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In the world of litigation healthcare providers can potentially fall victim to the False Claims Act (“FCA”) when they file medical claims for reimbursement from either Medicaid or Medicare. FCA claims against hospitals and other healthcare related entities usually involve allegations that the healthcare provider knowingly or recklessly filed a false claim for payment from a federally funded government program. Under the FCA qui tam provisions, private citizens, known as “relators”, can file lawsuits where they have suffered no personal injury. Instead, these relators allege the federal government was defrauded and can obtain a substantial monetary reward if they are successful in recovering a judgement from the court.

A hotly contested issue in qui tam cases is whether the violation of the regulation alleged in the case is material to the government’s obligation to pay a healthcare claim. For instance, whenever a physician or supplier of medical services completes a form 1500, it certifies the claims were medically indicated and necessary and that any “false claims, statements, or documents, or concealment of a material fact, may be prosecuted under applicable Federal or State laws.” Historically, the issue in a lot of cases involving alleged false claims is whether the claim made by the healthcare provider is either a “condition of payment” or a “condition of participation” in the governmental program. If the alleged false claim only violated a condition of participation, as opposed to a condition of payment, then there could be no false claim in violation of the FCA. Courts reasoned that conditions of payment were central to the government’s decision to pay claims as opposed to a mere violation of a condition of participation that could be handled administratively by the enforcing governmental agency.

After the United States Supreme Court’s ruling in Universal Health Servs. v. United States ex rel. Escobar 136 S. Ct. 1989 (2016), the old condition of payment or condition of participation standards for materiality were largely abandoned. Instead, the Supreme Court, adopted a new “rigorous” materiality standard. Escobar, 136 S.Ct. at 2004 n.6. Although promulgated conditions of payment in statutes or regulations are relevant in attempting to establishing materiality, they are not “automatically dispositive.” Id. at 2003. Moreover, the Supreme Court held that “A misrepresentation cannot be deemed material merely because the Government designates compliance with a particular statutory, regulatory, or contractual requirement as a condition of payment. Nor is it sufficient for a finding of materiality that the Government would have the option to decline to pay if it knew of the defendant’s noncompliance.” Escobar, a relator is now faced with a steeper climb to show that the violation of a particular statute or regulation is material to the government’s decision to a pay the medical claim.

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In its recent Advisory Opinion No. 17-05, OIG stated that the Proposed Arrangement (“Arrangement”) would not violate the anti-kickback statute (“AKS”) nor would it prompt administrative sanctions under the Civil Monetary Penalties (“CMP”) provision of the Social Security Act, prohibiting inducements to beneficiaries.

The Proposed Arrangement discussed in the Opinion centers around a retail pharmacy chain offering a voluntary membership program to Federal healthcare program beneficiaries that includes discounts on certain prescriptions and clinic services.

OIG further noted that Program Members receiving discounts would also be eligible to earn rewards in the form of credits when certain merchandise in-store photo-finishing services were purchased. On its face, the Arrangement would appear to invoke prohibitions of the CMP and AKS, since the discounted items and services and earned credits could induce a beneficiary to select the retail pharmacy chain as his or her supplier for federally reimbursable items or services.

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Home Health Agencies will now have an additional 6 months to comply with a new CMS rule intended to advance the quality of patient care.

CMS published a final rule on July 10th delaying the effective date for its rule addressing conditions of participation for home health agencies. CMS has moved the effective date of the rule back 6 months from its original July 13, 2017 to January 13, 2018. This delay pushes back the implementation of regulations primarily focused on improving patient quality of care.

Under the new rule Home Health Agencies are directed to begin implementing data-driven performance improvement projects. These data-driven programs are concentrated on quality assessment programs targeting indicators related to improved outcomes for patients and other quality indicators across the home health spectrum of care. This quality program requirement is now set to phase-in on July 13, 2018 instead of January 13, 2018.

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The Health Law Partners (HLP) is proud to be part of the upcoming Physician Legal Issues Conference co-sponsored by the American Bar Association Health Law Section and Chicago Medical Society.  The conference will take place at the Intercontinental Hotel in Chicago on June 8-9, 2017.  Adrienne Dresevic, Esq., a founding partner of the HLP, is Co-Chairing the conference this year.  Abby Pendleton, Esq., a founding partner of the HLP, will be a featured speaker at the conference. Ms. Pendleton’s speech is titled, Your Practice is Being Audited: Complying, Fighting and Winning. Her session addresses key issues when facing an audit including: appeals processes and auditors’ concepts, considerations affecting the decision to appeal, successful strategies for appeals, and using the audit to enhance future compliance. Attend the conference to learn the latest on health reform, payor alignment, clinical integration, and other issues that impact the legal profession. Programming includes topics such as: Stark Law, Health Reform, Anti-Kickback, and more!

