Tag Archives: Department of Health & Human Services (HHS)

HRSA asks for comment on provider relief fund and ARP rural reporting requirements

In a notice published on April 7, 2022, the Health Resources and Services Administration (HRSA), the division of HHS that manages the distribution and oversight of CARES Act Provider Relief Funds (PRFs), requested comments from stakeholders on proposed changes to its Information Collection Request (ICR) Form that it will be submitting to the Office of … Continue Reading

Health Care Provisions in the Infrastructure Investment and Jobs Act

On August 1, 2021, the Senate released the legislative text of the bipartisan infrastructure bill, the “Infrastructure Investment and Jobs Act,” H.R. 3684.  The Senate is expected to vote this week, before a month-long recess beginning on August 9, 2021.  The 2,702 page legislation contains several relevant health care-related provisions, including a delay of the … Continue Reading

Consensus among HHS agencies on addressing social determinants of health through better data capture, interoperability

Over the last decade, members of the medical and public health communities around the world have widely studied and acknowledged the impact of social determinants of health (SDOH)—the conditions in the environments where people live, learn, work, play, and age—on a wide range of health, functioning, and quality-of-life-risks and outcomes.[1]  In the past year or … Continue Reading

Final Rules Modernizing Stark Law and Anti-Kickback Statute Released

The Department of Health and Human Services (HHS) released complementary rules this past Friday, November 20, 2020, to modernize and clarify the regulations that interpret the Physician Self-Referral Law (the Stark Law) and the federal Anti-Kickback Statute. As we wrote when the proposed rules were released last autumn (see client alerts here and here), the … Continue Reading

HHS releases final rule and fact sheet to clarify Part 2: Standards for Substance Use Disorder Record Protection, Disclosure, and Registry

After nearly a full year of public comment consideration, last week, the U.S. Department of Health and Human Services (HHS) Substance Abuse and Mental Health Services Administration (SAMHSA) announced and published a Final Rule and Fact Sheet addressing 42 C.F.R. Part 2 (Part 2). Generally speaking, Part 2 affords privacy protections to patient records pertaining … Continue Reading

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 separate Federal … Continue Reading

Sebelius Stepping Down from HHS; Burwell Nominated

On April 11, 2014, President Obama formally nominated Sylvia Mathews Burwell to replace Kathleen Sebelius as Secretary of Health and Human Services (HHS). Burwell currently is the Director of the Office of Management and Budget (OMB). Previously, she served as President of the Walmart Foundation, President of the Global Development Program at the Bill & Melinda … Continue Reading

Final Rules Issued Extending Protections of Electronic Health Record Donations

On December 27, 2013, the Office of Inspector General and the Centers for Medicare & Medicaid Services each published, in the Federal Register, a final rule that amends regulations protecting, from the Anti-Kickback Statute and Stark law, certain arrangements related to the donation of interoperable electronic health records (EHR) software or information technology and training services related to such EHR software. Among these amended regulations was the extension of protections of the Stark law exception and the Anti-Kickback safe harbor from December 31, 2013 to December 31, 2021 (the "sunset" provisions).… Continue Reading

CMS Physician Payment “Sunshine” Final Rule — Overview and Analysis

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 … Continue Reading

Putting Contractors on Notice: The New Public-Private Partnership Joins DOJ, HHS, and Private Sector Partners to Combat Health Care Fraud

This post was written by Mel Beras. As part of the Obama administration’s ongoing effort to combat health care fraud, Health and Human Services (“HHS”) Secretary Kathleen Sebelius and Attorney General Eric Holder announced a new public-private partnership designed to share information and best practices in order to improve detection and prevent payment of fraudulent … Continue Reading

CMS Announces Data Collection for the Physician Payments Sunshine Act Will Not Be Required Before 2013

The Centers for Medicare & Medicaid Services (CMS), tasked with implementing the Physician Payments Sunshine Act, announced yesterday that it will not require pharmaceutical, device, and other applicable manufacturers and group purchasing organizations (GPOs) to begin collecting reportable data before 2013.… Continue Reading

Overview and Analysis of the Proposed Federal Sunshine Regulations

On December 19, 2011, the Centers for Medicare & Medicaid Services ("CMS") published a proposed rule (the "Proposed Rule") related to section 6002 of the Affordable Care Act, commonly referred to as the "Physician Payment Sunshine Act" (so referenced herein, or as the "Act"). The Physician Payment Sunshine Act requires applicable manufacturers of drugs, devices, biologicals, or medical supplies covered under Medicare, Medicaid, or CHIP to report annually to the Secretary of the Department of Health and Human Services ("Secretary") certain payments or other transfers of value to physicians and teaching hospitals. Additionally, applicable manufacturers and applicable group purchasing organizations ("GPOs") must report certain information regarding the ownership or investment interests in them that are held by physicians or their immediate family members.… Continue Reading

CMS Releases Long-Awaited Physician Payments Sunshine Act Proposed Rule

The Centers for Medicare & Medicaid Services ("CMS") released today a proposed 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 payments or other transfers of value to physicians and other covered recipients. In addition, the Act requires manufacturers and group purchasing organizations (GPOs) to report certain information regarding ownership or investment interests held by a physician in the manufacturer or GPO.… Continue Reading

HHS Releases Final Strategic Framework on Multiple Chronic Conditions (MCCs)

HHS has issued its final “Strategic Framework on Multiple Chronic Conditions.” The initiative is designed to represent a “paradigm shift” from a focus on individual chronic diseases to one that uses a multiple chronic conditions approach. HHS highlights the health care resource implications associated with MCCs, since 66% of the country’s total health care spending goes … Continue Reading

Guidance on Medical Care Services for People with Mobility Disabilities

The Department of Justice’s Civil Rights Division and the HHS OCR have issued technical assistance guidance for medical providers on requirements for providing accessible medical services to people with mobility disabilities. Specifically, “Access to Medical Care for Persons with Mobility Disabilities” describes how the Americans with Disabilities Act and Section 504 of the Rehabilitation Act … Continue Reading

Reed Smith Health Care Reform Review: The Affordable Care Act – Analysis and Implications for DMEPOS Suppliers

Suppliers and manufacturers of durable medical equipment (DME), prosthetics, orthotics, and supplies (DMEPOS) will be impacted, directly and indirectly, by numerous provisions of the recently-enacted health reform legislation, H.R. 3590, the Patient Protection and Affordable Care Act (PPACA), as amended by H.R. 4872, the Health Care and Education Reconciliation Act of 2010 (Reconciliation Act), collectively known as the "Affordable Care Act" or ACA.… Continue Reading

HHS Seeks Comments on Draft Strategic Framework on Multiple Chronic Conditions

HHS has published a notice announcing the availability of an interagency working group draft “Strategic Framework on Multiple Chronic Conditions (MCCs).” The draft plan addresses approaches to improving the health of individuals with concurrent multiple chronic conditions (e.g., arthritis, chronic respiratory conditions, diabetes, heart disease, hypertension, and mental health conditions) by providing options for HHS to … Continue Reading