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
Department of Health & Human Services
HHS Posts Fall 2014 Regulatory Agenda
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…
FY 2016 Federal Financial Participation Matching Amounts Released
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.
Presidential Bioethics Commission Seeks Comments on Ethical Implications of Public Health Response to Ebola Outbreak & Other Emergencies
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
…
NIH Releases Proposed Rule on FDAAA Requirements for ClinicalTrials.Gov Registration and Results Submission
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…
HRSA Withdraws Pending 340B Rule, Plans New 2015 Rulemaking
The Health Resources and Services Administration (HRSA) has officially withdrawn from Office of Management and Budget review a long-awaited proposed rule to establish comprehensive requirements for entities and manufacturers participating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…
HHS OMHA Soliciting Suggestions for Reducing Medicare Appeals Backlog
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…
Draft HHS Guidance on Disclosing Risks in Standards of Care Research
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…
ONC Invites Applications for “Market R&D Pilot Challenge”
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.…
Reed Smith Client Alert: Analysis of HHS OIG Proposed Rule to Amend the Anti-Kickback Safe Harbors, CMP Rules on Beneficiary Inducements & Gainsharing Regulations
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 Reed Smith Client Alert: Analysis of HHS OIG Proposed Rule to Amend the Anti-Kickback Safe Harbors, CMP Rules on Beneficiary Inducements & Gainsharing Regulations
ONC Final Rule on EHR Certification Criteria
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…
HHS OIG Paints with Broad Brush in Criticizing Drug Manufacturer Coupon Programs
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 HHS OIG Paints with Broad Brush in Criticizing Drug Manufacturer Coupon Programs
OMB Clears OIG Proposed Rule on Anti-Kickback Safe Harbors, CMPs for Beneficiary Inducements & Gainsharing
The Office of Management and Budget (OMB) has cleared an HHS Office of Inspector General (OIG) proposed rule that would expand the OIG’s Medicare and state health care program fraud and abuse authorities. Specifically, on September 4, 2014, the OMB gave final regulatory clearance to an OIG proposed rule that would add new anti-kickback safe…
CMS Final Rule Revises EHR Meaningful Use Timeline
The Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) have issued a final rule that gives providers additional options in how they use certified electronic health record (EHR) technology (CEHRT) to meet meaningful use requirements for the 2014 EHR Incentive Program reporting period. Under…
HHS Revises ACA Contraception Coverage Requirements
The Obama Administration has issued two regulations addressing coverage of contraceptive services under QHPs in response to recent court rulings (in particular the Supreme Court ruling in Burwell v. Hobby Lobby Stores, Inc.) addressing certain religious objections to such coverage. First, an interim final rule provides an additional pathway for nonprofit organizations eligible for a…
HHS Officially Sets October 1, 2015 Date for ICD-10 Implementation
HHS has published a final rule that makes official the October 1, 2015 compliance date for the International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) and the International Classification of Diseases, 10th Revision, Procedure Coding System (ICD-10-PCS). HHS had previously intended to transition from ICD-9 to ICD-10 on October 1, 2014, but the Protecting…
Proposed ACA Eligibility Redetermination/Renewal Process for 2015
HHS has issued a proposed rule that would specify additional options for annual eligibility redeterminations and renewal and re-enrollment notice requirements for qualified health plans offered through the ACA insurance Exchange/Marketplace, beginning with annual redeterminations for coverage for plan year 2015. Comments are due July 28, 2014.
Proposed ACA Eligibility Redetermination/Renewal Process for 2015
HHS has issued a proposed rule that would specify additional options for annual eligibility redeterminations and renewal and re-enrollment notice requirements for qualified health plans offered through the ACA insurance Exchange/Marketplace, beginning with annual redeterminations for coverage for plan year 2015. Comments are due July 28, 2014.
HHS Issues Spring 2014 Semiannual Regulatory Agenda
The Department of Health and Human Services (HHS) has released its Spring 2014 Semiannual Regulatory Agenda, which outlines planned regulatory initiatives across the Department and in a wide range of policy areas. Major prospective HHS rulemakings likely to have a significant economic impact on a substantial number of small entities are compiled in a …
Obama Administration Finalizes Employment Orientation Limit Applicable to ACA Health Coverage Waiting Period
On June 25, 2014, HHS and the Departments of Labor and Treasury are publishing a final rule addressing the treatment of employment orientation periods for purposes of the Affordable Care Act (ACA) health insurance coverage waiting period limitation. The ACA generally bars employer-sponsored group health plans and group health insurance issuers from imposing a…