In a judgment handed down on January 30, 2015, the Court of Québec held that the failure to respect the prescribed time limits or the violation of a patient’s fundamental rights and freedoms does not lead to the automatic exclusion of a psychiatric examination report concluding that the patient should be confined ...
On June 6th, 2015, Law No. 20,850, which creates the Financial Protection System for Diagnostics and Treatment of High Costs, and pays posthumous tribute to Luis Ricarte Soto Gallegos, has been published. This law creates a financial protection system for diagnostics and high cost treatments which will be defined by the Ministry of Health by means of a Supreme Decree ...
In a decision rendered on April 30, 20151, the Administrative Tribunal of Québec (the "ATQ") upheld a decision of the board of directors of a university hospital centre that refused to renew the status and privileges of a physician who failed to fulfill the obligations associated with the enjoyment of these privileges. Firstly, it should be noted that the applicant's clinical competence was not questioned in this case ...
The FDA recently issued final guidance regarding the size, shape, and other physical characteristics of generic-manufactured tablet and capsule dosage forms. The guidance noted that differences in physical characteristics of a dosage form could affect patient compliance and acceptability of medication regimens, or could lead to medication errors. The main reason for the FDA’s guidance appears to be that many patients can experience difficulty swallowing tablets and capsules ...
On August 18, 2015, the Tribunal administratif du Québec (TAQ) confirmed the decision of a health institution to not renew the status and privileges of one of its physicians after he refused to undergo refresher training to acquire skills that were necessary to perform his new duties.1 The physician in question, a hematology specialist, had been hired as a researcher several years ago ...
In a short three-week period, the U.S. Department of Justice announced three large, multi-million dollar False Claims Act settlements involving Stark Law violations. Each of the three cases alleged that health systems compensated physicians in excess of fair market value, and in excess of collections for services personally performed by those physicians, in order to induce referrals ...
On September 25, 2015, the Texas Board of Pharmacy (“TBP”) issued proposed rules that will allow pharmacists to substitute interchangeable biological products for brand name drugs. Currently, Texas regulations only allow for the substitution of lower-priced, generically equivalent drugs instead of certain brand name drugs. In contrast, the proposed rules allow pharmacists to dispense interchangeable biological products ...
It’s no surprise that the National Cybersecurity Center of Excellence (NCCOE) has extended the public comment period for one of its newest guides, “Securing Electronic Health Records on Mobile Devices ...
CMS and OIG Finalize Waivers for ACOs in the Medicare Shared Savings Program Effective October 29, 2015, the Centers for Medicare & Medicaid Services (“CMS”) and the Office of Inspector General (“OIG”) of the Department of Health & Human Services (“HHS” or “the Department”) finalized the waivers of certain fraud and abuse laws to specified arrangements involving accountable care organizations (“ACOs”) in the Medicare Shared Savings Program (“MSSP”) ...
Many healthcare boards believe that they have satisfied the 501(r) community health needs assessment (CHNA) requirements by completing their organization’s CHNA report and adopting an implementation strategy. After doing that, the board may feel ready to focus on other pressing issues until the next three-year CHNA deadline ...
Over the past year, the Tribunal administratif du Québec (TAQ) has issued several rulings dealing with oversight of the medical practice of professionals working in health and social services institutions. Several of these rulings will be of interest to institutions since they set out principles that tend to confirm the existence of a form of management rights over physicians, despite the lack of the traditional relationship of subordination between such institutions and their physicians ...
After a long wait, on February 12, 2016, the Centers for Medicare & Medicaid Services for HHS (“CMS”) issued a final rule that clarified the obligations of Medicare providers and suppliers to report and return overpayments within 60 days (the “Rule”).1 The Rule becomes effective on March 14, 2016. The Rule, which applies only to Medicare Part A and B providers and suppliers, enforces a statutory requirement from 2010 implemented by the Affordable Care Act (“ACA”) ...
