Getting the pill over-the-counter is only part of removing barriers to contraception

Making oral contraceptive pills available without a prescription should complement, not replace policies to reduce barriers to contraceptive use, according to a new analysis by the Guttmacher Institute. Moving the pill to over-the-counter (OTC) status should be done to enhance women’s access to the full range of contraceptive methods, instead of taking its place. It is important that, while the barrier of the counter is removed, other safeguards remain in place to protect women’s access to contraception, such as ensuring insurance coverage for OTC contraceptives and not imposing medically unnecessary age restrictions.

OTC rationale

Access to birth control has long been touted as the best way to prevent unintended pregnancies. Lifting the prescription requirement for birth control pills could lower barriers to access the pill and achieve the desired results. The Guttmacher Institute noted in their analysis that U.S. women rely on the pill more than any other method. In 2012, 26 percent of contraceptive users relied on the pill; the next most commonly used methods were female sterilization (25 percent) and male condoms (15 percent). The Institute believes that “increasing access to the pill by making it available OTC could improve contraceptive use and, in turn, lower unintended pregnancy rates, especially among women who are uninsured and those who lack the time, would need to arrange for child care, or otherwise would find it difficult to visit a health care provider to obtain a prescription.”


For a formulation of a birth control pill to switch to OTC status, a pharmaceutical company would need to initiate an often lengthy and expensive process that entails research (including studies of label comprehension and consumer actual use) and review by the FDA, which can be a huge deterrent. Once put in the hands of the FDA, the agency may decide to impose an age restriction on an OTC product, which would limit access for young women. These young women, the Guttmacher Institute notes, face a greater risk of unintended pregnancy and more barriers to accessing contraceptives than older women—and therefore have the most to gain from an OTC status switch. It is important they not be left out. Additionally, imposing an age requirement would then require a means of identification. This would be a disadvantage not only for adolescent and young women without government-issued photo IDs, but for immigrants as well, particularly those who are undocumented.

Packaging is also a consideration. Oregon and the District of Columbia this year enacted legislation requiring birth control pills to be packaged in one year supplies.

Comprehensive approach

The Guttmacher Institute advised that taking a comprehensive approach is best, and if policymakers truly wish to expand contraceptive access, they need find one that works for people of all ages and incomes, and covers the full range of contraceptive methods, services and care. It believes that OTC status for oral contraceptives is but one strategy to improving access that is unable to fulfill the wide range of needs of all people, especially if cost and age barriers were attached to any product.

Although the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148) goes a long way towards providing contraceptive coverage, it also has limitations. Some of these could be addressed by covering more women and dropping the need to obtain a prescription for OTC coverage. According to the Guttmacher Institute, what the ACA began in terms of contraception coverage policy should be only strengthened by providing OTC birth control pills. An OTC designation for birth control should not replace the contraception coverage requirements if public policy is truly meant to provide women with coverage options that are best for them.

Charitable hospitals: complying with the letter or the spirit of the ACA?

Charitable hospitals are required to comply with section 9007 of the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148) if they wish to maintain their status as tax-exempt 501(c)(3) organizations under the Internal Revenue Code.  Section 9007 requires charitable hospitals to conduct community health needs assessments (CHNAs) and implement policies in response to those results; establish a written financial assistance policy (FAP) outlining the parameters for offering financial assistance to patients and that they will offer emergency services to patients, regardless of FAP provisions; limit charges for emergency and medically necessary services to FAP-eligible patients to the lowest amount charged to patients with insurance; and not engage in extraordinary collection actions before making reasonable efforts to determine whether the patient is FAP-eligible. The IRS issued Final regulations governing the FAP as part of section 501(r) of the Internal Revenue Code on December 31, 2014 (79 FR 79854, December 31, 2014). A study from researchers at the University of Michigan Institute for Healthcare Policy and Innovation suggests that, while hospitals are establishing the FAPs in accordance with the law, they might not be discussing those policies with patients.


The researchers reviewed hospital data from 2012, the first year that section 9007 was effective.  They found that 94 percent of charitable hospitals and implemented written FAPs and emergency care policies. However, only 42 percent notified patients of their eligibility for charity care before attempting to collect medical bills and only 29 percent had begun charging uninsured and under-insured patients rates equivalent to private insurance and Medicare rather than standard, higher chargemaster rates.  Twenty percent were still using now-banned extraordinary debt-collection measures, such as garnishing wages and making negative reports to credit agencies, and only 11 percent had conducted community health needs assessments.

