year, hospitals must report on 7 quality measures in order to receive the full market basket increase of 3.3 percent in 2008. Hospitals that do not report quality data will have their annual update reduced by 2 percentage points.

Increased Packaging or "Bundling." As proposed, CMS is increasing the number of services to be packaged in 2008:

• CMS will package payment for the costs of image processing services in all cases–without regard to the possibility of the service being furnished without an independent service on the same date of service.
• CMS will unconditionally package payment for most supportive guidance services.
• Observation services (G0378) will be packaged, and CMS will create two new APCs (8002 and 8003) for extended assessment and management.
• Contrast media will be unconditionally packaged with associated independent diagnostic and therapeutic procedures. Most contrast agents are already packaged under the $60 threshold.
• Diagnostic radiopharmaceuticals will be packaged with associated nuclear medicine procedures.
• Imaging supervision and interpretation services that are dependent upon an independent separately payable procedure will be unconditionally packaged. CMS will pay separately for some imaging supervision and interpretation services in the cases where they are not furnished on the same date of service with a status indicator of "T."
• Intraoperative services will be packaged into the payment for the independent procedure for which the service is ancillary and supportive. Two intraoperative services without an independent service on the same date of service will not be packaged (93620, 93651).

The final rule is available on CMS's website at http://www.cms.hhs.gov/HospitalOutpatientPPS/.

Posted 11/05/2007

In Final Rule, Physicians Face a 10 Percent Payment Cut Unless Congress Intervenes

On Nov. 1, 2007, the Centers for Medicare & Medicaid Services (CMS) released the 2008 Physician Fee Schedule (PFS) final rule. ACCC is currently analyzing the rule, which becomes effective Jan. 1, 2008. Please check ACCC's website for updates and additional analysis. Key highlights include:

Physician Payments. The conversion factor will be set at $34.0682, a 10.1 percent reduction from the 2007 level of $37.8975. Congress could reverse this reimbursement cut through legislation, as it has done in the past. CMS continues to phase-in the new methodology for practice expense RVUs, which causes the practice expense RVUs for many services to change in 2008. The budget neutrality adjuster for work RVUs is set at .8806, down from 2007 level of .8994. This change will produce a slight reduction in payment for services, but the effect may not be noticeable for services with low physician work RVUs, such as drug administration services, due to CMS's method of rounding off the work RVUs to two decimal places.

Off-label Drug Use. CMS does not revise the list of compendia used to determine covered off-label uses of drugs used in anticancer chemotherapeutic regimens. In particular, DrugPoints was not specifically named a "successor publication" to USP-DI. Although this does not preclude DrugPoints from being a successor publication, the issue was not implicitly discussed in the final rule. The final rule does, however, create a new process for considering requests for changes to the list. Features of this new process, which will begin January 2008, include a shortened review time frame. Under the new process, CMS will receive requests annually during a 30-day window beginning on January 15. CMS will post on its website a request for comments on the requests by March 15. Comments will be accepted for 30 days. CMS will announce its decision no later than 90 days after the close of the comment period.

IVIG Payment. CMS will continue to pay for preadministration services for IVIG furnished in physicians' offices in 2008 at rates based on the practice expense RVUs established in 2007.

ESAs. CMS will provide implementing instructions for the new requirement to report hemoglobin or hematocrit levels for cancer patients receiving anti-anemia drugs.

Quality Reporting. The 2007 Physician Quality Reporting Initiative (PQRI) is extended for all of 2008. In addition, the rule designates the fund that will pay for the bonus payment.

CAP. To give physicians more flexibility, CMS revised its proposal to allow physicians to opt out of the competitive acquisition program (CAP) in exigent circumstances. CMS takes a broad view of what constitutes an "exigent circumstance," and will assess requests on a case-by-case basis rather than establish a specific list of circumstances. CMS also will allow physicians 60 days, instead of the proposed 30 days, after initial enrollment to request termination of the CAP participation agreement due to exigent circumstances. Physicians also may request termination after the first 60 days if they demonstrate that the request is based on information they did not have in the first 60 days.

The rule is available at http://www.cms.hhs.gov/PhysicianFeeSched/downloads/CMS-1385-FC.pdf

Posted 11/05/2007