McGuireWoods Healthcare Reform Guide: Installment No. 49
This is the 49th in a series of WorkCite articles concerning the Patient Protection and Affordable Care Act and its companion statute, the Health Care and Education Reconciliation Act of 2010 (referred to collectively as the Act). This article discusses recent frequently asked questions (FAQs) jointly issued by the Labor, Health and Human Services and Treasury departments concerning preventive services.
The Act added Section 2173 to the Public Health Service Act to require that non-grandfathered group health plans and health insurance offered in the individual or group market provide coverage with no cost-sharing requirements (such as copayments, deductibles or co-insurance) for certain preventive services. As used in this article, “plan” means both a non-grandfathered group health plan and a health-insurance issuer.
A preventive service includes the following four broad categories of service:
- Evidence-based screenings and counseling
- Routine immunizations
- Certain preventive services for children and youth
- Certain preventive services for women
For cases where Section 2713 and its implementing regulations do not expressly require a certain frequency, method, treatment or setting for the provision of a recommended preventive service, the PHSA allows plans to use reasonable medical management techniques to determine any such coverage limitations. Because there is not a formal regulatory definition for “reasonable medical management,” this standard has resulted in many questions.
The FAQs discuss coverage of BRCA testing, contraceptives approved by the Food and Drug Administration (FDA), sex-specific recommended preventive services, well-woman preventive care for dependents and anesthesia in connection with colonoscopies.
Coverage of BRCA Testing
Several screening tools are available for use with women who have family members with breast, ovarian, tubal or peritoneal cancer. These tools are designed to identify a family history that may be associated with an increased risk for potentially harmful mutations in breast cancer susceptibility genes (BRCA1 or BRCA2). The United States Preventive Task Force recommends that women with positive screening results receive genetic counseling and, if indicated after counseling, BRCA testing. The FAQs indicate that as long as a woman has not been diagnosed with BRCA-related cancer, the plan must cover preventive screening, genetic counseling and genetic (BRCA) testing, all without cost-sharing, if appropriate for the woman as determined by her attending provider, consistent with Section 2713 and its implementing regulations.
Coverage of FDA-Approved Contraceptives
The FAQs provide that a plan will not satisfy Section 2713 if it covers some forms of oral contraceptives, some types of intrauterine devices and some types of diaphragms without cost-sharing, but excludes completely other forms of contraception. Instead, plans must cover, without cost-sharing, the full range of FDA-identified contraceptive methods. The FDA currently has identified 18 distinct methods of contraception for women, and the plan must cover at least one service or item within each of the methods.*
However, a plan generally may use reasonable medical management techniques and impose cost-sharing (including full cost-sharing) to encourage an individual patient to use specific services or FDA-approved items within the chosen contraceptive method. If utilizing these techniques, the plan must have an easily accessible, transparent and sufficiently expedient exceptions process that is not unduly burdensome on the patient or her provider to ensure coverage, without cost-sharing, of any service or FDA-approved item within the specified method of contraception
The FAQs also provide that if multiple services and FDA-approved items within a contraceptive method are medically appropriate for an individual, the plan may use reasonable medical management techniques to determine which specific products to cover without cost-sharing as to that individual. However, if the individual’s attending provider recommends a particular service or FDA-approved item based on a determination of medical necessity as to that individual, the plan must cover that service or item without cost-sharing.
Additionally, the FAQs note that if a plan covers oral contraceptives (such as the extended/continuous-use contraceptive pill), it cannot impose cost-sharing on all items and services within other FDA-identified hormonal contraceptive methods (such as the vaginal contraceptive ring or the contraceptive patch).
Coverage of Sex-Specific Recommended Preventive Services
According to the FAQs, a plan may not limit sex-specific recommended preventive services based on an individual’s sex assigned at birth, gender identity or recorded gender. Instead, whether a sex-specific recommended preventive service that is required to be covered without cost-sharing under Section 2713 is medically appropriate for a particular individual is to be determined by his or her attending provider. Thus, for example, where an attending provider determines that providing a mammogram or pap smear for a transgender man who has residual breast tissue or an intact cervix is medically appropriate and the patient otherwise satisfies the criteria in the relevant recommendation or guideline as well as all other applicable coverage requirements, the plan must provide coverage for the recommended preventive service without cost-sharing, regardless of sex assigned at birth, gender identity or gender of the individual otherwise recorded by the plan.
Coverage of Well-Woman Preventive Care for Dependents
The FAQs provide that if a plan covers dependent children, it is required to cover, without cost-sharing, recommended women’s preventive care services for such children, including recommended preventive services related to pregnancy, such as preconception and prenatal care. For example, under Section 2713 a plan must cover, without cost-sharing, preconception care and many services necessary for prenatal care for a dependent where an attending provider determines that well-woman preventive services are age-appropriate and developmentally appropriate for her.
Coverage of Anesthesia in Connection with Colonoscopies
Under the FAQs, a plan may not impose cost-sharing as to anesthesia services performed in connection with a preventive colonoscopy if the attending provider determines that anesthesia would be medically appropriate for the patient.