In the News for the Week of 9-12-06
- New rules on painkiller prescriptions
- McClellan steps down as head of CMS
- Fully implantable heart approved
Health care disparities
- Upcoming conference on care for diverse populations
- ACP President warns of payment cuts in proposed fee schedule
- Claim payments on hold at end of fiscal year
- ACP President commends working group on health care access
The federal government has issued a proposal to allow physicians to prescribe up to 90 days of Schedule II controlled substances in a single office visit. This is a major reversal of the agency’s position for the last two years, which did not allow for multi-month prescriptions.
According to a Sept. 6 U.S. Drug Enforcement Administration (DEA) statement, the proposed rule is intended to clarify prior policy and expressly allow for the issuance of multiple Schedule II prescriptions in appropriate circumstances.
The agency had received more than 600 comments on the old policy from doctors, patients and others, the majority of which were opposed to the limitations on multiple prescriptions. The ACP has been among those critics, expressing support for a system which differentiated between refills and multiple prescriptions. In January 2005, ACP wrote the FDA saying that tighter restrictions “could have a chilling effect on appropriate pain care.”
The DEA statement noted that the law prohibits refilling powerful Schedule II controlled substance prescriptions but that the regulations did not address the issuance of multiple prescriptions. The new regulations will allow physicians to write three 30-day prescriptions, two of those future-dated, whenever a patient has a legitimate medical need for the prescribed substance.
“Physicians acting in accordance with accepted medical practice should be confident that they will not be criminally charged for prescribing all appropriate pain medications,” said the statement. The DEA statement added that the new policy is intended to make sure patients get the pain relief they need, and that doctors have the latitude to prescribe in a manner consistent with their sound medical judgment, while enabling DEA to fulfill its legal obligation to prevent drug abuse and diversion.
Mark B. McClellan, FACP, announced on Sept. 5 that he will leave the Centers for Medicare and Medicaid Services by early October. Dr. McClellan has served as administrator of CMS since March 2004.
In an interview in the Sept. 5 Washington Post, Dr. McClellan said that he is considering a return to academia or a position in a Washington think tank. Prior to joining CMS, Dr. McClellan was commissioner of the FDA, and from 2001 to 2002 he served in the White House as a member of the President's Council of Economic Advisors.
During his tenure at CMS, Dr. McClellan oversaw the implementation of the new Medicare prescription drug benefit. He was also a champion of using evidence-based clinical performance measures and health information technology to improve patient care. Last year, the ACP honored Dr. McClellan with its annual Joseph F. Boyle Award for Distinguished Public Service, in recognition of his outstanding work on improving health care.
According to the Washington Post, possible successors include Leslie V. Norwalk, the deputy administrator of CMS; Herb Kuhn, director of the agency's Center for Medicare Management; and Julie Goon, a special assistant to President Bush and formerly the director of Medicare outreach at the Department of Health and Human Services.
The Washington Post article is online.
The CDC recorded more cases of the human plague this year than in any year since 1994. In 2006, a total of 13 cases have been reported among residents of four states: New Mexico (seven cases), Colorado (three cases), California (two cases), and Texas (one case).
Plague is a zoonotic disease caused by the bacterium Yersinia pestis. The dates of illness ranged from Feb. 16 to Aug. 14. Two cases were fatal. Five patients had primary septicemic plague, and the remaining eight had bubonic plague. Two patients developed secondary plague pneumonia, leading to administration of antibiotic prophylaxis to their health-care providers.
The CDC’s Morbidity and Mortality Weekly Report summarizes six of the 13 cases, highlighting the severity and diverse clinical presentations of the plague and underscoring the need for prompt diagnosis and treatment when plague is suspected. The report is online.
More than 100 million doses of the flu vaccine are expected to be produced and distributed between now and January 2007, according to the CDC. That would be at least 17 million more doses than has ever been distributed in the past (the previous high was 83.1 million doses in 2003).
The CDC’s Sept. 6 statement said that manufacturers will distribute about 75 million doses by the end of October, an increase of about 15 million over the number of doses distributed by the end of October 2005.
The CDC has been working with influenza vaccine manufacturers and distributors to monitor this season’s influenza vaccine supply and the timing of its distribution. In addition, the FDA has successfully worked with the vaccine manufacturers to increase both the supply and its diversity and to facilitate early availability. The CDC release is online.
The FDA has approved the first totally implanted artificial heart for patients with advanced heart failure involving both pumping chambers of the heart. Under the limited approval, the two-pound mechanical heart can now be sold to up to 4,000 people per year.
