This roundup includes the following news briefs:
The FDA has approved updated labeling(www.fda.gov) on a reformulated version of oxycodone hydrochloride controlled-release (OxyContin) tablets that indicates the product has physical and chemical properties that are expected to make abuse via injection difficult and to reduce intranasal abuse.
According to the release, because the reformulated Purdue Pharma L.P.-produced tablets provide the same therapeutic benefits as the original version of OxyContin without the increased risk of abuse, the FDA has determined that the benefits of original OxyContin no longer outweigh its risks and has removed it from the market based on safety and effectiveness concerns. The FDA has the authority to require generics to have abuse-deterrent properties, as well, so the agency will no longer accept or approve any abbreviated new drug applications that rely on approval of the original formula for OxyContin.
The FDA said that the reformulated tablets are more difficult to crush, break or dissolve, and they form a viscous hydrogel that cannot be prepared easily for injection. That said, abuse of OxyContin by these routes, as well as the oral route, still is possible.
"The development of abuse-deterrent opioid analgesics is a public health priority for the FDA," said Douglas Throckmorton, M.D., deputy director for regulatory programs in the FDA's Center for Drug Evaluation and Research, in the release. "While both original and reformulated OxyContin are subject to abuse and misuse, the FDA has determined that reformulated OxyContin can be expected to make abuse by injection difficult and expected to reduce abuse by snorting compared to original OxyContin."
CMS has launched a website(www.cms.gov) to implement a provision in the health care reform law that requires drug and device manufacturers, as well as group purchasing organizations (GPOs), to report payments or gifts of $10 or more made to physicians, hospitals and other providers on an annual basis.
The website, which went live on April 11, includes fact sheets and additional information for physicians and other entities affected by the law, including manufacturers, GPOs and medical researchers. CMS is requiring manufacturers and GPOs to start collecting data on Aug. 1. These groups must submit data collected between Aug. 1 and the end of 2013 to CMS by March 31, 2014.
The transparency provision, formerly called the Physician Payments Sunshine Act and now known as Open Payments, also requires drug manufacturers and GPOs to report ownership and investment interests in these entities that are held by physicians or their immediate family members.
CMS plans to publish the initial data on the public website by Sept. 30, 2014. In subsequent years, the agency will post the information annually on June 30. CMS is required by law to give physicians at least 45 days to review, dispute and correct reported information before posting it, according to an AAFP summary of the rule.
Want to learn more about end-to-end testing ahead of the Oct. 1, 2014, implementation date for ICD-10-CM code sets for outpatient diagnosis coding? A CMS contractor -- National Government Services -- is offering free listening sessions in April(www.cms.gov), with each session targeting a different industry segment. All sessions are scheduled to run from 2-3 p.m. EDT.
The dates of scheduled sessions most applicable to family physicians are
- April 18: vendor to provider,
- April 25: large provider and
- April 30: small provider.
Session moderators will focus on reviewing checklists and common definitions for the administrative simplification requirements. Interested physicians should register to participate.
The National Committee for Quality Assurance (NCQA) recently launched a new evaluation program modeled on its patient-centered medical home (PCMH) recognition program but extending those concepts to health care specialists outside of primary care.
According to an NCQA press release(www.ncqa.org), the NCQA Patient-Centered Specialty Practice (PCSP) Recognition program is intended to enhance communication and care coordination between specialty practices and their colleagues in primary care.
As with NCQA's PCMH program, standards for the new PCSP program involve three levels of recognition -- each with its own set of standards. To date, 64 organizations around the country have enrolled to become early adopters of the PCSP program.
The number of Americans with employer-sponsored health insurance dropped by more than 11 million from 2000 to 2011, probably as a result of increases in health insurance premiums, according to a study(www.rwjf.org) issued by the Robert Wood Johnson Foundation.
The study found that 159 million Americans had employer-sponsored health insurance in 2011, a figure that represents nearly 60 percent of the U.S. population and a decrease of 11.5 million people who had employer-sponsored health insurance in 2000. Twenty-two states experienced declines in employer-sponsored insurance of at least 10 percentage points from 2000 to 2011.
Michigan experienced the largest percentage drop at 15.2 percent, while North Dakota had the smallest decrease at less than 1 percent. The average annual employee-only premium jumped from $2,490 to more than $5,000 during the 11-year period, and the amount employees contributed toward premiums also surged from $435 to $1,056, according to the report.
There was, however, an increase in employer-sponsored insurance coverage among adults between the ages of 19 and 25, an increase attributed to a provision in the health care reform law that allows adults below the age of 26 to remain on their parents' health insurance policy.