3. Medicare Proposes Conditions of Participation for Transplant Centers and Organ Procurement Organizations
To improve performance and quality of care for Medicare beneficiaries, CMS proposed new requirements that organ procurement organizations (OPOs) and organ transplant centers must meet to have their services covered by Medicare.
Proposals in a notice of proposed rulemaking for OPOs in the Federal Register, include conditions for coverage with both outcome and process performance measures, and focus on OPOs' performance improvement through sound operational policies.
The proposed requirements are key elements in the Gift of Life Donation Initiative, a multi-level approach to increasing organ, tissue, and bone marrow donation, and assuring the highest quality care for Medicare beneficiaries who need transplants.
Remarkable strides in transplantation technology and pharmacology are turning organ transplantation into a mainstream treatment for patients in end stage renal failure. However, the United States is facing a severe shortage of organs.
Today, there are more than 87,000 people in the United States waiting for a lifesaving organ transplant. Though 25,448 organ transplants were performed in 2003, nearly 7,000 people died while waiting for a transplant.
The proposed transplant center rule contains transplant center approval and re-approval standards as a subset of the CMS hospital conditions of participation (CoPs). The proposed requirements for transplant centers focus on a center's ability to perform successful transplants and deliver quality patient care as evidenced by good outcomes, as well as sound policies and procedures.
CMS said its goal in developing the transplant CoPs is to keep Medicare transplant outcome requirements current with state-of-the-art practice; develop process requirements for use in oversight and enforcement activities; and decrease confusion by codifying requirements for all transplant center types in one source. Once approved, transplant centers are eligible for re-approval every three years. The CoPs give CMS the ability to revoke the approval of under-performing centers if attempts at corrective action are unsuccessful.
Current OPO regulations, published in 1996, include performance standards based on the population in each OPO's service area. The organ donation community has raised concerns that population-based performance measures are not the best way to judge OPO performance . The Organ Procurement Organization Certification Act of 2000 required CMS to draft new standards.
The legislation requires CMS to increase the re-certification cycle for OPOs from 2 years to 4 years; provide new outcome and process performance standards based on empirical evidence obtained through reasonable efforts of organ donor potential and other related factors in each OPO's service area; use multiple outcome measures as part of the certification process; and provide a process for a qualified OPO to appeal a de-certification on substantive and procedural grounds.
The comment period for the proposed rule has been extended to early June 2005. With guidance from the ASN's Transplant Advisory Group, Dialysis Advisory Group, Practicing Nephrologists Advisory Group, and Policy & Public Affairs Committee, the ASN will submit comments on the proposed rule.
Both proposed rules were published in the Federal Register on Feb. 4, 2005.
4. MedPAC Releases Report on Medicare Payment Policies/Pay-for-Performance Takes Center Stage
Earlier this year, the Medicare Payment Advisory Commission (MedPAC) released its “ Report to the Congress: Medicare Payment Policy.” In its annual report, MedPAC made a series of recommendations for the Medicare program to begin differentiating among providers when making payments. Currently, Medicare pays providers the same regardless of their quality. The MedPAC report focuses on increasing the quality of patient care, specifically recommending implementation of a pay-for-performance system for physicians.
Some of the recommendations included that Congress adopt a pay-for-performance program and that Medicare pay more for higher quality performance from hospitals, home health agencies, and physicians, as the Commission recommended last year for Medicare Advantage plans and dialysis providers. The MedPAC report emphasized that CMS adopt quality measures to encourage and reflect the use and functions of IT systems and suggests that requirements be made on reporting lab values and prescription claims data. One key recommendation of particular importance to the renal community, is an update of policy improvements for various Medicare payment systems including outpatient dialysis payment system. The report strongly urges CMS to determine a timeline for the measures to be incorporated into a physician pay-for-performance program.
ASN remains actively engaged in the ESRD pay-for-performance issue. The ASN, in cooperation with the National Kidney Foundation, published a state-of-the-art paper, “ Payment of Quality in End-Stage Renal Disease,” (JASN, December 2004) and regularly participates in meetings with other medical professional societies that are building momentum to strengthen internal medicine from the perspective of quality improvement and pay-for-performance measures. ASN's advocacy initiatives include increased interaction with congressional representatives, relevant committees, and the Centers for Medicaid and Medicare Services (CMS).
5. CMS Launches Breakthrough Initiative for major Improvement in Care for Kidney Patients - Safe Vascular Access Through Collaborative "Fistula First" Initiative
In conjunction with National Kidney Month, and with close collaboration with key stakeholders in the kidney disease community, CMS announced the launch of its “Fistula First” initiative, to get "breakthrough" improvements in the use of safe vascular access.
Fistula First addresses the urgent need for patients who suffer from kidney failure (end stage renal disease - ESRD) to have safer, higher-quality access to hemodialysis through a fistula.
