Federal Health and Human Services Guidance and Regulatory Activity

Federal Guidance for and Regulation of State Health Policy

The Affordable Care Act (ACA) establishes a plan to facilitate the purchase and sale of qualified health coverage in the individual market, and to provide options for small business through American Health Benefit Exchanges. Exchanges will either be established and operated by the states or through a federally-facilitated process. The ACA directs that exchanges be fully operational in January of 2014. State-established government or nonprofit entities will certifying plans and identify individuals eligible for Medicaid, CHIP, and premium and cost-sharing credits. The ACA provides broad authority to the departments to establish standards and regulations to implement the statutory requirements related to the exchange. The Department of Health and Human Services (HHS), the Centers for Medicare and Medicaid Services (CMS), Department of Labor (DOL), Department of Treasury, and Internal Revenue Service (IRS) have initiated the process of promulgating rules that provide definition to the ACA statutory provisions to enabling those states who choose to operate an exchange to set up the necessary operational structure.


Rules released for implementing the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008

Benefits for patients with mental health and substance use disorders must be treated equally with medical/surgical benefits by insurers under final rules implementing the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act. The final rules, released November 8, 2013, require equity with respect to financial requirements and treatment limitations under group health plans and group and individual health insurance coverage. The Affordable Care Act (ACA) builds on the Mental Health Parity and Addiction Equity Act and requires coverage of mental health and substance use disorder services as one of ten essential health benefits categories. Under the essential health benefits rule, individual and small group health plans are required to comply with these parity regulations. The rule also contains a technical amendment relating to external review with respect to the multi-state plan program administration by the Office of Personnel Management (OPM). Additional information and summary of the final rule.


NCSL Submits Comments on Key Affordable Care Act (ACA) Regulations

NCSL submitted comments to the Department of Health and Human Services expressing state concerns regarding two sets of final and interim final health care rules implementing key provisions in the ACA. The comment periods ended on May 7 for rules governing the Medicaid program and eligibility changes under the ACA, and May 11 for rules guiding the establishment of exchanges and Qualified Health Plans (QHPs), and exchange standards for employers.

42 CFR Parts 431, 435, and 457—Medicaid Program; Eligibility Changes under the ACA

The ACA contained several provisions affecting Medicaid eligibility, enrollment and coordination with the Affordable Insurance Exchanges (AIE), CHIP, and other insurance affordability programs. CMS published final rules and interim final rules implementing statutory provisions changing the minimum Medicaid income eligibility level to 133 percent of the Federal Poverty Level (FPL), eliminating some eligibility categories, modernizing eligibility verification rules, and ensuring coordination across Medicaid, CHIP, and the exchanges. Submission of comments were due May 7, and NCSL provided remarks focusing on timeliness and performance standards, Federally-facilitated Health Insurance Exchanges, and Medicaid coverage of incarcerated individuals.

NCSL Comments Submitted May 7, 2012

 

42 CFR Parts 155, 156, and 157—Patient Protection and Affordable Care Act; Establishment of Exchanges and Qualified Health Plans; Exchange Standards for Employers

The ACA provides states with an opportunity to establish an exchange through which individuals can purchase affordbale insurance coverage.The exchanges will provide competitive marketplaces for individuals and small employers to directly compare available private health insurance options on the basis of price, quality, and other factors. The exchanges will become operational by January 1, 2014, and will help enhance competition in the health insurance market, improve choice of affordable health insurance, and give small business the same purchasing clout as large business. The final rule incorporates two proposed rules, the July 15, 2011 rule titled “Establishment of Exchanges and Qualified Health Plans” (Exchange establishment proposed rule), and the August 17, 2011 rule titled “Exchange Functions in the Individual Market: Eligibility Determinations and Exchange Standards for Employers” (Exchange eligibility proposed rule). While originally published as separate rulemaking, the provisions contained in these proposed rules are integrally linked, and together encompass the key functions of Exchanges related to eligibility, enrollment, and plan participation and management. In addition, several sections in this final rule are being issued as interim final rules and HHS is are soliciting comment on those sections.

