HHS finalizes regulations prohibiting state discrimination against abortion providers

Recipients of Title X Grants for Family Planning Services making subawards cannot restrict participating entities for any reason other than the entity’s ability to provide Title X services, under a new Final rule that will publish on December 19, 2016. The regulatory change was motivated by recent state-imposed restrictions and prohibitions against entities that provide abortions from receiving Title X funds. By statute, Title X funds cannot be used by programs that allow abortion as a method of family planning (42 U.S.C. §300a-6); such programs also cannot be required to perform or assist in the performance of an abortion, nor discriminate against an employee who performs or assists or refuses to perform or assist in the performance of an abortion (42 U.S.C. §300a-7). The regulations will be effective on January 18, 2017, two days before the inauguration of President-elect Donald Trump (R).

Title X

Title X of the Public Health Service Act (42 U.S.C. §§300–300a-8) created the Family Planning Program, which provides funding to nearly 4,000 community-based clinics that provide high quality, affordable, and cost-effective family planning and related preventive health services for women and men, with priority given to low-income patients. In 2015, more than 4 million individuals received services from Title X Family Planning Clinics.

Recipient restrictions

Section 2303 of 2010’s Patient Protection and Affordable Care Act (ACA) (P.L. 111-148) expanded family planning services for certain Medicaid beneficiaries. Soon thereafter, however, family planning organizations began facing funding challenges. According to the Final rule, 13 states have taken action since 2011 to restrict funding to abortion providers, and entities which do not provide abortion services but are affiliated with organizations—such as Planned Parenthood—which provide abortions at some facilities. These restrictions have affected family planning clinics both as subrecipients of Title X grants and as Medicaid providers, leading to decreased access to providers and limitations in the geographic distribution of services.

These restrictions led to litigation (see, e.g., (see Court grants preliminary injunction reinstating Planned Parenthood’s provider agreement with Alabama, Health Law Daily, October 29, 2015; Medicaid termination denied because Planned Parenthood is qualified, Health Law Daily, November 4, 2015; Patients’ provider choice rights violated by exclusion without cause, Health Law Daily, April 19, 2016), and HHS action telling states to end such restrictions (see States warned not to exclude qualified providers, especially family planning, Health Law Daily, April 20, 2016; No limits on choice of provider, contraceptive method for Medicaid enrollees, Health Law Daily, June 16, 2016). HHS also began granting Title X funding directly to providers as sole source replacement grants following the imposition of state restrictions (see Direct award Title X grant documentation properly withheld by HHS, Health Law Daily, February 5, 2015).

Regulatory changes

Earlier this year, HHS’ Office of Population Affairs published a Notice of proposed rulemaking in the Federal Register, declaring its intent to amend current Title X regulations to preclude project recipients from using criteria in their selection of subrecipients that are unrelated to the ability to deliver services to program beneficiaries in an effective manner (81 FR 61639, September 7, 2016). Approximately 91 percent of the 145,000 comments the agency received on the proposed regulations were in favor of the amendment.

In response to negative comments, the Final rule explained that there is no evidence that certain Title X funding recipients—Planned Parenthood, specifically—have engaged in Medicaid fraud, and pointed to research finding that every grant dollar spent on family planning saves an average of $7.09 in Medicaid-related expenditures. The Final rule similarly responded to commenters concerned that Title X service providers would use Title X funding to fund abortion by reiterating the statutory and regulatory requirements that prevent Title X funds from being used for abortions, and said that family planning services help prevent abortions by preventing unintended pregnancies.

Will the change last?

The Final rule was promulgated in accordance with notice-and-comment requirements under the federal Administrative Procedure Act, and its changes were announced months ago, which may prevent it from being considered a “Midnight Rule.” According to the New York Times, repealing these regulations would require either a new comment-and-notice rulemaking process, or a joint resolution of disapproval by the House and Senate, with concurrence by the new president. Both supporters and opponents of family planning services are preparing to fight for or against the regulations, while President-elect Trump, who has promised to repeal many of the Obama Administration’s regulatory actions, offered contradictory messages on Planned Parenthood and abortion during his presidential campaign.

ONC will directly review certified health IT products

The HHS Office of the National Coordinator for Health Information Technology (ONC) gained the authority to directly review certified health information technology (IT) products in circumstances that may pose a risk to public health or safety, or when practical challenges make it difficult for ONC-authorized certification bodies (ONC-ACBs) to do so. In an advance release of a Final rule to be published in the Federal Register on October 19, 2016, the ONC created a regulatory framework for such review. It also established a process allowing it to oversee accredited testing laboratories to align with its existing oversight of ONC-ACBs and made identifiable surveillance results of certified health IT publicly available.

Direct review

ONC-ACBs issue certifications for health IT and are responsible for conducting ongoing surveillance, based on adopted certification criteria, to ensure that certified health IT continues to conform with program requirements. However, their assessments may not involve interactions among certified capabilities and other capabilities or products that are not certified under the program, and may be limited to certain functional outcomes. Because the ONC is better suited to perform evaluations without such limitations, the Final rule grants it the authority to perform reviews both independent of, and in addition to, ONC-ACBs.

Circumstances of review

Section 3001 of the Public Health Service Act (PHSA) (42 U.S.C. §6A) permits the ONC to directly review health IT in a broad range of circumstances. However, the agency will use its limited resources to directly review products only in circumstances in which it believes that certified health IT is causing or contributing to serious risks to public health or safety, or in which practical challenges make it difficult for ONC-ACBs to effectively investigate or respond to non-conformities. For example, the ONC may have access to confidential information related to non-conformities that is unavailable to ONC-ACBs. Other investigations may require concurrent or overlapping investigations by multiple ONC-ACBs or may exceed the ONC-ACBs’ resources or expertise. The ONC will exercise its right not to review certified health IT for potential non-conformities, especially in circumstances in which it thinks other HHS agencies are better suited to oversee or enforce laws, including in circumstances involving threats to protected health information (PHI).

CAPs, suspensions, and terminations

Where the ONC determines that non-conformities may exist, it may require entities to follow corrective action plans (CAPs) and may suspend or terminate certification for failure to comply with CAPs. Furthermore, it will ban a health IT developer from obtaining future certification where the developer’s current complete electronic health record (EHR) or health IT module is: terminated by the ONC; withdrawn by an ONC-ACB at the developer’s request when it was the subject of a potential or actual non-conformity; or withdrawn by an ONC-ACB at the developer’s request when it was the subject of pending or actual surveillance. However, the ONC will allow developers to respond to ONC concerns and appeal suspensions and terminations. The Final rule requires developers participating in CAPs to notify potentially affected customers of non-conformities and plans for resolution, and requires suspended or terminated developers to notify customers of the suspension or termination.

ONC-ATLs

ONC-ACBs are only permitted to accept testing results from laboratories from laboratories accredited by the National Voluntary Laboratory Accreditation Program (NVLAP). The Final rule will require NVLAP-accredited labs to apply to become ONC-Authorized Testing Labs (ONC-ATLs), allowing the ONC direct oversight.

Surveillance results

To increase transparency and the availability of certified health IT information, the Final rule requires ONC-ACBs to post identifiable surveillance results on the publicly accessible Certified Health IT Product List (CHPL) on a quarterly basis. The ONC believes that, because most developers are conforming with certification criteria and other program requirements, the posted surveillance data will reassure stakeholders, while encouraging those developers that are not conforming to comply with requirements.