Law & Order: September 2009 Edition

September 21, 2009

by Astrid Fiano, Writer
DOTmed.com (press release) - New York,NY,USA

FTC Challenges Acquisitions by Carilion, Thoratec

The Federal Trade Commission (FTC) has authorized a lawsuit to block Thoratec Corporation's proposed $282 million acquisition of medical device maker HeartWare International, Inc. They also issued an administrative complaint challenging Carilion Clinic's 2008 acquisition of two outpatient clinics in the Roanoke, VA, area, according to FTC press releases.

In the Throatec case, the FTC says the acquisition transaction would "substantially reduce" competition in the U.S. market for left ventricular devices (LVADs). The FTC's administrative complaint alleges that Thoratec seeks to maintain its current monopoly by acquiring HeartWare, the only significant rival to Thoratec's LVAD market dominance. The FTC plans to seek a preliminary injunction in federal court to stop the transaction and limit harm to competition. The FTC says HeartWare's device, the HVAD, is currently in clinical trials and is positioned to be the next FDA-approved LVAD.

In the Carilion matter, the FTC notes that prior to acquisition the clinics in question-Center for Advanced Imaging (CAI) and the Center for Surgical Excellence (CSE)-"had strong reputations for offering high-quality care and convenient services at prices much lower than Carilion's." The FTC alleges Carilion's acquisition of these outpatient centers eliminated vital competition and will lead to higher health care costs. The complaint seeks divestiture of the centers and related assets necessary in order to restore the competition eliminated by the acquisition. A complaint is not a finding or ruling that the defendants have actually violated the law.

State: New North Carolina Law on Mental Health Facility Transparency

North Carolina Governor Bev Perdue has signed legislation increasing the transparency of state mental health, developmental disability and substance abuse facilities, and making more information in death records public. According to the Governor's press release, she had proposed the legislation in March with North Carolina Attorney General Roy Cooper.

"This legislation puts the safety of our patients first by ensuring that important information in death records is available to the public," Governor Perdue said on her website. "By increasing transparency, we will make state facilities more accountable to the people in their care, restore public confidence and rebuild public trust." AG Cooper stated, "More disclosure can shine a light on problems and help ensure patients' safety."

The legislation will require information regarding deaths in state facilities, such as the circumstances and manner of death, if known, to be public information. In addition, the records of criminal investigations conducted by any law enforcement unit of a State facility will be public record. The Secretary of the Department of Health and Human Services may also inform any person of any incident involving the welfare of a client, or former client, when the Secretary determines that the release of the information is essential to maintaining the integrity of the Department, unless disclosure is prohibited by State or federal law.

National: Amendment will allow study of antidepressant use and suicide rate among combat troops

U.S. Senator Benjamin L. Cardin (D-MD) has announced that the Senate has adopted his amendment 1475 to the National Defense Authorization Act. This amendment mandates a study of the increased use of antidepressants among combat troops and the effect of these drugs on mental health. In a press release, Senator Cardin said his introduction of the Amendment is based upon the disturbing increase of suicides and attempted suicides in the active military.

The senator stated: "It is imperative that we determine if the Department of Defense (DoD) is prescribing anti-depressants to its service members appropriately, including the necessary observation by a highly trained mental health provider. My concern is not the long-term efficacy of these drugs, but the sheer volume and manner in which these drugs are being administered to our service men and women overseas." The release says the Army's Fifth Mental Health Advisory Team 2007 report indicated 12% of combat troops in Iraq and 17% of troops in Afghanistan are taking prescription antidepressants or sleeping pills to cope with stress. The senator added nearly 40% of Army suicide victims in 2006 and 2007 might have taken some type of antidepressant drugs.

Senator Cardin's amendment has directives for the DoD to record the volume and types of antidepressants, psychotropics or anti-anxiety drugs being prescribed to the men and women serving in Iraq and Afghanistan. The amendment will also require the DoD, starting in June of 2010 and then annually through 2015, to report to Congress an accurate percentage of those troops that have been prescribed such drugs.

State: New York AG Announces Arrests in Medicaid Fraud

New York State Attorney General Andrew M. Cuomo has announced the indictment of six individuals and seven corporations charged in a Medicaid fraud scheme totaling $47,000,000. The AG's press release says in the past ten years, Alexander Levy, assisted by several cohorts, allegedly secretly controlled a string of health care entities to both illegally obtain payment for Medicaid recipients' treatment and also to launder the profits from the scheme. According to the press release, Levy had already been excluded from participation in Medicaid in 1997 for submitting false claims.

Levy had set up a series of corporations designed to conceal his control and ownership interest of various companies and medical clinics, the AG's release stated, and did not put his name on any documents filed with the New York State Department of Health. These companies billed Medicaid for millions of dollars of services. The Medicaid money was directed to the Levy-controlled health care entities through a series of bank accounts and transfers, and funneled to shell companies that he created and owned. Attorney General Cuomo has filed a civil forfeiture complaint against Levy, his cohorts, and a total of 16 corporations.

"This individual is accused of cheating New York taxpayers out of tens of millions of dollars through an elaborate money laundering scheme," Attorney General Cuomo said. "But as we have done before, we 'followed the money,' which led us to today's serious charges. Ensuring that Medicaid payouts are made only to those who rightfully deserve them has been a top priority of my administration." The charges against the defendants are accusations, and the defendants are presumed innocent until, and unless, proven guilty.

Federal: Nursing Home Executive Agrees to Permanent Exclusion

The Office of Inspector General (OIG) for the Department of Health and Human Services (HHS) has announced in a press release that the president and chairman of the board of Pleasant Care Corporation, Emmanuel Bernabe, has agreed to permanent exclusion from Federal health care programs. The exclusion follows an OIG investigation of Pleasant Care, concerning allegations of substandard care in Pleasant Care nursing facilities between 2003 and 2007.

