As part of its ongoing implementation of the 21st Century Cures Act (Public Law 114-255), the Department of Health and Human Services last month released a number of new HIPAA guidance tools, including additional information about research uses and disclosures. The research guidance contains helpful tips for covered entities regarding authorizations, revocations, and “reviews preparatory … Continue Reading
Last week, the Chairman on the House of Representatives’ Committee on Energy and Commerce, Greg Walden (R-OR), sent a formal letter to the Dept. of Health and Human Services (“HHS”) requesting that HHS “develop a plan of action for creating, deploying, and leveraging [bill of materials] for health care technologies.” Walden gave HHS until December … Continue Reading
Rejecting a contrary holding in the Fourth Circuit, the Sixth Circuit decided a healthcare provider has no “fundamental right to participate in federal health care programs.” Accordingly, the Department of Health and Human Services (HHS) was correct to exclude a pharmacist from federal healthcare programs simply because he was convicted of misdemeanor misbranding.… Continue Reading
The recent WannaCry ransomware attack and the bevy of breaches over the past few years demonstrate that cyber risks in the healthcare arena are substantial and widespread. The Department of Health and Human Services (HHS) Health Care Industry Cybersecurity (HCIC) Task Force Report (HCIC Report), required under the federal Cybersecurity Information Sharing Act of 2015, … Continue Reading
Late last year, the Department of Health and Human Services Office of the Inspector General (OIG) published a final rule (Final Rule) that amends the safe harbors to the federal Anti-Kickback Statute (AKS) by modifying an existing safe harbor, adding new safe harbors and codifying existing statutory provisions that provide further protections from sanctions under the … Continue Reading
On Thursday, CMS announced that it intends to allow providers to “pick their pace of participation” for the first compliance year of Medicare’s new payment reform model emphasizing quality patient care. The start of the first compliance year is January 1, 2017. Thursday’s announcement lays out four options that allow providers more flexibility to comply … Continue Reading
Last month, the U.S. Department of Health and Human Services (HHS) entered into a historic Memorandum of Understanding (MOU) with Cuba’s Ministry of Public Health. The MOU establishes coordination across a broad spectrum of public health issues, including: Healthcare systems and public health management; Quality management and patient safety systems in hospitals and outpatient settings; … Continue Reading
In a move that could affect all hospitals reimbursed by Medicare, the American Hospital Association (AHA) this week renewed strenuous objections to various aspects of ongoing hospital compliance reviews conducted by the Department of Health and Human Services (HHS) Office of Inspector General (OIG). AHA’s most recent correspondence references the “numerous legal defects” it had … Continue Reading
Yesterday, in a blow to the Obama Administration, the United States District Court for the District of Columbia struck down a key ACA provision designed to reduce insurance costs. Specifically, Section 1402 of the ACA requires insurers participating in the Exchanges to reduce deductibles, coinsurance, copayments, and other means of cost-sharing on qualified health plans. … Continue Reading
The Centers for Medicare and Medicaid Services (CMS) recently released a proposed rule (the “Proposed Rule”) establishing two physician payment systems introduced by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). These two systems, the Merit-based Incentive Payment System (MIPS) and the Alternative Payment Models (APM), change the way Medicare incorporates quality metrics … Continue Reading
Today, CMS submitted to the Federal Register (for publication on April 27th) its annual notice of proposed IPPS rates and policy changes for federal fiscal year (“FY”) 2017. Today’s notice contains a proposal to eliminate permanently the .2% payment reduction that CMS had implemented in FY 2014 to offset a projected net increase in IPPS … Continue Reading
On March 30, 2016, the US Department of Justice (DOJ) announced that healthcare providers who serve the elderly in the following 10 states will have task forces looking over their shoulders: California, Georgia, Kansas, Kentucky, Iowa, Maryland, Ohio, Pennsylvania, Tennessee and Washington. Known as the Elder Justice Task Forces (Task Forces), these partnerships combine the … Continue Reading
Hospital systems are on notice for ransomware attacking their health IT systems after three hospital systems are reported to be victims of computer viruses. In response, one hospital system paid almost $17,000 in Bitcoin to retrieve their EHR, while the other two hospital systems worked off paper records and backup systems for a few days … Continue Reading
On February 29th, CMS published its final rule regarding the 2017 benefit and payment parameters for the Federally-facilitated health insurance exchanges. As part of the final rule, CMS creates standardized health care plans that insurers can offer on the exchanges. CMS created the standardized plans in order to simplify health insurance shopping for consumers. According … Continue Reading
The United States Department of Health and Human Services (HHS) recently entered into a $750,000 resolution agreement with the University of Washington (UW) following an investigation. The investigation was prompted by UW reporting a breach of about 90,000 people’s personal health information (PHI) after an employee unknowingly downloaded malicious malware from an email attachment. Similar … Continue Reading
On November 16, 2015, the Department of Health and Human Services, Centers for Medicare and Medicaid Services, issued a final rule revising, clarifying, and adding exceptions to the Physician Self-referral Law (“Stark”) in order to (1) accommodate delivery and payment system reform; (2) reduce burdens; and (3) ensure and facilitate compliance. These changes include two new … Continue Reading
Only two days after releasing its latest fraud alert, a deputy director from HHS’s Office of Inspector General announced that the OIG will be hiring additional attorneys to look into taking more administrative actions against physicians in their individual capacity. This announcement emphasizes that the OIG means serious business – not only is the OIG … Continue Reading
Board members for organizations of all sizes need to be familiar with the OIG’s recent publication of Practical Guidance for Health Care Governing Boards on Compliance Oversight. This informative guide is intended to assist the Board member of any health care organization fulfil compliance obligations with the myriad of health care laws and regulations. Although … Continue Reading
The Centers for Medicare and Medicaid Services (CMS) continues to mull over the knotty problem of what it means to identify an overpayment from the government. Healthcare providers do not have the same luxury. Five years ago, the Affordable Care Act required a provider that received an overpayment from the government to report and repay it within 60 days of identifying the … Continue Reading
Happy Halloween! In addition to costumes and candy, October 31 saw the release of the 2015 Work Plan by the Office of Inspector General for Health and Human Services. Always a lengthy document, the Work Plan can indicate areas that providers and suppliers want to monitor closely, as they are areas receiving attention from the government. In … Continue Reading
On January 8, 2014, we noted several proposed changes to the Medicare Part C and D programs as delineated in CMS’ January 8th proposed rule (hereinafter “Proposed Rule”). On Monday, May 19, 2014, CMS issued the final rule, titled Medicare Program; Contract Year 2015 Policy and Technical Changes to the Medicare Advantage and the Medicare … Continue Reading
On Wednesday, the Centers for Medicare and Medicaid Services (“CMS”) issued a second round of long-awaited red tape reduction initiatives aimed at ameliorating overly burdensome provider regulations. The changes, memorialized within a Final Rule scheduled for publication on May 12, 2014 (available for review here: http://federalregister.gov/a/2014-10687) (“Unpublished Final Rule”) include significant easing of Conditions of … Continue Reading
Given the 880,000 names of physicians released by Medicare Wednesday, physicians who treat Medicare patients can expect their names to be on the list. The list, searchable here, contains the name of the provider, the specialty area, the city, county and state as well as the total payments made to the provider by Medicare for … Continue Reading
On February 7, 2014, the Centers for Medicare and Medicaid Services (CMS) issued a memorandum that adds to the growing library of federal guidance on the permissibility of and limitations for health care providers and other entities paying the premiums of patients covered by qualified health plans (QHPs) in the health insurance exchanges or marketplaces. … Continue Reading