Archives: Other HHS Developments

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HHS Deputy Secretary Hargan Names Innovation/Investment Summit Participants; First Meeting Scheduled for December 18, 2018

Health and Human Services Deputy Secretary Eric Hargan has selected 15 health industry and investment professionals to participate in the Deputy Secretary’s Innovation and Investment Summit (DSIIS), which will hold its inaugural meeting on December 18, 2018.  As previously reported, this initiative is intended to provide a forum for private sector and government experts to … Continue Reading

Healthcare Investors, Innovators Wanted for HHS Summit – Nominations Due October 3, 2018

HHS Deputy Secretary Hargan has announced the creation of the “Deputy Secretary’s Innovation and Investment Summit” (DSIIS), which will provide a forum “to discuss the innovation and investment landscape within the healthcare sector, emerging opportunities, and the government’s role in facilitating more investment and accelerated innovation.”  The DSIIS will involve quarterly meetings between healthcare innovation … Continue Reading

Reed Smith Analysis: Trump Administration’s Drug Pricing Blueprint

As previously reported, the Trump Administration has released its “Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs.”  Many of the recommendations in the Blueprint were previously made in President Trump’s fiscal year 2019 budget proposal, while numerous others are framed as open-ended questions rather than policies.  While the near-term impacts on drug pricing based … Continue Reading

Trump Administration Releases Drug Pricing “Blueprint” and Request for Comments on Reducing Drug Costs

The Trump Administration has launched a high-profile initiative aimed at reducing prescription drug prices, including release of a blueprint containing a series of short- and long-term policy proposals and a request for public comments on additional reforms. First, on May 11, 2018 the Department of Health and Human Services released its “Blueprint to Lower Drug … Continue Reading

New HHS Advisors Appointed to Develop Strategy on Drug Pricing, Opioid Policy

HHS Secretary Alex Azar has appointed two advisors to help advance Department strategy to address prescription drug pricing and the opioid crisis. Daniel M. Best, the new Senior Advisor to the Secretary for Drug Pricing Reform, is charged with leading the HHS initiative to lower the cost of prescription drugs. He recently served as Corporate … Continue Reading

ONC Proposes Trusted Exchange Framework for Health Information Networks

The Office of the National Coordinator (ONC) for Health Information Technology has released a draft trusted exchange framework that proposes policies, procedures, and technical standards to further Congressionally-mandated efforts to establish a nationwide, interoperable health system under the 21st Century Cures Act of 2016.  Currently, there are dozens of Health Information Networks (HINs) that operate … Continue Reading

HHS Creates Conscience and Religious Freedom Division within OCR

On January 18, 2018, HHS announced it has established a new Conscience and Religious Freedom Division within the HHS Office for Civil Rights (OCR).  The Division will focus on enforcement of (1) existing protections for health care providers who refuse to perform certain health care services on religious or moral grounds, and (2) laws that … Continue Reading

HHS Announces New Appeals Settlement Initiatives

The HHS Departmental Appeals Board (DAB) is inviting the public to submit recommendations for precedential Medicare Appeals Council (Council) decisions that will be binding on all CMS, HHS, and Social Security Administration components that adjudicate matters under CMS jurisdiction. The designation of precedential decisions was authorized by regulations adopted earlier this year; the DAB will … Continue Reading

President Trump’s Proposed FY 2018 Budget Spares Medicare, But Calls for Deep Medicaid Cuts & FDA User Fee Hikes

President Trump has released his FY 2018 budget proposal, which the Administration dubs “A New Foundation for American Greatness.”  The proposed budget – which received a generally chilly reception on Capitol Hill – offers a mixed bag for the health care industry.  On the one hand, a document summarizing the Department of Health and Human … Continue Reading

Trump Administration Proposes 17.9% Cut to HHS Programs, Doubling of FDA User Fees

