Category — Prevention and Wellness

Section 4205 of the Patient Protection and Affordable Care Act of 2010 (PPACA) requires chain restaurants and vending machine operators with 20 or more locations or machines to provide calorie and other nutrition information to consumers.  Although FDA’s statutory deadline to publish the proposed rules was March 23, 2011 (within one year of PPACA’s enactment), the rules, entitled Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments and Food Labeling; Calorie Labeling of Articles of Food in Vending Machines were published in the April 6, 2011 Federal Register and the public is invited to submit comments by July 5, 2011.

The Department of Health and Human Services, the Department of Labor and the Internal Revenue Service issued a Request for Information (RFI) on December 28, 2010 on how group health plans and health insurance providers can deliver high-quality preventive care services cost-effectively under the Patient Protection and Affordable Care Act.  The agencies are interested particularly in suggestions on how welfare benefit plans can encourage use of the most beneficial preventive services and discourage use of the least beneficial services.  Public comments must be submitted before February 28, 2011.

The Departments of Health and Human Services, the Treasury and Labor (DOL) posted on the DOL website answers to new questions about the Patient Protection and Affordability Act and earlier healthcare legislation.  Previously issued answers are also available on the website.  The new  guidance addresses the design of preventive health care benefits; automatic enrollment in group health plans; notices to participants about material modifications in individual or group plans; coverage of dependent children up to age 26; pre-existing condition exclusions for children in the individual health insurance market; and grandfathered health plans.  The agencies anticipate issuing further guidance in response to stakeholder questions.

On November 1, 2010, the IRS announced the names of the companies that received tax credits or grants under the Qualifying Therapeutic Discovery Project program.  The program was created as part of the Patient Protection and Affordable Care Act to promote the development of therapeutic drugs.  Eligible companies had to have no more than 250 employees.  The IRS, in conjunction with the Department of Health and Human Services, approved applications for projects that showed significant potential to produce new and cost-saving therapies, support jobs and increase U.S. competitiveness.  

Under the program, a total amount of $1 billion was allocated for credits and grants with a $5 million limit per each eligible applicant. Since awards were made by project, companies were eligible to receive funding for multiple projects, each worth up to $244,479.24, designed to offset 50 percent of qualifying research and development costs.

Several important provision aimed at protecting insurance consumers will soon be required.  Specifically, for plan years beginning on or after September 23, 2010, insurers can no longer:

• Deny coverage to children with pre-existing conditions;
• Impose lifetime limits on benefits;
• Retroactively cancel insurance coverage without proving fraud;
• Deny claims without a chance for appeal;
• Charge out-of-pocket costs for preventive health services; or
• Require prior approval or charge higher copayments or coinsurance for emergency room services outside the network.  

Insurers must also provide coverage for a beneficiary’s dependent child who is under 26 and unable to obtain coverage from an employer.  For more information, see the federal health reform website and the AG Health Reform insurance reform summary.

On September 14, 2010, the U.S. Department of Health and Human Services (“HHS”) announced $31 million in awards to support community public health efforts to reduce obesity and smoking, increase physical activity and improve nutrition.  The awards are funded by the Prevention and Public Health Fund included in the Patient Protection and Affordable Care Act, and are part of the Communities Putting Prevention to Work (“CPPW”) program administered by the Centers for Disease Control and Prevention (“CDC”).  Ten communities in eight states and one state health department received awards to increase the availability of healthy foods and beverages, improve access to safe places for physical activity, discourage tobacco use, and encourage smoke-free environments.  More information about the CPPW program and CPPW awardees is available through the CDC website.

The departments of Health and Human Services (HHS), Labor and the Treasury issued interim final regulations on July 14, 2010 requiring health plans beginning on or after September 23, 2010 to cover certain recommended preventive services.  Under the new regulations, such health plans may not charge patients copayments, coinsurance or deductibles for these services when they are delivered by a network provider.  Covered preventive services include—

• evidence-based items or services with an A or B rating in the U.S. Preventive Services Task Force recommendations with respect to the individual involved
• immunizations for routine use in children, adolescents and adults with a recommendation from the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention with respect to the individual involved
• evidence-informed preventive care and screenings for infants, children and adolescents that are included in the comprehensive guidelines supported by the Health Resources and Services Administration (HRSA)
• Evidence-informed preventive care and screening for women included in the comprehensive guidelines supported by HRSA (not otherwise addressed by the recommendations of the Task Force). HHS expects to issue these guidelines by August 2011.

Click here for a complete list of recommendations and guidelines that are required to be covered under the new regulations.  Click here to view the new regulations.

The National Prevention, Health Promotion and Public Health Council, a new entity established by the Patient Protection and Affordable Care Act within the Department of Health and Humans Services, issued its first annual status report (http://www.hhs.gov/news/reports/nationalprevention2010report.pdf) on July 1, 2010.  The Council is tasked with coordinating prevention activities across federal agencies and establishing a National Prevention and Health Promotion Strategy.  The report outlines some of the key areas that will be addressed in the National Strategy, including the current five leading causes of death (heart disease, cancer, stroke, chronic lower respiratory disease and unintentional injury) as well as substance abuse, domestic violence and behavioral and mental health.  The strategy intends to incorporate a community health approach to prevention activities and will coordinate activities in both the public and private sectors.  In developing the National Strategy, the Council will also hear input from an Advisory Group comprised of 25 non-federal members appointed by the President.  The Council is only one of several new prevention priorities included in the Patient Protection and Affordable Care Act along with Medicare coverage for annual wellness visits and eliminating cost sharing for recommended preventive services, which hope to place a new focus on prevention and wellness within the health care system.

On June 25, 2010, CMS issued for display its Proposed Rule entitled “Medicare Program: Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2011.”  This Proposed Rule, which is expected to be published in the Federal Register on July 13, 2010, would implement key provisions of the health reform legislation that expand preventive services for Medicare beneficiaries, improve payments for primary care services, and promote access to health care services in rural areas.  These rules are applicable for services furnished on or after January 1, 2011. Stay tuned for our posting when the official Proposed Rule is published, which will include additional information on the comment period.

On Friday, June 18, the IRS and HHS released application materials related to the Qualifying Therapeutic Discovery Project program (QTDP) which was established under the Patient Protection and Affordable Care Act.   The QTDP allows small companies that undertake certain biomedical research projects to apply for and receive tax credits or grants of up to 50 percent of the qualified investment made toward such research.  The application materials released on Friday include IRS Form 8942 and the accompanying Project Information Memorandum form.  The IRS will review Form 8942 to determine whether the company and its stated investment meet the statutory requirements for the program, and also whether the project is likely to create jobs and increase competitiveness in the United States.  HHS, through the NIH, will review the information provided in the Project Information Memorandum to determine whether a project meets the definition of a “qualifying” research project, if so, whether it shows a ”reasonable potential” to result in new therapies, reduce long-term health care costs, or advance the goal of curing cancer.  With the release of these application forms, the IRS has officially begun to accept applications for certification under the program.  Completed applications are due to IRS by no later than July 21, 2010.  The IRS expects to issue certifications for approved research projects by the end of October.       IRS posted the following application documents to its Web site, in addition to its press release—

• Form 8942
• Instructions for completing Form 8942. 

HHS posted the following application-related documents to the the NIH Office of Extramural Research Web site—

• Project Information Memorandum 
• Several documents that describe the process by which HHS will review and “score” applications according to the specified criteria, including the QTDP Reviewer Response Sheet and a flowchart of the QTDP Review Process.   

All of the application materials, along with several new Q&A documents, can be accessed on the NIH Web site.