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A Practical Guide to Conducting a HIPAA Security Risk Analysis

How do organizations go about conducting a Health Insurance Portability and Accountability Act (HIPAA) security risk analysis (HRSA)? In this Health Law Weekly article, McDermott Partner Ryan S. Higgins provides a step-by-step guide to conducting an HRSA and offers practical guidance to address the key issues effectively.

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Are Out-of-Pocket Costs on Their Way Out? At-Home COVID-19 Testing and Expanded Preventative Healthcare for Women and Children

In response to a directive from the White House, based on provisions of the Families First Coronavirus Response Act (FFCRA) and the Coronavirus Aid, Relief and Economic Security (CARES) Act that eliminated cost sharing for COVID-19 diagnostic testing, three federal government departments—the US Department of Health and Human Services (HHS), the US Department of Labor (Labor) and the US Department of the Treasury (Treasury)—issued guidance in the form of frequently asked questions (FAQs) that states group health plans and insurers must also cover over-the-counter (OTC) COVID-19 diagnostic testing. This guidance is effective beginning January 15, 2022.

In addition, the Health Resources and Services Administration (HRSA) updated the Affordable Care Act’s (ACA) comprehensive preventive care and screening guidelines for women and children to cover additional services and supplies without a copay or deductible, effective 2023.


On January 10, 2022, HHS, Labor and the Treasury together issued FAQs that elaborated on prior guidance and indicated that group health plans and insurers are required to cover OTC COVID-19 diagnostic tests without cost sharing. Because of the recent spike in COVID-19 cases resulting from the rapid spread of the Omicron variant, the guidance will continue for the duration of the public emergency.

Most consumers with private health coverage will be able to buy OTC COVID-19 tests and either have the cost covered upfront or be reimbursed later by submitting a claim to their health plan. The new requirement only applies to “diagnostic” OTC COVID-19 testing. It does not include the treatment of COVID-19 or testing that is for employment purposes.

The guidance provides that health plans and insurers must cover at least eight OTC COVID-19 diagnostic tests per covered individual per a 30-day period. Insurers will be able to set up networks of preferred suppliers to provide OTC COVID-19 tests directly to participants without upfront costs. Insurers must still reimburse OTC COVID-19 tests purchased outside the direct coverage program, however, the reimbursable amount is limited to $12 per test if the health plan also provides tests through its preferred pharmacy network and through a direct-to-consumer shipping program without upfront costs.

Besides the risk of increasing the average cost of OTC COVID-19 tests, the new initiative raises concerns over fraud and abuse. For health plans and insurers to protect themselves, the FAQs provide several examples of permissible activities to prevent fraud and abuse, like requiring proof of purchase or an attestation that the test was purchased for proper purposes (i.e., is being used by the covered individual, is not being reimbursed by another source, is not being resold and is not for employment purposes).


On January 11, 2022, HRSA announced that it updated the preventive health and screening guidelines for women, infants, children and adolescents. Under the ACA, certain group health plans and insurers must provide coverage with no out-of-pocket costs for preventive health services within these HRSA-endorsed comprehensive guidelines.

HRSA accepted the updates recommended by the Women’s Preventative [...]

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Recent Government-Issued FAQs Cause Plan Sponsors to Clarify Preventive Care and Wellness in Health Plan Communications

On October 23, 2015, the U.S. Departments of Labor (DOL), Health and Human Services (HHS) and Treasury issued frequently asked questions (FAQs) on the implementation of preventive care and wellness provisions of the Affordable Care Act (ACA) and mental health parity disclosure, adding to the existing list of 28 previous editions of FAQs on the implementation of ACA.

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New Guidelines Issued on Preventive Services for Women, Including Religious Employer Exception

by Amy M. Gordon, Susan M. Nash and Jamie A. Weyeneth

The U.S. Departments of Treasury, Labor, and Health and Human Services recently released joint guidance regarding mandatory coverage of contraceptive services for women under the preventive services requirements of health care reform.  The new guidance coincides with the issuance of expanded preventive care coverage requirements for women released by the Health Resources and Services Administration (HRSA).

Health care reform requires non-grandfathered group health plans and health insurance issuers to provide first-dollar coverage of certain preventive services furnished by in-network providers.  The preventive services coverage requirements are based on recommendations of the U.S. Preventive Services Task Force, the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention, and HRSA.  In addition, HRSA was charged with developing additional preventive care and screening guidelines for women.  HRSA commissioned the Institute of Medicine (IOM) to help to identify gaps in preventive care services already required under health care reform.

When the IOM released its recommendations in mid-July 2011, concerns about the inclusion of contraceptive services were raised by religious organizations.  The regulators determined it would be appropriate to take into account the religious beliefs of religious employers and issued guidance providing for limited religious accommodation.  Specifically, the interim final regulations on mandatory preventive care were revised to permit HRSA to create an exception for group health plans established or maintained by religious employers with respect to any requirement to cover contraceptive services.  A religious employer is one that has the inculcation of religious values as its purpose; primarily employs persons who share its religious tenets; primarily serves persons who share its religious tenets; and is a nonprofit organization under Section 6033(a)(1) and Section 6033(a)(3)(A)(i) or (iii) of the Internal Revenue Code.  The regulators noted this approach is consistent with most states that require coverage of contraceptive services under state insurance laws.  The final guidelines released by HRSA on August 1, 2011, include this exception for religious employers.

Click here to view the new women’s preventive services guidelines issued by HRSA.  Recommended preventive services issued after September 23, 2009, are effective as of the first day of the first plan year/policy year beginning on or after the one-year anniversary of the date the recommendation is issued.  Therefore, these new guidelines (including the religious employer exception) will apply for plan years/policy years beginning on or after August 1, 2012.

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