The final rule:

(1) Sets forth the minimum federal standards that states must meet if they elect to establish and operate an Exchange, including the standards related to individual and employer eligibility for and enrollment in the Exchange and insurance affordability programs;
(2) Outlines minimum standards that health insurance issuers must meet to participate in an Exchange and offer qualified health plans (QHPs); and
(3) Provides basic standards that employers must meet to participate in the Small Business Health Options Program (SHOP).

NCSL comments submitted May 11 continue to advocate for state flexibility in structuring exchange governing boards and urges HHS to give that same flexibility to states in forming their navigator programs. It raises concern over the issue of deeming multi-state plans as certified by the states and exempts them from complyance with state laws. Interim final rule comments address agents and brokers, the eligibility process, and verification of eligibility process.


 

Regulation/Agency/Public Law

Action

Description

Effective Date

Food Labeling; Gluten-Free Labeling of Food

FDA/HHS

Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA)

  The FDA proposes to establish a definition of the term "gluten-free" and uniform conditions for its use in food labeling will help ensure that individuals with celiac disease are not misled and are provided with truthful and accurate information with respect to foods so labeled. 

The Food and Drug Administration (FDA) is issuing a final rule to define the term "gluten-free" for voluntary use in the labeling of foods. A food that bears the claim "no gluten," "free of gluten “or” without gluten" in its labeling and fails to meet the requirements for a "gluten-free" claim will be deemed to be misbranded. In addition, a food whose labeling includes the term "wheat" in the ingredient list or in a separate "Contains wheat" statement as required by a section of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and also bears the claim "gluten-free" will be deemed to be misbranded unless its labeling also bears additional language clarifying that the wheat has been processed to allow the food to meet FDA requirements for a "gluten-free" claim.
 
9/4/2013

Supplemental Nutrition Assistance Program:  Privacy Protections of Information from Applicant Households

 

FNS/USDA
Affirmation of interim rule as final rule The Food and Nutrition Service (FNS) issued this affirmation of a final rule, without change, of an interim rule that amended Supplemental Nutrition Assistance Program (SNAP) regulations at § 272.1, to permit SNAP State agencies to share information with local educational agencies (LEAs) administering the National School Lunch Program established under the Richard B. Russell National School Lunch Act or the School Breakfast Program established under the Child Nutrition Act of 1966, in order to directly certify the eligibility of school-age children for receipt of free school lunches and breakfasts based on their receipt of SNAP benefits. 8/2/2013

Medicare, Medicaid, and Children’s Health Insurance Programs: Announcement of Temporary Moratoria on Enrollment of Ambulances Suppliers and Providers and Home Health Agencies in Designated Geographic Areas

CMS/HHS

ACA
Notice This notice announces the imposition of a temporary moratorium on the enrollment of home health agencies in Miami-Dade and Cook counties as well as selected surrounding areas, and on the enrollment of new ambulance suppliers and providers in Harris County and surrounding counties to prevent and combat fraud, waste, and abuse.  

Request for Information Regarding Nondiscrimination in Certain Health Programs or Activities

 

Office of Civil Rights (OCR)/HHS

ACA
Request for Information Section 1557 of the Affordable Care Act prohibits discrimination on the basis of race, color, national origin, sex, age, or disability in certain health programs and activities. Section 1557(c) of the Affordable Care Act authorizes the HHS Secretary to promulgate regulations to implement the nondiscrimination requirements in Section 1557. This notice is a request for information (RFI) to inform the Department’s rulemaking for Section 1557. This RFI seeks information on a variety of issues to better understand individuals’ experiences with discrimination in health programs or activities and covered entities’ experiences in complying with federal civil rights laws.  

National Vaccine Injury Compensation Program

 

HRSA/HHS
NPRM The Secretary has made findings as to intussusceptions that can reasonably be determined in some circumstances to be caused or significantly aggravated by rotavirus vaccines. Based on these findings, the Secretary proposes to amend the Vaccine Injury Table (Table) by regulation. These proposed regulations will apply only for petitions for compensation under the National Vaccine Injury Compensation Program (VICP) filed after the final regulations become effective. The Secretary is seeking public comment on the proposed revisions to the Table.  