The Trump Administration is calling for deep cuts to Department of Health and Human Services (HHS) funding for fiscal year (FY) 2018 along with a $1 billion hike in Food and Drug Administration (FDA) user fees in its “budget blueprint,” dubbed “America First: A Budget Blueprint to Make America Great Again.”  The blueprint — which … Continue Reading

Trump Administration Signals More Administrative Flexibility for State Medicaid Programs, with Emphasis on “Most Vulnerable Populations”

In her first act as CMS Administrator, Seema Verma joined HHS Secretary Tom Price in writing to the nation’s Governors to urge collaboration on improving the Medicaid program, with an emphasis on services for “truly vulnerable” populations. Price and Verma contend that the “expansion of Medicaid through the Affordable Care Act (ACA) to non-disabled, working-age … Continue Reading

Senate Confirms Verma as CMS Administrator; Trump Nominates Gottlieb for FDA, Hargan as Deputy HHS Secretary

The Senate has approved the nomination of Seema Verma to be CMS Administrator on a vote of 55 to 43. In other nomination news, President Trump has nominated Scott Gottlieb to be Commissioner of Food and Drugs. Dr. Gottlieb is a physician, resident fellow at the American Enterprise Institute, and venture capital firm partner who … Continue Reading

Court Orders HHS to Fix the Medicare Appeals Backlog by the End of 2020

Medicare providers with pending cases at the administrative law judge (“ALJ”) level received positive news last week as a federal judge for the United States District Court for the District of Columbia (the “Court”) granted summary judgment in favor of the American Hospital Association (“AHA”) in its case against the Secretary of the Department of … Continue Reading

PTAC Announces Timeline for Submission of Physician-Focused Alternative Payment Model Proposals

The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) established the Physician-Focused Payment Model Technical Advisory Committee (PTAC) to provide recommendations on arrangements that meet the criteria for a physician-focused payment model (PFPM) under the reformed system for updating the Medicare physician fee schedule. The PTAC has announced that it will begin accepting letters … Continue Reading

OCR Plans to More Widely Investigate HIPAA Breaches Affecting Fewer than 500 Individuals

This month the HHS Office for Civil Rights (OCR) has launched an initiative “to more widely investigate the root causes” of HIPAA breaches affecting fewer than 500 individuals, according to an August 18, 2016 OCR email announcement. While Regional Offices will retain discretion to prioritize investigation of smaller breaches, each office is directed to “increase … Continue Reading

Obama Administration, Congress Take Steps to Fight Opioid Epidemic

HHS has announced a series of actions to address the nation’s opioid epidemic, as Congress has cleared the Comprehensive Addiction and Recovery Act for the President’s signature. As part of the HHS activities, the Substance Abuse and Mental Health Services Administration (SAMHSA) has published a final rule to expand from 100 to 275 the number … Continue Reading

HHS Office of Civil Rights Releases Guidance for Long-Term Care Facilities Using the Minimum Data Set to Facilitate Opportunities to Live in the Most Integrated Setting

The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) has issued new guidance to help long-term care facilities comply with anti-discrimination obligations when they administer the Minimum Data Set (MDS) patient assessment tool so that the facilities’ residents receive care in the most integrated setting appropriate to their needs. Those … Continue Reading

HHS Finalizes HIPAA Amendments to Allow Reporting of Certain Mental Health Information to the National Instant Criminal Background Check System

On January 6, 2016, HHS published a final rule to modify the HIPAA Privacy Rule to expressly permit certain HIPAA covered entities to disclose to the National Instant Criminal Background Check System (NICS) the identities of individuals who are subject to a federal “mental health prohibitor” that disqualifies them from shipping, transporting, possessing, or receiving … Continue Reading

ONC Releases Final 2016 Interoperability Standards Advisory

The Office of the National Coordinator for Health Information Technology (ONC) has released its final 2016 Interoperability Standards Advisory, which catalogs the “best available” interoperability standards and implementation specifications for industry use to fulfill specific clinical health information technology (IT) interoperability needs. The Advisory focuses only on clinical health IT systems’ interoperability; it does not … Continue Reading
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