This report originally appeared in the June 2009 issue of DOTmed Business News

State: New York Introduces Legislation on Ultrasound Administration

The New York State Assembly has introduced bill A05978, which changes the legal requirement for administration of ultrasounds. The bill provides that the administration of any ultrasound upon a pregnant woman would only be performed by an order or a referral by a physician, physician assistant, specialist assistant, nurse practitioner or midwife. This now prohibits any referrals and orders for entertainment purposes or any other purpose that is not due to the condition of the patient. A violation would constitute a class "A" misdemeanor as well as professional misconduct, prosecution by the Attorney General, and grounds for a cease and desist order.

According to the justification detailed in the legislation, the Food and Drug Administration (FDA) has warned women about the potential dangers of having ultrasounds performed in facilities offering "keepsake" videos of a fetus for entertainment purposes. The high resolution ultrasound offered by these businesses has been brought to the attention of the FDA's Office of Science and Technology. Because the long-term effects of repeated ultrasound exposures on the fetus are not fully known, any unnecessary exposure to ultrasound machines is discouraged, especially if the facility is in the entertainment industry rather than the medical community. The legislation justification also says there may be a problem of women mistaking a keepsake video performed for entertainment purposes as a form of medical reassurance of a healthy pregnancy and forsaking essential care and diagnosis by an obstetrician.

National: Family and Medical Leave Inclusion Act Introduced

Rep. Carolyn Maloney (D-NY) and eleven co-sponsors have just introduced H.R. 2132, which would amend the Family and Medical Leave Act of 1993. Rep. Maloney had previously introduced the amendment in 2007. The Family and Medical Leave Act of 1993 requires covered employers to grant an eligible employee up to a total of 12 work weeks of unpaid leave during any 12-month period for applicable health and medical related-reasons. The new amendment does not change the act but expands coverage-it permits leave to care for a same-sex spouse, domestic partner (person recognized as the domestic partner of the employee under any domestic partner registry or civil union laws of the State or political subdivision of a State where the employee resides), parent-in-law, adult child, sibling, or grandparent who has a serious health condition.

For domestic partners, the definition also includes an unmarried employee who lives in a state where a same-sex marriage under the laws of the state is illegal, if that partner is a single, unmarried adult person of the same sex as the employee and is in a committed, intimate relationship with the employee, not a domestic partner to any other person, and who is designated to the employer by the employee as that employee's domestic partner. The legislation has been referred to the Committee on Education and Labor, and in addition to the Committees on House Administration, and Oversight and Government Reform.

State: Minnesota AG Announces Settlement on MedCredit Interest Case

The Minnesota Attorney General's Office and Allina Hospitals & Clinics have announced reaching a settlement in the suit filed by the Attorney General, against Allina earlier in 2009. The suit related to interest charged to users of MedCredit, Allina's consumer medical financing program. Allina Hospitals & Clinics is a not-for-profit health care system of hospitals, clinics and other patient care services providing care to communities in Minnesota and western Wisconsin.

According to a press release on AG Lori Swanson's web site, the terms of the settlement have Allina reimbursing patients (who were charged more than eight percent interest on their MedCredit account) the amount those patients paid over eight percent between January 22, 2007 and January 31, 2009. On February 1, 2009, the interest on all current and future MedCredit accounts was capped at 8 percent. The total amount Allina will reimburse to these patients will be at least $1.1 million, covering thousands of patients.

For patients eligible to receive the refund who currently have a balance on their MedCredit account, the refund will be applied to their existing balance. If the refund is greater than their existing balance, the difference will be held in the account and applied to future charges at Allina. "I realize that hospitals are facing their own financial pressures as a result of the bad economy and lack of adequate insurance coverage for patients," said AG Swanson. "I commend Allina and its President, Ken Paulus, for constructively resolving a problem in a way that helps patients."

