Archives: Other HHS Developments

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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

ONC Issues Final Health IT Interoperability Roadmap

The HHS Office of the National Coordinator for Health Information Technology (ONC) has released its final “Roadmap” to promote the secure exchange and use of electronic health information. The document, “Connecting Health and Care for the Nation: A Shared Nationwide Interoperability Roadmap Version 1.0,” describes policy and technical actions needed to meet ONC’s “vision of … Continue Reading

OMHA Expands Settlement Conference Facilitation Pilot

The HHS Office of Medicare Hearings and Appeals (OMHA) has announced that it is expanding its Settlement Conference Facilitation pilot’s eligibility criteria to include more pending appeals. As previously reported, this pilot program is designed to bring the appellant and CMS together to discuss the potential of a mutually-agreeable resolution to claims appealed to an … Continue Reading

ONC Releases Final Health IT Strategic Plan, Draft Interoperability Standards Advisory

The Office of the National Coordinator for Health Information Technology (ONC) has released its final Federal Health IT Strategic Plan for 2015-2020. The 50-page document details how the federal government intends to effectively use health information technology (IT) “to help the nation achieve high-quality care, lower costs, a healthy population, and engaged individuals.” The strategic … Continue Reading

White House Releases Proposed Precision Medicine Initiative Privacy Framework

Earlier this year, President Obama launched a high-profile “Precision Medicine Initiative” (PMI) to develop treatments, diagnostics, and prevention strategies tailored to the individual genetic characteristics of each patient.  On July 8, 2015 the White House released for public comment a draft document entitled “Precision Medicine Initiative: Proposed Privacy and Trust Principles,” which provides broad guidance … Continue Reading

ONC Updated Electronic Health Information Privacy/Security Guidance

The Office of the National Coordinator for Health Information Technology (ONC) has released a revised Guide to Privacy and Security of Electronic Health Information. The guide is intended to help health care providers – especially those from smaller organizations – address federal health information privacy and security requirements in their practices. The new version updates … Continue Reading

Obama Administration Announces Plan to Combat Antibiotic Resistant Bacteria

On March 27, 2015, the Obama Administration released its National Action Plan for Combating Antibiotic Resistant Bacteria (NAP), a five-year, government-wide plan to address the spread of resistant bacteria. The main components of the strategy, which identifies roles for the public and private sectors, are as follows: Slow the emergence of resistant bacteria and prevent the … Continue Reading

CMS Launches Health Care Payment Learning and Action Network

On March 25, 2015, CMS formally launched the Health Care Payment Learning and Action Network, a public-private partnership intended to support HHS’s goal of moving Medicare and the broader health industry from a fee-for-service model towards alternative payment models that emphasize value. According to CMS, more than 2,800 entities have registered to join the Network, … Continue Reading

CMS Proposes Removing Two NCDs under Expedited Process

In 2013, CMS adopted an expedited administrative process to remove certain national coverage determinations (NCDs) older than 10 years since their most recent review. In December 2014, CMS removed seven NCDs under this process. On March 18, 2015, CMS proposed removing two more NCDs under this process, addressing coverage of Apheresis (therapeutic pheresis) and Smoking and Tobacco-Use … Continue Reading

Obama Administration Releases FY 2016 Budget Proposal with Medicare/Medicaid Provisions

On February 2, 2015, the Obama Administration released its proposed federal budget for fiscal year (FY) 2016. The budget would impact all types of health care providers, health plans, and drug manufacturers if adopted as proposed – which is unlikely given Republican control of the House and Senate. Nevertheless, Congress can be expected to consider … Continue Reading
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