News Briefs: Week of March 14-18

March 16, 2011 05:25 pm News Staff

This roundup includes the following news briefs:

MedPAC Recommends Physician Payment Increase, Assails SGR Formula

The Medicare Payment Advisory Commission, or MedPAC, has recommended a 1 percent increase in the Medicare physician payment rate for 2012. That recommendation was included in MedPAC's March report( to Congress. The report also denounced the sustainable growth rate, or SGR, formula as ineffective.

MedPAC's payment recommendation takes several factors into account, including the level of beneficiary access to Medicare physician services, physician acceptance of Medicare patients and a "modest expected growth in physician and other health professionals' costs."

The report found that beneficiary access to Medicare physicians and other health professionals is good overall. But a small share of the Medicare population continues to report problems finding a new primary care physician -- an essential component to a well-functioning delivery system, the report notes.

The report also criticizes the SGR, saying that it "neither rewards individual providers who restrain unnecessary volume growth nor penalizes those who contribute most to inappropriate volume increases." Indeed, says the report, a largely untold cost of the SGR is "mounting frustration in the provider community stemming from the uncertainty of future Medicare payments."

Pfizer Subsidiary Recalls Extended-release Opioid Analgesic

King Pharmaceuticals Inc., a wholly owned subsidiary of Pfizer, is recalling all dosage forms of its morphine sulfate and naltrexone hydrochloride medication, which is marketed as Embeda Extended Release Capsules, because the product failed to meet stability requirements during routine testing.

According to a statement on the Embeda website, the manufacturer said that the issue is not likely to cause adverse events, and patients can continue to take the pain medication as prescribed. King said patients should not stop taking the medication abruptly but should instead talk to their physician about alternative treatments before completing their current prescription.

King said the medication, a long-acting Schedule II opioid analgesic, likely will be unavailable for several months and added that patients seeking a refund should contact their pharmacy.

The drug was approved by the FDA in 2009 as an abuse-resistant painkiller. However, 13 lots of the medication were recalled in June 2010( after it failed stability testing, and two lots were recalled in December(

GSK Updates Prescribing Information, Patient Guide for Advair Products

GlaxoSmithKline, or GSK, is informing physicians about new prescribing guidelines and other information( for the combination asthma medication fluticasone propionate and salmeterol xinafoate inhalation powder, which is marketed as Advair Diskus, and fluticasone propionate and salmeterol xinafoate inhalation aerosol, which is marketed as Advair HFA. Also included are new patient-oriented medication guides for the two drugs.

The FDA announced last year that manufacturers of long-acting beta agonists, or LABAs, must include new warnings on their package labels. Both Advair products are included in this class.

GSK said it made the following changes to prescribing guidelines for the products:

  • Use of an LABA without concomitant use of a long-term asthma control medication, such as an inhaled corticosteroid, is contraindicated in the treatment of asthma;
  • LABAs should not be used in patients whose asthma is adequately controlled on low- or medium-dose inhaled corticosteroids;
  • LABAs should be used as additional therapy only for patients with asthma who are currently taking, but are not adequately controlled on, a long-term asthma control medication, such as an inhaled corticosteroid;
  • After asthma control is achieved and maintained, patients should be assessed at regular intervals, and step-down therapy should begin if it can be accomplished without loss of asthma control. The patient should continue to be treated with a long-term asthma control medication, such as an inhaled corticosteroid.

GSK notified physicians earlier this year about similar changes for its asthma medication salmeterol xinafoate inhalation powder, which is marketed as Serevent Diskus.

Merck & Co. Inc. issued updated prescribing information and medication guide for formoterol fumarate inhalation powder, which is marketed as Foradil Aerolizer, last August.

PCPCC Creates New ACO-Focused Center

The Patient-Centered Primary Care Collaborative, or PCPCC, has launched a new center to help ensure that the patient-centered medical home, or PCMH, serves as the foundation of accountable care organizations, or ACOs, nationwide.

The new Center for Accountable Care will focus on identifying and making recommendations on regulations and policies to advance the success of ACOs with a strong PCMH foundation. In this capacity, the center will identify and share best practices involved in establishing PCMH-centered ACOs and work to educate stakeholders about the center's policy recommendations.