National: Routine HIV Screening Coverage Act of 2009 Introduced

Rep. Maxine Waters (D-CA) and eleven co-sponsors have introduced H.R. 2137, which would amend the Public Health Service Act, ERISA law, the Internal Revenue Code of 1986, and title 5, United States Code, to require individual and group health insurance coverage, and group health plans and Federal employees health benefit plans to provide coverage for routine HIV screening.

A press release on Rep. Waters' web site stated the bill would require health insurance plans to cover routine HIV tests under the same terms and conditions as other routine health screenings. "Standard health insurance plans now cover HIV tests only when there are clinical indications of infection or when there are known risk factors present, but they should cover HIV tests as routine procedures," said Congresswoman Waters in the press release. "Routine HIV screening is a key to stopping the spread of HIV/AIDS. It will encourage more people to get tested and raise awareness about the continuing risk of the disease. It will also allow thousands of Americans who are living with HIV/AIDS but do not know it to find out about their infection, begin life-extending treatment, and avoid spreading the virus to others."

The legislation has been referred to the Committee on Energy and Commerce, and to the Committees on Education and Labor, Ways and Means, and Oversight and Government Reform.

Federal: DOJ Settles with Quest Diagnostics over Misbranded Test Kits

The U.S. Department of Justice (DOJ) has announced that Quest Diagnostics Incorporated and its subsidiary, Nichols Institute Diagnostics (NID), have entered into a global settlement with the United States to resolve criminal and civil claims concerning various types of diagnostic test kits the DOJ says NID manufactured, marketed and sold to laboratories in the U.S. until 2006. Part of the settlement is a payment of $302 million to resolve the allegations. According to a press release by the DOJ, this payment represents one of the largest recoveries ever in a case involving a medical device.

As part of the criminal resolution, NID pleaded guilty in a U.S. District Court in Brooklyn, New York to a felony misbranding charge in violation of the Food, Drug and Cosmetic Act relating to NID's Nichols Advantage Chemiluminescence Intact Parathyroid Hormone Immunoassay. The DOJ says this test was used by laboratories throughout the country to measure parathyroid hormone (PTH) levels in patients. As per the plea agreement, NID will pay a criminal fine of $40 million. Quest has also entered into a non-prosecution agreement with the United States.

For the civil settlement, the DOJ says that Quest and NID will pay the United States $262 million plus interest to resolve False Claims Act allegations relating to the Advantage Intact as well as four other NID assays that allegedly provided inaccurate and unreliable results. Quest has also agreed to pay various state Medicaid programs approximately $6.2 million for similar civil claims. The DOJ's press release says that Quest has also entered into a Corporate Integrity Agreement with the Office of Inspector General of the U.S. Department of Health and Human Services.

State: Florida Passes Prescription Drug Monitoring Legislation

The Florida legislature has responded to concerns that proper prescribing, dispensing, and monitoring of controlled substances - most notably pain medication - continues to be bypassed through fraud, theft, phony pharmacies, and internet medical evaluations, as well as through illegal sales of prescription drugs on the black market. The legislature has passed a new prescription drug monitoring bill, and notes in the legislative findings that an estimated 8,620 drug-related deaths occurred in Florida in 2007, including 3,159 by prescription drugs.

The bill requires the Florida Department of Health (DOH) to establish a comprehensive electronic database system to monitor the prescribing and dispensing of certain controlled substances, and requires specified prescribing and dispensing information to be reported to the electronic database system. The law also includes the following: a requirement for the DOH to establish policies and procedures for the system, including reporting requirements and exemptions; requires all nonexempt, dispensing pharmacists and practitioners to submit information in a specified format; that information in the database is not discoverable or admissible in any civil or administrative action; that the data transmission must comply with state and federal privacy and security laws; and that criminal penalties for violations be established.

The bill awaits Florida Governor Charlie Crist's signature to become law.

The House of Representatives Committee on Veterans' Affairs, led by Chairman Bob Filner (D-CA), has approved several bills, some of which concern health issues for veterans.