Menthol in Cigarettes, Tobacco Products (Request for Comments)

 

FDA/HHS
ANPR The Food and Drug Administration (FDA) is issuing this advance notice of proposed rulemaking (ANPRM) to obtain information related to the potential regulation of menthol in cigarettes. FDA is also making available its preliminary scientific evaluation of public health issues related to the use of menthol in cigarettes. The preliminary scientific evaluation indicates there is likely a public health impact of menthol in cigarettes. This ANPRM is seeking comments, including comments on FDA’s preliminary evaluation, and data, research, or other information that may inform regulatory actions FDA might take with respect to menthol in cigarettes.  
HIV Care Continuum Initiative; Improvement Acceleration of Prevention and Care in the U.S. - Executive Order 13649 Executive Order The Initiative directs federal agencies to prioritize addressing the continuum of HIV care, by accelerating efforts and directing existing federal resources to increase HIV testing, services, and treatment, and improve patient access to all three. To ensure success in this effort, the executive order establishes an HIV Care Continuum Working Group. The group will coordinate federal efforts to improve outcomes nationally across the HIV care continuum, and be co-chaired by the White House Office of National HIV/AIDS Policy and HHS’s Office of the Assistant Secretary for Health. The working group will provide annual recommendations to the President on actions to take to improve outcomes along the HIV care continuum.  

Exchange Functions:  Standards for Navigators and Non-Navigator Assistance Personnel; Consumer Assistance Tools and Programs of an Exchange and Certified Application Counselors

 

CMS/HHS

ACA
Final Rule This final rule addresses various requirements applicable to Navigators and non-Navigator assistance personnel in Federally-facilitated Exchanges, including State Partnership Exchanges, and to non-Navigator assistance personnel in State Exchanges that are funded through federal Exchange Establishment grants. It finalizes the requirement that Exchanges must have a certified application counselor program. It creates conflict-of interest, training and certification, and meaningful access standards; clarifies that any licensing, certification, or other standards prescribed by a state or Exchange must not prevent application of the provisions of title I of the Affordable Care Act; adds entities with relationships to issuers of stop loss insurance to the list of entities that are ineligible to become Navigators; and clarifies that the same ineligibility criteria that apply to Navigators apply to certain non-Navigator assistance personnel. 8/12/2013

Essential Health Benefits in Alternative Benefit Plans, Eligibility Notices, Fair Hearing and Appeal Processes, and Premiums and Cost Sharing; Exchanges:   Eligibility and Enrollment

CMS/HHS

ACA
Final Rule

The rule finalizes new Medicaid eligibility provisions; finalizes changes related to electronic Medicaid and the Children’s Health Insurance Program (CHIP) eligibility notices and delegation of appeals; modernizes and streamlines existing Medicaid eligibility rules; revises CHIP rules relating to the substitution of coverage to improve the coordination of CHIP coverage with other coverage; and amends requirements for benchmark and benchmark-equivalent benefit packages consistent with sections 1937 of the Social Security Act (which we refer to as “alternative benefit plans”) to ensure that these benefit packages include essential health benefits and meet certain other minimum standards.

The rule also implements specific provisions including those related to authorized representatives, notices, and verification of eligibility for qualifying coverage in an eligible employer-sponsored plan for Affordable Insurance Exchanges. This rule also updates and simplifies the complex Medicaid premium and cost sharing requirements, to promote the most effective use of services, and to assist states in identifying cost sharing flexibilities. It includes transition policies for 2014 as applicable.
 
This rule includes many provisions and effective dates ranging from 9/1/2013 to 1/1/2014

Information Reporting for Affordable Exchanges

Treasury/IRS

ACA
NPRM

This document contains proposed regulations relating to requirements for Affordable Insurance Exchanges (Exchanges) to report information relating to the health insurance premium tax credit enacted by the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010. These proposed regulations affect Exchanges that make qualified health plans available to individuals and employers.

