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Washington Highlights: April 14, 2006

CMS Releases Medicare Inpatient Proposed Rule

The Centers for Medicare and Medicaid Services (CMS) April 12 released a proposed FY 2007 Medicare inpatient rule. Major teaching hospitals would see their Medicare per case payments increase by significantly less than what Congress authorized if the rule is finalized. The rule will be published in the Federal Register April 25. According to the CMS press release, this proposed rule begins a transition to the "first significant revision of the Inpatient Prospective Payment System (IPPS) since its implementation in 1983."

While current law specifies that the Medicare base per case payment increase by 3.4 percent in FY 2007, CMS estimates that teaching hospitals training 100 or more residents would see average per case payments in FY 2007 that would be only 2.1 percent higher than last year. Other teaching hospitals and nonteaching hospitals would see increases of 2.6 percent and 4.8 percent, respectively; rural hospitals would see an average increase of 6.7 percent.

A portion of the lower increase is due to the legislatively mandated cut in indirect medical education (IME) payments, from 5.55 percent to 5.35 percent. However, the reduction also is due to a proposed significant regulatory change to the diagnosis-related group (DRG) payment weight calculation from a charge-based method to a hospital-specific cost-based method. According to the proposed rule, this change reduces payments from those cases that require more ancillary services, such as surgical cases, while medical cases would see payment increases.

The movement from a charge-based to cost-based weighting methodology is the first of CMS's envisioned two-part transformation to the IPPS. In FY 2008, CMS proposes to move to a new DRG system that would better reflect severity. In theory, such a change should help major teaching hospitals because they tend to treat the most severe Medicare patients.

CMS has indicated it will consider comments it receives in response to its proposal. In a press release, CMS Administrator Mark McClellan states that "This proposed rule will be shaped by the public comment process... We look forward to comprehensive feedback from hospitals, suppliers, and other stakeholders that will help to refine and improve the final version of the rule."

The rule also contains several changes to Medicare direct graduate medical education (DGME) and IME payments [see related article].

Information:
Karen Fisher, Sr. Director, Health Care Affairs
AAMC Health Care Affairs
kfisher@aamc.org
(202) 862-6140

CMS IPPS Rule Includes Medicare GME "Clarification"

CMS's annual inpatient prospective payment system proposed rule, released April 12, includes "clarification" related to Medicare direct graduate medical education (DGME) and indirect medical education (IME) payments. It would prohibit teaching hospitals from including time that residents spend in didactic activities and could have an impact on both teaching hospital Medicare payments as well graduate medical education (GME) educational activities. The proposed rule also contains a number of other significant changes [see related story].

The proposed rule states that resident training that occurs in nonhospital sites must be related to patient care if a hospital wishes to count that time for DGME and IME payment purposes. Resident time spent in didactic activities that often may occur in associated medical schools, such as educational conferences, journal clubs, and seminars, would be specifically excluded. CMS noted that its statement in a previous letter on this topic "implying that didactic time spent in nonhospital settings could be counted for direct GME and IME...was inaccurate." CMS noted that time spent in these activities could be counted for DGME purposes if they occur in a hospital; however, the counting prohibition applies for IME payments regardless of where the educational activity occurs.

The proposed rule also contains several more minor technical changes relating to documentation requirements, GME aggregation agreements, and determination of per resident amounts when teaching hospitals merge.

Information:
Karen Fisher, Sr. Director, Health Care Affairs
AAMC Health Care Affairs
kfisher@aamc.org
(202) 862-6140

NIH Director Highlights Research Benefits before House Panel

National Institutes of Health (NIH) Director Elias Zerhouni, M.D., testified April 6 before the House Labor, Health and Human Services, and Education Appropriations Subcommittee on the medical advances achieved as a result of the investment in the NIH budget. Citing the decrease in deaths due to coronary heart disease and cancer, Dr. Zerhouni noted the substantial return on investment and improvements to both longevity and quality of life brought about by biomedical research. He described current progress in treating a host of diseases, ranging from HIV/AIDS to diabetes and Parkinson's disease. He also discussed NIH's vision to transform medicine by making it more "predictive, personalized and preemptive."