Medicaid non-expansion

Hospitals in states that did not expand Medicaid under the ACA generally required patients to be poorer to be eligible for charity care and were less likely than hospitals in expansion states to notify patients of eligibility for charity care before they left the hospital. John Z. Ayanian, M.D., MPP, one of the study’s authors, noted that hospitals in non-expansion states, “will likely experience additional demand for charity care because they now need to publicize their charity care policies and comply with other IRS provisions.” Co-author Sayeh Nikpay, Ph.D., MPH, noted that this may cause these hospitals to become less generous in the offering charity care, something that is not controlled by the ACA.

Looking forward

“So far,” Nikpay said, “it appears many aren’t complying with the part of the rules that could increase their charity care.”  Hospitals may be beginning to meet the requirements on paper, but they do not seem to be offering more charity care to patients and helping them escape from the dire financial consequences of medical debt.  The researchers indicated that the 2012 data did reflect regulations governing compliance and penalties for noncompliance, which could impact hospitals’ actions.  Whether the 2014 regulations change charitable hospitals’ actions remains to be seen.

CMS clarifies user fee adjustment mechanism for contraception accommodation

Third-party administrators (TPAs) must submit the Notice of Intent Disclosure Form to CMS stating their intention to seek a user fee adjustment even though the original deadline has passed. CMS has issued answers to frequently asked questions for TPAs, pharmacy benefit managers (PBMs), and federally-facilitated marketplace (FFM) issuers who are seeking reimbursement for contraceptive services. The information that these parties must submit will allow CMS to determine the discount to be applied to the user fee paid for participation on the FFM (CMS FAQ, November 9, 2015).

User fee discount

The government has provided an accommodation for self-insured nonprofit religious organizations that object to the contraceptive coverage mandate found in sections 1001 and 1004 of the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148). Under the accommodation, the nonprofit or their TPA notifies HHS of the objection. The TPA will cover the contraceptive services and will contract with an FFM issuer. The FFM reduces the issuer’s marketplace user fee to account for the payment made to the TPA to cover the services. In order to receive this discount, FFM issuers and TPAs must submit certain information to CMS.


TPAs and PBMs must submit the notice of intent form by November 13, 2015, via email. FFM issuers seeking the 2014 benefit year adjustment should submit their spreadsheets by December 11, 2015. CMS will provide webinar training on completing the forms. The document contains instructions regarding recipient email address, subject lines, and attachments.

CMS clarifies that PBMs can enter in the same arrangements as TPAs to provide contraceptive services. PBMs must follow the requirements imposed on TPAs. However, if the TPA or PBM and the FFM issuer are part of the same entity or parent company, only the FFM should submit its spreadsheet. If the entities are separate, the TPA must submit its form indicating the total value of eligible paid claims.

The user fee discount is limited to the dollar amount of contraceptive claims. CMS intends to deduct the appropriate amount from the issuer’s monthly obligation at the end of the 2015 calendar year. The FFM issuer is also eligible for an additional 15 percent payment for administrative costs. Although CMS has not established reimbursement for TPA or PBM administrative costs, these groups may require that the FFM share part of its administrative payment.

Cover your constituents! Study says Medicaid ‘is clearly better than no coverage’

Medicaid coverage improves awareness of treatment options, chronic disease management, utilization of preventive care services, and access to health care, according to a study published in the American Journal of Public Health (AJPH). The study supports the premise that Medicaid expansion under the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148) does in fact lead to better health.

AJPH Study

The study was based upon data gathered from national surveys conducted by the Centers for Disease Control and Prevention (CDC). It looked at the care received by 4,460 poor Americans. Researchers found that Medicaid leads to significant improvements in health. For example, individuals with Medicaid were 69 percent more likely to be aware of having high blood pressure and 62 percent more likely to have control of their high blood pressure than people without coverage. The study’s researchers noted that awareness and treatment of high blood pressure is a critical preventive measure, calling it the “key to preventing strokes and heart attacks.”

Oregon study

The study’s lead researcher believes the findings point out flaws in the Oregon Health Insurance Experiment, a study which is regularly used as evidence that Medicaid doesn’t improve health. While the Oregon study determined that Medicaid is effective at reducing rates of depression, the Oregon experiment found that Medicaid did not improve physical health. The lead researcher of the AJPH study suggested that the Oregon study may not be representative for much of the country because it was conducted in Portland where uninsured patients “have much better access to safety-net care than do uninsured Americans elsewhere.”


A co-author of the study, an associate professor of medicine at Harvard Medical School, said that “we need to get everyone covered in a single-payer system, but until we do, Medicaid is clearly better than no coverage.” He also asked “With mounting proof that Medicaid improves health, why are politicians refusing to cover their constituents?”