On December 14, 2018, the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) published a Request for Information (RFI) about ways to modify the HIPAA Privacy and Security Rules[1]to promote the transition of the health care industry to a value-based Medicare payment model and improve care coordination for patients. See “Request for Information on Modifying HIPAA Rules to Improve Coordinated Care,” 83 FR 64302 Page:64302-64310 ...
Law No. 21,121 (the “Law”), which came into force on November 20, 2018, amends the Criminal Code, Law No. 20,393 on Criminal Liability of Legal Entities, and Law No. 19,913 on Money Laundering, in connection with various criminal conducts relating to corruption and conflicts of interest. The following is a summary of the main aspects of the Law: 1.Domestic Passive and Active Bribery ...
While buzzwords like consolidation and price transparency continue to dominate headlines, major players throughout the healthcare ecosystem are working tirelessly behind the scenes to deploy creative and complex service methods that leverage a smarter, more holistic approach to care. The goal? Control escalating costs and deliver tangible value to patients – all while maintaining a healthy balance sheet ...
Background The UK invoked the exit procedure under Article 50 of the Treaty on European Union in March 2017. Unless the UK's decision is withdrawn or the period is extended, this will become effective in a little over 80 days ...
As one of the final acts of its 99th Legislative Session, the Michigan Legislature passed amendments to the Medical Marihuana Facilities Licensing Act (MMFLA), as well as changes to the Marihuana Tracking Act. These amendments were signed by outgoing Governor Rick Snyder on December 28, 2018, with the MMFLA amendments effective January 1. The Tracking Act amendments took effect immediately ...
The U.S. Centers for Medicare and Medicaid Services (CMS) has once again stepped up its oversight of Accrediting Organizations (AOs).[1] On December 18, 2018, CMS issued a Request for Information (RFI) seeking to determine whether AOs have a conflict of interest between their governmental contract and their private business. See “Medicare Program: Accrediting Organizations Conflict of Interest and Consulting Services; Request for Information,” 83 FR 65331 ...
On the last day of the legislative session, the Michigan Legislature passed House Bills 6330, 6331, and 6380 to create the Industrial Hemp Research and Development Act (IHRDA). If signed by the Governor, IHRDA will require the registration of industrial hemp growers and processors as a prerequisite to grow or sell industrial hemp. Oversight authority is given to the Michigan Department of Agriculture and Rural Development (MDARD) ...
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 ...
In the latest development in an eventful year, Federal Decree-Law 24 of 2018 introduces amendments to the Federal Penal Code, originally enacted as Federal Law 3 of 1987. The amendments are designed to make the Penal Code consistent with other recent federal legislation and current federal enforcement policies. Only ten provisions of the statute have been affected, out of the more than 400 total articles contained in the statute ...
“Arbitration agreement” is defined under section 19 of the Arbitration Ordinance (Cap 609) as an agreement by the parties to submit to arbitration all or certain disputes which have arisen or which may arise between them in respect of a defined legal relationship, whether contractual or not. Disputes submitted to arbitration may involve contractual claims and non-contractual claims, such as tortious claims ...
Several years ago the U.S. Centers for Medicare and Medicaid Services (CMS) required skilled nursing facilities (SNFs) to report nurse staffing levels using the SNF’s payroll records, in an effort to obtain more accurate information about actual daily nurse presence in SNFs. CMS has collected this Payroll Based Journal (PBJ) information for a few quarters now ...
Capturing lightning in a bottle: As fast-growing San Francisco concludes its largest rezoning in 10 years, will its novel new urban-planning guidelines for South of Market represent what the city's downtown needs in a fast-moving business, cultural and economic environment? In early December 2018, the San Francisco Board of Supervisors gave final approval of the "Central SOMA Plan," (the Plan) resulting in the largest rezoning of the commercial heart of the city since the renowned Downt
"What are the 'waters of the United States'? As it turns out, defining that statutory phrase—a central component of the Clean Water Act—is a contentious and difficult task." This observation, recently made by Justice Sonia Sotomayor, understates the difficulty in answering what should otherwise be an anodyne question: Does my project require a Clean Water Act permit? At this moment, answers to this question may be far from certain ...
Last week, State Senator Scott Weiner (D-San Francisco) announced new legislation intended to immediately encourage more residential construction in areas near public transit and job centers. Entitled the More Housing, Opportunity, Mobility, Equity and Stability (More HOMES) Act, SB 50 is essentially version 2.0 of SB 827, a similar housing bill proposed by Senator Weiner that failed in committee earlier this year ...
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 ...
Michigan voters approved Proposal 1 and made Michigan the twelfth U.S. jurisdiction to legalize recreational marijuana. The Michigan Regulation and Taxation of Marihuana Act (MRTMA) went into effect December 6. What has been lost in all the smoke from the past several weeks is how MRTMA impacts the regulation of industrial hemp ...
Medicare and Medicaid certified nursing homes are frequently required to pay fines (called “civil money penalties” or “CMPs”) to the U.S. Centers for Medicare and Medicaid Services (“CMS”) when government surveyors find them out of compliance with the Requirements for Participation for Long-Term Care Facilities. It is not uncommon for CMS to assess CMPs in the hundreds of thousands of dollars ...
Under the Affordable Care Act (“ACA”), large employers (generally those with 50 or more full-time employees or full-time equivalents) must report annually to the IRS information about the health coverage offered to their full-time employees during the prior year using IRS Form 1095-C. The IRS uses the forms to assess whether an employer "shared responsibility" penalty applies. Employers also must provide copies of the forms to their full-time employees ...
Increased federal oversight may be on the horizon for skilled nursing facility involuntary transfers and discharges. The Office of Inspector General (OIG) included in its 2019 Work Plan reviewing SNFs’ involuntary transfers and discharges, focusing on reviewing whether State agencies have effectively investigated and enforced proper transfer and discharge procedures ...
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 ...
On November 20, 2018, the IRS Criminal Investigation (CI) unit issued a memorandum to IRS Division Commissioners on voluntary disclosure practice following the end of the Offshore Voluntary Disclosure Program (OVDP). How Did We Get Here? For the last 7 years, the IRS maintained a consistent, robust program for taxpayers with exposure to potential criminal liability or substantial civil penalties due to a willful failure to report foreign financial assets ...
The U.S. Supreme Court heard oral arguments on December 4, 2018, inHelsinn Healthcare SA v. Teva Pharmaceuticals USA Inc.as to whether the “on-sale” bar under the America Invents Act (“AIA”) renders an inventor’s private sale to a third party as prior art for purposes of determining patentability. 35 U.S.C ...
The UAE federal government has recently issued a raft of important legislation. The raft addresses and updates areas of law that are key to businesses in the jurisdiction. Amongst this legislation is Federal Decree-Law 14 of 2018 concerning the central bank and the organisation of financial institutions and activities (the New Banking Law) ...
