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Waller | February 2012

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 ...

Haynes and Boone, LLP | February 2012

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 ...

PLMJ | February 2012

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 ...

Gianni & Origoni | January 2012

Within the scope of the measures intended to promote the competition and liberalization of the business activities approved by the Council of Ministers on January 20, 2012, are included, among other things, special provisions concerning the performance of insurance services which introduce relevant amendmentsto the Legislative Decree No. 209 of September 7, 2005 (“Insurance Code”) ...

Lavery Lawyers | January 2012

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Waller | January 2012

Can participation in an Accountable Care Organization (ACO) cause a nonprofit hospital’s bonds to become taxable?  A quick inquiry to bond counsel would probably yield an answer of “it shouldn’t” in many cases ...

Haynes and Boone, LLP | January 2012

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 ...

Deacons | December 2011

After being reviewed four times in three years, the Social Insurance Law of the People’s Republic of China (the “Social Insurance Law”) was finally adopted by the Standing Committee of the National People’s Congress of China on 28 October 2010. Its implementation rules (the “Implementation Rules”) were subsequently released by the Ministry of Human Resource and Social Security (“MHRSS”) on 29 June 2011. Both the Social Insurance Law and the Implementation Rules came into force on 1 July 2011 ...

Lavery Lawyers | December 2011

The advent of social networks such as Myspace, Facebook, Diaspora, Photobucket, Twitter, You Tube, and others has brought significant changes to social relationships. In Quebec alone, more than 3,250,000 persons 1 have a profile on Facebook. In 2012, the use of social media intensified in Quebec; indeed, more than three quarters of netsurfers in Quebec visited at lease one social medium or contributed to its content ...

Imagine the effect on the privatization effort and the stability of the workers’ compensation insurance market in West Virginia if the standard workers’ compensation insurance policy1 was held to give an insured employer coverage for “deliberate intent” claims even though the insured employer did not inquire about, request, or pay for such coverage.2 Imagine the risk management implications and the effect on premiums for workers’ compensation insurers ...

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 ...

Haynes and Boone, LLP | November 2011

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 ...

Haynes and Boone, LLP | October 2011

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 ...

Waller | October 2011

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 ...

Waller | October 2011

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 ...

Waller | September 2011

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 ...

Haynes and Boone, LLP | September 2011

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 ...

Haynes and Boone, LLP | September 2011

Hurricane Irene’s path along the Eastern Seaboard has affected millions of people and exposed businesses to property loss, business interruption, and supply network disruption. Those affected by Irene should immediately think about insurance coverage for their loss. Commercial Property Insurance In the event of a loss, a company should take steps to preserve coverage ...

MinterEllison | September 2011

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 ...

Haynes and Boone, LLP | August 2011

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 ...

Waller | August 2011

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 ...

Haynes and Boone, LLP | July 2011

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 ...

Haynes and Boone, LLP | July 2011

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 ...

Haynes and Boone, LLP | July 2011

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 ...

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