VIA ELECTRONIC SUBMISSION
Centers for Medicare & Medicaid Services
U.S. Department of Health and Human Services
P.O. Box 8010
Baltimore, MD 21244-8010
Group Health Plans and Health Insurance Issuers Relating to Coverage of Preventive Services Under the Patient Protection and Affordable Care Act
Dear Secretary Sebelius:
The National Health Law Program (?NHeLP?) applauds your decision to adopt the recommendations from the Institute of Medicine (?IOM?) to require insurance coverage of women?s preventive health services without cost-sharing. We are pleased to offer these comments on the August 3, 2011 interim final rules for group health plans and health insurance coverage in the group and individual markets under provisions of the Patient Protection and Affordable Care Act (?the ACA?) regarding preventive health services. NHeLP is a public interest law firm working to advance access to quality health care and protect the legal rights of low-income and underserved people. NHeLP provides technical support to direct legal services programs, community-based organizations, the private bar, providers, and individuals who work to preserve a health care safety net for the millions of uninsured or underinsured low-income people.
The ACA requires group health plans and health insurance issuers to cover, without cost-sharing, certain preventive services.1 Among other things, the ACA requires new group health plans and health insurance issuers to cover such additional preventive care and screenings as provided for in guidelines supported by the Health Resources and Services Administration (?HRSA?).2 By doing so, the ACA recognizes that women have unique reproductive and gender specific health needs, disproportionately lower incomes and disproportionately higher out-of-pocket health care expenses.
HRSA commissioned the independent IOM to conduct a scientific review and provide recommendations on specific preventive measures that meet women?s unique health needs and help keep women healthy. The IOM developed eight recommendations based on scientific evidence, including the input of independent physicians, nurses, scientists, and other experts.3 HRSA recently adopted the recommendations submitted by the IOM.4 Adherence to the HRSA guidelines based on the IOM recommendations will ensure that women?s health and well-being are adequately addressed. Requiring coverage of all eight preventive services recommended by the IOM is good medical and economic policy.
HRSA?s proposed refusal clause, 45 C.F.R. § 147.130(a)(1)(iv)(A)-(B), however, contravenes the text and purpose of the ACA?which includes no such exception, and HRSA?s Women?s Preventive Services: Required Health Plan Coverage Guidelines. The proposed refusal clause subordinates an affected woman?s health to her employer?s religious beliefs?religious beliefs that the woman may not even share. NHeLP urges HRSA to withdraw its proposed refusal clause.
1. The requirement to cover contraceptives as a component of preventive care is evidence-based.
Family planning is an essential preventive service for the health of women and families.5 HRSA charged the IOM with convening a committee to determine the preventive services necessary to ensure women?s health and well-being.6 To this end, the IOM convened a committee of 16 eminent researchers and practitioners to serve on the Committee on Preventive Services for Women.7 The Committee met five times in six months.8 The Committee reviewed existing guidelines, gathered and reviewed evidence and literature, and considered public comments.9 With respect to women, the IOM identified gaps in the coverage for preventive services not already addressed by the ACA, including services recommended by the United States Preventive Services Task Force, the Bright Futures recommendations for adolescents from the American Academy of Pediatrics, and vaccinations specified by the Centers for Disease Control and Prevention?s Advisory Committee on Immunization Practices. The IOM recommended that, among other things, women receive coverage for all United States Food and Drug Administration (?FDA?)-approved methods of contraception free of cost-sharing because: (1) pregnancy affects a broad population; (2) pregnancy prevention has a large potential impact on health and well-being; and (3) the quality and strength of the evidence is supportive of the recommendation to provide contraceptive coverage free of cost-sharing.10
2. Unintended pregnancy carries adverse risks for an affected woman and her family.
Unintended pregnancy, which can effectively be prevented through contraception, can adversely impact the health and well-being of affected women and their families. A woman?s ability to control her reproductive life and to become a parent when she has made an affirmative decision to become pregnant is fundamental to her ability to obtain an education and to be economically self-sufficient. In Planned Parenthood v. Casey, the United States Supreme Court recognized the importance of women?s ability to make decisions about when and whether to have a child: ?The ability of women to participate equally in the economic and social life of the Nation has been facilitated by their ability to control their reproductive lives.?11
Further, the importance of women?s ability to prevent pregnancy for many health-related reasons is well established within medical guidelines across a range of practice areas. Children, for one, benefit from women?s control over reproduction. Children born from wanted pregnancies tend to be healthier than those born from unwanted pregnancies.12 Unwanted pregnancy is associated with, for example, low-birth weight babies and insufficient prenatal care.13 The CDC/Agency for Toxic Substances and Disease Registry Preconception Care Work Group and the Select Panel on Preconception Care highlighted the numerous poor health outcomes including low birth weight, premature birth, and infant mortality which result when health conditions are not optimized prior to pregnancy.14 In addition, in deciding whether to become pregnant, women take into account factors such as age, the presence of a partner, medical condition, mental health, and whether they are taking medications that are contra-indicated for pregnancy. For example, a number of commonly prescribed pharmaceuticals are known to cause impairments in the developing fetus or to create adverse health conditions if a woman becomes pregnant while taking them. Approximately 11.7 million prescriptions for drugs the FDA has categorized as Pregnancy Classes D (there is evidence of fetal harm, but the potential may be acceptable despite the harm) or X (contraindicated in women who are or may become pregnant) are filled by significant numbers of women of reproductive age each year.15 Pregnancy for women taking these drugs carries risk for maternal health and/or fetal health.16 Women taking these drugs who might be at risk for pregnancy are advised to use a reliable form of contraception to prevent pregnancy.17
Access to family planning supplies is also essential to optimal women?s health. Unwanted pregnancy is associated with maternal morbidity and risky health behaviors. The World Health Organization recommends that pregnancies should be spaced at least two years apart.18 Pregnancy spacing allows the woman?s body to recover from the pregnancy. Further, if a woman becomes pregnant while breastfeeding, the health of both her baby and fetus may be compromised as her body shares nutrients between them. According to the American College of Obstetricians and Gynecologists, women who become pregnant less than six months after their previous pregnancy are 70 percent more likely to have membranes rupture prematurely, and are at a significantly higher risk of other complications.19 Family planning is a focus area of the Healthy People 2010 health promotion objectives set out by the United States Department of Health and Human Services. Goal 9 of Healthy People 2010 is, ?Improve pregnancy planning and spacing and prevent unintended pregnancy.?20 Specific indicators include increasing intended pregnancies from 51 percent to 70 percent; increasing pregnancy spacing to 24 months; increasing the proportion of women at risk for unintended pregnancy who use contraceptives to 100 percent, and increasing the proportion of teens that use contraceptive methods that both prevent pregnancy and prevent sexually transmitted disease.21
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