The Federal Council of Pharmacy published Resolution No. 658/2018 to regulate publicity, advertisement and announcement of activities related to the pharmaceutical profession. Such include any disclosure arising or promoted by pharmacists, regardless of the means of communication ...
The dispute between ride sharing companies Uber and 99 is increasingly fierce. Now the main stage is Rio de Janeiro. In May 2018, Uber filed a lawsuit against 99 in the city, claiming misleading advertising. Less than two months ago, 99 began an aggressive discount campaign in the city to promote the 99Pop service in Rio, competing directly with Uber ...
Haynes and Boone CDG is proud to continue to feature a chapter in Global Arbitration Review’s (GAR)Guide to Energy Arbitrations, the Third Edition of which has just been published. TheGuide to Energy Arbitrationsis a widely regarded reference tool for energy companies, their advisers and arbitrators ...
In case C-323/17 People Over Wind and Peter Sweetman v Coillte, the Court of Justice of the European Union (CJEU) ruled that mitigation measures could not be taken into account at the screening stage of an appropriate assessment. Facts This case focused on proposed works that were necessary to lay a cable connecting a wind farm to the electricity grid and the potential effects that this would have on two special areas of conservation ...
During 2017-2018, the Federal Antimonopoly Service of Russia (“FAS”) paid close attention to advertisements of OTC medicines and considered large number cases of violations of advertising legislation by pharmaceutical companies. At the end of 2018, FAS in collaboration with the Association of International Pharmaceutical Manufacturers and other market players, established a guideline on recommended advertising of OTC medicines (“Guideline”) ...
The U.S. Centers for Medicare and Medicaid Services (CMS) issued a final rule redesigning the Medicare Accountable Care Organization (ACO) program via a new Pathways to Success ACO model. [1]See83 FR 67816 (Dec. 31, 2018). CMS stated five goals for this redesign: ACO Accountability, Competition, Engagement, Integrity, and Quality ...
Bona Fide Relationship Requirement Law. Public Act 247 of 2107, MCL § 333.7303a(2), requires that except as provided in exceptions detailed in administrative rules, a prescriber must be in a bona fide prescriber-patient relationship with a patient before prescribing a schedule 2-5 controlled substance (“CS”) ...
On January 5, 2018, the U.S. Department of Labor (“DOL”) published a much-anticipated proposed rule that would make it easier for groups or associations of employers to band together to form association health plans (“AHPs”).[1] The proposed rule comes in response to an executive order issued by the White House in October 2017 directing the DOL to consider issuing such a rule ...
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 ...
Minority shareholders – often forced to silently accept the rule of the majority – should be given a voice. In May last year, Jerry Low, a minority investor in Asiatic Group (Holdings), wrote an open letter to the management highlighting concerns regarding the SGX-listed company’s poor performance, juxtaposing this against the high remuneration enjoyed by its senior management team ...
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 ...
The tsunami of consolidation activity in the dental services industry has created remarkable financial opportunities for dentists and investors. Primarily, these opportunities play out in the form of Dental Services Organizations formed by entrepreneurial dentists and/or private financial interests through the acquisition of established, profitable practices ...
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 ...
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 ...
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 ...
