Regulations & Guidance

On October 2, 2014, the FDA released a set of comprehensive guidelines governing the Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. The guidelines are intended to provide direction for manufacturers of medical devices on how to appropriately safeguard devices from a potential security breach; particularly in light of the sensitive

On October 1, 2014, the Departments of Health and Human Services (“HHS”), Labor (“DOL”) and Treasury (collectively, the “Departments”) published regulations finalizing a proposed amendment to the “excepted benefit” rules, i.e., the rules that govern when certain types of benefits are exempt from HIPAA’s portability rules as well as various requirements under ERISA (including applicability of the Mental Health Parity and Addiction Equity Act) and the Affordable Care Act (“ACA”), including the ACA’s market reforms (such as the prohibition on lifetime and annual limits, etc.). These final rules largely adopted proposed rules from December 2013, with a few clarifications and changes.

After the enactment of the ACA, various stakeholders became increasingly concerned about whether or not an employee assistance program (“EAP”) would be considered to be a “group health plan” under the ACA, and thus subject to all of the ACA’s market reforms. Because the benefits provided under an EAP are generally very limited, most (if not all) EAPs would have difficulty meeting these market reforms (including, particularly, the ACA’s prohibition on annual dollar limits). The final rules largely adopted the provisions of the proposed rule that specify that EAPs will be considered to be excepted benefits (and thus not subject to the ACA’s market reforms) if they meet four criteria (which, the Departments make clear, are intended to ensure that EAPs are supplemental to other coverage offered by employers):


Continue Reading HHS, Labor, and Treasury Issue Proposed Amendments to “Excepted Benefit” Rules

The Office of Inspector General, Department of Health and Human Services, has recently issued guidance for those of its contractors seeking to self-disclose reportable conduct under the Federal Acquisition Regulations (“FAR”). Under federal regulations governing relationships between the federal government and its contractors, any contractors with credible evidence of a potential violation of the False Claims Act or federal criminal law involving fraud, bribery, gratuity, or conflict of interest must make a timely disclosure of such violations to the Office of Inspector General for the agency with which they contract. Failure to timely self-report these potential violations can result in the suspension of contracts or the debarment of the contractor. This requirement applies only to contractors whose contracts are governed by the FAR and which are valued at over $5,000,000.

The guidance details the information required to be included on the disclosure form, including the date the issue was discovered, detailed descriptions of any internal investigation undertaken, and a quantification of the financial harm to the government and any potential overpayments. In addition to the guidance, issued in April of 2014, OIG has provided FAQs for contractors covered by the FAR who may be considering a disclosure.


Continue Reading OIG Issues Self-Disclosure Guidance for Contractors

Continuing to usher in a new wave of EHR technology changes, on September 11, 2014, the Office of the National Coordinator for Health Information Technology (“ONC”) adopted the “2014 Edition Release 2” final rule, which provides alternative criteria and approaches for the voluntary certification of heath information technology. The final rule, effective October 14, 2014[1], introduces regulatory flexibilities and general improvements to the certification processes.

First, the rule adopts a new (albeit smaller) subset of optional EHR Certification Criteria. Of the 57 proposed certification criteria in the February 26, 2014 notice of proposed rulemaking, the final rule adopts only ten optional and two revised EHR Certification Criteria. The Certification Criteria changes include:


Continue Reading ONC Announces New EHR Certification Criteria

On September 4, 2014, the Department of Health and Human Services (“HHS”) published a final rule modifying the Medicare and Medicaid Electronic Health Record (“EHR”) Meaningful Use Incentive Program. The modification brings welcome change, allowing increased flexibility while also assuaging several provider concerns.

