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 ...
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 ...
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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 ...
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 ...
The Joint Select Committee on Marcellus Shale (the “Committee”) reported a 121 page bill governing horizontal wells that utilize 210,000 gallons of water or more per month or that involve surface disturbance of 3 acres or more. The final version of the bill was posted to the West Virginia Legislature’s website on November 18, 2011 (the “Bill”) ...
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 ...
November 8, 2011- The Minister of Finance and Economic Development delivered his Budget Speech on the 4th of November 2011. The Budget aims at providing for innovative measures to support key economic sectors (such as ICT/BPO, Tourism, Financial Sector...) and new markets (renewable energies...). The Budget also provides for a National Resilience Plan to support the economy in a global economic downturn ...
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 ...
President Obama recently sent to Congress proposed legislative language and analyses of his proposed deficit-reduction plan. Among the proposed legislative changes is a change to the formula used for calculating the cap on the amount that the federal government will reimburse federal contractors for executive compensation ...
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 ...
The long anticipated America Invents Act (the “Act”) was signed into law today. However, given that certain provisions of the Act are now in effect while others do not come online until March 16, 2013, innovating companies and individuals should consider the impact and timing of those provisions on their overall patent strategy. Below is a link to some practice pointers and strategic tips you may want to consider when operating under the Act ...
The government has recently published a consultation document seeking views in relation to its proposals for business rate retention ("BRR") in England and options for enabling local authorities to carry out Tax Increment Financing ("TIF") within the business rates retention system. The business rates consultation may interest developers, the public sector and those involved in renewables or regeneration, particularly those considering Tax Increment Financed projects ...
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 ...
The aim of the recent freedom of information (FOI) reforms was to encourage a pro-disclosure culture, and to provide additional assistance and guidance to both the applicant and agencies in processing FOI requests. However, since the commencement of those reforms, maintaining the balance between the philosophy and the practical operation of the FOI Act has presented challenges for agencies in meeting their statutory FOI obligations ...
A new change in the Italian regulation of the industrial design has been recently introduced by section 8, paragraph 10, of Law Decree no. 70 of May 13, 2011 (“First urgent provisions for the economy”), aimed at restricting the temporary protection granted to industrial design works under copyright law under section 239 of the Industrial Property Code (Legislative Decree no. 30 of February 10, 2005, as amended by Legislative Decree no ...
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 ...
As you will be aware, 1 January 2012 is the go live date for OHS harmonisation. A new OHS Act, Regulation and Codes of Practice will commence in the Commonwealth and in each State and Territory at this time. The new package of OHS legislation will be based on model legislation, so will be substantially similar in each jurisdiction. For detailed information about the state of play in relation to OHS harmonisation, see our HR&IR Update of 22 June 2011 ...
Following the introduction of the Tertiary Education Quality and Standards Agency Bill 2011 (Bill) and the Tertiary Education Quality and Standards Agency (Consequential Amendments and Transitional Provisions) Bill 2011 (Transitional Bill) into the Commonwealth Parliament (as reported in our news alert of 23 March 2011), the Senate referred the Bill and the Transitional Bill to the Senate Education, Employment and Workplace Relations Legislation Committee (Commi
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 ...
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 ...
