By Leah Voigt*
February 26, 2010
FDA Reorganization Plan to Replace DDMAC With New Office
A proposed reorganization at the U.S. Food and Drug Administration (FDA) would replace the agency's Division of Drug Marketing, Advertising, and Communications (DDMAC) with a new Office of Prescription Drug Promotion (OPDP), an agency official said this week.
The new office would have two divisions, one governing materials for healthcare professionals and one for materials intended for consumers of drugs, according to Rachel E. Behrman, director of the FDA Office of Medical Policy (OMP) and associate FDA commissioner for clinical programs. She spoke at an annual Drug Information Association pharmaceutical marketing conference. DDMAC is part of OMP within FDA's Center for Drug Evaluation and Research. The new OPDP would remain under OMP, which would expand its medical policy functions and also take on responsibilities for Consumer Medication Information (CMI), Behrman said. The change must be approved by FDA human resources officials and the commissioner's office, she said, which would probably take "a couple of months."
The conversion into OPDP would recognize that DDMAC "has outgrown single-division status," she continued. OPDP would be expected to provide leadership on program and policy issues, and the change in structure would afford more freedom to do that job, she suggested. The new structure would not signal a change in philosophy or emphasis, Behrman said. It would, however, bring a "new era" with expanded efforts, she added. "We're feeling energized, and we're feeling innovative," she noted.
John Herzfeld, FDA Reorganization Plan to Replace DDMAC With New Office, Official Says, BNA's Health Care Daily Report (Feb. 25, 2010) (note: registration is required to view this content).
Data Security Breaches Often Triggered by Carelessness
Often the biggest threat to a physician's practice and patient data is not an outside hacker or a snooping employee--it's somebody's forgetfulness. As technology becomes smaller and more portable, it becomes easier to lose. Surveys from a data protection solutions company in 2009 found that in a six-month period, 12,500 mobile devices were left in taxis, and 4,500 USB memory sticks were left in pockets of pants sent to dry cleaners.
Most people--including those in the security business--are not protecting the data on their mobile devices. So if the device is lost, the data could be accessed. Just having your phone drop out of your pocket could launch a time-consuming and expensive nightmare of reconstructing data and adhering to fixes mandated under the Health Insurance Portability and Accountability Act (HIPAA).
So how you do protect yourself from an accidental loss of a device containing sensitive data? Experts recommend two strategies. One is to find a way to handle or store your mobile technology so you cannot lose it easily. The other is to make sure the device has security and encryption features that make it next to impossible to access by anyone who happens to find it. Paul Stephens, director of policy and advocacy for the Privacy Rights Clearinghouse, said he has seen a recent increase of health information breaches because of the use of mobile devices. Privacy Rights, a San Diego-based consumer advocacy group focused on educating the public on how technology impacts privacy, is developing a database of all known data breaches in the United States to analyze how each breach occurred, Stephens said.
Credant Technologies, a Dallas-based data protection solutions company, noted in a 2008 survey that although more than a third of healthcare professionals store patient data on laptops, smartphones, and USB memory sticks, most do not adequately secure the data. Sean Glynn, vice president of product marketing at Credant, said the company surveyed smartphone users at a commuter train stop in 2009. When asked if the data on their phones were encrypted, few said yes. When the same survey was conducted among data security professionals at a trade show, the results were nearly identical. Credant also performed the studies about mobile devices left in taxis and at dry cleaners. Those covered all devices, not just those owned by healthcare professionals.
Encrypting the data can eliminate the HIPAA obligation to notify patients of a lost device, under a provision that allows an exception if the data cannot be accessed. But in most cases, encryption is not being done. The Healthcare Information and Management Systems Society, in a survey released in November 2009, found that despite the strengthening of HIPAA regulations, healthcare organizations have made relatively few changes to their security policies and procedures. For example, only 39% reported using mobile device encryption.
Pamela Lewis Dolan, Data Security Breaches Often Triggered by Carelessness, Am. Med. News (Feb. 22, 2010).
Appeals Court Says Transplant Coordinator May Not Sue for Alleged Retaliatory Firing
A woman who was fired from her position as the organ transplant coordinator for a Colorado hospital failed to show she was fired in retaliation for voicing quality of care concerns, a federal appeals court ruled on February 19, 2010. (Rohrbough v. University of Colorado Hospital Authority, 10th Cir., No. 07-1498, 2/19/10.)
