Find out what’s happening in the world of federal healthcare regulations by reviewing some recent headlines from across the country.

EMTALA violations declining

The number of U.S. hospitals cited for violating the Emergency Medical Treatment and Active Labor Act (EMTALA) has decreased over a 10-year period, according to a study published in the Annals of Emergency Medicine. Researchers analyzed a list from CMS of EMTALA investigations conducted from 2005?2014 and found that the percentage of U.S. hospitals cited for violations citations decreased from 5.3% to 3.2%. The percentage of hospitals investigated also declined during this period from 10.8% to 7.2%.

EMTALA aims to prevent the practice of discharging or transferring patients to other hospitals before stabilizing treatment is provided for emergency medical conditions. It requires hospital emergency departments to provide medical screening examinations to patients seeking medical treatment regardless of their ability to pay, citizenship, or legal status.

Stark Law, EMTALA violation penalty amounts increase

Due to several years of inflation, the U.S. Department of Health and Human Services recently issued an interim final rule that calls for steeper maximum penalties for violating federal regulations, including EMTALA and the Stark Law.

For hospitals with more than 100 beds, the maximum penalty for an EMTALA violation is $ 103,139, up from the previous maximum of $ 50,000 set in 1987. For hospitals with less than 100 beds, the maximum penalty is $ 51,570, up from $ 25,000.

Circumventing the Stark Law’s self-referral restriction can now result in a maximum penalty of more than $ 159,000, up from previous maximum of $ 100,000 set in 1994. Submitting claims in violation of the Stark Law can result in a penalty of nearly $ 24,000, up from $ 15,000.

Home health agency owner sentenced for healthcare fraud, kickbacks

Khaled Elbeblawy, the former owner and manager of three home health agencies in the Miami area, will spend 20 years in prison for his role in a scheme that fraudulently billed Medicare for millions of dollars.

Elbeblawy was sentenced to prison and ordered to pay more than $ 36 million in restitutions following his conviction in January of one count of conspiracy to commit healthcare fraud and wire fraud and one count of conspiracy to defraud the United States and pay healthcare kickbacks. According to evidence presented at trial, from 2006?2013, Elbeblawy and his co-conspirators claimed to have provided medically necessary home health services to Medicare beneficiaries through the three agencies: Willsand Home Health Agency Inc., JEM Home Health Care LLC, and Healthy Choice Home Services Inc. In reality, those services were either medically unnecessary or never provided. The conspirators also paid kickbacks to physicians, patient recruiters, and staffing groups for referrals of beneficiaries.

In all, Elbeblawy and his co-conspirators submitted $ 57 million in false or fraudulent claims and received approximately $ 40 million in payments. In 2012, Eulises Escalona, a former owner of Willsand and JEM, pled guilty to one count of conspiracy to commit healthcare fraud and was sentenced to 10 years in prison. Cynthia Vilches, former co-owner of Healthy Choice, also pled guilty to one count of conspiracy to commit healthcare fraud and is awaiting sentencing.

Healthcare systems calls for dismissal of antitrust lawsuit

Carolinas HealthCare System (CHS) has argued that the joint antitrust lawsuit filed against it by the U.S. Justice Department and the North Carolina Attorney General’s office has no basis. According to the Charlotte Observer, the lawsuit alleges CHS uses its size to drive up prices to prevent competition. CHS operates 10 hospitals in the Charlotte area. Its closest competitor, Novant Health, operates five.

The lawsuit alleges CHS uses its clout to encourage health insurers to steer patients away from other lower-priced hospitals and toward CHS hospitals.

In asking for a dismissal, CHS has said the lawsuit has failed to allege any actual competitive harm to the marketplace.

HCPro.com – Credentialing and Peer Review Legal Insider

Legal and regulatory news roundup

Find out what’s happening in the world of federal healthcare regulations by reviewing some recent headlines from across the country.

