New government requirements regarding commercial insurance coverage for preventive care mark an important step to broadening access for adult vaccines. Mandated by the health reform law, the requirements are part of an interim final rule from HHS, the Labor Department and the Treasury Department, scheduled to appear in the Federal Register July 19.

The rule requires new insurance plans in the group and individual markets to cover specific preventive services and therapies, including vaccines, without cost-sharing, starting with policy years beginning on or after Sept. 23.

Although the rule takes effect 60 days after it is published, HHS will also accept public comments on it until then.

The rule covers immunizations recommended by the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices and endorsed by the CDC director for routine use in children, adolescents, and adults.

For adults, the vaccines include: tetanus/diphtheria/ pertussis, TD plus acellular pertussis, human papillomavirus, varicella, herpes zoster, measles/mumps/rubella, influenza, pneumococcal, hepatitis A, hepatitis B and meningococcal.

Many states already require first-dollar coverage or no deductible for children's vaccines, but such assistance is not widely available for adult immunization. As a result, the law is likely to have a bigger impact on the market for adults, particularly those not yet eligible for Medicare, than on vaccination rates in children.

The next step in promoting broader access to adult vaccines will be outreach. Vaccine marketers are expected to target both physicians and insurers with educational activities. An upcoming public meeting of the National Vaccine Advisory Committee may provide a springboard for education efforts.

NVAC is scheduled to meet Sept. 14-15 to hear recommendations from its working group on adult immunization for a comprehensive, sustainable national program to improve adult immunization coverage levels.

In addition to vaccines, the preventive care rule applies to all recommendations from the U.S. Preventive Services Task Force that have been rated "A" or "B," indicating a strong evidence basis. Health Resources and Services Administration-recommended preventive care and screening services for women and children are also governed by the rule.

Drug And Diagnostic Screening Recommendations

Only a few specific drug therapies carry USPSTF A or B recommendations, such as chemoprevention against breast cancer in high-risk women, smoking cessation products and aspirin for preventing cardiovascular disease. However, many of the recommendations relate to diagnostic screening, which can also influence drug prescribing.

The USPSTF had a relatively low public profile until recently, when it provoked a firestorm by proposing changes in mammography screening (¹ Also see "Mammogram Recommendations Show Perils Of Communicating CER Results" - Pink Sheet, 14 December, 2009.). Recently, the group has moved to solicit more public input as a way to enhance its deliberations. For example, the task force is seeking comments until Aug. 3 on draft recommendations regarding osteoporosis screening.

The preventive care rule applies to new plans and exempts plans already in existence when the Patient Protection and Affordable Care Act was signed March 23. However, it would apply to those plans if they change materially, such as by eliminating certain benefits, or substantially increasing copays, deductibles or other costs of coverage to consumers.

It is unclear how many insurance plans will be subject to the new requirements right away; however, it is likely that many plans' current benefit designs will be grandfathered the first year or two.

The interim rule on preventive care is one of a series of insurance market reforms being implemented ahead of the establishment of the insurance exchanges in 2014. Other recent rules have covered insurance for dependent children and a ban on pre-existing conditions, policy rescissions and annual or lifetime coverage limits.

The rules are being issued jointly by HHS, Labor and Treasury because of overlapping jurisdiction. At HHS, they are being handled by the recently formed Office of Consumer Information and Insurance Oversight.

- Cathy Kelly ( ² c.kelly@elsevier.com )

Adult Vaccines Stand To Gain From Preventive Care Rule, Outreach Is Next

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