Tag Archives: EBG

HEALTH REFORM: Changes to the Federal Physician Self-Referral Law Included in the Patient Protection and Affordable Care Act

Narrowing the Ability of Physicians to Own an Interest in a Hospital

In 2003, Congress modified the federal physician self-referral law (commonly referred to as the “Stark Law”) and adopted an 18-month moratorium on the ability of physicians to own an interest in a specialty hospital.[1] Although the moratorium officially lapsed in June 2005, over the last several years, Congress has continued to monitor and debate the issue of whether this exception to the Stark Law should be modified.

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HEALTH REFORM: Health Care Reform: What Employers Need to Know

On March 23, 2010, President Obama signed into law the Patient Protection and Affordable Care Act (“Act”), which provides for significant changes in the delivery of health care. The Health Care and Education Reconciliation Act of 2010 (“Reconciliation Bill”), which reconciles and amends certain provisions of the Act, was signed into law by President Obama on March 30, 2010. The following is a high-level summary that identifies some of the key provisions of the Act, as amended by the Reconciliation Bill. 

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U.S. Department of Labor Ramps Up Enforcement Efforts With We Can Help Campaign

On April 1, 2010, the U.S. Department of Labor (DOL) delivered on its promise to focus its agenda and resources on enforcement efforts, launching a new public awareness campaign called We Can Help.

The campaign is designed to educate workers about their rights under the federal Fair Labor Standards Act (FLSA), but its implications are more significant and far-reaching. According to the DOL’s Web site, the Wage and Hour Division is targeting workers’ rights and pay issues—and it is doing so regardless of their immigration status, reaching out to employees who are traditionally among the lowest paid, including non-citizens and/or undocumented workers. The Webs site directs workers how to file a complaint with the Wage and Hour Division, and it encourages them to provide information to the Division, including copies of pay stubs, hours of work and any information related to the employer’s pay practices.

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NJ Supreme Court Restricts Employer’s Ability To Review Employee’s Communications With Personal Attorney on Employer’s Computers

While many employers worry that some court decisions will add “insult to injury,” New Jersey employers must now be aware of Stengart v. Loving Care Agency Inc., — A.2d –, — N.J. — (2010), decided March 30, 2010, which presages adding “injury to injury.” That is because it first injures employers’ interests by stating that an employer cannot write an enforceable policy that “ban[s] all personal computer use and provide[s] unambiguous notice that an employer could retrieve and read” all emails that an employee wrote through a personal email account using an employer’s computer. Slip op. at 28. InStengart, this meant that an employee’s communications with personal counsel concerning matters adverse to the company may occur during work time using the employer’s resources. And if that were not injury enough to the employer’s interests in having employees actually work on company business while at the office using the company’s resources, the Stengart Court then went on to add another possible injury—on remand, the trial court should consider disqualifying the company’s counsel for not immediately upon finding such communications on the employer’s computer returning to the departed employee (or her counsel) all copies of such communications. The Stengartdecision demands that employers, especially in New Jersey, not only revisit their written policies, but also that they consider how such policies are actually being applied and enforced. Decisions like Stengart can also directly impact on steps that have become part of best practices responses in trade secret and restrictive covenant cases involving departing employees, and which occur in all manner of employment situations.

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New York State Emergency Regulations Modify NY Employers’ WARN Responsibilities

With very little fanfare, the New York State Department of Labor (the “Department”) recently filed a Notice of Emergency Adoption and Proposed Rule Making (the “Emergency Regulations”) that significantly amends the existing regulations to the New York State Worker Adjustment and Retraining Notification Act (the “NYS WARN Act” or the “Act”). The Emergency Regulations became effective on February 12, 2010. For additional information about the Emergency Regulations, visit the Department’s Web site at http://www.labor.ny.gov/workforcenypartners/warn/warnportal.shtm.