The new rule, effective October 1, 2014, comes in response to numerous public comments lamenting the inability of providers to meet the 2014 meaningful use objectives—an inability that brought with it financial penalties. As part of the new rule, HHS made four distinct changes to the EHR Incentive Program:

1. Altered the meaningful use stage timeline and definition of certified electronic health record technology (“CEHRT”). The new rule implements a one-year extension of Stage 2 for providers that first joined the Program in 2011 or 2012. The timeline to begin Stage 3 has thus been postponed until 2017. In keeping with this timeline shift, HHS also formally modified the CEHRT definition to reflect this date change, thus postponing until 2015 the required start date for exclusive use of 2014 Edition CEHRT.


Continue Reading New HHS Rules Focus on Increased Flexibility, Improvements in the World of EHR Technology

On September 2, 2014, the Centers for Medicare & Medicaid Services (CMS) announced a Final Rule specifying enrollment notice requirements and re-enrollment options for plans offered through the Exchange in 2015. Regarding notice requirements, the Final Rule states that consumers in the Exchange will receive notices from the marketplace before open enrollment begins that explain

On July 31, the Centers for Medicare & Medicaid Services (CMS) issued a final rule establishing October 1, 2015 as the official deadline for the implementation of the International Classification of Diseases, 10th Edition diagnosis and procedures codes (ICD-10). ICD-10 codes are used to classify diagnoses and procedures on claims submitted to Medicare and private

Insurers in U.S. Territories will soon be exempt from popular market-reform and non-discrimination provisions of the Affordable Care Act (ACA). In a July 16 letter, the Department of Health and Human Services (HHS) clarified that the ACA provisions on guaranteed availability, community rating, single risk pool, medical loss ratio, and essential health benefits only

On July 16, 2014, the Consumer Information and Insurance Oversight (CCIIO) division of the Centers for Medicare & Medicaid Services (CMS) released an Enrollment Bulletin for the individual markets of Federally-facilitated Exchanges (FFEs) about grace periods for premium non-payment. The Bulletin addresses when grace periods related to terminations for premium non-payment fall across enrollment periods for the next benefit year. Issuers must provide a three-month grace period to Exchange enrollees who receive advance premium tax credits (APTCs), pay at least one month’s premium during the benefit year, and subsequently fail to pay their portion of the monthly premium. If the three-month grace period passes and the enrollee does not pay all outstanding premiums, the issuer must terminate the enrollee’s coverage, retroactive to the last day of the first month of the grace period. All other Exchange enrollees receive grace periods according to state law. The Bulletin explains the following for APTC recipients in FFEs:
Continue Reading CCIIO Issues New Guidance on Grace Periods for Non-payment of Premiums in Exchanges

The Congressional Research Service published a report detailing more than a dozen pending ACA-related rulemakings. The report comes on the heels of the Spring 2014 Unified Agenda and identifies 14 proposed rules and 17 final rules regarding the ACA that are expected during the next twelve months. Notable expected proposed rules include:

  • CY 2016 Notice of Benefit and Payment Parameters (CMS-9933-P) (0938-ASI9)—Expected in November 2014, this rule would provide the CY 2016 payment parameters for Exchanges, including cost-sharing reductions, advance premium tax credits, reinsurance, and risk adjustment.
  • Application of the Mental Health Parity and Addiction Equity Act to Medicaid Programs (CMS-2333-P) (0938-AS24)—Expected in December 2014, this rule would specify how MHPAEA would apply to Medicaid (including managed care), CHIP, and other benefit programs.
  • Nondiscrimination Under the Patient Protection and Affordable Care Act (0945-AA02)—Expected in August 2014, this rule would implement the ACA Section 1557’s prohibitions against discrimination in health programs and activities by covered entities on the basis of race, color, national origin, sex, age, and disability.
  • State Option to Provide Health Homes for Enrollees With Chronic Conditions (CMS-2331-P) (0938-AQ48)—Expected in October 2014, this proposed rule would provide guidance for development of a Medicaid State Plan option to provide health homes for enrollees with chronic conditions.


Continue Reading ACA Regulatory Preview: CRS Teases Upcoming ACA Rulemakings