The U.S. Court of Appeals for the Tenth Circuit said Lisa M. Rohrbough could not prevail on her claims that she was illegally fired by the University of Colorado Hospital Authority for exercising her First Amendment rights under the U.S. Constitution because all of her statements were made within the scope of her official duties as an employee of a public hospital. The court ruled that reports to co-workers, supervisors, and other hospital personnel concerning an alleged "staffing crisis," as well as "occurrence reports" she generated to document certain allegedly unsafe conditions, were all made in conjunction with her official duties as a public employee.
The court found her report concerning an alleged "heart misallocation and cover-up" at the hospital to the United Network for Organ Sharing (UNOS), an entity established by Congress to administer organ transplants, "presents a closer question" but ultimately found that even assuming this report was outside of Rohrbough's official duties, she failed to allege that report was the motivating factor behind her termination.
The court noted that the free speech rights of employees of public entities are generally constrained by those employers' right to exercise "a significant degree of control over their employees' words and actions." In cases where the speech is made in conjunction with an activity that the employee is paid to perform, that speech is most often found to be not protected under the First Amendment, the court said. In the end, the court found Rohrbough's claims failed because her discussions with other hospital employees about an alleged staffing crisis, about the alleged incidents of substandard care, and about the alleged heart misallocation were all within the scope of her official duties. Even if Rohrbough's reporting of the alleged heart misallocation to UNOS could be considered outside of her official duties, she could not show that the report was a motivating factor in her termination, the court added.
Appeals Court Says Transplant Coordinator May Not Sue for Alleged Retaliatory Firing, BNA's Health Care Daily Report (Feb. 24, 2010) (note: registration is required to view this content).
FDA Approves Aerosol Treatment for Cystic Fibrosis
FDA has approved the inhalant cystic fibrosis treatment aztreonam (Cayston) for patients eight and older with P. aeruginosa, according to the manufacturer, Gilead Sciences of Foster City, CA.
The drug should be taken three times daily over twenty-eight days, with the use of a bronchodilator before administration, the company said. It uses a specialty inhaler that aerosolizes the drug through a vibrating, perforated membrane. Approval was based on a twenty-eight-day randomized, double-blind, placebo-controlled multicenter clinical trial.
The endpoint of the study was respiratory symptom improvement on the last day of drug treatment as well as a two-week follow-up after treatment completion. Among symptoms assessed were cough, wheeze, and sputum production. A statistically significant positive difference in symptoms was noted in pediatric and adult groups treated with aztreonam versus those treated with placebo, with a substantially smaller difference in adult patients. Patients showed fewer symptoms in the drug group than the placebo group during the two week post-test with less difference between groups, the company said.
Adverse reactions included cough, nasal congestion, wheezing, pharyngolaryngeal pain, pyrexia, chest discomfort, abdominal pain, vomiting, and bronchospasm. Patients should inhale a seventy-five mg dose per use, the company said. Patients who take 225 mg or more per dose are at increased risk for adverse effects of the drug. Those without P. aeruginosa infection should not take aztreonam, as it increases the risk of developing drug-resistant bacteria, the company warned.
Cole Petrochko, FDA Approves Aerosol CF Treatment, MedPage Today (Feb. 25, 2010).
Health Insurance Executive Defends Premiums
A top health insurance company executive told a Congressional committee on Wednesday that higher premiums were justified by soaring medical costs and warned that pending legislation could make the problem worse, further driving up costs for young, healthy people. The executive, Angela F. Braly, president of WellPoint, made the comments in testimony prepared for a hearing of the House Energy and Commerce Committee.
The hearing comes amid growing criticism of WellPoint and the health insurance industry by President Barack Obama and Democrats in Congress, who say the proposed rate increases show the need for federal review and regulation of insurance premiums.
Anthem Blue Cross, a unit of WellPoint, recently informed subscribers in California that premiums for individual insurance policies would rise an average of 25%, with some rates going up as much as 39%.
"Raising our premiums was not something we wanted to do," Braly said. "But we believe this was the most prudent choice, given the rising cost of care and the problems caused by many younger and healthier policyholders dropping or reducing their coverage during tough economic times. By law, premiums must be reasonable in relationship to benefits provided, which means they need to reflect the known and anticipated costs they will cover." The increases in premiums are driven by prices charged by doctors, hospitals, drug companies, and other suppliers, and by increases in the use of healthcare by an aging population, Braly said.
