On January 31, 2019, the United States Department of Health and Human Services (HHS) Office of Inspector General (OIG) announced a proposed rule that would significantly change the federal Anti-Kickback Statute (AKS) regulatory safe harbors regarding prescription drug rebates and discounts ...
On December 28, 2018, the Department of Health and Human Services (HHS), in partnership with the Health Sector Coordinating Council (HSSC), published the “Health Industry Cybersecurity Practices: Managing Threats and Protecting Patients” (HICP Publication), which is a four-volume publication designed to provide voluntary cybersecurity practices to health care organizations of all types and sizes, ranging from local clinics to large health care systems ...
On January 25, 2019, the National Labor Relations Board (Board) returned to the common-law agency test for determining whether workers qualified as independent contractors. SuperShuttle DFW, Inc., 367 NLRB No. 75 (2019) The decision expressly overrules the Board’s decision in FedEx Home Delivery, 361 NLRB 610 (2014), enf. denied 849 F.3d 1123 (D.C. Cir. 2017) ...
The Department of Health and Human Services Office for Civil Rights (OCR) has published a Request for Information on Modifying HIPAA Rules to Improve Coordinated Care (RFI). OCR announced the publication of the RFI through a December 12, 2018 press release available here. OCR Director Roger Severino stated that OCR is “looking for candid feedback about how the existing HIPAA regulations are working in the real world and how we can improve them ...
Employers, as you settle into 2019 and solidify your plans and objectives for the year, consider adding worksite immigration compliance to your to-do list. In 2018, the Trump administration held true to its Buy American, Hire American policy. As a result, worksite investigations, I-9 audits, and criminal and administrative worksite-related arrests surged by 300 to 750 percent over 2017 ...
Employers, as you settle into 2019 and solidify your plans and objectives for the year, consider adding worksite immigration compliance to your to-do list. In 2018, the Trump administration held true to its Buy American, Hire American policy. As a result, worksite investigations, I-9 audits, and criminal and administrative worksite-related arrests surged by 300 to 750 percent over 2017 ...
Eliminating Kickbacks in Recovery Act Overview On October 24, 2018, Congress enacted the Eliminating Kickbacks in Recovery Act of 2018 (EKRA) as part of the SUPPORT Act, which is a comprehensive attempt to combat the opioid epidemic. EKRA established an all-payer anti-kickback prohibition that extends to arrangements with recovery homes, clinical treatment facilities, and laboratories. Unlike the Anti-Kickback Statute (AKS) under 42 U.S ...
Generally, mediation and its process are foreign to most litigants. With the possible exception of the parties’ lawyers and insurance adjusters, often even the most sophisticated business clients have never been in mediation and do not fully understand the process or know what to expect. Frequently, as the mediator, in the early stages of the day I hear: “It is not my fault ...
Generally, mediation and its process are foreign to most litigants. With the possible exception of the parties’ lawyers and insurance adjusters, often even the most sophisticated business clients have never been in mediation and do not fully understand the process or know what to expect. Frequently, as the mediator, in the early stages of the day I hear: “It is not my fault ...
On January 21, 2019, Google was fined nearly $57 million (approximately 50 million euros) by France’s Data Protection Authority, CNIL, for an alleged violation of the General Data Protection Regulation (GDPR).[1] CNIL found Google violated the GDPR based on a lack of transparency, inadequate information, and lack of valid consent regarding ad personalization. This fine is the largest imposed under the GDPR since it went into effect in May 2018 and the first to be imposed on a U.S ...
The use of marijuana in patient care has undergone widespread growth and acceptance nationwide. Thirty-three states and the District of Columbia have laws authorizing the use of marijuana in some form. Two of those states – Utah and Missouri – joined that list this past mid-term cycle, as voters passed initiatives authorizing the use of medical marijuana. Others, such as Kentucky and Virginia, have pending legislation seeking to authorize the use of medical marijuana ...
