July 1, 2013
Volume 77, Number 7
Focus on the Future: Key Issues in the Legislative and Regulatory Arena
Erin A. Sullivan, M.D., Chair, ASA Committee on Governmental Affairs
The 2013 ASA Legislative Conference held in Washington, D.C. on April 29-May 3 highlighted the legislative, regulatory and state issues impacting our specialty and our patients. While listening to the various presentations from our distinguished speakers, I was reminded of the responsibility that each of us has to preserve physician-led anesthesia care teams, patient access to physician care and patient safety. Through our grassroots efforts, along with ASA leadership and the staff in our Washington, D.C. office, we are making significant headway toward achieving these goals.
Since 2006, the number of new drug shortages has increased from 70 to 204 in 2012. Anesthesiologists, in particular, have experienced a dramatic increase in the number of shortages of critical drugs, including propofol, succinylcholine, epinephrine and fentanyl, to name a few.
In March 2012, ASA conducted a survey of 3,063 anesthesiologists to quantify the impact of drug shortages on our patients and practices. The survey results demonstrated that as a result of drug shortages, 97.6 percent of respondents reported they are experiencing a shortage of at least one anesthesia drug, 96.3 percent had to use alternative drugs and 66.7 percent of patients experienced a less optimal outcome (e.g., prolonged recovery, increased pain, post-op nausea and vomiting, increased costs).
The causes of drug shortages are specific and unique to each drug but can be categorized as follows: 1) regulatory and legislative factors such as a lack of contingency plans for critical drugs that are vulnerable to shortages; 2) raw materials sourcing and manufacturing factors such as single-source suppliers and difficulty in complying with the FDA Good Manufacturing Practice regulations; 3) business and market factors such as consolidation of firms and lack of business incentive to enter a specific product market; and 4) distribution factors such as just-in-time inventory. These causes are multi-factorial, which dictates that
a variety of solutions are needed to alleviate present and future drug shortages.
In 2012, Congress addressed drug shortages by passing the Food and Drug Administration Safety and Innovation Act (FDASIA), bipartisan legislative that includes Title X, a section dedicated to prevention and mitigation of national drug shortages. ASA and other stakeholders endorsed FDASIA, which requires manufacturers to report to the FDA a permanent discontinuance or interruption of the manufacture of many critical drugs, including those used by anesthesiologists during emergency medical care, during surgery and for the treatment of chronic pain. FDASIA also requires the FDA to mitigate drug shortages through establishment of a Drug Shortages Task Force that is charged with development and implementation of a strategic plan to enhance the agency’s response to drug shortages. FDASIA requires the Government Accountability Office (GAO) to conduct a study to examine the causes of drug shortages and make recommendations to prevent and alleviate shortages.
Medicare Payments to Anesthesiologists
Beginning in 2014, the non-elected Independent Payment Advisory Board (IPAB) created by the Patient Protection and Affordable Care Act (PPACA) will have sweeping powers to mandate added across-the-board or other targeted reductions in Part B payments in addition to sustainable growth rate (SGR)-related and sequestration-related cuts.
The current application of the Medicare SGR formula fails to distinguish high-volume growth services, whether necessary or not, from medical services such as anesthesiology services that are not contributing to the growth of the program spending. Data from the Congressional Budget Office (December 2008 CBO Report: Budget Options Volume 1: Health Care) shows that Medicare anesthesia cumulative spending is decreasing and is below the SGR target for the foreseeable future. Despite this fact, as SGR reductions are calculated each year, anesthesiology is targeted with the same percentage cuts as all other eligible Part B professionals. This is especially ironic since anesthesiologists have long been recognized as the leaders in patient safety but unfairly paid through Medicare at the lowest rate among all health professionals at only 33 percent of private payment rates.
With the Medicare Part B payments cut of 2 percent that are effective April 1, 2013, due to the previous sequestration, further SGR or IPAB cuts could cause Medicare anesthesiology payments to collapse and endanger safe access to care for millions of Americans. Innovative pilot program approaches to care delivery, such as the newly conceived Perioperative Surgical Home model, hold great promise to help contain overall hospital costs and coordinate and improve quality care related to surgery. Anesthesiologists are the common medical denominator for surgical patients, and our unique training makes us natural team leaders in this care model, just as primary care physicians are now doing through the Medical Home. As Congress and the Administration seek to advance alternative payment methodologies that advance quality and coordination of care, consideration should be given to the Perioperative Surgical Home model.
What’s New: On Thursday, May 16, 2013, the U.S. House of Representatives passed H.R. 45, a bill “to repeal the Patient Protection and Affordable Care Act and health care-related provisions in the Health Care and Education Reconciliation Act of 2010,” by a vote of 229-195. The vote, similar to previous repeal votes, fell largely along party lines. All Republicans voted in support of repeal with two Democrats, Rep. Mike McIntyre (D-NC) and Rep. Jim Matheson (D-UT), joining in support. The legislation would repeal PPACA outright. It did not offer a replacement reform.