 

Coverage of Certain Preventive Services under the Affordable Care Act

Treasury/IRS; DOL/EBSA; HHS/CMS

Final rule

This document contains final regulations regarding coverage of certain preventive services under section 2713 of the Public Health Service Act (PHS Act), added by Affordable Care Act, incorporated into the Employee Retirement Income Security Act of 1974 and the Internal Revenue Code. Section 2713 of the PHS Act requires coverage without cost sharing of certain preventive health services by CMS-9968-F non-grandfathered group health plans and health insurance coverage. Among these services are women’s preventive health services, as specified in guidelines supported by the Health Resources and Services Administration (HRSA).

As authorized by the current regulations, and consistent with the HRSA guidelines, group health plans established or maintained by certain religious employers (and group health insurance coverage provided in connection with such plans) are exempt from the otherwise applicable requirement to cover certain contraceptive services. These final regulations simplify and clarify the religious employer exemption.

These final regulations also establish accommodations with respect to the contraceptive coverage requirement for group health plans established or maintained by eligible organizations (and group health insurance coverage provided in connection with such plans), as well as student health insurance coverage arranged by eligible organizations that are institutions of higher education. These regulations also finalize related amendments to regulations concerning Affordable Insurance Exchanges.

7/28/2013

Exchange Functions:  Eligibility for Exemptions; Miscellaneous Minimum Essential Coverage Provisions

CMS/HHS

ACA
Final Rule

This final rule implements certain functions of the Affordable Insurance Exchanges (‘‘Exchanges’’). These specific statutory functions include determining eligibility for and granting certificates of exemption from the individual shared responsibility payment described in section 5000A of the Internal Revenue Code. Additionally, this final rule implements the responsibilities of the Secretary of Health and Human Services, in coordination with the Secretary of the Treasury, to designate other health benefits coverage as minimum essential coverage by providing that certain coverage be designated as minimum essential coverage. It also outlines substantive and procedural requirements that other types of individual coverage must fulfill in order to be certified as minimum essential coverage.

8/26/2013

National School Lunch Program and School Breakfast Program; Nutrition Standards for All Foods Sold in Schools as Required by the Healthy, Hunger-Free Kids Act of 2010

USDA/FNS

(HHFKA)
Interminal final rule This interim final rule amends the National School Lunch Program and School Breakfast Program regulations to establish nutrition standards for all foods sold in schools, other than food sold under the lunch and breakfast programs. Amendments made by Section 208 of the Healthy, Hunger-Free Kids Act of 2010 (HHFKA) require the Secretary to establish nutrition standards for such foods, consistent with the most recent Dietary Guidelines for Americans, and directs the Secretary to consider authoritative scientific recommendations for nutrition standards; existing school nutrition standards, including voluntary standards for beverages and snack foods; current State and local standards; the practical application of the nutrition standards; and special exemptions for infrequent school-sponsored fundraisers (other than fundraising through vending machines, school stores, snack bars, a` la carte sales and any other exclusions determined by the Secretary). In addition, this interim final rule requires schools participating in the National School Lunch Program and School Breakfast Program to make potable water available to children at no charge in the place where lunches are served during the meal service, consistent with amendments made by section 203 of the HHFKA, and in the cafeteria during breakfast meal service. 8/27/2013

Requirements for Long Term Care Facilities; Hospice Services

HHS/CMS

President’s Executive Order 13563
Final Rule


This final rule will revise the requirements that an institution will have to meet in order to qualify to participate as a skilled nursing facility (SNF) in the Medicare program, or as a nursing facility (NF) in the Medicaid program. These requirements will ensure that long-term care (LTC) facilities (that is, SNFs and NFs) that choose to arrange for the provision of hospice care through an agreement with one or more Medicare-certified hospice providers will have in place a written agreement with the hospice that specifies the roles and responsibilities of each entity.

