FOR INFORMATION CONTACT:
Lori Gardner, Senior Director
Communications & Marketing
301.984.9496 ext. 226
For Immediate Release: April 6, 2008
Oncology-Related Legislative/Regulatory Issues 2007—2008
Hospital Outpatient Department Issues
In March 2007 ACCC testified at the Ambulatory Payment Classification (APC) Panel meeting at CMS headquarters in Baltimore, Md., and presented a three-phase plan, supported by the stakeholder community, to adequately reimburse for pharmacy overhead services. Phase one provided for a flat, automatic payment whenever a drug was billed. These flat payments were divided into three categories that reflected the amount of time taken to prepare the drugs. Phase two called for a survey to determine if these flat payments were sufficient to cover costs. Phase three called for implementation of permanent codes for pharmacy services. The APC Panel agreed with ACCC’s plan and recommended it to CMS; however, the agency did not adopt the recommendation and did not include the plan in its proposed 2008 Hospital Outpatient Prospective Payment System (HOPPS) rule.
The proposed 2008 HOPPS rule, issued in July 2007, called for a reduction in drug reimbursement to average sales price (ASP) +5 percent for 2008 and ASP +3 percent for 2009. In addition, CMS proposed a pharmacy reporting plan that did not include reimbursement for the extra work entailed, and the agency proposed to change how radiopharmaceuticals were paid. On the positive side, CMS called for an increase in all drug administration APCs.
In July and November ACCC conducted conference calls with members to discuss the proposed and final rules. ACCC also conducted a survey of hospital pharmacists to determine which oncology and supportive care drugs would be underwater at the proposed ASP +5 percent rate. As expected, the survey showed that a majority of respondents would lose money on most therapies at ASP +5 percent. ACCC provided this information to CMS and Congress.
In November 2007, CMS released the 2008 HOPPS final rule. Despite ACCC’s best efforts, in the final rule HOPD drug reimbursement was reduced to ASP +5 percent in 2008, and is slated to go to ASP +3 percent in 2009.
In the final rule, CMS lowered reimbursement for radiopharmaceuticals to levels that would make it very difficult for hospitals to offer the treatments. However, ACCC along with other advocacy groups called on Congress to roll back these payment changes to radiopharmaceuticals. In December Congress passed new Medicare legislation that extended the 2007 reimbursement methodology for radiopharmaceuticals until June 2008. The 2008 HOPPS final rule increased drug administration payments for most APCs, but at lower levels than proposed; and one APC was decreased. Finally, CMS did not adopt the pharmacy reporting proposal.
Since the release of the 2008 HOPPS final rule, ACCC has been working to return drug reimbursement levels to at least ASP +6 percent. We have been visiting members of Congress in order to gain support for legislation that would return reimbursement for drugs back to 2007 levels. The legislation has the support of more than 40 national organizations and local hospitals. ACCC is using grassroots advocacy efforts to try to persuade Congress to insert this legislation into the larger Medicare package expected sometime in June 2008.
Throughout the year, ACCC worked with Congress and other advocacy groups to encourage Congress to implement a long-term fix of the Sustainable Growth Rate (SGR) problem.
Unfortunately, no long-term fix was implemented in the 2008 Physician Fee Schedule. Once again, physicians were left with a last-minute fix. In December 2007, Congress passed legislation that halted the 10.1 percent cut and replaced it with a 0.5 percent increase for physicians through June 30, 2008. Congress will have to address the issue again in mid-2008 to avoid yet another payment cut for physicians in July.
In ACCC’s comments to the proposed 2008 Physician Fee Schedule rule, the Association voiced its concerns that the proposed changes to work and practice expense RVUs for drug administration and imaging services would harm beneficiary access to quality cancer care. In addition, ACCC expressed its support for the proposed extension of the Physician Quality Reporting Initiative (PQRI) into 2008, and also the proposed process to update and review the list of approved compendia. In the final 2008 Physician Fee Schedule rule released in November 2007, CMS adopted both the PQRI extension and the compendia review methodology.
More than 150 members participated in two ACCC conference calls, scheduled in July and November, to discuss the proposed and final 2008 Physician Fee Schedule rule.
Coverage and Other Issues
Under CMS’s new compendia review process, the agency has received five requests to recognize the addition and/or deletion of drug compendia. The period to submit applications for new compendia under the CMS process closed on February 15, 2008. CMS internally, requested that the now defunct American Medical Association Drug Evaluations (AMA-DE) compendium be removed from the approved list. The other applications included adding the NCCN Drugs & Biologics Compendium™, Thomson Micromedex’s DrugPoints®, Thomson Micromedex’s DrugDex®, and the Clinical Pharmacology compendium, which was submitted by the Gold Standard, Inc./Elsevier Health Sciences. In keeping with its previous comments to CMS, ACCC sent a letter of support for the addition of both the NCCN Drugs & Biologics Compendium and DrugPoints. CMS has 90 days from the close of the comment period to make a decision on the applications.
ACCC congratulates Patrick A. Grusenmeyer, ScD, FACHE, who has been appointed to serve a four-year term on the Ambulatory Payment Classification (APC) Panel beginning with its March 5-6, 2008, meeting. Dr. Grusenmeyer serves on ACCC’s Governmental Affairs and Editorial Committees.
In 2007 CMS released its National Coverage Decision (NCD) on Erythropoiesis Stimulating Agents (ESAs), severely limiting the usage of ESAs in chemotherapy-induced anemia patients. ACCC, along with others in the advocacy community, wrote to CMS and Congress, voicing concerns over this policy. In addition, ACCC testified before the Blood Safety and Availability Panel about the impact on blood transfusions that this policy would have. ACCC presented its findings from a study that was conducted of more than 100 ACCC-member institutions showing overwhelming concern that the CMS policy would strain hospital resources and blood supplies. Unfortunately, CMS has not changed the NCD, and limitations remain in place on the usage of ESAs.
CMS also attempted to change its policy of coverage of clinical trials for Medicare patients. CMS proposed two NCDs, both of which would have severely reduced the number of Medicare patients enrolled in clinical trials. ACCC expressed deep concern about these proposals to CMS and Congress. Thanks to the efforts of ACCC and others in the advocacy community, neither proposal was adopted by CMS. ACCC will continue to advocate for the coverage of Medicare patients in clinical trials.
ACCC also continues to support a range of important legislation on Capitol Hill, including those concerning tobacco marketing, medical imaging cuts, better drug reimbursement, impending nursing shortage, and reimbursement for chemotherapy planning and teaching. However, given the tight budget environment, passage of any legislation in these areas will be difficult.