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 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 ...
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 ...
Beginning today, September 7, 2011, owners of registered trademarks can file applications to block third parties from registering adult-oriented .XXX domains that contain their marks. This “Sunrise” period runs through October 28, 2011. Opt-out applications can be submitted using any .XXX accredited registrar. The current list of accredited registrars is available here. Registars’ fees vary but typically range from $200 to $500 per mark ...
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 U.S. Attorney’s Office in Nashville, Tennessee, arguably the capital of the investor-owned healthcare industry, is taking on healthcare providers and winning. In a series of summary judgment rulings over the past year, the federal district court has assessed tens of millions of dollars in damages and penalties under the federal False Claims Act (FCA). In these cases, the court found that the defendants flagrantly violated clearly written provisions of Medicare rules ...
The Hungarian Parliament enacted Act no CXII of 2011 on Information Rights and the Freedom of Information ("New Data Protection Act"), which will replace the currently effective Act no LXIII of 1992 on the Protection of Personal Data and the Publication of Data of Public Interest ("Old Data Protection Act") from 1 January 2012. Below, we briefly summarize the main changes brought about by the New Data Protection Act ...
On June 20, 2011, in Singapore, ICANN (Internet Corporation for Assigned Names and Numbers), the global coordination company for Internet addresses, approved the new program for the thematic extension of gTLDs. This program will certainly lead to significant growth in the number of domain names (gTLDs) on the Internet ...
On June 20, 2011 in Singapore, ICANN ( Internet Corporation for Assigned Names and Numbers), the global co-ordination body for Internet addresses, approved the new program for the thematic extension of GTLDS. This program will certainly lead to significant growth in the number of domain names (GTLDS) on the Internet ...
Today the federal government released final rules for the formation and operation of Accountable Care Organizations (ACOs) under the Medicare Shared Savings Program. The regulations initially proposed in March 2011 generated considerable attention and comment as ACOs represent a key component of the Affordable Care Act, the healthcare reform legislation enacted in 2010 ...
On October 20th, the federal government released a final rule and other companion releases relating to Accountable Care Organizations (ACOs) under the Medicare Shared Savings Program (MSSP), a key component of the Affordable Care Act enacted in March 2010. The proposed rule, issued in March 2011, generated extensive comment from the healthcare industry ...
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 ...
On 10 October 2011 the Council of Ministers of the European Union approved a new Directive on consumer rights in the European Union. This directive is aimed at strengthening the rights of consumers in all Member States of the European Union by bringing uniformity to the rules applicable to all European citizens with a special focus on the online shopping sector ...
Super injunctions and online libel revisited--Injunctions are ‘pointless’, ‘unbelievably expensive’ and counterproductive because ‘there’s an assumption of guilt about which you can do nothing...’ These are just some of the frustrated words of Top Gear presenter Jeremy Clarkson when he abandoned his super injunction (obtained in September 2010 to silence rumours he had an affair with ex-wife Alexandra Hall, whilst married to current wife Frances) on 26 October 2011 ...
If your trademarks and business names contain letters with accents and you are the owner of domain names linked with them, it is important to familiarize yourself with the following. With a view to offering owners the possibility of registering domain names that comply with French spelling, the Canadian Internet Registration Authority (the « CIRA »), the organization that manages the register of ...
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 ...
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 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 ...
Starting tomorrow, organizations may start submitting applications for new gTLDs (generic Top Level Domains). The application window will close on April 12, 2012. The new gTLDs move well beyond the core group of generic top level domains of .com, .net, .org, .biz, .info, and .edu. Specifically, they can consist of any combination of three or more letters that an applicant chooses ...
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 ...
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 ...
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 ...
Only two days after the government’s announcement that it recovered a record-breaking $4.1 billion from its healthcare fraud enforcement efforts in 2011, the Centers for Medicare and Medicaid Services (CMS) published a draft regulation in today’s Federal Register implementing the Affordable Care Act’s (ACA) 60-day overpayment report and return provision ...
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 ...