This final rule reflects the Centers for Medicare and Medicaid Services’ (CMS’) commitment to the principles of the President’s Executive Order 13563, released on January 18, 2011, titled ‘‘Improving Regulation and Regulatory Review.’’
8/26/2013

Transition Relief for Employees and Related Individuals Eligible to Enroll in Eligible Employer-Sponsored Health Plans for Non-Calendar Plan Years that Begin in 2013 and End in 2014

 

Treasury/IRS
IRS Notice

This notice provides relief from the § 5000A of the Affordable Care Act (ACA) shared responsibility payment for specified individuals who are eligible to enroll in certain eligible employer-sponsored health plans with a plan year other than a calendar year (non-calendar year plans) if the plan year begins in 2013 and ends in 2014.

In order to provide transition relief during the first year that § 5000A applies to individual taxpayers, an employee, or an individual having a relationship to the employee, who is eligible to enroll in a non-calendar year eligible employer-sponsored plan with a plan year beginning in 2013 and ending in 2014 (the 2013-2014 plan year) will not be liable for the § 5000A shared responsibility payment for certain months in 2014. The transition relief begins in January 2014 and continues through the month in which the 2013-2014 plan year ends. The relief provided by this notice applies only for determining a taxpayer’s § 5000A shared responsibility payment for not maintaining minimum essential coverage. Any month in 2014 for which an individual is eligible for the transition relief provided by this notice will not be counted in determining a continuous period of less than 3 months for purposes of the short coverage gap exemption described in § 5000A(e)(4).
 

Authorization of Emergency Use of an In Vitro Diagnostic for Detection of the Novel Avian Influenza A(H7N9) Virus; Availability

HHS/FDA

Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (P.L. 113-5)
Notice

The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for an in vitro diagnostic device for detection of the novel avian influenza A(H7N9) virus. FDA is issuing this Authorization under the Federal Food, Drug, and Cosmetic (FD&C) Act, as requested by the Centers for Disease Control and Prevention (CDC).

The Authorization contains, among other things, conditions on the emergency use of the authorized in vitro diagnostic device. The Authorization follows the determination by the Secretary of Health and Human Services (HHS) that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad that involves the novel avian influenza A(H7N9) virus. On the basis of such determination, the Secretary also declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of the novel avian influenza A(H7N9) virus subject to the terms of any authorization issued under the FD&C Act.
 
4/22/2013

Program Integrity:  Exchange, SHOP, Premium Stabilization Programs, and Market Standards

 

CMS/HHS

 

ACA
NPRM This proposed rule sets forth financial integrity and oversight standards with respect to Affordable Insurance Exchanges; Qualified Health Plan (QHP) issuers in Federally-facilitated exchanges (FFEs); and states with regard to the operation of risk adjustment and reinsurance programs. It also proposes additional standards with respect to agents and brokers. These standards, which include financial integrity provisions and protections against fraud and abuse, are consistent with Title I of Affordable Care Act.  

State Long-Term Care Ombudsman Program

ACL/HHS

Older Americans Act
NPRM This Notice of Proposed Rulemaking, with request for comments, implements provisions of the Older Americans Act related to the State Long-Term Care Ombudsman program and a 1994 proposed rule. Since 1992, the functions of this program have been delineated in the Older Americans Act; however, regulations have not been promulgated for any Title VII program. In the absence of regulatory guidance, there has been significant variation in the interpretation and implementation of these provisions among states. Recent inquiries from states and an Administration on Aging (AoA) compliance review in one state have highlighted the difficulty of determining state compliance in carrying out the Long-Term Care Ombudsman program functions. This rulemaking provides the first regulatory guidance for states’ Long-Term Care Ombudsman programs

 to provide clarity about implementation.

HHS estimates that a number of states may need to update their statutes, regulations, policies and/or practices in order to operate the program consistent with federal law and this proposed regulation. The effective date of the rule is anticipated to be one year after publication of any final rule to allow states appropriate time for such changes, if needed. AoA anticipates little or no financial impact on the providers of long-term care ombudsman services, the consumers served by the program, or long-term care providers through implementation of the proposed rules.
 
