A Medical Device Daily

The Centers for Medicare and Medicaid Services reported that because of concerns about marketing practices, seven healthcare sponsors have signed an agreement to suspend the marketing of Private-Fee-For-Service (PFFS) plans.

CMS said that any suspension of a given plan will be lifted only until the systems and management controls in place meet all of the conditions in a call letter and guidance that it issued May 25.

The signatories include: United Healthcare , Humana , Wellcare ,Universal American Financial Corporation (Pyramid), Coventry , Sterling , and Blue Cross/Blue Shield of Tennessee .

Leslie Norwalk, acting administrator of CMS, said that most health insurance agents are helpful and responsible in describing and explaining choices to beneficiaries, there are a few bad actors that need to be removed from the system for good."

She said that the agreement "demonstrates that CMS and the plans are stepping up to ensure that deceptive marketing practices end immediately, and that beneficiaries understand what they are purchasing. Through a variety of methods, including our 'secret shopper' program … CMS is proactive in protecting beneficiaries from rogue agents. Although the 2,700 agent complaints we logged from December 2006 to April 2007 represent less than one-half of 1% of the 1.3 million members enrolled in individual PFFS plans, we can always do better."

The agreement will continue to apply to individual plans until they have demonstrated that they have systems and management controls in place to ensure that they can meet all the CMS requirements. CMS said that any such review will begin "as soon as plans indicate they are ready."

Plans signing the agreement will be monitored and violations will be subject to penalties such as suspension of enrollment, suspension of payment for new enrollees, civil-monetary penalties and termination of a plan's involvement in Medicare. The updated conditions will be in effect for all sponsors of PFFS plans beginning Oct. 1, and violations of those conditions will be subject to the same types of penalties.

Primary provisions that the plans signing the agreement must meet to have the suspension lifted are:

• All materials, including but not limited to advertisements, enrollment materials, and materials used at sales presentations by employees or contracted representatives of a health insurance company will include the model disclaimer language provided by CMS in its May 25, 2007, guidance.

• All representatives selling the product to beneficiaries on behalf of the plan sponsor will pass a written test that demonstrates familiarity with both the Medicare program and the product being sold.

• A provider outreach/education program will ensure that providers have access to the plan terms and conditions of payment, and that provider staff are accessible to assist providers with questions.

• Outbound education and verification calls will be made to all beneficiaries requesting enrollment to ensure that they understand the plan rules.

• Lists of marketing and sales events provided to CMS will include events sponsored by delegated brokers and agents as well as those sponsored by the plan.

• Plan sponsors will provide a list of all representatives marketing a PFFS and authorize CMS to make that list available to state insurance departments on request.

FDA issues food protection software

The FDA has released what it called a new software program to help growers, packers, processors, manufacturers, warehousers, transporters, and retailers in the food industry determine the vulnerability of individual food facilities to biological, chemical, or radiological attack.

The CARVER + Shock Software Tool is intended "to maximize protection of the American food supply," said FDA Assistant Commissioner for Food Protection David Acheson, MD. "The relative risk-ranking methodology used by the CARVER + Shock software tool has been designed to assist facility operators in identifying potential vulnerabilities and assist in providing preventive measures to increase the defense of products and operations."

CARVER + Shock was developed by FDA's Center for Food Safety and Applied Nutrition, in collaboration with Sandia National Laboratories , the Institute of Food Technologists , U.S. Department of Agriculture's Food Safety and Inspection Service , National Center for Food Protection and Defense , State representatives and private industry representatives.

CARVER is an acronym standing for six attributes used to evaluate targets for attack.

• Criticality: What impact would an attack have on public health and the economy?

• Accessibility: How easily can a terrorist access a target?

• Recuperability: How well could a system recover from an attack?

• Vulnerability: How easily could an attack be accomplished?

• Effect: What would be the direct loss from an attack, as measured by loss in production?

• Recognizability: How easily could a terrorist identify a target?

The software also evaluates a seventh attribute — the psychological impacts of an attack or "shock" attributes of a target. For example, the psychological impact tends to be greater when a large number of deaths is involved or if the target has historical or cultural significance.

The FDA said that since 9/11 it has worked with its partners in federal, state, and local government, and with the food industry to assess existing food defense measures and augment them for improved protection.