Articles Posted in Health Law

The U.S. Department (DOJ) and the Health Alliance of Greater Cincinnati entered into an agreement to settle a False Claims Act lawsuit with the DOJ alleging that from 1997 to 2004 Christ Hospital, a former member of the Health Alliance, scheduled cardiologists at a diagnostic unit based on the amount of business they brought to the hospital. The DOJ alleged that the arrangement was a kickback scheme because the cardiologists could bill for their diagnostic services and obtain new patients for follow-up procedures. The case was initiated by a whistle-blower lawsuit that the DOJ joined in 2008.

In the settlement agreement, Health Alliance of Greater Cincinnati and Christ Hospital deny the allegations and do not admit liability. The organizations agreed to pay a total of $108 million in the agreement.

This case – and similar cases that have been brought against health care providers by the DOJ over the past several years – highlight the importance of ensuring compliance with federal laws including the Stark law and the Anti-Kickback Statute to protect against the possibility of costly False Claims Acts lawsuits.

Earlier this month, the U.S. District Court for the Western District of Michigan granted a defendant’s motion to dismiss a qui tam action against it. The court held that the relator failed to state a claim with the required particularity.

Robert Lauricia filed the qui tam action under the False Claims Act (FCA) against Stryker Corporation. Mr. Lauricia’s complaint alleged that Stryker was engaged in a kickback scheme with Dr. Hari K. Parvateneni. The scheme involved Dr. Parvateneni’s agreement to use Stryker’s medical devices for implantation into Medicare patients in exchange for Stryker’s agreements to fund the training of Parvateneni’s residents and research projects. Mr. Lauricia alleged that since Parvateneni and Stryker engaged in the illegal kickback scheme, any claims submitted for reimbursement from Medicare were violations of the FCA.

The defendants’ motion to dismiss was granted by the district court. The court expressed that the allegations failed to state a claim for relief as the relationship between the defendants was neutral on its face, with Mr. Lauricia failing to produce any specific conduct that would render it illegal. The court also noted that the claim failed to allege the time or place of the alleged misrepresentations, any injury resulting from the alleged fraud, or even a single particular fraudulent claim.

In the same vein as the Healthcare Reform legislation’s vendor-providing reporting requirements known as the “sunshine law,” several leading professional medical organizations have adopted the new ethics codes, including: the American College of Physicians, the American College of Cardiology, and the American Society of Clinical Oncology. The ethical codes require the professional organizations to publicly post any industry support the group receives, decline industry funding for developing medical practice guidelines, disclose financial ties that leaders and board members have with companies, and ban company or product names and logos form pens, bags and other gifts at conferences. The goal of the ethical codes is to make financial ties more transparent.

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The Health Reform bill, also known as the Patient Protection and Affordable Care Act, includes amendments to the Anti-Kickback Statute (AKS), including a relaxation of the “specific intent” requirement. The Health Reform bill amended Section 1128B of the Social Security Act to add the following statement: “with respect to violations of this section, a person need not have actual knowledge of this section or specific intent to commit a violation of this section.” The change rejects previous interpretations of the AKS that required the government to prove that an individual “knowingly and willfully” violated the statute. This amendment in the health care reform bill will make it much easier for federal prosecutors to prove the requisite intent in AKS cases.

The Health Reform bill also amended the AKS to expressly state that a claim billed pursuant to an arrangement that violates the statute is a false or fraudulent claim under the false claims act, a position that was previously taken by some courts.

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The healthcare reform legislation included changes for home health and DME providers. First of all, DME or home health services may only be ordered for Medicare beneficiaries by Medicare enrolled physicians or eligible professionals. In addition, Medicare enrolled physicians are required to have a face-to-face encounter with a patient prior to issuing a certification for home health services or written order for DME. Finally, Medicare physicians, suppliers, and providers are required to maintain and provide access to documentation related to written orders or requests for payment for DME, certifications for home health services or referrals for other items and services. Failure to maintain these documents or to provide access to them could result in the revocation of enrollment for not more than one year for each act.

For more information on health law issues, please visit www.wachler.com or contact a Wachler & Associates attorney at 248-544-0888.

The College of American Pathologists (CAP) recently announced that it is changing its accreditation checklist for CLIA accreditation in response to an interpretation communicated by the Centers for Medicare and Medicaid Services (CMS) with regard to the qualifications for “processing” personnel. Previously CAP treated “processing” personnel different from “grossing” personnel and did not require “processing” personnel to meet the requirements for “high complexity testing.” Laboratory providers who previously relied upon the distinction of “processing” vs. “grossing” must now ensure that all personnel who perform macroscopic tissue examinations meet the educational requirements of 42 CFR §493.1489 or are grandfathered pursuant to 42 CFR §493.1489 or 42 CFR §493.1491. If personnel meet the requirements to be “grandfathered”, additional supervision requirements may apply.

For more information, please visit www.wachler.com or contact a Wachler & Associates attorney at 248-544-0888.

The Healthcare Reform legislation includes vendor-provider reporting requirements, also known as the “sunshine law.” The law requires manufacturers of drugs, medical devices, medical supplies, and biologics to report financial arrangements with certain “covered recipients.” “Covered recipients” include physicians or teaching hospitals. The manufacturer must make the report to the U.S. Department of Health and Human Services (HHS). Then HHS must disclose the information on a public website.

The purpose of the reporting and disclosure requirements is to promote transparency of these financial arrangements. The goal is to encourage the avoidance of conflicts of interest that can compromise clinical care, biomedical research, and medical education, and potentially lead to violations of federal anti-fraud statutes.

The federal sunshine law generally preempts state sunshine laws with the exception of state laws that require disclosure of information not required under the federal legislation or excluded by the federal legislation, by any person or entity other than an applicable manufacturer or a covered recipient, or reporting of information to a Federal, State, or local government agency for public health surveillance, investigation, or other public health purpose. Manufacturers practicing in states with sunshine laws must now be attentive to both the federal and state law requirements to ensure compliance to both requirements.

The Health Reform bill, or the Patient Protection and Affordable Care Act, amended the definition of remuneration in the Civil Monetary Penalties Law. The amendment clarifies that certain charitable activities are not prohibited under the law. The amended law excludes the following from qualifying as remuneration:

The Patient Protection and Affordable Care Act, also known as the Healthcare Reform Bill, signed into law last week by President Obama, includes several provisions from the National Pain Care Policy Act. The National Pain Care Policy Act is legislation designed to improve pain care for the more than 76.5 million Americans affected by pain. The American Pain Foundation made an announcement regarding this inclusion, attributing the success to a grassroots effort to bring attention to improving pain care in the United States.

The provisions of the National Pain Care Policy Act 2009 included in the Patient Protection and Affordable Care Act are located in Section 4305 of the Act, “Advancing research and treatment for pain care management.”

Yet another way that the Patient Protection and Affordable Care Act (the Act), otherwise known as the Health Reform bill, impacts health care providers is the strengthening of the Federal False Claims Act (FCA).

For example, Section 6402 of the Act amends Section 1128 B of the Social Security Act to expressly define services performed or billed in violation of the anti-kickback statute as false claims: “…a claim that includes items or services resulting from a violation of this section constitutes a false or fraudulent claim…”

In addition to the reinforcement of false claims liability for anti-kickback violations, Section 6402 establishes deadlines for repaying health care overpayments. Failure to meet the deadlines causes providers to be in violation of the FCA’s “reverse false claims” provision. The deadline for reporting and returning overpayments is the later of 60 days after the date the overpayment is identified, or the date any corresponding cost report is due, if applicable.