Pleasant Care once was the second largest nursing home chain in the State of California, with more than 29 different facilities in 14 counties. Currently, Pleasant Care does not manage any nursing facilities or provide patient services. Bernabe had contested OIG's allegations and denied any liability. No judgment or finding of liability has been made against Bernabe. The OIG alleges in the press release that under Bernabe's management, Pleasant Care placed nursing home residents at risk through the level of care failing to meet professionally recognized standards. This included inadequate hydration and nutrition, failing to administer appropriate wound care and inadequate staffing levels.

"This settlement reflects our commitment to ensuring that executives who are ultimately responsible for care furnished in nursing homes are held accountable when those homes fail to provide quality care," said Inspector General Daniel R. Levinson, in the press release. "It is critical that boards and management make compliance with professionally recognized standards of care a priority at all levels of their organizations."

State: Maine Enacts New Laws to Improve Health Care

The state of Maine has recently enacted new laws to improve its state of medical care. In June, a law was enacted to increase transparency in the health insurance marketplace. Also, under a new law, Maine hospitals will perform targeted surveillance for methicillin-resistant Staphylococcus aureus in high-risk populations consistent with the federal Centers for Disease Control and Prevention guidelines.

In July, Governor John Baldacci signed legislation creating the Doctors for Maine's Future Scholarship Program. This law provides a tuition subsidy for Maine residents to support their medical education at various state medical school programs. "We have a need for more primary care physicians and those who serve in rural areas of the State," Baldacci said in a press release. "Research shows that doctors tend to settle near the hospitals where they complete their training. I know that given the chance, young doctors will stay in Maine." The tuition subsidy will cover half the cost of attendance annually up to $25,000 for eligible students in the medical school programs.

Baldacci also signed a law allowing pharmacists who meet certain requirements to administer several different vaccines, including influenza vaccine, pneumococcal vaccine, tetanus-diphtheria-pertussis vaccine and others. "This bill expands access to important preventive health care services," Governor Baldacci said in his press release. "In particular, I know the Maine Center for Disease Control supports the efforts to provide influenza vaccines to as many people as possible."

National: Senator Introduces Legislation to Ease Nationwide Nursing Shortage

Assistant Senate Majority Leader Dick Durbin (D-IL) has introduced legislation to remedy the U.S.'s nursing shortage which, according to the senator's press release, is expected to exceed one million by 2020. The Nurse Training and Retention Act builds on the current health care workforce through creation incentives for health care workers to become nurses and for current nurses to become nurse faculty.

"Everyone depends on nurses for quality patient care, yet the health care system in America lacks an adequate supply of nurses and the problem is getting worse," said Senator Durbin in the press release. "By 2020, the shortage in Illinois alone could exceed 21,000. Today's legislation proposes a new, innovative program that builds on our existing health care workforce - an important, but currently untapped resource. The debate in Congress over health care reform must include solutions that address this growing problem."

The new legislation would build upon the current health care workforce through a new grant program at the Department of Labor. It would also provide education and training to incumbent health care workers to earn a nursing certificate or degree it would also assist current nurses in obtaining specialty training or advanced degrees to serve as nurse faculty, which increases the capacity of nursing schools to train more nurses.

State: New Jersey Makes Tenth Arrest in Phony Dentist Case

New Jersey Attorney General Anne Milgrim reports that the Newark Police Department and investigators from the state Division of Consumer Affairs' Enforcement Bureau has arrested two men for unlicensed practice of dentistry, the ninth and tenth such arrests in New Jersey in the past year. A press release on the AG's website says Carlos Bello and Aristoteles Berenzon were arrested and charged with unlicensed practice of dentistry.

The AG's web site says that such unlicensed "dentists" operate out of residences, basements and dental laboratories. They have performed dental procedures and also administered prescription medications by both injection and dispensing drugs. These treatments have led to injuries for patients, including broken teeth, infections and unconsciousness. The prior undercover investigations resulted in arrests for unlicensed practice of dentistry, possession of a prescription legend drug, obtaining prescription drugs without a prescription, possession of hypodermic syringes and possession of a Controlled Dangerous Substance.

"Our Enforcement Bureau investigators are teaming up with local police departments to shut these so-called 'dentists' down. The public's health, safety and welfare are clearly being put at risk when unlicensed individuals attempt to practice dentistry," Attorney General Anne Milgram said in the press release. "The licensing requirements established by the Board of Dentistry ensure that those treating patients have the education and skills to do so," David Szuchman, Consumer Affairs Director, added.

National: Congresswoman Introduces Community-Based Health Care Retraining Act

Congresswoman Eddie Bernice Johnson (D-TX) introduced the Community-Based Health Care Retraining Act. The legislation would fund programs to retrain displaced workers for careers in health care jobs. The Act would also amend the Workforce Investment Act to provide $25 million in funding for qualifying community partnerships to either create retraining programs or expand those already in existence. The bill has been referred to the Committee on Education and Labor and to the Committee on Energy and Commerce.

"Displaced workers in the manufacturing, construction and service sectors need jobs, particularly now, during the most severe economic downturn in decades," Congresswoman Johnson said in a press release on her web site. "While some industries continue to contract, the health services sector remains robust. Funding programs that retrain workers for the health care professions is not only the right thing to do; it's the smart thing to do."

The project would create grants to eligible entities in order to pay for the Federal share of the cost to enable the entities to carry out programs, in covered communities, to train covered workers for employment as health care professionals. The grants would each be between $100,000 and $500,000 for a period of five years. Eligible entities would include local workforce investment boards serving the covered communities and institutions of higher education in partnership with facilities including health clinics, hospitals and long-term care facilities.

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