"For 2010," Ms. Braly said, "we expect hospital inpatient and outpatient costs in California to grow by over 10 percent, driven primarily by hospital reimbursement rates. Additionally, we expect pharmacy costs in California to grow by over 13 percent."
Braly said healthcare providers were charging more to the private sector, "including our members," because payments from Medicare and Medicaid did not fully cover providers' costs.
She criticized healthcare bills passed by the House and the Senate, with strong support from President Obama. The bills would require insurers to accept all applicants and would require most Americans to have health insurance or pay a penalty. But Braly said the "personal coverage requirement" would not be fully effective, because millions of people would be exempted and others would make a "logical choice" to pay the penalty rather than buy insurance, unless they needed healthcare. "The result," she said, "will be a national health insurance market that is similar to New York, where the average individual market premium is over twice the average individual premium in California."
Robert Pear, Health Executive Defends Premiums, N.Y. TIMES (Feb. 24, 2010).
Lawsuit Accuses Medtronic of Violating FCA by Off-Label Promotions of Biliary Stents
A False Claims Act qui tam lawsuit unsealed in a federal district court on February 19, 2010, accused medical device maker Medtronic Inc. of causing the submission to the U.S. government of thousands of false claims for reimbursement involving biliary stents (United States ex rel. Nowak v. Medtronic Inc., D. Mass., No. 08-10368, complaint unsealed 2/19/10).
According to the amended complaint filed in the U.S. District Court for the District of Massachusetts, Medtronic "unlawfully and unabashedly developed, marketed and promoted its biliary stent medical devices for uses unapproved by the Food and Drug Administration." Relators Tricia Nowak and Enda Dodd further alleged that Medtronic committed a fraud on the FDA by obtaining approval for its devices through false certifications and statements to the agency and that the company intended all along that its products be used almost exclusively off-label. The complaint also contained claims for violations of state false claims statutes.
The federal claim alleged that Medtronic knowingly presented or caused to be presented false or fraudulent claims to the federal government for payment or approval in violation of the FCA, 31 U.S.C. § 3729. According to the complaint, a medical stent is a tube-shaped device that is inserted into tube-shaped structures in the body. There are two types of stents--vascular, which are used in blood vessels, and biliary, which are used in bile ducts and other areas of the body. "Each model of stent, and each class of stents, is functionally and compositionally different from others based upon its intended use," the complaint said. In other words, they "are not interchangeable."
FDA recognizes the difference between the two types of stents, the complaint continued. Vascular stents are considered high-risk, class III medical devices that must receive premarket approval (PMA) before being marketed. Biliary stents, by contrast, are class II medical devices that can be marketed upon receiving Section 510(k) clearance, the complaint said. FDA's requirements as to what must be submitted to the agency to obtain PMA are far more rigorous than those for Section 510(k) clearance.
FDA reported in 2008 that it has received far fewer PMA applications for vascular stents than 501(k) submissions for biliary stents. According to the complaint, this caused the agency to become concerned that manufacturers were marketing biliary stents for uses within the peripheral vascular system. Not only is such a use "off-label"--meaning that the device is used for a purpose or in a manner other than that stated in the FDA-approved label--but it is also potentially dangerous because biliary stents are not tested or evaluated for this use, the complaint said.
Further, relators asserted that Medtronic deliberately sought the less expensive and less time-consuming 501(k) clearance for its biliary stents while it intended all along to market them for vascular indications. Thus, they said, the company committed a fraud on the FDA that eventually led to a fraud on government healthcare programs.
Mary Anne Pazanowski, Lawsuit Accuses Medtronic of Violating FCA By Off-Label Promotions of Biliary Stents, BNA's Health Care Daily Report (Feb. 25, 2010) (note: registration is required to view this content).
AHLA Teaching Hospital Updates are intended to provide quick summaries of cutting-edge issues of interest to teaching hospitals and their counsel. Additional information and more in-depth coverage on these topics may be available from AHLA Health Lawyers Weekly and appropriate AHLA Practice Groups.
*We would like to thank Leah Voigt, Esquire (Squire Sanders & Dempsey LLP, Washington, DC), for providing this week's update.