Regulatory Developments

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

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

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 cuts would “provide more than enough deficit reduction to replace the damaging cuts required by the Joint Committee sequestration”).

Virtually all provider types – and drug manufacturers – would be impacted by the budget provisions, if adopted as proposed. The budget proposal is certainly subject to change during the legislative process, particularly as the House and Senate leadership pursue alternative budget frameworks, and indeed, gridlock could prevent significant action on entitlement reform this year. Nevertheless, the proposals bear careful monitoring because they could eventually be included in any long-elusive “grand bargain” to reform the Medicare program and reduce the federal debt.

Highlights of the Administration’s Medicare and Medicaid proposals include the following:Continue Reading Obama Administration’s Proposed FY 2014 Budget Includes $401 Billion in Health Program Savings

In case you missed them, Reed Smith attorneys have recently prepared the following Client Alerts on major regulatory issues:

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,

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

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

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

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

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

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

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

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 of the Affordable Care Act (ACA)). A “taxable medical device” is any device (as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FFDCA)) that is intended for humans, excluding eyeglasses, contact lenses, hearing aids, and any other medical device of a type that is generally purchased by the general public at retail for individual use. The final regulations set forth the IRS’s interpretation of key elements of the excise tax, including the retail exemption, as discussed after the jump.Continue Reading IRS Issues Regulations to Implement ACA Medical Device Tax

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

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

On June 26, 2012, the Internal Revenue Service (IRS) published proposed regulations implementing ACA requirements for charitable hospitals relating to financial assistance and emergency medical care policies, charges for certain care provided to individuals eligible for financial assistance, and billing and collections. Note that the proposed regulations do not address the ACA’s community health needs

On April 17, 2012, the Internal Revenue Service (IRS) published proposed regulations that implement and provide guidance on an ACA provision imposing 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

The Obama Administration has recently published additional regulations addressing various Affordable Care Act (ACA) insurance reforms, including:

  • A CMS final rule establishing requirements for student health insurance policies offered by college and universities. The rule clarifies that such student policies are subject to certain ACA consumer protections, including a prohibition on lifetime dollar caps on

As previously reported, the Architectural and Transportation Barriers Compliance Board (Access Board) has published a proposed rule that would establish accessibility standards for medical diagnostic equipment, as mandated by the ACA. The proposed standards contain minimum technical criteria to ensure that medical diagnostic equipment, including examination tables, examination chairs, weight scales, and imaging equipment