Published 1/1/2012

Second Look—Clinical News and Views

CMS extends revalidation deadline
The U.S. Centers for Medicare & Medicaid Services (CMS) has extended the deadline for physicians to complete a revalidation process required under the Patient Protection and Affordable Care Act (PPACA) by an additional 2 years, through March 2015. PPACA requires all physicians and other health professionals to undergo enhanced screening procedures before enrolling or re-enrolling in Medicare. The original deadline was March 23, 2013, and CMS states that physicians who have already received revalidation letters are still required to meet the stated deadlines. Failure to revalidate within the designated time frame will cause deactivation of a physician’s enrollment.

Merck settles Vioxx® case
The U.S. Department of Justice states that Merck, Sharp & Dohme has agreed to pay $950 million to resolve criminal charges and civil claims related to its promotion and marketing of the painkiller Vioxx (rofecoxib). Under the terms of the agreement, the company will plead guilty to a single violation of the Food, Drug, and Cosmetic Act for introducing a misbranded drug into interstate commerce and to a misdemeanor for its illegal promotional activity. In addition to a $321,636,000 criminal fine, Merck is entering into a civil settlement agreement under which it will pay $628,364,000 to resolve additional allegations regarding off-label marketing and false statements about the drug’s cardiovascular safety.

Are physicians liable for using pain pumps?
According to Outpatient Surgery, a manufacturer of pain pumps has asked a court to recognize medical liability charges against an orthopaedic surgeon for unauthorized use of its product in shoulder surgery. An attorney for the plaintiff states that this is the first time a manufacturer has sought to bring a physician into such a case. The manufacturer told the court that its pain pump instructions no longer recommended the device’s use in arthroscopic shoulder surgeries at the time of the plaintiff’s procedure. Because the physician did not request updated literature, the company argues that he was at fault. Patients claiming chondrolysis due to use of pain pumps have filed more than 500 lawsuits against manufacturers of the devices, alleging that the companies encouraged off-label use.

JC: Text messaging is not acceptable
Text messaging is an unacceptable method for physicians to use to send orders to hospitals or other healthcare settings, according to a statement issued by the Joint Commission (JC). The organization explains that text messaging offers no ability to verify the identity of the person sending the text or to retain the original message for validation. The statement appears on the Standards FAQ Details section of the JC website.

Physician victims of identity theft
CMS has developed a validation and remediation initiative for physicians whose identities have been stolen and used to defraud federal health programs. CMS has made arrangements with program safeguard and zone program integrity contractors to investigate instances of identity theft after being notified by a potential victim. The contractors will investigate physician complaints and generate a report to CMS for “a final decision whether to relieve providers of liability based upon the evidence.” CMS asks physicians who believe they are victims of identity theft but have not yet incurred any financial liability to call their Medicare administrative contractors or the HHS Office of Inspector General hotline at 800-447-8477 (HHS-TIPS).

How free is speech?
Reuters reports that a lawsuit involving a patient’s online review of his dentist could have implications for how healthcare providers respond to what patients post online about their providers. The plaintiff in this class action case was asked to sign a privacy agreement before the dentist would treat an infected cavity. After paying the bill, the plaintiff alleged that the dental office refused to submit the proper paperwork to the insurer so he could be reimbursed.

The plaintiff then posted a negative online review—an alleged breach of the privacy agreement, which stated that the patient would not publish comments about the dentist’s work and would assign to the dentist copyright of any commentary posted. The dentist responded by requesting $100 for each day the negative review remained online. The lawsuit calls the privacy agreement a breach of medical ethics and not valid under state law. It also argues that posting commentary on a website is legally protected speech and considered “fair use” under copyright laws.

These items originally appeared in AAOS Headline News Now, a thrice-weekly enewsletter that keeps AAOS members up to date on clinical, socioeconomic, and political issues, with links to more detailed information. Subscribe at www.aaos.org/news/news.asp (member login required)