Senate Finance Committee aims to reform Stark Law

The Senate Finance Committee hopes to introduce legislation to reform the federal physician self-referral law, commonly referred to as the Stark Law. During a recent hearing, Chairman Orrin Hatch (R-Utah) said the committee would take some action by the end of 2016 but did not elaborate on what that might be.

In June, Hatch released a white paper discussing potential reforms to the Stark Law. Several commenters suggested repealing the law in its entirety. Others suggested changes to the law that would allow providers to implement new payment models.

In a statement released with the white paper, Hatch said the Stark Law is "a real burden for hospitals and doctors trying to find new ways to provide high quality care while reducing costs as they work to implement recent healthcare reforms."

Hundreds charged with healthcare fraud in nationwide sweep

More than 300 physicians, nurses, and other medical professionals across the country allegedly involved in healthcare fraud schemes face criminal and civil charges following what the U.S. Department of Justice called the largest coordinated takedown in history. The Medicare Fraud Strike Force in 36 federal districts led the sweep, which also involved 23 state Medicaid Fraud Control Units and 26 U.S. Attorney’s Offices.

The individuals charged are suspected of collectively submitting approximately $ 900 million in fraudulent billing to Medicare and Medicaid. They face multiple healthcare fraud-related charges, including conspiracy to commit healthcare fraud, aggravated identity theft, money laundering, and violations of the anti-kickback laws for schemes in which they submitted claims for medically unnecessary treatments. Often the treatments were never provided. In some cases kickbacks were paid to Medicare beneficiaries, patient recruiters, and other co-conspirators in return for providing beneficiary information to providers to use in submitting fraudulent billing.

Some of the highlights of the sweep include:

• One-hundred defendants from southern Florida were charged for their alleged involvement in schemes that resulted in $ 220 million in fraudulent billings for home healthcare, mental health services, and pharmacy fraud.
• Eleven defendants in southern Texas were allegedly responsible for $ 47 million fraudulent billing, including one physician who allowed unlicensed individuals to perform services and then billed Medicare as if he had performed them.
• Twenty-two defendants in central California allegedly defrauded Medicare of $ 162 million. One physician is believed to be responsible for nearly $ 12 million through fraudulently billing for medically necessary vein ablation procedures.

In an announcement of the arrests, Attorney General Loretta E. Lynch said, "The wrongdoers that we pursue in these operations seek to use public funds for private enrichment. They target real people?many of them in need of significant medical care. They promise effective cures and therapies, but they provide none. Above all, they abuse basic bonds of trust?between doctor and patient; between pharmacist and doctor; between taxpayer and government?and pervert them to their own ends."

Cardiologist agrees to pay $ 2 million to settle kickback, false billing lawsuit

Asad Qamar, MD, of the Institute of Cardiovascular Excellence (ICE) of Ocala, Florida, has agreed to pay $ 2 million to resolve a lawsuit alleging he paid kickbacks to patients and improperly billed Medicare, Medicaid, and TRICARE?a healthcare program of the U.S. Department of Defense Military Health System. Qamar will also release any claim to $ 5.3 million in suspended Medicare funds and agreed to a three-year exclusion from participating in any federal healthcare program. This will be followed by a three-year integrity agreement with the Department of Health and Human Services Office of the Inspector General.

According to the U.S. Department of Justice, the lawsuit against Qamar claimed that he and ICE billed for peripheral artery interventional services and other related procedures, many of which were medically unnecessary according to the patients’ medical histories or records, or by the severity of their symptoms.

The lawsuit also alleged that Qamar and ICE persuaded patients to agree to the unnecessary procedures by routinely and indiscriminately waiving the 20% Medicare copayment. The copayment is typically used to help patients be smarter healthcare consumers and deter them from unnecessary procedures.

According to The Wall Street Journal, following a legal effort by the paper, CMS made public Medicare payment data which showed that Qamar had collected more than $ 18 million from Medicare in 2012. That ranked him second highest paid among all physicians in the country and four times more than the third highest paid cardiologist.

