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 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 ...
The online retail sector has seen a considerable increase in intervention by the competition authorities both on a national level and in Brussels. Most recently, in December 2018, the European Commission fined the clothing company Guess € 39.8 million for applying online sales and advertising restrictions ...
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latest development in an eventful year, Federal Decree-Law 24 of 2018 introduces amendments to the Federal Penal Code, originally enacted as Federal Law 3 of 1987.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 ...
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 ...
The government has approved, by royal decree-law, a legal reform introducing a number of changes to the Retail Trade Law. Royal Decree-Law 20/2018, of December 7, 2018, on urgent measures to foster economic competitiveness in the industrial and trading sectors in Spain, published in the Official State Gazette last Saturday, December 8, amends Retail Trade Law 7/1996, of January 15,1996 ...
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 ...
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 ...
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 ...
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 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 ...
View a PDF of the November 2018 Edition of the Haynes and Boone Media, Entertainment and First Amendment Newsletter. Must Websites Comply With the ADA? Website ADA compliance litigation is all the rage, manifesting itself as an epidemic of “website drive-by lawsuits.” Beyond the litigation controversy, the issue is whether websites must be accessible to the visually-impaired via screen reader software to comply with the ADA. Circuit Courts are split ...
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) ...
While the motivation behind the Civil Justice Commission’s consultation paper – aimed at enhancing the Court system – is laudable, the proposed introduction of litigation scale costs may hurt Singapore’s standing as a global litigation hub. In 2015, the Chief Justice established the Civil Justice Commission (CJC) to review Singapore’s civil justice system, with the goal of transforming and modernising the litigation process ...
Obviously, they are all natural disasters that climate scientists believe will increase in severity and intensity in the coming years. And they are all events that nursing homes and assisted living facilities (and all Medicare/Medicaid certified health care providers) are legally required to prepare for in order to protect their residents and patients. More pointedly, though, they are all events which the U.S ...
On November 15, 2018, the Food and Drug Administration (FDA) published a Proposed Rule, which, if finalized, will allow an institutional review board (IRB) to waive or alter certain informed consent requirements if a clinical trial poses minimal risk to human subjects and includes appropriate safeguards to protect the rights, safety, and welfare of those human subjects ...
The Construction Industry Payment and Adjudication Act 2012 (“Act”) was introduced to address cash flow issues affecting contractors in the construction industry as a result of delays and/or lengthy periods of payment under construction contracts. Under the Act, an unpaid party [1] is entitled to initiate an adjudication proceeding in order to claim any amounts due and/or owing to them under a construction contract ...
This case highlights the importance of registering a franchise with the Registrar of Franchises and the consequences of not doing so. In particular, the effect and applicability of section 6(1) of the Franchise Act 1998 (“FA 1998”) are discussed. Facts The subject matter was “Dr. Fong’s Method” of teaching mathematics to students in primary and secondary school, which was developed by Dr. Fong Ho Kheong (“Dr. Fong”). Dr ...
In the last quarter of 2018, the Office of the Inspector General (OIG) announced that ImmediaDent of Indiana, LLC (ImmediaDent), which operates nine dental care practices, and Samson Dental Partners, LLC (SDP), which provides administrative support to Immediadent, have agreed to pay the United States and the state of Indiana $5.1 million to resolve allegations that they improperly billed Indiana’s Medicaid program ...
In an order dated at the end of 2018, the DIFC Court accepted that a party seeking an anti-suit injunction against proceedings in a foreign court must show that proceeding before the foreign court is or would be “vexatious or oppressive” to that party ...
