Tag Archives: Regulatory Developments

IRS Finalizes ACA Individual “Shared Responsibility” Payment Requirements

The Internal Revenue Service (IRS) has issued final regulations to implement the ACA requirement that every individual have basic health insurance coverage, qualify for an exemption, or make a “shared responsibility” payment when filing a federal income tax return, beginning in 2014. Individuals are exempt from the payment obligation if coverage is unaffordable, if they … Continue Reading

Hard Drives on Used Photocopiers Result in HIPAA Violations and $1.2M Settlement to the OCR

As covered on Reed Smith’s Life Sciences Legal Update blog, Affinity Health Plan, Inc. (Affinity) recently reached a $1.2 million settlement with the HHS Office for Civil Rights related to potential violations of the Health Information Portability and Accountability Act of 1996 (HIPAA). Affinity self-reported a breach after learning from a CBS Evening News investigative report … Continue Reading

China Life Sciences Regulatory Crackdown Spreads to Medical Device Sector

As reported on Reed Smith’s Life Sciences Legal Update blog, the local Beijing office of the Ministry of Health (MOH) of the People’s Republic of China recently announced that it has started a three-month review of the use of high-value medical consumables and large-scale medical equipment in Beijing. Noting that prior inspections of hospitals had … Continue Reading

Obama Administration Announces Delay in Employer ACA “Shared Responsibility” Payments, Reporting Requirements until 2015

On July 2, 2013, the Obama Administration announced (via a web posting) that it is delaying the Affordable Care Act’s (ACA) employer “shared responsibility” payment obligation (commonly referred to as the “employer mandate”) until January 1, 2015. The “shared responsibility” payment requirement, originally scheduled to begin January 1, 2014, requires certain employers with 50 or … Continue Reading

DOL Releases Insurance Exchange Notice Guidance and Model Notices

On May 8, the Department of Labor (DOL) issued guidance regarding the ACA requirement that employers provide notice to employees describing the coverage options available under Health Insurance Marketplaces/Exchanges. DOL also has released model notices to employees of coverage options. A Reed Smith summary of DOL’s guidance is available here.… Continue Reading

Obama Administration Issues Final ACA Wellness Program Rules

On May 29, 2013, the Internal Revenue Service and the Department of Labor (DOL) and HHS released final regulations regarding wellness programs integrated with employer-sponsored health plans. The new wellness program standards apply to insured and self-insured programs, grandfathered and non-grandfathered, and are effective for plan years beginning on and after January 1, 2014.  A … Continue Reading

Bioethics Panel Seeks Comments on Ethical/Legal Issues Involving “Incidental Findings” in Research and Testing

The Presidential Commission for the Study of Bioethical Issues is requesting public comment on the ethical, legal, and social issues raised by “incidental findings” (e.g., information obtained from testing that was not its intended or expected object) that arise from genetic and genomic testing, imaging, and testing of biological specimens conducted in the clinical, research, and … Continue Reading

IRS Proposes Regulations to Implement Certain ACA Insurance Premium Tax Credit, Medical Loss Ratio Provisions

On May 3, 2013, the Internal Revenue Service (IRS) published proposed regulations implementing the ACA’s health insurance premium tax credit, as amended by subsequent legislation. These proposed regulations affect individuals who enroll in qualified health plans through Affordable Insurance Exchanges (Exchanges) and claim the premium tax credit, and Exchanges that make qualified health plans available … Continue Reading

IRS Proposes Hospital Community Health Needs Assessment Regulations

On April 5, 2013, the Internal Revenue Service published proposed regulations that provide additional guidance to charitable hospital organizations on the community health needs assessment (CHNA) requirements and related excise tax and reporting obligations under the ACA. The regulations address the requirement a hospital organization conduct a CHNA at least once every three years, taking … Continue Reading

HRSA Rule Transitions HIPDB to NPDB

The Health Resources and Services Administration (HRSA) has published a final rule to incorporate ACA requirements that eliminate duplicative data reporting to the Healthcare Integrity and Protection Data Bank (HIPDB) and the National Practitioner Data Bank (NPDB). Among other things, the rule establishes a transition period to transfer all data in the HIPDB to the … Continue Reading

Obama Administration’s Proposed FY 2014 Budget Includes $401 Billion in Health Program Savings

Today, the Obama Administration released its proposed federal budget for fiscal year 2014. As widely reported, the budget incorporates an offer the President made to Congress in December 2012 to achieve nearly $1.8 trillion in additional deficit reduction over the next 10 years, including $401 billion in health savings (the Administration observes that this level of … Continue Reading

Recent Reed Smith Analyses of Sunshine Act Rule, ACA Qualified Health Plans, HITECH Final Rule

In case you missed them, Reed Smith attorneys have recently prepared the following Client Alerts on major regulatory issues: “CMS Physician Payment "Sunshine" Final Rule — Overview and Analysis”; “ACA Affordable Insurance Exchanges and Qualified Health Plans”; and   “The HITECH Final Rule: New Privacy/Security Rules of the Road Finally Here.” … Continue Reading

