Only a few days remain before the enforcement delay that the Centers for Medicare & Medicaid Services (CMS) exercised due to COVID-19 will end and the agency will require certain payors to publish a Patient Access application programming interface (“API”) and a Provider Directory API under the requirements of the CMS Interoperability and Patient Access Final Rule. Starting on July 1, 2021, all health plans that offer Medicare Advantage, Medicaid and Children’s Health Insurance Program (CHIP) and most Qualified Health Plans offered through the Federally-facilitated Exchange will be required to make enrollee electronic health information held by the payor and the health plan’s Provider Directory (QHP Issuers on the FFEs are required to make a Provider Directory under a different CMS rule, not under this rule) available through application programming interfaces (“Open APIs”). CMS is also hopeful that when these payors see the benefit of offering easy access for their federally subsidized health care program enrollees to use and exchange their electronic protected health information, the payors will offer the same opportunity for enrollees in their commercial and Employer Sponsored plans.
Our colleagues Alaap Shah and Stuart Gerson of Epstein Becker Green have written an Expert Analysis on Law360 that will be of interest to our readers: “Health Cos. Must Prepare for Growing Ransomware Threat.”
The following is an excerpt (see below to download the full version in PDF format):
Ransomware attacks have become big business, and they are on the rise. And entities in the health care and life sciences space have become primary targets of opportunity for attackers.
The roll out of the Office of the National Coordinator’s (ONC) 21st Century Cures Act Interoperability and Information Blocking Rules is reminiscent of the way HIPAA has rolled out over the course of the past 25 years. As of May 1, 2021, Actors have been required to comply with the Information Blocking rules. However, it will take some time before all Actors know who they are and for complaints of Information Blocking to be determined to be actual instances of Information Blocking, by which time the penalties that have not yet been finalized may also need to be adjusted.
The issue of mandatory vaccines has been a sensitive one for employers. Although the EEOC cleared the way for employers to mandate vaccines in its Technical Assistance guidance, What You Should Know About COVID-19 and the ADA, the Rehabilitation Act, and Other EEO Laws, most employers have taken the route of strongly encouraging rather than mandating vaccines. Now, with the rate of vaccines leveling off, employers are re-thinking that approach. A Texas federal court’s recent decision dismissing a challenge to an employer’s vaccine requirement may provide just the legal support some employers need to implement a vaccine mandate. Read more…
The U.S. Department of Labor’s Occupational Safety and Health Administration (“OSHA”) has announced it will issue an emergency temporary standard (ETS) to protect healthcare workers from contracting coronavirus. Read more…
On May 17, 2021, the U.S. Department of Justice (“DOJ”) announced the establishment of a COVID-19 Fraud Enforcement Task Force (“Task Force”) to ramp up enforcement efforts against COVID-19-related fraud.
Organized and led by Deputy Attorney General Lisa Monaco, the Task Force convened its first meeting on May 28 and aims to “marshal the resources of the [DOJ] in partnership with agencies across government to enhance enforcement efforts against COVID-19 related fraud.” The Task Force will involve coordination among several DOJ components, including the Criminal and Civil Divisions, the Executive Office for United States Attorneys, and the Federal Bureau of Investigation. “Key interagency partners” have also been invited to join the Task Force, including the Department of Labor, the Department of the Treasury, the Department of Homeland Security, the Social Security Administration, the Department of Veterans Affairs, the Food and Drug Administration’s Office of Criminal Investigations, the U.S. Postal Inspection Service, the Small Business Administration, the Special Inspector General for Pandemic Relief, and Pandemic Response Accountability Committee, among others.
In this episode of the Diagnosing Health Care Podcast: The Departments of Labor, Health and Human Services, and the Treasury jointly released a set of frequently asked questions (“FAQs”) related to recent changes made to the Mental Health Parity and Addiction Equity Act effective as of February 10, 2021, and enacted by the Consolidated Appropriations Act at the end of 2020. Accordingly, health plans and insurers must ensure that they understand, and are prepared to provide regulators with documentation of their compliance with, parity requirements on at least a small group of specific non-quantitative treatment limits.
District Court Invalidates Medicare GME Regulation and Orders CMS to Recalculate Hospitals’ Medicare Reimbursement
Teaching hospitals should find that their Medicare reimbursement for training physicians will be a little sweeter thanks to a decision by the United States District Court for the District of Columbia. Milton S. Hershey Medical Center, et al. v. Becerra, No. 19-2680 (D.D.C. May 17, 2021). The hospitals challenged a 1997 regulation that set out a formula for counting the number of full-time residents and fellows. Under the Medicare statute, the government reimburses hospitals for salaries and administrative costs directly related to graduate medical education (“GME”). The statute contains a formula for determining the weighted number of full-time equivalent residents (“FTEs”) employed by the hospital. The formula weights FTEs based on the length of their employment, and imposes a cap on the number of FTEs that a hospital can count for Medicare reimbursement. 42 U.S.C. § 1395ww(h)(3-5). The formula also counts residents differently from fellows, who have completed a residency in a specialty and are receiving further training in a subspecialty; for purposes of the FTE count, the weighting factor for residents is 1.0 and for fellows the weighting factor is 0.5. 42 U.S.C. § 1395ww(h)(4)(C). Congress also capped the number of FTEs that can be counted for purposes of Medicare reimbursement at the FTE count for that hospital as of December 31, 1996.
Podcast: Federal and State Cannabis Rules Are Moving in Different Directions – Diagnosing Health Care
In this episode of the Diagnosing Health Care Podcast: Federal and state cannabis regulation and enforcement appear to be moving in different directions. While the Food and Drug Administration (“FDA”) has broadened its net to target businesses making claims that their products can treat specific conditions, a growing number of states have passed bills that, among other things, legalize adult-use cannabis.
Responding to COVID-19 was uncharted territory for many employers. The EEOC helped guide employers through many challenging employment aspects of the pandemic with regular updates to its Technical Assistance document, What You Should Know About COVID-19 and the ADA, the Rehabilitation Act, and Other EEO Laws. However, since addressing just a few vaccine-related issues in December 2020, the EEOC has been silent for months. With questions mounting, employers and business groups have clamored for answers from the EEOC on critical issues such as vaccine mandates, incentives, proof of status, and confidentiality. Now, with progress on vaccines well underway and many employers implementing return to office plans, the EEOC finally weighed in with updated guidance on May 28, 2021. Read more…