Patients who receive dialysis with an access other than a fistula have a 20 to 70 percent greater chance of death in the first year after their placement. Currently, only one third of American patients are dialyzed with a fistula, compared with two thirds to nearly 90 percent in other countries. This difference in practice patterns is one of the primary reasons why the unadjusted mortality rate for ESRD patients is much higher in the U.S. (about 21 percent) than in Europe (about 16 percent) and is associated with over 5,000 unnecessary deaths each year.
The goal of this initiative is to double the percentage of patients with fistulas as their access - moving from 33 percent to 66 percent over the next five years. More than 300,000 Medicare beneficiaries currently receive dialysis treatment, a number that is expected to double by 2010.
The most critical component to make the Fistula First breakthrough initiative a success is partner involvement. By marshalling the knowledge and leadership of organizations and experts throughout the renal community, CMS has identified and put into place key practices to jumpstart the rate of fistula adoption. For Fistula First, a renal coalition was formed with professional and trade organizations and other stakeholders that have a significant impact on helping make the clinical decision as the only choice.
6. New Fistula First Website
The Forum of ESRD Networks announced a new educational website for the National Vascular Access Improvement Initiative – FISTULA FIRST at www.fistulafirst.org.
The new website provides information on tools and resources, as well as contact information for each of the ESRD Network organizations who partner with providers to improve care.
The network organizations hope members of the renal community will visit the site frequently, and find it useful in their efforts to improve AV fistulas rates.
7. Antonio Scarpa, M.D., Ph.D., Named New Director of the Center for Scientific Review
National Institutes of Health Director Elias A. Zerhouni, M.D., announced the appointment of Antonio Scarpa, M.D., Ph.D., as the new director of the Center for Scientific Review (CSR). Dr. Scarpa is currently the David and Inez Myers professor and chair of the Department of Physiology and Biophysics at Case Western Reserve University in Cleveland , Ohio . Dr. Scarpa will join NIH on July 1, 2005 .
"Dr. Scarpa brings an expansive intellect, distinguished research career, and extensive administrative experience to the critical task of leading CSR in managing the receipt and referral of NIH grant applications and coordinating their review in CSR peer review groups," says Dr. Zerhouni. "He also brings an abiding commitment to the peer review process and the scientific community."
Dr. Scarpa has served as a permanent member of three NIH peer review committees between 1983 and 2003, and he has served on peer review committees for the American Heart Association.
"NIH peer review is world renowned for enabling NIH to fund the most promising biomedical research," Scarpa said. "I am excited to join NIH and work to ensure the integrity, thoroughness, and efficiency of CSR operations as it faces many challenges."
Dr. Scarpa has conducted biophysical research into the cellular and molecular mechanisms of ion transport and homeostasis and the metabolic consequences induced by transport. His investigations have been supported by grants from the National Heart, Lung and Blood Institute; the National Institute on Alcohol Abuse and Alcoholism; and the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Scarpa has more than 225 peer-reviewed publications and has edited or co-edited 9 books or special journal supplements.
The Center for Scientific Review organizes the peer review groups that evaluate the majority of grant applications submitted to the National Institutes of Health. CSR also receives all NIH and many Public Health Service grant applications and assigns them to the appropriate NIH Institutes and Centers, and PHS agencies.
8. Continued Growth in Physician Spending May Trigger 'Funding Warning,' MedPAC Told – While Members of Congress Vow to Fix Physician Reimbursement
At the April 2005 meeting of the Medicare Payment Advisory Commission MedPAC, commissioners were told that continued growth in physician Medicare spending could lead to a Medicare "funding warning" that would require special legislation to be submitted by the president. The escalating volume of various Part B services could serve to trigger a situation where general revenues exceeded 45 percent of Medicare spending.
Excess general revenue Medicare funding is defined in the 2003 Medicare Modernization Act (MMA) law as general revenue Medicare funding, expressed as a percentage of total Medicare outlays in excess of 45 percent. The MMA includes a formula for calculating the 45 percent.
If the MedPAC trustees make the funding warning two years in a row, the president must submit legislation designed to eliminate the excess funding to Congress. Within three days of receiving the president's legislative proposal, the majority and minority leaders of the House are required to introduce the proposal.
In a March 31, 2005 letter to MedPAC, CMS said, based on the latest data on spending related to the physician fee schedule, expenditures for 2004 increased by about 15 percent. Also in the letter to MedPAC, CMS said physicians' Medicare reimbursement will be cut by 4.3 percent in 2006, as a result of the spending increases and how the increases are calculated as part of the sustainable growth rate formula.
Meanwhile, key members of Congress from both parties said they would work to change a Medicare physician reimbursement formula that is set to cut payments to doctors. Nancy Johnson (R-CT) ,Chair of the House Ways & Means Subcommittee on Health, has been quoted as saying that fixing the formula is high on her agenda. Principally, Congresswoman Johnson will once again introduce legislation that repeals the sustainable growth rate (SGR) tie updates to an index based on the Medicare Economic Index (MEI). Influential Senate and House members have said Congress cannot continue to place a band-aid on the payment problem, and a long-term solution is necessary.
