The recently passed “Coronavirus Aid, Relief, and Economic Security Act” (CARES Act) is sweeping legislation that will have widespread impact on companies in the health care and life sciences space. In addition to expanding coverage of COVID-19 testing and preventive services, the Act includes provisions to address health care workforce needs, eases restrictions surrounding telehealth … Continue Reading
Today, the Department of Health and Human Services (HHS) announced proposed changes to modernize the regulations that interpret the Physician Self-Referral Law (the Stark Law) and the Federal Anti-Kickback Statute. In a press release, HHS states these proposed rules are intended to “provide greater certainty for healthcare providers participating in value-based arrangements and providing coordinated … Continue Reading
On July 18, 2018, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) submitted to the Office of Management and Budget (OMB) for regulatory review a proposed rule entitled “Removal Of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor … Continue Reading
Immediately following Sunday’s tragic shooting at a nightclub in Orlando, friends and family frantically gathered at Orlando Regional Medical Center, attempting to get information about their loved ones. However, hospital officials hesitated to provide specific updates. Why? Because the Health Insurance Portability and Accountability Act (HIPAA) and implementing regulations restrict the patient-identifiable health information that … Continue Reading
On June 17, 2015, the Health Resources and Services Administration (HRSA) issued a proposed rule to implement civil money penalty (CMP) provisions added to section 340B of the Public Health Service Act as part of the Affordable Care Act (ACA). The proposed rule addresses three primary issues: (i) the calculation of the 340B “ceiling price” … Continue Reading
The Administration has updated its regulatory agenda, which lists major pending or planned regulatory actions and the anticipated timing of rulemaking activity. The agenda lists numerous pending HHS proposed and final rules in a range of policy areas, including Medicare payment updates, 340B drug pricing policies, and changes to fraud and abuse authorities, among many others.… Continue Reading
Today HHS published a request for public comments regarding the health plan identifier (HPID), including the requirements regarding health plan enumeration, and the requirement to use the HPID in electronic health care transactions. Specifically, HHS is seeking information regarding the following: The HPID enumeration structure outlined in the September 5, 2012 HPID final rule, including … Continue Reading
On May 8, 2015, the Health Resources and Services Administration (HRSA) published a final rule to implement the HIV Organ Policy Equity Act (HOPE Act), which modifies standards related to Organ Procurement Transplantation Network (OPTN) acquisition of organs from individuals known to be infected with human immunodeficiency virus (HIV). Under the final rule, organs from … Continue Reading
Today the Health Resources and Services Administration (HRSA) officially requested White House Office of Management and Budget (OMB) review of new “omnibus guidelines” on the 340B drug discount program. While the guidelines are not yet available to the public, the document will presumably fulfill HRSA’s pledge last year to address “key policy issues raised by … Continue Reading
The Health Resources and Services Administration (HRSA) is seeking White House review of its proposed rule to implement new Affordable Care Act 340B drug discount program enforcement authorities and pricing policies. More than four years after soliciting comments on the planned rulemaking, the HRSA proposal will address its authority to impose civil monetary penalties (CMPs) on … Continue Reading
On March 30, 2015, the Centers for Medicare & Medicaid Services (CMS) published its proposed rule on Stage 3 meaningful use criteria, which focus on the advanced use of Electronic Health Record (EHR) technology to promote improved outcomes for patients. The proposed rule would establish the requirements that eligible professionals (EPs), eligible hospitals, and critical access … Continue Reading
The Departments of Labor, Health and Human Services, and Treasury published a final rule on March 18, 2015 that amends the definition of excepted benefits to allow group health plan sponsors, in limited circumstances, to offer wraparound coverage to individuals who are purchasing individual health insurance in the private market, including through the Affordable Care … Continue Reading
HHS has sent to the White House Office of Management and Budget (OMB) for final regulatory clearance a proposed rule on Stage 3 meaningful use criteria for the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs. The Stage 3 rule will focus on advanced use of EHR technology to promote improved outcomes for patients, … Continue Reading
