December 2012

As the year draws to a close, industry is speculating about the release date of the long-awaited Health Information Technology for Economic and Clinical Health Act (“HITECH”) final rule, which is expected to address modifications to the Privacy, Security, Enforcement, and Breach Notification Rules. While the publication date has not yet been announced, it is

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

The Department of Justice recently announced that it secured a record $4.9 billion in settlements and judgments in civil fraud cases in FY 2012, including health care fraud recoveries totaling more than $3 billion. The Department notes that some of the largest recoveries during the year – representing nearly $2 billion — involved false

In light of a continued high rate of Medicare fee-for-service improper payments (8.6% in FY 2011), the GAO recently assessed the use of Medicare prepayment edits and CMS’s oversight of Medicare Administrative Contractors (MACs) that process claims.  In the report, "Medicare Program Integrity: Greater Prepayment Control Efforts Could Increase Savings and Better Ensure Proper Payment," the

A recent GAO report, “Medicaid Integrity Program: CMS Should Take Steps to Eliminate Duplication and Improve Efficiency,” points to a number of shortcomings in CMS Medicaid program integrity efforts. Among other things, the GAO found that Medicaid Integrity Group’s (MIG) oversight and support activities had mixed results in achieving the goal of enhancing

The Medicare electronic health record (EHR) incentive program is vulnerable to paying incentives to professionals and hospitals that do not fully meet meaningful use requirements due to gaps in CMS oversight, according to a recent OIG report. Based on a review of CMS’s oversight of self-reported meaningful use of certified EHR technology in 2011, the

The Health Information Technology for Economic and Clinical Health (HITECH) Act provided funding to promote the adoption and meaningful use of certified EHR technology, including a Medicaid EHR program. In 2011, the first year of the Medicaid EHR program, 1,964 hospitals and 45,962 professionals were awarded a total of approximately $2.7 billion in Medicaid EHR

The Department of Health and Human Services (HHS) published a proposed rule on December 7, 2012 to establish additional regulatory requirements regarding ACA health insurance provisions that go into effect in 2014. The proposed rule would establish a risk adjustment methodology, a transitional reinsurance program, and a temporary risk corridors program from 2014 to 2016.

CMS has announced that the CY 2013 Medicare outpatient therapy limit is $1900 for physical therapy (PT) and speech-language pathology (SLP) combined and $1900 for occupational therapy (OT). CMS also has updated the Medicare Claims Processing Manual and the Medicare Benefit Policy Manual to implement the Middle Class Tax Relief and Jobs Creation Act’s (MCTRJCA)

The Food and Drug Administration (FDA) recently issued two draft guidance documents related to the conduct of clinical trials. The first draft guidance, Draft Guidance for IRBs, Clinical Investigators and Sponsors: IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE Is Needed is intended to

On December 13, 2012, the FDA issued two draft guidance documents related to product safety and risk minimization. The first guidance, Design Considerations for Devices Intended for Home Use, is intended to assist manufacturers in designing and developing home use medical devices that comply with applicable standards of safety and effectiveness and other regulatory

CMS has published a notice requesting information that will be used to develop a survey regarding patient experiences with emergency department care. The survey is intended to support the goals of HHS’s National Quality Strategy under the ACA. In issuing the request for comments, CMS notes that while CMS and the Agency for Healthcare

On December 7, 2012, CMS published an interim final rule with comment period that updates the Data Element Catalog (DEC) standard and the Quality Reporting Document Architecture (QRDA) Category III standard adopted in a September 4, 2012 final rule. The interim final rule with comment period also revises the Medicare and Medicaid Electronic Health Record

CMS recently published a notice announcing a $532.00 calendar year 2013 application fee for institutional providers that are initially enrolling in the Medicare or Medicaid program or the Children’s Health Insurance Program (CHIP); revalidating their Medicare, Medicaid or CHIP enrollment; or adding a new Medicare practice location. This fee is required with any enrollment application

CMS has released its Final Decisions on the August 2012 Recommendations of the Hospital Outpatient Payment Panel on Supervision Levels for Select Services. The document provides CMS’s final determinations regarding the appropriate supervision levels for 29 individual hospital outpatient therapeutic services, effective January 1, 2013. CMS has determined that 22 of the considered services