Now that the holidays are in the rearview and business as usual has begun to pick up where it left off, it’s time for public companies to do a deep download of key securities law updates and business developments of the past year so they are positioned for success in 2019. Below is a review of the 2018 proxy season, along with a summary of new and anticipated changes that may impact reporting and disclosure requirements for the 2019 proxy season ...
The U.S. Court of Appeals for the Sixth Circuit, in Massachusetts Bay Insurance Company v. Christian Funeral Directors, Inc., No. 18-5267 (6th Cir. Dec. 26, 2018), recently upheld a district court’s declination of jurisdiction over an insurer’s declaratory judgment action on coverage ...
In a recent opinion out of the U.S. District Court for the District of Columbia, U.S. District Court Judge Rudolph Contreras held that the U.S. Department of Health and Human Services (HHS) exceeded its authority when it substantially reduced the amount Medicare pays for 340B-acquired medications ...
The U.S. Court of Appeals for the Sixth Circuit, in Massachusetts Bay Insurance Company v. Christian Funeral Directors, Inc., No. 18-5267 (6th Cir. Dec. 26, 2018), recently upheld a district court’s declination of jurisdiction over an insurer’s declaratory judgment action on coverage ...
Recently, the Ohio Department of Medicaid (ODM) finalized Ohio Administrative Code 5160-1-32.1 (the Final Rule) which provides two standard authorization forms for the use and disclosure of protected health information (PHI). The standard forms are designed to comply with both the HIPAA Privacy Rule (45 C.F.R. § 164.508) and 45 C.F.R. Part 2, which covers certain substance abuse treatment information ...
Why is April 1, 2019 Important? April 1, 2019 is the first day U.S. Citizenship and Immigration Services (USCIS) may accept H-1B specialty worker petitions for the next fiscal year, which begins October 1, 2019 ...
On December 23, 2018, new State Medical Board of Ohio regulations became effective which marked another change in the legal standards governing provider use of opiates for treatment of pain ...
Beginning January 1, 2019, employers in Illinois will have new requirements for reimbursing employee expenses. An amendment to the Illinois Wage Payment and Collection Act (IWPCA) is the first Illinois law regulating employer reimbursement for employees’ business-related expenditures. Previously, the IWPCA did not address employee reimbursement, so employers were free to implement their own rules and procedures for reimbursing employees for business expenses ...
On December 7, 2018, the Food and Drug Administration (FDA) released a Proposed Rule that clarifies procedures and criteria for the de novo medical device clearance pathway. In a statement accompanying the Proposed Rule, FDA Commissioner Scott Gottlieb stated FDA believes the Proposed Rule will help facilitate classification of innovative low- to moderate-risk novel medical devices by providing more structure, clarity, and transparency to the de novo pathway ...
On December 11, 2018, Pennsylvania Auditor General Eugene A. Depasquale released a long-awaited report discussing the role of pharmacy benefit managers (PBMs) in Pennsylvania’s health care system ...
Often, board of education members believe what happens in executive session, stays in executive session. However, you and your board’s members, both new and old, are well-served to remember that many issues, including those involving personnel, discussed in executive session are communications that may be subject to discovery in a deposition or other legal proceeding by an affected employee ...
The deadline for meeting the previously issued nursing home compliance mandate is approaching. The Centers for Medicare & Medicaid Services (CMS) issued the mandate in 2016 and gave facilities three years to become compliant. On November 28, 2019, skilled nursing facilities (SNF) and nursing homes will be required to adopt and implement a compliance program as a condition for participation in Medicare and Medicaid ...
Educational institutions (“recipient” or “recipient institutions”) have been waiting for the Department of Education to issue formal Title IX regulations after it issued interim guidance in September 2017. This interim guidance rescinded previous Obama-era guidance that called for strict enforcement of Title IX and indicated that new formal guidance would be forthcoming ...
In a letter to state Medicaid directors on Nov.13, 2018, the Secretary of the U.S. Department of Health and Human Services, Alexander Azar, announced a new demonstration opportunity that will allow states to provide improved care for adults with a serious mental illness (SMI) and children with serious emotional disturbance (SED) ...