 

Health Plans; Small Business Health Options Program (SHOP)

 

CMS/HHS

ACA
Final Rule This final rule implements provisions of the Affordable Care Act related to the Small Business Health Options Program (SHOP). Specifically, this final rule amends existing regulations regarding triggering events and special enrollment periods for qualified employees and their dependents and implements a transitional policy regarding employees’ choice of qualified health plans (QHPs) in the SHOP. 7/1/2013

Incentives for Nondiscriminatory Wellness Programs in Group Health Plans

 

Treasury/IRS; DOL/EBSA; HHS

 

ACA
Final Rule This document contains final regulations, consistent with the Affordable Care Act, regarding nondiscriminatory wellness programs in group health coverage. Specifically, these final regulations increase the maximum permissible reward under a health-contingent wellness program offered in connection with a group health plan (and any related health insurance coverage) from 20 percent to 30 percent of the cost of coverage. The final regulations further increase the maximum permissible reward to 50 percent for wellness programs designed to prevent or reduce tobacco use. These regulations also include other clarifications regarding the reasonable design of health-contingent wellness programs and the reasonable alternatives they must offer in order to avoid prohibited discrimination.  

TRICARE Young Adult

DOD, Office of the Secretary

Ike Skelton National Defense Authorization Act for FY 2011
Final Rule An interim final rule was published in the Federal Register on April 27, 2011 (76 FR 23479–23485) that established the TRICARE (TYA) program by implementing Section 702 of the Ike Skelton NDAA for FY 2011 (Pub. L. 111–383). The TYA program provides TRICARE Program coverage to unmarried children under the age of 26 of TRICARE-eligible sponsors who no longer meet the age requirements for TRICARE eligibility (age 21, or 23 if enrolled in a full-time course of study at an approved institution of higher learning, and the sponsor provides more than 50 percent of the student’s financial support), and who are not eligible for medical coverage from an eligible employer-sponsored plan based on their individual employment status (as defined in section 5000A(f)(2) of the Internal Revenue Code of 1986). If qualified, they can purchase TRICARE Standard/Extra or TRICARE Prime benefits coverage. The particular TRICARE option available depends on the uniformed service sponsor’s eligibility and the availability of the TRICARE option in the dependent’s geographic location. 6/28/2013

Pre-existing Condition Insurance Plan Program

CMS/HHS

ACA
Interim Final rule with comment This interim final rule with comment period sets the payment rates for covered services furnished to individuals enrolled in the Pre-Existing Condition Insurance Plan (PCIP) program administered directly by HHS beginning with covered services furnished on June 15, 2013. This interim final rule also prohibits facilities and providers who, with respect to dates of service beginning on June 15, 2013, accept payment for most covered services furnished to an enrollee in the federally-administered PCIP from charging the enrollee an amount greater than the enrollee’s out-of-pocket cost for the covered service as calculated by the plan. The PCIP program was established under Section 1101 of Title I of the Patient Protection and Affordable Care Act (Affordable Care Act). 6/15/2013

Child Care and Development Fund (CCDF) Program

Office of Child Care/ACF/HHS

NPRM The Administration for Children and Families (ACF) proposes to amend the Child Care and Development Fund (CCDF) regulations. This proposed rule makes changes to CCDF regulatory provisions in order to strengthen health and safety requirements for child care providers.  

State Medicaid Fraud Control Units; Data Mining

 

OIG/HHS

Final Rule This final rule amends a provision in HHS regulations prohibiting State Medicaid Fraud Control Units (MFCU) from using Federal matching funds to identify fraud through screening and analyzing State Medicaid data, known as data mining. To support and modernize MFCU efforts to effectively pursue Medicaid provider fraud, it finalizes proposals to permit federal financial participation (FFP) in costs of defined data mining activities under specified circumstances. In addition, we finalize requirements that MFCUs annually report costs and results of approved data mining activities to OIG. 6/17/2013