To effectuate repeal, H.R. 45 would have to be accepted for consideration by the U.S. Senate and pass a vote in the Senate. To date, Senate Democrat leaders have expressed no interest in considering repeal legislation.
Improve Rural Access to Anesthesiologist Medical Care
There are ongoing challenges to ensure access to medical care services for Americans living in rural areas of the country. Insufficient Medicare payments and low patient volume have made it particularly difficult for many rural facilities to attract and retain qualified health care providers. In response to these challenges, Congress enacted a variety of incentive programs to encourage providers to practice in these rural areas. One of these programs is the anesthesia rural “pass-through” program, created as an incentive for anesthesia providers to practice in small rural hospitals. Under the “pass-through” program, eligible hospitals may use reasonable costs-based Part A funds in lieu of the conventional Part B fee schedule to attract anesthesia providers such as anesthesiologist assistants and nurse anesthetists to provide anesthesia services in small rural hospitals and critical access facilities. According to the Centers for Medicare & Medicaid Services’ (CMS’) interpretation of the statute creating the “pass-through” program, eligible rural hospitals are not permitted to use the “pass-through” funds to employ or contract with anesthesiologists.
Legislation introduced in the 112th session of Congress (H.R. 1044, the “Medicare Access to Rural Anesthesiology Act of 2011”) would reform the program and allow rural hospitals to use these already available “pass-through” funds to employ or contract with all anesthesia providers, including anesthesiologists. ASA strongly supports this legislation and is actively engaged in obtaining additional cosponsors in the U.S. House of Representatives and Senate.
With the ongoing debate over health care reform in the United States, there remains a heightened need to ensure that patients have adequate information to make wise and cost-conscious health care choices and decisions. Patients want, need and require accurate information about their care and the persons providing it. Currently, there is little “transparency” associated with the most fundamental and important component of health care delivery: the many health professionals who interface with patients every day.
Patients lack information about the wide variety of individuals working in health care settings and they are confused by the ambiguity of health care provider-related advertisements, marketing and degree titles. This compromises patient autonomy and decision-making. In order to ensure patient empowerment and prudent expenditure of health care dollars, Congress should act to enhance information flow to patients and address the lack of clarity in health care provider advertisements, marketing and self-identification.
H.R. 1427, the “Truth in Healthcare Marketing Act,” introduced by Reps. Larry Buschon, M.D. (R-IN) and David Scott (D-GA), would improve transparency in the identification of health care providers and in health care provider-related advertisements and marketing. ASA is actively engaged to obtain Senate companion legislation that would strengthen patient autonomy and decision-making with accurate information about health care providers.
Maintain Patient Safety
In recognition of the risks associated with the delivery of anesthesia to Medicare beneficiaries, Medicare has provided for physician supervision or oversight of the delivery of anesthesia since the program’s inception. Under Medicare’s rules, participating hospitals are subject to anesthesia patient safety standards known as the Conditions of Participation: Anesthesia Services. The standards provide that an anesthesiologist must personally perform or that a physician (an anesthesiologist or operating practitioner) must supervise the delivery of anesthesia by a nurse anesthetist. For decades, this standard has ensured the delivery of safe, high-quality anesthesia care to millions of Medicare beneficiaries with no additional cost to Medicare. The current supervision requirement is consistent with coordinated and team-based care. Medicare’s standard represents one of health care’s most successful and longstanding delivery teams, the anesthesia care team (ACT). According to Medicare data, the ACT, which includes anesthesiologists, nurse anesthetists and anesthesiologist assistants working together as a team, is the most common model used to deliver anesthesia services in the United States.
Changes made to the anesthesia standard in 2001 permit governors to waive or “opt-out” of the patient safety standard. To date, 17 governors have chosen to “opt-out.” CMS reports that the current requirement provides “the proper flexibility for providers while ensuring safety for all patients.” ASA remains committed to continue to urge Congress to oppose any legislation or regulatory change to the current standard that would remove the requirement for physician-led anesthesia care teams and supervision.
The major highlight of the ASA Legislative Conference was the visits to Capitol Hill. Five hundred forty seven anesthesiologists (including 118 anesthesiology residents, fellows and medical students) went to the Hill to address these important issues with their respective legislators and their legislative health care staff. The feedback from these visits is generally positive, but much more work lies ahead!
I have mentioned only a few of the legislative and regulatory issues facing our specialty, and each day presents us with a new challenge. It will take the active participation of all ASA members to ensure the continued advancement of our medical specialty and the delivery of high-quality care and safety that we provide to our patients each day. Be an advocate for anesthesiology and your patients by getting involved with the ASA Grassroots Network grassroots.asahq.org today!
Erin A. Sullivan, M.D. is Associate
Professor of Anesthesiology, and Director, Division of Cardiothoracic Anesthesiology, University of Pittsburgh, Pennsylvania. She is Alternate Director from Pennsylvania.
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