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 ...
Three proposed rules for the establishment of Affordable Insurance Exchanges – intended to create competitive marketplaces for private health insurance and a key component of the healthcare reform legislation enacted in March 2010 – were released today by Departments of Health and Human Services and Treasury ...
The Internal Revenue Service has proposed guidelines detailing how tax-exempt hospitals can conduct a Community Health Needs Assessment (CHNA), as required in the 2010 Patient Protection and Affordable Care Act (PPACA). Although this new requirement is not effective until taxable years commencing after March 23, 2012, the IRS issued its guidance now because hospitals may choose to start the process of conducting CHNAs and implement strategies in advance of the effective date ...
Texas health care providers, health insurers and health clearinghouses face new mandates and increased penalties over the use of electronic health records (EHR) as a result of HB300, which was passed in the 2011 Texas legislative session and signed into law by Governor Rick Perry. The Texas legislation expands privacy rights of patients beyond that contained in federal HIPAA legislation ...
On July 1, the Texas Supreme Court handed down an opinion that has the potential to impact any case where medical or health expenses are at issue. In the wake of the Court’s ruling, a plaintiff may not recover medical expenses for amounts that the plaintiff’s health providers bill but have no right to be paid. In addition, the Court held that such bills are inadmissible - including to show pain and suffering. Case Background and Issues Presented Haygood v ...
On July 5, 2011, the Centers for Medicare and Medicaid Services (CMS) published a proposed rule in the Federal Register that would make a number of changes to the Medicare program’s home health prospective payment system for calendar year 2012.Most significantly, the proposed rule would reduce Medicare payments to home health agencies by 3.35% or approximately $640 million in 2012. The reduction reflects the combined effects of (i) a home health market basket update of 2 ...
During the 2011 legislative session that just ended, Texas Governor Rick Perry signed into law a bill that allows rural hospitals to employ physicians, known as the “corporate practice of medicine,” despite the state’s long-standing ban on such practices. This legislation, along with similar recent legislation, signals that Texas might eventually do away with its ban on corporate employment of physicians altogether ...
Yesterday a three-judge panel from the United States Court of Appeals for the Sixth Circuit became the first appellate court to uphold the constitutionality of the minimum coverage provision of the Patient Protection and Affordable Care Act (the “Act”), requiring that Americans obtain health insurance. Opinions are expected from the Fourth and Eleventh Circuits later this summer ...
On June 16, 2011, the Supreme Court issued an opinion in Smith v. Bayer allowing a plaintiff to pursue class certification in a state court action after a federal court had denied certification in a substantially similar case. The Court held that it was improper for the federal court to enjoin the state proceeding under the “relitigation exception” of the Anti-Injunction Act because the issues were not identical and the state court plaintiff was not a party to the federal lawsuit ...
A bipartisan U.S. Senate committee has asked both the Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services to study the proliferation of physician owned distributorships (PODs), citing a lack of regulatory guidance on how these arrangements square with existing federal law ...
On May 25, 2011, the en banc Federal Circuit announced its decision in Therasense, Inc. v. Becton, Dickinson & Company regarding the appropriate standards for succeeding with an inequitable conduct defense ...
The Office for Civil Rights (OCR) of the Department of Health and Human Services today proposed an expansion of the rights of individuals to obtain reports from health providers and insurers about how their protected health information (PHI) is used.1 The draft regulations will require health providers and insurers (called “Covered Entities”) to provide more data faster and in a variety of formats as requested by individuals ...
The Centers for Medicare and Medicaid Services (CMS) announced the creation of so-called “Pioneer ACOs” on May 17 in an attempt to blunt heavy criticism over the draft regulations on Accountable Care Organizations (ACOs) issued on March 31, 2011 (the “Draft Regulations”).1 The Draft Regulations have been criticized due to their burdensome data collection requirements, large start-up costs, uncertain savings, possible losses and troublesome governance mandates ...
Southwest Health Alliance (“Southwest”), an independent practice association with approximately 900 member-physicians, has agreed to a proposed order recently entered by the Federal Trade Commission (“FTC”) settling charges that it engaged in anticompetitive conduct in its dealings with insurers and other payors for the provision of physician services (collectively, “insurers” or “payors”) ...
A former GlaxoSmithKline attorney, Lauren Stevens, was acquitted on May 10 of all criminal charges stemming from her response to an FDA investigation. The acquittal, ordered by U.S. District Judge Roger W. Titus, is a stunning defeat for the government’s anti-fraud enforcement measures. The judge also severely rebuked the government’s efforts in the matter, stating the case should never have been prosecuted. Had she been convicted, Stevens would have faced a prison term of up to 60 years ...
On April 18, 2011, the Centers for Medicare and Medicaid Services (CMS) began the attestation phase under its $27 billion Medicare EHR Incentive Program. Incentive payments for the meaningful use of electronic health records (EHR) will begin in May 2011 and will continue over the next several years. Eligible professionals (i.e ...
As we stated in our bulletin last week, on March 31st, the federal government outlined proposed actions relating to Accountable Care Organizations (ACOs), a key component of the healthcare reform legislation (the Affordable Care Act, or ACA) enacted in March 2010. In this bulletin, we provide some additional information regarding each of the March 31st releases ...
Accountable Care Organizations (ACOs) will face large start-up costs under proposed rules issued on March 31, 2011 by the Centers for Medicare and Medicaid Services (CMS), with an uncertain outlook for savings and even possible losses. An ACO is an organization of health care providers that agrees to be accountable for cost, quality and the overall care of Medicare beneficiaries who are assigned to it ...
How is health care in your jurisdiction organised? The basic principles of the organisation of the health-care system are governed by Act CLIV of 1997 (the Health-care System Act), more specifically by sections 141 et seq. Pursuant to section 141, the state is ultimately responsible for the state of health of the population, and for the creation of a system that protects, promotes and – if necessary – restores it ...
The Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services has recently announced two significant enforcement actions against health care providers for violating the HIPAA Privacy Rule. In the first matter, Cignet Health Care of Prince George’s County, MD was fined $4.3 million for failure to provide patients with access to their health records and for failing to cooperate with the ensuing OCR investigation ...
HARMONIZATION OF CLINICAL RESEARCH CONTRACTS IN QUEBEC OLGA FARMAN and MARIE-ÈVE CLAVET [email protected] [email protected] Over the past few decades, a high-quality system of research and innovation has been built in the Province of Quebec. The contractual research conducted by university-affiliated health-care institutions in Quebec has become a fundamental scientific, economic and social activity ...
As part of the Medicare hospital outpatient prospective payment system and ambulatory surgery center payment system final rule for calendar year 2011 (the “Final Rule”), the Centers for Medicare and Medicaid Services (CMS) recently issued final regulations that implement the changes that were made to the whole hospital exception by the Patient Protection and Affordable Care Act and the Health Care Education and Reconciliation Act of 2010 (collectively, the “Acts
In Sweden, the directive has been implemented through amendments to the Medical Devices Act (1993:584), and through the regulation which the Medical Products Agency has issued in connection with this Act and the directive. The revised directive contains some clarifications but also some news ...
After decades of debate, US healthcare reform became a reality in 2010 when President Obama signed the Patient Protection and Affordable Care Act (ACA) in March. Yet public opinion remains sharply divided on the merits of this sweeping legislation, both in terms of its ability to address the problems of access to, and the rising cost of, healthcare services and in terms of the financial burden on the federal and state governments of implementing ACA ...
