The U.S. Fourth Circuit Court of Appeals has reversed a $44 million judgment against Tuomey Hospital in Sumter, South Carolina that arose from Tuomey’s employment arrangements with physicians that allegedly violated the federal Stark Law.1 The Stark Law prohibits hospitals from submitting claims to Medicare for designated health services that were referred by physicians with whom the hospital has a financial relationship, unless the relationship fits within an exception ...
After three days of historic oral arguments before the U.S. Supreme Court, the fate of the Affordable Care Act (ACA), the momentous 2010 health reform law, is uncertain, given robust questioning of the ability of Congress to force individuals to purchase health insurance ...
In response to a court order, EPA has announced proposed rules that would establish new source performance standards (“NSPS”) applicable to greenhouse gas emissions from new, fossil fuel-fired power plants (“power plants”). The proposal is a highly controversial one, which will effectively prohibit the construction of coal-fired power plants that do not capture carbon ...
On March 26, 2012, the Fifth Circuit Court of Appeals (“the Court”) vacated and remanded EPA’s disapproval of Texas’s request for approval of the minor source standard permit for pollution control projects (“PCP”) as part of its air quality state implementation plan (“SIP”). The Court’s reasoning may also affect other pending disputes between EPA and Texas regarding air quality permitting and other issues ...
On Wednesday, March 22, the United States Supreme Court ruled that a compliance order issued under EPA’s Clean Water Act enforcement authority to individuals for allegedly filling part of their property without the necessary “dredge and fill” permit could be challenged in federal district court. The ruling marks a major loss for EPA’s enforcement practices under the Clean Water Act ...
Law no.11/2012 of 8 March establishes new rules for prescription and dispensing of medicines. Prescriptions for medicines must now include the International Nonproprietary Name (INN) of the active substance,its pharmaceutical form, the dosage, the presentation and the posology. The prescription may also include a trade name by brand or indication of the name of the holder of the marketing authorisation ...
On March 13, 2012, the Standing Committee on Environment and Sustainable Development issued recommendations for improving the Canadian Environmental Assessment Act (CEAA) process (click on Print Format for the complete report). The recommendations focus on: improving timeliness; decreasing duplication with provincial processes; improving aboriginal consultation processes; and improving outcomes ...
On March 21, 2012, the United States Supreme Court issued a unanimous decision in the much-publicized case of Sackett v. EPA (No. 10-1062), less than three months after oral argument, holding that the Sacketts were not precluded from judicially challenging EPA’s issuance of an administrative compliance order ...
On February 24, 2012, two years after oral argument, the Texas Supreme Court issued its watershed decision in Edwards Aquifer Authority (the “Authority”) v. Day. The Court’s long-awaited decision included two significant pronouncements on groundwater that are likely to have ripple effects throughout the water community and could open the flood gates to a wave of litigation ...
The Centers for Medicare and Medicaid Services (CMS) on February 16, 2012 proposed rules1 implementing Section 6402(a) of the Affordable Care Act,2 requiring persons to report and return Medicare overpayments by the later of 60 days after an overpayment is identified or the date any corresponding cost report is due. Twice in the past, CMS had proposed rules requiring the return of Medicare overpayments, but did not finalize the regulations ...
The new abbreviated regulatory approval pathway for “biosimilar” and “interchangeable” types of biologic drug products was implemented in the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) as part of the Patient Protection and Affordable Care Act of 2010. The details about the use of this pathway were left for further development through Food & Drug Administration (“FDA”) action ...
The Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services has begun the pilot phase of HIPAA privacy and security audits of health care providers, health insurers and health care clearinghouses (“covered entities”) to assess HIPAA compliance efforts. Up to 150 covered entities will be subject to the initial audits, to be conducted by KPMG, LLP, the OCR audit contractor ...
In its judgment of 19 January 2012 (case no. 08332/11), the Southern Central Administrative Court, decided that INFARMED - Autoridade Nacional do Medicamento e Produtos de Saúde, I.P. (the national authority for medicines and healthcare products), is obliged to issue a certificate of subsidisation of the price of a medicine even when the person requesting the issue of the certificate was not the person who applied for the subsidy ...
On November 15, 2011, existing facilities subject to the federal Spill Pollution Control and Countermeasure Rule (“SPCC Rule”), 40 C.F.R. Part 112, were required to finalize and implement a plan—known as an “SPCC plan”—detailing the equipment, workforce, procedures and steps to be taken to prevent, control and provide adequate countermeasures to a discharge of oil to navigable waters of the United States or adjoining shorelines ...
In connection with the recent changes in legislation in the field of health, the Federal Commission for protection against health risks ("Cofepris") has taken various actions against the sale, distribution and advertising of the so-called "miracle products," which are distributed without scientific evidence to demonstrate its therapeutic properties ...
2011 saw significant developments in the courts in relation to the issue of directors’ liability for the costs of remediation of waste sites, an issue which is particularly crucial where the company which disposed of the waste is not in a position to pay ...
The Centers for Medicare and Medicaid Services (CMS) has delayed the start date for data collection of payments made to physicians and teaching hospitals by drug and device manufacturers and group purchasing organizations (GPOs). Under the Physician Payment Sunshine Act (the “Sunshine Act”), such payments were to have been recorded beginning on January 1, 2012 ...
EPA recently made an announcement of interest to those in the oil field services sector as well as in the energy sector itself. On November 23, the agency announced that it was granting in part a petition by Earthjustice to initiate rulemaking under the Toxic Substances Control Act (TSCA), relating to chemical substances and mixtures used in oil and gas exploration or production ...
Given the ongoing worldwide economic concerns and discussion of another recession, it is hard to believe that major provisions of the 2009 Stimulus Act impacting employers have yet to be fully implemented ...
Medicaid providers will be subject to new audits by Medicaid Recovery Audit Contractors (RACs), beginning in January 2012. These new audits will be in addition to existing audits being conducted by Medicare RACs, Medicaid Integrity Contractors (MICs) and Zone Program Integrity Contractors (ZPICs), among others.1 The Medicaid RAC audits, mandated as part of the 2010 Patient Protection and Affordable Care Act (the Health Reform Act), are expected to result in the recovery of $2 ...
Under final rules issued by the Centers for Medicare and Medicaid Services (CMS), Accountable Care Organizations (ACOs) will continue to face large start-up costs and uncertain savings, despite a decreased regulatory scheme and increased financial incentives ...
The Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector General (OIG) for the U.S. Department of Health & Human Services (HHS) have responded to the U.S. Senate’s request for information on physician-owned distributorships (PODs). Earlier this summer, a bi-partisan U.S. Senate committee asked CMS and the OIG to study the proliferation of PODs, citing a lack of regulatory guidance on how these arrangements square with existing federal law ...
Once their compound patents have expired many blockbuster drugs remain protected by secondary 'method of treatment' patents. The validity and enforceability of these secondary patents can be less certain in many jurisdictions. In Sanofi-Aventis Australia Pty Ltd v Apotex Pty Ltd (No ...
The Florida Agency for Health Care Administration (“AHCA”) earlier this month fined Humana $3.4 million for failing to promptly report suspected cases of Medicaid fraud and abuse by others, as required by statute and Humana’s Medicaid HMO contract. Though many states have similar laws or regulations, this appears to be the first enforcement action of its kind in the nation ...
Introduction A plant variety right (PVR) is an IP right which rewards breeders of new plant varieties for their efforts in creating those varieties. The current PVR law dates back to 1975 and is based on the 1961 International Convention for the Protection of New Varieties of Plants. The convention has since been amended several times, most recently and radically in 1991 ...
