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 ...
Communications policy 1. Policy - Summarise the regulatory framework for the telecoms and media sector. What is the policymaking procedure? In connection with the regulatory framework for the telecoms and media sector in Chile, there are two general laws to take into account, the General Telecommunications Law (the GTL) and the National Television Council Law (the NTCL) ...
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 ...
The AGCOM (the Italian Media Authority) has recently published (on December 28th, 2010) two resolutions concerning the broadcasting services of audio and/or video contents (so-called “audiovisual media services”) in “linear” mode (“streaming” or “simulcast” services: Resolution n ...
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 ...
Hunton & Williams announced today the launch of its new website — the Hunton & Williams Health Care Reform Center, huntonhealthcarereform.com ...
The hospital has lost lengthy legal proceedings about the uninsured patients from the governments of the Netherlands Antilles and Curaçao. The governments are not obligated to write a “blank check”, as it were, for the costs Sehos had to incur for uninsured persons that cannot be recovered, according to judge Van Schendel yesterday ...
The U.S. Department of Health and Human Services, the U.S. Department of Labor and the U.S. Department of Treasury have released another set of interim final regulations (the “IFR”) regarding the coverage of preventive care without cost sharing. As with all guidance, the IFR cannot be considered in isolation ...
CASE REVIEW The Federal High Court in the recent case of NOBLE DRILLING (NIGERIA) LIMITED V THE NIGERIAN MARITIME ADMINISTRATION AND SAFETY AGENCY (NIMASA) & THE MINISTER OF TRANSPORTATION, (Suit No. FHC/L/CS/78/2008) provides clarity on Sections 2, 5 and 22(5) of the Coastal and Inland Shipping (Cabotage) Act, Cap. C51, Laws of the Federation of Nigeria, 2004 (Cabotage Act) ...