Subcommittee Chair Ralph Regula's (R-Ohio) questions addressed the need for interdisciplinary research, causing Dr. Zerhouni to highlight the trans-institute initiatives on obesity and neuroscience. Ranking Member David Obey (D-Wisc.) stated his dismay that the President's budget proposes level funding for NIH, noting that the agency has seen only a three-fold increase in real dollars since 1974.

Other Democratic members of the panel also focused on the proposed level funding for the agency at $28.4 billion in FY 2007, noting that this is insufficient to allow NIH to build upon its current successes. Reps. Dave Weldon (R-Fla.) and Lucille Roybal-Allard (D-Calif.) expressed concern with the administration's proposed termination of the National Children's Study, a national longitudinal study of environmental influences on children's health and development. Dr. Zerhouni stated that the study is estimated to cost $3.2 billion through 2034 and needs to be halted due to budget constraints. He noted the related work to be supported under the recently announced cross-institute Genes, Environment and Health Initiative.

In response to Rep. Ernest Istook's (R-Okla.) question as to why a decrease is proposed for the Institutional Development Award Program, which supports institutions in states not traditionally successful at acquiring NIH grants, Dr. Zerhouni replied that the number of grants to these states has tripled due to the program. He noted the decrease is not an indication of lack of support, but rather of tight budget times.

Rep. Istook also asked about the status of NIH's public access policy, noting that the public is paying billions of dollars supporting biomedical research but cannot afford the expensive publications that publish the results. Dr. Zerhouni responded that the current policy of encouraging researchers to provide their peer-reviewed manuscripts voluntarily to the National Library of Medicine (NLM) may not be sufficient. He said NIH has three goals with respect to publishing research results: create a new agency-wide searchable database; continue to improve information technology at the NLM to ease public access to studies; and develop a uniform system for researchers to deposit information. He emphasized it is important that these changes do not come at the expense of the peer review system.

Information:
Erica Froyd, Director, Public Health and Research Legislative Affairs
AAMC Government Relations
efroyd@aamc.org
(202) 828-0525

CMS Publishes "Katrina" GME Rule

The Centers for Medicare and Medicaid Services (CMS) April 12 published an interim final rule addressing Medicare direct graduate medical education (DGME) and indirect medical education (IME) payments for hospitals that took on displaced residents as a result of Hurricanes Katrina and Rita. Unlike most other rules that are effective prospectively, this rule has an effective date retroactive to Aug. 29, 2005, the date of Hurricane Katrina. It also is an "interim" final rule, which means that even though it is effective now, comments are still being solicited.

The rule is in direct response to Medicare GME and IME payment issues surrounding resident displacements when New Orleans hospitals were forced to close or severely limit their operations and had to transfer residents to hospitals throughout the country. The rule is also meant to address future emergency situations in which teaching hospitals are so debilitated that residents must be transferred to other hospitals for training.

Medicare places a cap on the number of residents each teaching hospital can claim for GME and IME payment purposes. Taking on the displaced residents caused many hospitals to go over their caps. In the aftermath of Katrina, CMS published a Q and A document that allowed New Orleans hospitals to temporarily give their cap slots to these "host" hospitals, so they could receive Medicare reimbursement associated with the displaced residents.

However, CMS learned from hospitals and medical schools in the area that the policy was insufficient because it only applied if the New Orleans hospitals residency programs were completely shut down. In many cases, training programs remained minimally open during that period. Moreover, for those programs that had closed, they are now starting to reopen but can only do so partially, still leaving large numbers of displaced residents that need to train at other hospitals.

The new rule provides significant flexibility for hospitals in emergency situations to transfer their Medicare cap slots temporarily to other hospitals-specifically allowing such a transfer to occur even when the residency program is partially open.

Comments on the rule are due June 12, 2006.

