Other HHS Developments

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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…

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…

President Trump has named Eric Hargan to serve as Acting HHS Secretary, replacing Don Wright (who was just named to the post on September 29, 2017).  The HHS Secretary vacancy was created when Tom Price, MD resigned the post September 29.  Hargan, an attorney who served at HHS during the George W. Bush Administration, was …

In the wake of the resignation of former Secretary Tom Price, MD over concerns about his travel expenses, President Trump has named Don Wright, MD, MPH, as Acting Secretary of the Department of Health and Human Services (HHS). Wright previously served as Acting Assistant Secretary for Health.  The Administration has not yet indicated who will…

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…

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…

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…

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…

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 Health and Human Services (“HHS”).1

Since 2014, AHA has been litigating with HHS regarding HHS’ failure to meet statutorily-imposed deadlines for Medicare administrative appeals.2 On remand from the D.C. Circuit3 with instructions for further proceedings, the Court determined that there were equitable grounds to issue a writ of mandamus. The Court reasoned that even with certain good faith efforts made by HHS to reduce the backlog (such as a Proposed Rule4 issued this past summer), the appeals backlog was “still unacceptably high.”5 In its decision, the Court found that HHS did not “point to any categorically new administrative actions” and continues “to promise the elimination of the backlog only ‘with legislative action’ — a significant caveat.”6Continue Reading Court Orders HHS to Fix the Medicare Appeals Backlog by the End of 2020

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…

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…

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 of patients that qualified practitioners may treat with buprenorphine, a medication to treat opioid use disorder. Furthermore, as noted in a separate post, the proposed 2017 OPPS rule would remove certain pain management questions from consideration for purposes of Hospital Value-Based Purchasing (VBP) Program payment adjustments “to mitigate even the perception that there is financial pressure to overprescribe opioids.” In addition, HHS announced its research priorities regarding opioid misuse and pain treatment, and the Indian Health Service adopted a requirement that prescribers and pharmacists check state Prescription Drug Monitoring Program (PDMP) databases before prescribing or dispensing opioids for pain.

These actions come as the OIG has highlighted significant Medicare Part D spending on commonly abused opioids, which the OIG estimates exceeded $4 billion in 2015. In fact, almost one in three Medicare Part D beneficiaries received a commonly abused opioid in 2015, according to the OIG. The OIG recommends that CMS take additional actions to prevent opioid abuse within the Medicare program, signaling the potential for additional policies in this area.

In another related development, this month both the House and Senate approved the conference report to accompany S 524, the Comprehensive Addiction and Recovery Act. Among many other things, the bipartisan legislation would:
Continue Reading Obama Administration, Congress Take Steps to Fight Opioid Epidemic

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 obligations arise under Section 504 of the Rehabilitation Act (29 U.S.C. § 701 et seq.) (Section 504) and the Americans with Disabilities Act (42 U.S.C. § 12101 et seq.) (ADA), which prohibit long-term care facilities receiving federal financial assistance from discriminating against individuals based on disability.  The unnecessary placement of residents in an inpatient setting when they could live in a more integrated setting may constitute discrimination under Section 504 and the ADA, as interpreted by the U.S. Supreme Court in Olmstead v. L.C., 527 U.S. 581 (1999).

OCR’s guidance, issued May 20, 2016, includes recommendations concerning MDS administration. OCR issued the guidance after finding that long-term care facilities have misinterpreted certain required questions when administering the MDS to their residents, namely – MDS Section Q, questions Q0400, Q0500 and Q0600.  Those questions, as well as others in Section Q of the MDS, are intended to ensure that long-term care facilities provide all residents with the opportunity to learn about home and community-based services.  The guidance sets forth detailed instructions concerning how operators should answer each of the three questions.  According to OCR, proper administration of these questions is critical to assisting residents to receive services in the most integrated setting.
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

HHS is forming a new “Health Care Industry Cybersecurity Task Force” as part of the Administration’s effort to improve preparedness for cybersecurity threats affecting the health care industry.  HHS is accepting nominations for the Task Force until March 9, 2016.  Key qualifications for panelists include:
Continue Reading HHS Seeks Nominees for New Health Care Cybersecurity Task Force; Nominations Due March 9

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…

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…

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…