Reed Smith Alert: ACA Affordable Insurance Exchanges and Qualified Health Plans

In less than one year, Affordable Insurance Exchanges (“Exchanges”) authorized by the Affordable Care Act (“ACA”) are scheduled to be operational, providing a marketplace for the purchase of Qualified Health Plans (“QHPs”) in the individual and small group markets. The Obama Administration has recently accelerated rulemaking and subregulatory guidance associated with the new Exchange/QHP framework, … Continue Reading

HHS Issues ACA Benefit, Payment Parameter Rules for 2014

HHS published a final rule on March 11, 2013 to establish additional regulatory requirements regarding ACA health insurance provisions that go into effect in 2014. Specifically, the rule provides detailed standards for the permanent risk adjustment methodology, a transitional reinsurance program, and a temporary risk corridors program from 2014 to 2016, which are intended to stabilize … Continue Reading

OSHA, IRS, and OPM Release ACA Regulations

Several agencies besides HHS have recently issued regulations on ACA various provisions, including the following: The Occupational Safety and Health Administration (OSHA) has published an interim final rule with comment period that protects employees against retaliation by an employer for reporting alleged violations of various insurance provisions under Title I of the Act or for … Continue Reading

HHS Invites Comments on Advancing Interoperability and Health Information Exchange

CMS and the Office of the National Coordinator for Health Information Technology (ONC) are seeking comments on a series of potential policies intended to accelerate electronic health information exchange (HIE) across providers. The notice identifies various gaps that the policies and programs are intended to address, such as low rates of electronic health record (EHR) … Continue Reading

CMS Physician Payment “Sunshine” Final Rule — Overview and Analysis

The Centers for Medicare & Medicaid Services (CMS) has published the long-awaited Final Rule to implement the “Sunshine” provisions of the Affordable Care Act of 2010 (ACA).  The Sunshine provisions – intended to provide increased transparency regarding the scope and nature of financial and other relationships among manufacturers, physicians, and teaching hospitals – require that … Continue Reading

The HITECH Final Rule: New Privacy/Security Rules of the Road Finally Here

This post was also written by Elizabeth D. O’Brien. On January 25, 2013, the HHS Office for Civil Rights published its long-awaited final rule implementing major changes to the HIPAA Privacy, Security, Breach Notification, and Enforcement Rules mandated by the 2009 Health Information Technology for Economic and Clinical Health Act (HITECH Act). Among other things, the … Continue Reading

D.C. Circuit Decision Upholding DOD Rule May Leave Drug Manufacturers on the Hook for Refunds

The D.C. Circuit recently upheld a Department of Defense (DOD) rule that will require drug manufacturers to provide partial refunds on certain prescription drugs, dating back to 2008. The rule that was the subject of the case imposes a cap on the retail price of drugs and requires manufacturers to refund the difference between the … Continue Reading

IRS Proposes ACA Employer “Shared Responsibility” Requirements for Employee Health Coverage

This post was also written by Allison Warden Sizemore. On January 2, 2013, the Internal Revenue Service (IRS) published a notice of proposed rulemaking and notice of public hearing regarding implementation of an ACA “shared responsibility” provision that requires certain large employers (generally 50 full-time employees and full-time equivalents) to offer minimum essential health coverage … Continue Reading

IRS Issues Regulations to Implement ACA Medical Device Tax

This post was also written by Ruth N. Holzman and Angelo Ciavarella. On December 7, 2012, the IRS published final regulations that provide guidance on the 2.3% excise tax imposed on any sale occurring after December 31, 2012, of any “taxable medical device” by the manufacturer, producer or importer of such device (such tax enacted as part … Continue Reading

IRS Issues Notice on ACA Branded Prescription Drug Fee Parameters for 2013

The IRS has issued Notice 2012-74, which provides guidance on the ACA branded prescription drug (BPD) fee for the 2013 fee year. Specifically, the guidance addresses: (1) the submission of Form 8947, “Report of Branded Prescription Drug Information,” (2) the time and manner for notifying covered entities of their preliminary fee calculation, (3) the time … Continue Reading

IRS Regulations Implement Insurer Fee to Fund PCORI Trust Fund

On December 6, 2012, the IRS published final regulations implementing fees on issuers of certain health insurance policies and plan sponsors of certain self-insured health plans to fund the Patient-Centered Outcomes Research Trust Fund. The Trust Fund supports the Patient-Centered Outcomes Research Institute (PCORI), which was established by the ACA to assist patients, clinicians, purchasers, … Continue Reading

OPM Proposes Parameters for ACA Multi-State Insurance Exchanges

The Office of Personnel Management (OPM) published a proposed regulation on December 5, 2012 to establish rules for the ACA Multi-State Plan Program (MSPP). In order to promote competition and choice in the insurance marketplace, the ACA MSPP provisions require OPM to enter into contracts with private health insurance issuers to provide at least two … Continue Reading