The Modern Slavery Act 2015 introduces a new area of compliance for commercial organisations. The Act is amongst the toughest anti-slavery and human trafficking legislation in the world. Although legal penalties are restricted, interest from patients, consumers, investors, NGOs, pressure groups and brand risk is expected to enforce compliance ...
Increased deal activity is likely in Australia's health and aged care sector in 2016, driven by:• investment interest from China• Australian players targeting outbound opportunities through joint ventures and partnerships; and• consolidation in the aged and home care services areas.Rapidly ageing populations across our region are driving demand for high quality health care, especially in countries such as China and Japan ...
On January 4th, 2016, the President of the Republic introduced a series of amendments to the bill of law that, “modifies the Health Code in order to regulate generic bioequivalent pharmaceutical products and prevent the vertical integration of pharmaceutical laboratories and pharmacies”, – Bill No. 9914-11- (“Pharmaceutical Bill II”) ...
On March 30, the Department of Justice (DOJ) announced a major new initiative to target quality of care and fraud and abuse in elder care by forming 10 Elder Justice Task Forces throughout the United States. The DOJ intends to build these task forces on interdisciplinary teams – including Health Care Fraud Enforcement Action or HEAT Teams – already at work in several districts across the country. The teams include representatives from the U.S ...
As the delivery of health care continues to evolve and hospitals bear additional pressures to adapt to new payment models, more nonprofit hospitals are partnering with for-profit providers, through a sale, joint venture, or other arrangements. Partnerships between independent nonprofit hospitals and larger health care systems (nonprofit and for-profit) have been growing over the past two decades ...
A number of events have occurred recently involving the Federal Trade Commission and healthcare entities. First, garnering the lead spotlight, the FTC began presenting its case in the U.S. District Court for Northern Illinois to enjoin a merger between Advocate Health and NorthShore University HealthSystem, two large Chicago-area health systems ...
Last month, CMS issued a proposed rule that would drastically expand the agency’s authority to further its program integrity efforts through the provider and supplier enrollment process. This proposed rule, referred to as CMS-6058-P, (located in the Federal Register at 81 Fed. Reg. 40 ...
On April 18, the Office of Inspector General (“OIG”) of the U.S. Department of Health and Human Services issued revised guidance regarding exclusions imposed under section 1128(b)(7) of the Social Security Act ...
On April 19, 2016 Association of European Business (hereinafter – “AEB”) and the Russian Federal Antimonopoly Service (hereinafter – the “FAS”) presented the Code of Good Practice in the Pharmaceuticals Industry (hereinafter – the “Code”). The full text of the Code (both in Russian and English) is available at the official web-site of the antimonopoly authority (http://fas.gov.ru/documents/documentdetails.html?id=14513). Below is short outline of the Code. 1 ...
The U.S. International Trade Commission (“ITC”) recently issued a Final Determination concluding that certain dental implants imported by Instradent USA, Inc. and by JJGC Industria e Comercio de Materiais Dentarios S/A of Brazil (“Respondents”) infringe U.S. Patent Numbers 8,714,977 and 8,764,443 and should be blocked from entry into the United States ...
1 Which legislation sets out the regulatory framework for the marketing, authorisation and pricing of pharmaceutical products, including generic drugs? Which bodies are entrusted with enforcing these rules? The relevant legislation includes the following: • Law on Medicines 1996;
Following up on the passage of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), the Department of Health and Human Services (HHS) recently issued a proposed rule to replace the Medicare sustainable growth rate (SGR) methodology which was repealed by MACRA. The proposed rule would implement the Merit-based Incentive Payment System (MIPS) to replace SGR and establish incentives for participation in Advanced Alternative Payment Models (Advanced APMs) ...
Last week, Waller co-hosted a roundtable discussion on interoperability with Brentwood Capital Advisors and were joined by healthcare IT companies, investors, providers and payors. Will Morrow, VP of HCA’s Health Insight Capital, and Hal Andrews, President of Healthcare for Digital Reasoning, kicked off the discussion with a case study on HCA’s work to achieve data interoperability and how HCA’s strategy led to its recent investment in Digital Reasoning ...