The heart is intended only for patients who are not eligible for a heart transplant and who are unlikely to live more than a month without intervention. An internal battery on the heart allows patients to be free from all external connections for up to one hour, while external batteries allow movement for up to two hours.
The device was tested on 14 patients between 2001 and 2004, all of whom have since died. In two cases, the device extended survival by 10 and 17 months, respectively, according to a Sept. 5 FDA statement. The artificial heart costs $250,000 and is manufactured by Abiomed, Inc.
The FDA statement is online.
Health care disparities
The Fifth National Conference on Quality Health Care for Culturally Diverse Populations will be held in Seattle on Oct. 17-20, 2006. The conference aims to build links between health care quality, cultural competence and disparities reduction. It provides a forum for cross-discipline exchange to promote integration of these fields in health care practice and policy.
Sessions range in focus from intensive skills-building workshops to presentations of international perspectives. The conference draws prominent health leaders who will frame cultural competence in the context of national health issues. Tony award winning actress Sarah Jones will perform “A Right to Care,” which explores the ways in which ethnic, racial and economic health disparities impact people’s daily lives.
The College is a conference partner of the event. Conference registration and information is online.
ACP President warns of payment cuts in proposed fee schedule
In an Aug. 28 letter, ACP President Lynne M. Kirk, FACP, informed all ACP members of the release of the proposed 2007 Medicare Physician Fee Schedule. The proposed fee schedule would cut physician payments by 5.1% starting on Jan. 1, 2007.
The sustainable growth rate (SGR) formula, which determines Medicare payments to physicians, was created in 1997. This formula ties physician payments to growth in the overall economy. When growth in physician expenditures exceeds growth in the economy, the difference is subtracted from physician payments. This is the sixth year that the formula could potentially cut payments. However, with the exception of 2002, every year Congress has passed legislation that prevented the cuts from going into effect.
Dr. Kirk asked ACP members to contact Congress to ask them to take action to replace the cuts with stable and positive Medicare physician reimbursement updates over both the immediate and long term.
Dr. Kirk went on to discuss changes that the CMS had proposed earlier in the summer that would result in payment increases for internists. She stated that these changes remain extremely beneficial to internists by redistributing approximately $4 billion in Medicare payments to services performed principally by internists and family physicians. However, she also warned, “if the SGR cuts are allowed to go into effect all or most of this initial gain for internists and their patients will be eliminated.”
Physicians who bill Medicare for services are advised that a hold will be placed on payments for all claims during the last nine days of the federal fiscal year (Sept. 22 - 30, 2006).
These payment delays, mandated by the Deficit Reduction Act of 2005, will not result in interest accrual or late penalties, according to the CMS' MLN Matters newsletter. The normal payment floor of 14 days and payment ceiling of 29 days will continue to apply during this time, so this hold will affect claims that are filed 14-29 days prior to the payment hold. All claims held during this time will be paid on Oct. 2, 2006.
The MLN Matters article is online.
In an Aug. 22 letter to the Citizens’ Health Care Working Group, ACP President Lynne M. Kirk, FACP, praised the group for bringing attention to the issue of access to health care.
In commenting on the group’s report, “Health Care That Works for All Americans,” Dr. Kirk noted similarities with ACP’s own proposal for a step-by-step expansion of health insurance coverage. She said that the two are based on many of the same principles, and that ACP agrees with the Working Group’s conclusion that all Americans should be guaranteed access to affordable health care.
In 2002 ACP developed a proposal for a step-by-step expansion of health care access, “Achieving Affordable Health Insurance Coverage for All within Seven Years: A Proposal from America's Internists.” This paper offered a framework for policies that would enable all Americans to have access to affordable health insurance coverage within seven years.
“ACP commends the Working Group for giving a greater voice to everyday Americans by presenting these thoughtful recommendations on how best to guarantee health care for all,” Dr. Kirk concluded in the letter. “We look forward to working with you to fix our nation’s broken health care system.”
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Copyright 2006 by the American College of Physicians.
A 38-year-old woman is evaluated during a follow-up visit. She has a history of well-controlled hypertension and type 1 diabetes mellitus. She is at 16 weeks' gestation with her first pregnancy. Prior to conception she was taking lisinopril, which was discontinued in anticipation of the pregnancy, and labetalol was initiated. Other medications are insulin glargine, insulin lispro, and a prenatal vitamin. Following a physical exam and lab studies, what is the most appropriate step in the management of this patient's hypertension? .
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