Of note is H.R. 466, the Wounded Veteran Job Security Act. This bill prohibits employment discrimination, including retaliatory acts, against any person treated for injury, illness, or disability (determined by the Secretary of Veterans Affairs) that has been incurred in or aggravated by military service. The original bill introduced to the House was amended for an allowance for employers to demonstrate that any such prohibition would impose "undue hardship" to the employer. The amendment also brings the bill line with the current protections afforded to service members and veterans in the Uniformed Services Employment and Reemployment Rights Act.




In addition, H.R. 1170 directs the Secretary of Veterans Affairs to establish a grant program to encourage the development of new assistive technologies for specially adapted housing for disabled veterans. Grant amounts would be limited to $200,000 annually per recipient. "This will provide our nation's heroes with the tools and resources to modify their homes and vehicles with the most state-of-the-art equipment that meets the challenges our disabled veterans face head-on," Rep. John Boozman (R-AR) stated in a press release on his web site concerning the legislation he introduced. "It is essential for us to find ways to improve the lives of our veterans who worked hard defending this country."

"Caring for veterans is an ongoing cost of war and the measures passed today will have an impact on our veterans," said Chairman Filner in a press release on the Committee passage on the bills. The bills will now be considered for vote by the House of Representatives.

State: California AG Announces Criminal Charges in Hospice Scam

California Attorney General Edmund G. Brown Jr. has announced the filing of criminal charges against six individuals who have been accused of paying healthy seniors to be admitted to a hospice for the terminally ill and then billing Medicare and the state Medi-Cal program for what the AG calls "phantom procedures," which were never performed for the seniors.

According to a press release on the AG's web site, the six defendants were physicians and staff at "We Care" hospice in Sherman Oaks. One defendant has been arrested, four will surrender to later in May and one remains at large. "We Care obviously didn't care about doing the right thing or helping sick people," Brown said in the press release. "The owners, physicians, and staff of We Care paid healthy seniors to be admitted to hospice and then billed Medicare and Medi-Cal for phantom procedures. In total, they bilked the public out of $9 million and used the funds to enrich themselves and pay for expensive homes and luxury cars." The arrests come after a joint investigation by Brown's office and the U.S. Department of Health and Human Services, when it was discovered that a "suspiciously large" number of patients admitted to We Care were in good health and the mortality rate was lower than expected for a hospice.

The AG says staff of We Care paid a finder's fee for identifying and enrolling relatively healthy Medicare and Medi-Cal beneficiaries into hospice care. Patients were then falsely diagnosed patients as suffering from a terminal disease, such as end-stage Chronic Obstructive Pulmonary Disease (COPD). In one case the AG points out as example, We Care billed Medicare $39,031 for hospice care for a patient whose serious medical problems were only arthritis and high blood pressure.

National: Senate and House Committees Approach Health Reform

Both the Senate and the House held Committee meetings on issues in health reform in May. Comprehensive health reform ideas have been one of the most discussed and debated issues in the first hundred days of the Obama Administration, and Congressional Committees have taken strong steps in presenting public hearings and discussions.

The Senate Committee on Finance offered the Roundtable Discussion on "Expanding Health Care Coverage." Committee Chairman Max Baucus (D-MT) stated in his opening remarks that after the Committee has spent time laying the groundwork for comprehensive health reform, "The time for action approaches." The Discussion included witness statements from a spectrum of expert and advocacy group perspectives, including representatives from the Henry J. Kaiser Foundation, AARP, Heritage Foundation, Families USA, and the U.S. Chamber of Commerce. As an example, Gary Klaxton of the Kaiser Foundation described the problems in care for the uninsured and inadequate coverage even for some with health insurance plans.

On the House side, the Committee for Ways and Means continued its fifth hearing in the series on health reform in the 111th Congress by welcoming Health and Human Services (HHS) Secretary Kathleen Sebelius to a hearing on health reform in the 21st Century. In her opening statement to the committee, Secretary Sebelius stated, "I know there`s a lot of talk about not having bureaucrats make health decisions, but I think it`s equally important not to have private insurance companies make health decisions, overruling protocol recommended by health providers. And part of health reform is to change those underlying rules, to have major insurance reform along with this effort."