The settlement resolves two consolidated lawsuits originally filed under the whistleblower provision of the False Claims Act. The two individuals who originally brought the suit will receive about $ 1.3 million for their share of the settlement.

Former Warner Chilcott president acquitted on anti-kickback charge

W. Carl Reichel, former president of Warner Chilcott, was found not guilty of conspiring to pay kickbacks to physicians to induce them to prescribe its drugs.

The government’s case against Reichel alleged that he encouraged members of the sales force to provide physicians with payments, meals, and other rewards. According to court documents, Reichel was acquitted on grounds that there wasn’t insufficient evidence to suggest that he had ever given the sales team any such direction.

Last October Warner Chilcott agreed to plead guilty before a federal judge in U.S. District Court for the District of Massachusetts to a felony healthcare fraud charge and pay $ 125 million to settle criminal and civil liability related to illegal marketing of several of its drugs. This included paying kickbacks to physicians throughout the country to encourage them to prescribe their drugs.

HCPro.com – Credentialing and Peer Review Legal Insider

Legal and regulatory news roundup

Find out what’s happening in the world of federal healthcare regulations by reviewing some recent headlines from across the country.

Legislation introduced to stop Stark Law loophole

A bill introduced in Congress seeks to close a loophole in the Stark Law that allows physicians to self-refer patients for certain services that they have a financial interest in and that they provide in their offices. The Promoting Integrity in Medicare Act (PIMA), also known as H.R. 5088, aims to prevent harmful and wasteful Medicare spending by prohibiting self-referrals for the following four services: advanced diagnostic imaging, anatomic pathology, radiation oncology, and physical therapy.

Under the Stark Law, physicians are banned from referring Medicare patients for healthcare services in which they have a financial interest. However, the law includes an exception for in-office ancillary services, which are those that are can be provided at the time of a patient’s initial visit. The four services targeted by PIMA are typically not performed the same day.

According to the Congressional Budget Office, closing the loophole on the four services could save an estimated $ 3.3 billion over 10 years.

"How many [U.S. Government Accountability Office] studies outlining the abuse and billions of dollars of Medicare reimbursement to doctors for unnecessary services that are driven purely for personal profit does it take to shut this activity down?" said Rep. Jackie Speier, the bill’s sponsor, in a statement. "This is a golden opportunity to put patient health and program health over profits."

The bill has been referred to the Committee on Energy and Commerce and the Committee on Ways and Means.

Healthcare product manufacturer, supplier pay to settle kickback allegations

To resolve allegations that it paid unlawful kickbacks to a medical products supplier, Hollister, Inc., has agreed to pay $ 11.4 million. In turn, the medical products supplier Byram Healthcare Centers, Inc., has agreed to pay $ 9.3 million to settle allegations of receiving the kickbacks.

According to the U.S. Department of Justice, from 2007 to 2014, Hollister, which manufactures disposable healthcare products, allegedly paid Byram kickbacks in return for marketing promotions, conversion campaigns, and other patient referrals to its products. Several times throughout the years, Hollister allegedly paid Byram’s costs for bonus commission paid to its sales personnel for new patient orders of Hollister products. Hollister also allegedly paid Byram $ 200,000 every year from 2009 to 2014 for "catalog funding," which instead was used to generate recommendations of its products to Byram’s patients.

Byram’s settlement payment resolves allegations it received kickback payments from Hollister and three other manufacturers?Coloplast Corp., Montreal Ostomy, and Safe N’ Simple?in exchange for promotional campaigns and patient referrals to their products.

As part of the settlement, Byram must also pay $ 127,000 to California to resolve allegations it submitted falsely inflated claims to the state’s Medicaid program, Medi-Cal. Byram allegedly failed to account for substantial discounts it received for products when it billed Medi-Cal for products sold to Medi-Cal beneficiaries.

