CMS has put on display a final rule that implements reductions to state Medicaid Disproportionate Share Hospital (DSH) allotments mandated by the ACA. The final rule sets forth the methodology to implement the annual reductions for fiscal years (FYs) 2014 and 2015, and it establishes additional DSH reporting requirements for use in implementing the DSH

On May 17, 2013, the HHS Office of Inspector General (OIG) published a final rule amending current 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). In order to “support and modernize MFCU efforts to effectively pursue

On April 2, 2013, CMS published a final rule establishing increased Federal Medical Assistance Percentage (FMAP) rates for certain adult populations under states’ Medicaid programs effective January 1, 2014, as authorized by the Affordable Care Act (ACA). The rule sets forth the method states will use to claim the matching rate that is available for

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

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 Centers for Medicare & Medicaid Services (CMS) released late today its final rule implementing the physician payment transparency provisions of the Patient Protection and Affordable Care Act (Section 6002), commonly referred to as the “Physician Payments Sunshine Act.” Among other things, the Act requires drug, device, biological or medical supply manufacturers to report

FDA has issued a final rule on the current good manufacturing practice (CGMP) requirements applicable to combination products. The rule clarifies which CGMP requirements apply when drugs, devices, and biological products are combined to create combination products. For certain types of combination products the application of CGMP requirements is straightforward – the constituent parts

The Office for Civil Rights (“OCR”) of the Department of Health and Human Services released today the long awaited, and much anticipated, omnibus final rule modifying the HIPAA Privacy, Security, Breach and Enforcement Rules. The final rule, which implements the statutory requirements of the Health Information Technology for Economic and Clinical Health Act (“HITECH”) and the Genetic Information Nondiscrimination Act (“GINA”), is comprised of four final rules and addresses the July 2010 HITECH proposed rule, the Breach Notification and Enforcement interim final rules, as well as the October 2009 GINA proposed rule (collectively, the “HITECH Final Rule”). Notably, the HITECH Final Rule does not address the May 2011 proposed accounting and access report rule.
Continue Reading It’s Here: OCR Releases Long Awaited HIPAA/HITECH Final Rule

On November 27, 2012, CMS sent to the White House Office of Management and Budget for final clearance its long-awaited final rule implementing the ACA’s “Physician Payment Sunshine Act” provisions. Under the ACA, applicable manufacturers of drugs, devices, biologicals, or medical supplies covered under Medicare, Medicaid, or CHIP will be required to report annually to

On November 6, 2012, CMS published a final rule implementing an ACA provision requiring states to reimburse certain primary care physicians in CYs 2013 and 2014 at rates not less than the applicable Medicare rates. This minimum payment level applies to specified primary care services furnished by a physician with a specialty designation of

On October 29, 2012, CMS published additional corrections to its August 31, 2012 final FY 2013 Medicare inpatient prospective payment system (IPPS) rule. The corrections address the achievement thresholds and benchmark values presented in the Clinical Process of Care measures section of the final performance standards for the FY 2015 Hospital Value-Based Purchasing Program table. 

This post was written by Erin Janssen.

The FDA issued a final rule in August amending current regulations to reflect recent statutory amendments to the device registration and listing provisions of the FD&C Act. The Food and Drug Administration Amendments Act of 2007 (FDAAA), enacted on September 27, 2007, amended the FD&C Act

On June 20, 2012, HHS is publishing a final rule to implement the first phase of a process to recognize accrediting entities that will certify qualified health plans for participation in ACA Affordable Insurance Exchanges. In phase one, HHS is recognizing the National Committee for Quality Assurance and URAC as accrediting entities on an

The Centers for Medicare & Medicaid Services (CMS) published a final rule on May 29, 2012 that makes changes to Medicaid regulations regarding overpayments recoveries, state repayment of Medicaid disallowances, and other various policies. Among other things, the rule implements an Affordable Care Act (ACA) provision increasing the period of time states have to

On May 10, 2012, CMS released two final rules designed to reduce regulatory burdens on health care providers as part of the Administration’s ongoing regulatory review initiative. According to CMS, the regulations, will save approximately $1.1 billion across the health system in the first year and more than $5 billion over five years.  The rules are summarized below.Continue Reading CMS Issues Final Rules to Ease Regulatory Burdens on Hospitals, Other Providers

FDA recently published a final rule that expands the scope of clinical investigator disqualification. Under the rule, when the FDA determines that an investigator is ineligible to receive one kind of test article (drugs, devices, or new animal drugs), the investigator also will be ineligible to conduct any clinical investigation that supports an application

This post was written by Erin A. Janssen.

On May 3, 2012 the FDA issued its final rule on sterility testing, amending the requirements for most licensed biological products effective June 4, 2012.  The rule is intended to promote improvement and innovation in the development of sterility test methods by allowing manufacturers the

HHS published a rule on February 27, 2012 that implements the procedural framework for submission and review of State Innovation Waiver applications under section 1332 of the ACA, effective April 27, 2012. Under the rule, states will have flexibility to apply for a State Innovation Waiver to pursue their own strategies to provide their

On February 27, 2012, CMS published a final rule that implements an ACA provision establishing transparency and public notice procedures for experimental, pilot, and demonstration projects approved under section 1115 of the Social Security Act relating to Medicaid and the Children’s Health Insurance Program (CHIP). The rule is intended to expand publicly-available information about Medicaid