The Administration has posted its fall regulatory agenda listing major pending or planned regulatory actions and anticipated timing of rulemaking. The agenda lists numerous pending HHS proposed and final rules in a range of policy areas, including Medicare payment updates, revisions to provider conditions of participation, and changes to fraud and abuse authorities, among many others. … Continue Reading
HHS has published the FY 2016 Federal Medical Assistance Percentages (FMAP), Enhanced FMAP, and disaster-recovery FMAP adjustments. These percentages, which will apply from October 1, 2015 through September 30, 2016, apply in determining the federal matching for state expenditures for Medicaid and certain other medical and other social services.… Continue Reading
On December 8, 2014, HHS is publishing a notice announcing that the Presidential Commission for the Study of Bioethical Issues is requesting public comment on ethical considerations related to public health emergency response, focusing on the current Ebola virus disease (EVD) epidemic. In particular, the Commission is examining: U.S. public policies that restrict association or … Continue Reading
NIH has just released a proposed rule that would clarify and expand requirements for the submission of clinical trial registration and results information, including adverse event information, to the ClinicalTrials.gov database in conformance with the Food and Drug Administration Amendments Act of 2007 (FDAAA). The rule would implement the statutory requirement for the submission of … Continue Reading
The Health Resources and Services Administration (HRSA) has officially withdrawn from Office of Management and Budget review a long-awaited proposed rule to establish comprehensive requirements for entities and manufacturers participating in the 340B Drug Pricing Program. HRSA notes in a web posting that it intends to issue proposed guidance for notice and comment in 2015 … Continue Reading
The HHS Office of Medicare Hearings and Appeals (OMHA) is seeking public comments on ways to address the substantial growth in the number of hearing requests being filed with OMHA and the backlog of pending cases. In particular, OMHA is seeking suggestions related to current OMHA initiatives or other recommendations for addressing the increased workload and/or backlog … Continue Reading
On October 24, 2014, the HHS Office for Human Research Protections published a notice announcing that it is seeking comments on draft guidance for the research community entitled “Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care.” The guidance addresses risks to subjects that are presented by research evaluating risks associated with … Continue Reading
The Office of the National Coordinator for Health Information Technology (ONC) is launching the “Market R&D Pilot Challenge,” which will bring together health care organizations and innovative companies to test new health information technology products through pilot funding awards and facilitated matchmaking. Pilot proposals could be awarded in three domains: clinical environments (e.g., hospitals, ambulatory … Continue Reading
The Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) has published a major proposed rule that would amend the safe harbors to the Anti-Kickback Statute (AKS) and the Civil Monetary Penalty rules to protect certain payment practices and business arrangements from criminal prosecution or civil sanctions under the AKS. Reed Smith has prepared a Client Alert analyzing the proposed rule, highlighting areas where the OIG is seeking public comment. Overall, the OIG appears to recognize that new health care delivery mechanisms demand a more flexible approach to fraud and abuse enforcement than has been the case in the past, as discussed in our analysis.… Continue Reading
The Office of the National Coordinator for Health Information Technology (ONC) published a final rule on September 11, 2014 that is intended to introduce regulatory flexibilities with regard to certification to the 2014 Edition Electronic Health Records (EHR) Certification Criteria. The rule also codifies certain revisions to the ONC Health Information Technology (HIT) Certification Program … Continue Reading
On September 19, 2014, the Office of Inspector General (OIG) of the Department of Health & Human Services issued a Special Advisory Bulletin (SAB) in which it identified several potential regulatory risks to federal health care programs as the result of coupon programs used by drug manufacturers to reduce or eliminate patient copayments for brand-name drugs. In the SAB, the OIG explains that coupon program sponsors and pharmacies will risk the receipt of penalties if they do not take steps to actively prevent federal health care program beneficiaries from using the coupons. According to the OIG, these coupon programs qualify as examples of remuneration offered to consumers to encourage the purchase and use of specific items, and therefore implicate the federal Anti-Kickback Statute. In addition, a claim that includes items or services resulting from such a kickback violation would constitute a false or fraudulent claim under the False Claims Act.… Continue Reading