Of the settlements, U.S. Attorney Carmen M. Ortiz, for the District of Massachusetts, said, "We are committed to rooting out commercial bribery, especially in the healthcare industry where the payment of kickbacks erodes patients’ trust in the quality of their medical care … These unlawful cash incentives also threaten the integrity of the healthcare system and siphon taxpayer dollars from our nation’s healthcare programs."

The settlements also resolved a whistleblower lawsuit filed by one current and two former Coloplast employees. A provision of the False Claims Act allows whistleblowers a share in any recovery. The whistleblowers’ share of the settlement has not yet been determined.

ACLU launches campaign over alleged EMTALA violations

The American Civil Liberties Union (ACLU) and MergerWatch recently released a report to bring attention to what they believe is the practice among Catholic hospitals of denying emergency reproductive healthcare on religious grounds.

The report takes issue with Catholic hospitals’ partial or full adherence to Ethical and Religious Directives for Catholic Healthcare Services, a set of policies issued by the U.S. Conference of Catholic Bishops. The ACLU claims that implementation of these directives has led to instances in which pregnant patients are denied care, which is a violation of the Emergency Medical Treatment & Active Labor Act of 1986 (EMTALA).

EMTALA requires hospitals that receive Medicare funds to provide medical screening exams to patients who arrive at their emergency departments and appear to need emergency medical services. These screenings must be conducted by a qualified medical staff professional to determine whether a patient has an emergency condition. If so, the patient must be provided stabilizing treatment.

The report collects accounts of patients suffering miscarriages who were denied reproductive health services, such as emergency abortions or tubal ligations, even when their own health was at risk, due to the directives.

The report recommends that CMS issue a statement emphasizing that denial of emergency reproductive healthcare violates EMTALA, regardless of religious affiliation. It also calls for CMS to investigate any alleged violations and take corrective actions when necessary.

A statement released by the Catholic Health Association denounces the ACLU-MergerWatch report and states, "To frighten families with scary, one-sided stories and exaggerated data is grossly disrespectful to the thousands of physicians, midwives and nurses working in Catholic hospitals who are so devoted to their patients and to the care they deliver."

The statement adds that allegations made in the report are unsubstantiated and that some have been subject to lawsuits that have been dismissed by the courts. It also defends the Ethical and Religious Directives for Catholic Healthcare Services as guidelines consistent with the delivery of safe and effective patient care.

Healthcare company owner convicted on kickback charges

A New Orleans jury convicted Tracy Richardson Brown, owner and operator of Psalms 23 DME, LLC, for directing a scheme that billed Medicare $ 3.9 million for often fraudulent claims. Brown was convicted on nine counts of healthcare fraud, seven counts of paying illegal kickbacks, one count of conspiracy to commit healthcare fraud, and one count of conspiracy to pay illegal kickbacks.

According to evidence introduced at trial, Brown paid patient recruiters for the information of Medicare recipients in the New Orleans area. Her company then used names and Medicare numbers to bill Medicare for medical equipment that was not needed, such as power wheelchairs and orthotics. Often the equipment was not even provided to the patients. Brown also billed Medicare for high-cost back and knee braces, when in reality she provided patients with much cheaper versions. In all, Medicare paid Brown $ 1.9 million for her fraudulent claims.

Brown’s sentencing hearing is scheduled for August 10.

Physician sentenced to nine years in prison for fraud scheme

A Miami physician who admitted to his role in a Medicare fraud scheme has been sentenced to 108 months in prison and ordered to pay more than $ 30 million in restitutions.

In February, Henry Lora, the former medical director of Miami-based clinic Merfi Corporation, pleaded guilty to one count of conspiracy to commit healthcare fraud and one count of conspiracy to defraud the United States, receive healthcare kickbacks, and make false statements relating to healthcare matters.

As part of a plea deal with prosecutors, Lora admitted he and his co-conspirators wrote prescriptions for home health care and other services for Medicare beneficiaries that were not medically necessary or provided in exchange for bribes and kickbacks from multiple home healthcare agencies in the Miami-Dade area. He also admitted to falsifying patient records so that it appeared beneficiaries qualified for the services.

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