Medicaid Disproportionate Share Hospital Allotment Reductions

CMS/HHS

ACA
NPRM The statute, as amended by the Affordable Care Act, requires aggregate reductions to state Medicaid Disproportionate Share Hospital (DSH) allotments annually from fiscal year (FY) 2014 through FY 2020. This proposed rule delineates a methodology to implement the annual reductions for FY 2014 and FY 2015. The rule also proposes to add additional DSH reporting requirements for use in implementing the DSH health reform methodology  

General and Plastic Surgery Devices: Reclassification of Ultraviolet Lamps for Tanning, Henceforth To Be Known as Sunlamp Products

FDA/HHS

Proposed order The Food and Drug Administration (FDA) is proposing to reclassify ultraviolet (UV) lamps intended to tan the skin from class I (general controls) exempt from premarket notification to class II (special controls) and subject to premarket notification, and to rename them sunlamp products. FDA is also designating special controls that are necessary to provide a reasonable assurance of the safety and effectiveness of the device. FDA is proposing this reclassification on its own initiative based on new information.  

HIPAA Privacy Rule and the National Instant Criminal Background Check System (NICS)

Office of Civil Rights/HHS

HIPAA
ANPR

On January 16, 2013, President Obama announced a series of executive actions to reduce gun violence in the United States, including efforts to improve the federal government’s background check system for the sale or transfer of firearms by licensed dealers, called the National Instant Criminal Background Check System (NICS). Among those persons disqualified from possessing or receiving firearms under federal law are individuals who have been involuntarily committed to a mental institution; found incompetent to stand trial or not guilty by reason of insanity; or otherwise have been determined, through a formal adjudication process, to have a severe mental condition that results in the individuals presenting a danger to themselves or others or being incapable of managing their own affairs (referred to below as the ‘‘mental health prohibitor’’).

Concerns have been raised that, in certain states, the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule may be a barrier to states’ reporting the identities of individuals subject to the mental health prohibitor to the NICS. The U.S. Department of Health and Human Services (HHS), which administers the HIPAA regulations, is issuing this Advance Notice of Proposed Rulemaking (ANPRM) to solicit public comments on barriers to reporting and ways in which these barriers can be addressed.

In particular, HHS is considering creating an express permission in the HIPAA rules for reporting the relevant information to the NICS by those HIPAA-covered entities responsible for involuntary commitments or the formal adjudications that would subject individuals to the mental health prohibitor, or that are otherwise designated by the states to report to the NICS.

In addition, HHS is soliciting comments on the best methods to disseminate information on relevant HIPAA policies to state level entities that originate or maintain information that may be reported to NICS. Finally, HHS is soliciting public input on whether there are ways to mitigate any unintended adverse consequences for individuals seeking needed mental health services that may be caused by creating express regulatory permission to report relevant information to NICS. The Department will use the information it receives to determine how best to address these issues in the future.

 

 

 

Key to Terms/Acronyms:

 

Administration for Children and Families (ACF)
Administration on Aging/Administration for Community Living (ACL)
Advanced Notice of Proposed Rulemaking (ANPR)
Centers for Consumer Information and Insurance Oversight (CCIIO)
Centers for Medicaid and Medicare Services (CMS)
Children’s Health Insurance Program (CHIP)
Children’s Health Insurance Program Reauthorization Act (CHIPRA)
Department of Agriculture (USDA)
Department of Health and Human Services (HHS)
Department of Defense (DOD)
Department of Labor (DOL)
Employment Services Benefit Administration (ESBA)
Food and Nutrition Service (FNS)
Healthy, Hunger-Free Kids Act of 2010 (HHFKA)
Internal Revenue Service (IRS)
Notice of Proposed Rulemaking (NPRM)
Office of the Inspector General (OIG)
Patient Protection and Affordable Care Act (ACA)
Small Business Options Program (SHOP) Exchange
U.S. Department of Agriculture (USDA)

 

NCSL State Federal Relations staff contacts: Joy Johnson Wilson, Federal Affairs Counsel, Health Policy Director at joy.wilson@ncsl.org  or Rachel B. Morgan RN, BSN, Health Committee Director, at rachel.morgan@ncsl.org  , and Tamra Spielvogel