AAFP Past President Ted Epperly, M.D., of Boise, Idaho, will serve as one of four co-chairs of the PCPCC center. Epperly currently is program director and CEO of the Family Medicine Residency of Idaho and a clinical professor in the family medicine department at the University of Washington School of Medicine in Seattle.

FDA Takes Action Against McNeil

A permanent injunction has been filed against McNeil PPC and two of its officers for failing to follow good manufacturing practices, the FDA said in a March 10 news release( The action prevents McNeil, a subsidiary of Johnson & Johnson, from manufacturing and distributing products from its Fort Washington, Pa., facility until it is cleared by the FDA.

The consent decree also requires McNeil to adhere to a strict timetable to bring facilities in Puerto Rico and Lancaster, Pa., into compliance. McNeil also must hire an independent expert to inspect all three facilities to determine whether violations have been corrected and to certify that proper manufacturing practices are in place.

Manufacturing deficiencies have led McNeil to conduct several recalls in the past two years. The FDA opened a company-wide investigation of McNeil Consumer Healthcare last year.

CDC Revamps Website in Anticipation of National Infant Immunization Week

The CDC has redesigned its National Infant Immunization Week website( The site has been updated with new messages and materials to promote the annual event, which is scheduled for April 23-30.

One of the new tools is a binational immunization resource( designed to help physicians who provide care to children who received some of their vaccinations in Mexico. The resource has information regarding 17 vaccine-preventable diseases -- including a chart that illustrates the English and Spanish names of the vaccines and the doses and ages recommended in both countries -- to help physicians review a child's Mexican immunization records and determine which vaccinations are needed.

Advance Care Planning Is Focus of Special Day

Family physicians are encouraged to participate in activities that raise awareness about advance care planning as part of National Healthcare Decisions Day(, or NHDD, on April 16.

The NHDD initiative is a collaborative effort involving national, state and community organizations that are committed to ensuring adults with decision-making capacity have the information to communicate and document their health care decisions regarding end-of-life treatment preferences.

The initiative's website offers resources( and ideas for participants to engage in outreach activities( to bring attention to this issue.

IOM Report Focuses on Healthy People 2020 Priorities

The Institute of Medicine, or IOM, has identified 12 leading health indicators and two dozen objectives that it says should be treated as high priorities in implementing the federal interagency initiative Healthy People 2020(, which covers more than 40 topic areas and nearly 600 objectives.

The IOM released the information in a March 15 report( The leading health indicators cited in the report are the following measures of health-related concepts that reflect public health concerns:

  • proportion of the population with access to health care;
  • proportion of the population engaged in healthy behaviors;
  • prevalence and mortality of chronic disease;
  • proportion of the population experiencing a healthy physical environment;
  • proportion of the population experiencing a healthy social environment;
  • proportion of the population that experiences injury;
  • proportion of the population experiencing positive mental health;
  • proportion of healthy births;
  • proportion of the population engaged in responsible sexual behavior;
  • proportion of the population engaged in substance abuse;
  • proportion of the population using tobacco; and
  • proportion of the population receiving quality health care services.

Many of the objectives identified by the IOM are aligned with priorities of the AAFP, such as

  • increase the proportion of people with a primary care provider;
  • increase the proportion of people who receive evidence-based clinical preventive services;
  • improve health literacy;
  • reduce the prevalence of children and adolescents who are considered obese;
  • reduce the consumption of calories from solid fats and added sugars in children ages 2 years and younger;
  • increase the proportion of adults who meet federal physical activity guidelines;
  • reduce tobacco use by adults; and
  • reduce the initiation of tobacco use by children, adolescents and young adults.

U.S. Supreme Court Rejects Vaccine Design Defect Claim

The U.S. Supreme Court has ruled( that vaccine manufacturers cannot be sued in state courts for injuries allegedly caused by vaccines. The court's 6-2 ruling in Bruesewitz v. Wyeth Inc. on Feb. 22, which preserved the National Vaccine Injury Compensation Program, upheld an earlier ruling by the U.S. Court of Appeals for the Third Circuit that said a claim brought by the parents of Hannah Bruesewitz was preempted by federal law.

In a concurring opinion, Justice Stephen Breyer cited an amicus curiae ("friend of the court") brief( filed by the American Academy of Pediatrics. The AAFP signed on to that brief, which urged the court to confirm that the National Childhood Vaccine Injury Act of 1986 preempts all design defect claims against vaccine manufacturers.