Information:
Karen Fisher, Sr. Director, Health Care Affairs
AAMC Health Care Affairs
kfisher@aamc.org
(202) 862-6140

Education Commission to Hold Open Meeting

The Secretary of Education's Commission on the Future of Higher Education plans to hold its fifth meeting May 18 and 19 in Washington, DC. The Commission is charged with initiating a national dialogue about the future of higher education and how best to improve the country's system of higher education to ensure graduates are well prepared to meet future workforce needs. The agenda for the May meeting includes a discussion of preliminary findings, possible recommendations and a proposed format for the final report, which must be submitted to the Secretary by August 2006.

The meeting will be open to the public, but individuals interested in attending must register in advance by contacting Kristen Vetri at kristen.vetri@ed.gov. Opportunities for public comment and more information on the Commission are available on the Department of Education's Web site.

Information:
Matthew Shick, Senior Legislative Analyst
AAMC Government Relations
mshick@aamc.org
(202) 862-6116

Burr Introduces Biodefense Bill

Senator Richard Burr (R-N.C.), chair of the Health, Education, Labor and Pensions Subcommittee on Bioterrorism and Public Health Preparedness, introduced April 6 the Biodefense and Pandemic Vaccine and Drug Development Act of 2006 (S. 2564). The legislation seeks to enhance and reorganize the Department of Health and Human Services' (HHS) authority over bioterrorism and public health preparedness by creating the Biomedical Advanced Research and Development Authority (BARDA). BARDA would be the lead federal office charged with supporting research and development of medical countermeasures, including drugs and vaccines to respond to bioterrorism and natural disease outbreaks.

The legislation is intended to build upon the existing Project Bioshield program, created in 2004, which sets asides federal funds to purchase bioterrorism countermeasures developed and produced by biotech companies. S. 2564 authorizes additional funds aimed at encouraging academic researchers and manufacturers to commit substantial resources to bring new products to the market more quickly.

The legislation also creates a National Biodefense Science Board to provide expert guidance to HHS on potential bioterrorist threats. Also included is expansion of orphan drug market exclusivity to include countermeasures, antibiotics, and antiinfectives developed to treat a rare disease or condition caused by biological agent or toxin. This provision allows the manufacturer exclusive patent rights for an established period of time pending a study examining the impact of the patent.

Information:
Erica Froyd, Director, Public Health and Research Legislative Affairs
AAMC Government Relations
efroyd@aamc.org
(202) 828-0525

House Subcommittee Holds Fourth HIT Hearing

At an April 6 House Ways and Means Subcommittee on Health hearing, Chair Nancy Johnson (R-Conn.) expressed concern about the slow adoption of health information technology (HIT). Stating that "additional actions are needed by both the public and private sectors" to achieve the President's goal of providing most Americans with electronic health records (EHRs) by 2014, Rep. Johnson urged the witnesses to suggest ways to expedite HIT adoption.

Among those testifying was Brent Henry, Vice President and General Counsel for Partners HealthCare System in Boston. Mr. Henry stated that Congress should craft a Stark law exception and an anti-kickback safe harbor for the provision of HIT and related services. He commended Chairwoman Johnson for introducing legislation (H.R. 4157) that would assure these exceptions. According to Lewis Morris of the Health and Human Services (HHS) Office of the Inspector General, his colleagues are exploring whether and how HIT exceptions/safe harbors could assure a "balance between fostering the adoption of beneficial [EHR] systems and preventing fraud and abuse in the Federal health care programs."

Ken Kizer, M.D., M.P.H., Chairman and CEO of Medsphere Communications, suggested that the federal government "support and utilize open source software as the preferred option" whenever possible. Open source software is non-proprietary, available at no or minimal cost, and is designed to operate in collaboration with multiple systems. He also testified that the use of EHRs should be a condition of participation for Medicare providers. Ranking Member Pete Stark (D-Calif.) supported this option, explaining that it would eliminate the need to alter Stark and anti-kickback laws.

Also testifying at the hearing was David Brailer, M.D., Ph.D., HHS National Coordinator for Health Information Technology. Responding to privacy concerns related to remote monitoring technology, Dr. Brailer announced that HHS plans to initiate a demonstration project evaluating remote monitoring for multiple sites.

Information:
Christiane Mitchell, Senior Legislative Analyst
AAMC Government Relations
cmitchell@aamc.org
(202) 828-0526