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HEALTH REFORM: Health Care Reform: Tax Provisions Affecting Large Employers

The Patient Protection and Affordable Care Act (the “Act“) was signed into law by President Obama on March 23, 2010. The Health Care and Education Reconciliation Act of 2010 (the “Reconciliation Bill“), which reconciles and amends certain provisions of the Act, was signed into law by President Obama on March 30, 2010. The tax provisions in the Act, as amended by the Reconciliation Bill, will significantly impact how large employers structure their health benefits. At a minimum, employers will be subject to new administrative obligations relating to their employee health benefits. Given that some of the more significant provisions will not become effective for a number of years, employers will have time to become familiar with and plan accordingly for such new demands. The tax-related provisions of the Act that affect large companies and employers include:

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HEALTH REFORM: Federal Transparency Is Now a Reality: Challenges and Opportunities for Pharma, Devices, and PBMS

On March 23, 2010, President Obama signed H.R. 3590, the Patient Protection and Affordable Care Act (“PPACA“), into law. Following the enactment of PPACA, H.R. 4872, the Health Care and Education Reconciliation Act of 2010, was enacted into law on March 30, 2010, “reconciling” and revising portions of PPACA. This expansive legislation includes provisions from the Physician Payment Sunshine Act (“Sunshine Act“) introduced previously by Senators Charles Grassley (R-IA) and Herb Kohl (D-WI) in 2009.[1] Early versions of the Sunshine Act were endorsed by the Pharmaceutical Research and Manufacturers of America, the Advanced Medical Technology Association, the American Medical Association and individual industry organizations.[2]

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HRSA Finally Publishes Final Contract Pharmacy Guidelines For 340B Program

On March 5, 2010, the Health Resources and Services Administration (“HRSA”) published the final Contract Pharmacy Guidelines, nearly three years after the close of the comment period to its proposed guidelines.[1] The final guidelines now formally recognize the ability of a 340B covered entity to enter into a broader range of arrangements with contract pharmacies.

To what extent can covered entities enter agreements with contract pharmacies?

Prior to the issuance of these final guidelines, a covered entity was allowed to use only a single point of service for pharmacy such that it could not supplement an in-house pharmacy with a contract arrangement. Also, prior to the issuance of these final guidelines, a covered entity could only enter into an agreement with one contract pharmacy. A limited variety of other arrangements could be approved as Alternative Methods Demonstration Projects. These final guidelines now expand the types of permissible contract pharmacy arrangements. 

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HEALTH REFORM: Medicaid Drug Rebate Program ‘Reform’: Key Considerations and Implementation Tips for Pharmaceutical and Biotech Manufacturers

On March 23, 2010, President Obama signed H.R. 3590, the “Patient Protection and Affordable Care Act” (“PPACA”), into law. This legislation includes significant revisions to Section 1927 of the Social Security Act (42 U.S.C. § 1392r-8), which governs the Medicaid Drug Rebate Program (“MDRP”). Following the enactment of PPACA, H.R. 4872, the “Health Care and Education Reconciliation Act of 2010” was enacted into law on March 30, 2010, “reconciling” and revising portions of PPACA. The term “PPACA” used herein shall refer to PPACA as amended by H.R. 4872. We have set forth below some key considerations and implementation tips to assist pharmaceutical and biotech manufacturers in understanding the impact of this legislation with respect to the MDRP. In addition, we have outlined the significant changes to the MDRP in the sidebars, organized by their respective effective dates.

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Supreme Court Holds That County and State Reports, Not Only Federal Ones, Trigger The Public Disclosure Bar of the Federal False Claims Act

Suits in the name of the United States under the Federal False Claims Act (“FCA”) brought by private individuals known as qui tam relators are among the most common forms of whistleblower action in the federal system. The Supreme Court today rendered its much-anticipated decision in Graham County Soil and Water Conservation District et al. v. United States ex rel. Wilson, No. 08-304. 2010, imposing a significant limitation on the ability of these relators to satisfy an important jurisdictional bar.

The FCA authorizes both the Attorney General and private qui tam relators to bring actions against persons who make or facilitate fraudulent claims for payment from the United States. However, in the absence of the government, a relator will be barred from proceeding on his own if the action is based upon the public disclosure of allegations or transactions in, inter alia, “a congressional, administrative, or Government Accounting Office [(GAO)] report, hearing, audit, or investigation.” 31 U. S. C. §3730(e)(4)(A). TheGraham County case involved federal contracts and funding for the repair of flood damage. The relator, Wilson, a local government employee, alerted both federal and county and state officials to irregularities in performance. Both the county and the state issued reports making findings about these potential irregularities and Wilson thereupon filed a qui tam action against the county conservation districts administering the contracts. The District Court dismissed for lack of jurisdiction because the allegations publicly disclosed in the county and state reports constituted “administrative” reports under the FCA’s public disclosure bar. The Fourth Circuit reversed, holding that only federal administrative reports may trigger the public disclosure bar. 

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