 

To the view the brochure with program details please click here.  To register for the conference please click here.

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Compliance programs are mandatory (pending final regulations) for all health care organizations post-Affordable Care Act. In some states, and for some provider/supplier types, compliance programs are already mandatory. In any event, compliance programs in health care organizations are crucial in today’s overregulated environment, with qui tam attorneys, whistleblowers, regulators, and payors seeking any potential excuse to recoup.

Compliance programs work as a set of internal controls that assist in preventing, detecting, and resolving illegal or unethical conduct/errors that may take place. In order to ensure compliance with all appropriate laws and regulations, radiology providers and suppliers should implement compliance programs that at a minimum meet all laws and regulations.

The elements of effective compliance programs are relatively straightforward and known. However, many organizations struggle to implement, execute, measure, and evaluate their compliance programs.

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On March 6, 2017, House Republicans released the much-anticipated American Health Care Act (“AHCA”) bill that would effectively replace the Patient Protection and Affordable Care Act (the “ACA”), which is currently responsible for covering approximately 20 million individuals through a combination of health insurance offered through state-based and federally-run Exchanges and the expansion of healthcare coverage.

One of President Trump’s policy promises has been that “On day one of the Trump Administration, we will ask Congress to immediately deliver a full repeal of Obamacare.” Now that President Trump is in office, and Republicans control the legislative branch of the government, members of Congress are actively working through the legislative process to repeal and replace the ACA.

In fact, the AHCA passed by the House Energy and Commerce Committee and the House Ways and Means Committee on March 9, 2017 and passed the House Budget Committee on March 26, 2017.  The AHCA is proceeding to the Rules Committee, which will set the terms of the debate before the bill goes to the full House.  Upon passage by the House, the bill will move to the Senate under budget reconciliation rules.

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Recent letters from New York’s Medicaid Fraud Control Unit (“MFCU”) to those healthcare providers in New York State who have “percentage of collection” arrangements with their outside billing companies are demanding that such providers refund money paid to them by Medicaid based on MFCU’s determination that such billing arrangements are illegal under the Medicaid law and may also constitute unprofessional conduct under New York’s Education Law.

Healthcare providers, especially those who accept Medicaid, should immediately review their billing vendor service contracts to make sure they do not provide compensation to the billing company that is based on a percentage of collections.

In response to the letters recently sent to New York licensed physicians by MFCU, the Medical Society of the State of New York (MSSNY) is urging its members to amend the fees they pay to their billing companies for Medicaid claim submissions so that they reflect either: (1) payments based on time; or (2) a flat fee for claims submitted.

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On December 7, 2016, the Department of Health and Human Services Office of Inspector General (“OIG”) released a final rule (“Final Rule”) codifying new safe harbors to the Anti-Kickback Statute (“AKS”) and new exceptions to the beneficiary inducement provisions of the Civil Monetary Penalties law (“CMP”). The Final Rule will go into effect on January 6, 2017. The final rule can be found using the following link, https://www.gpo.gov/fdsys/pkg/FR-2016-12-07/pdf/2016-28297.pdf.

The Final Rule creates several new safe harbors to the AKS and new exceptions to the beneficiary inducement provisions of the CMP. Below is a summary of the newly codified Local Transportation Safe Harbor to the AKS.

The Local Transportation Safe Harbor that protects free or discounted local transportation made available by an “eligible entity” to federal health care program beneficiaries as long as the following conditions are met:

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Relief will (eventually) be granted to Medicare appellants.  After a years-long battle, on December 5, 2016, the U.S. District Court of the District of Columbia granted mandamus relief to the American Hospital Association (“AHA”) and its co-plaintiffs.

The Court requested that the parties propose actions the Secretary could take to address the backlog of pending appeals.  The AHA proposed three particular interventions, and, in the alternative, proposed a timetable by which the Secretary would be required to achieve reductions in the backlog.

The three proposed interventions included the following: (1) offer reasonable settlements to certain broad groups of providers and suppliers; (2) for some subset of disputed Medicare claims, defer providers’ duty to repay the Secretary and toll the accrual of interest on those claims awaiting adjudication beyond the statutory deadlines; and (3) impose financial penalties on Recovery Audit Contractors for high reversal rates by Administrative Law Judges (“ALJs”).

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The OIG issued a Policy Statement regarding Gifts of Nominal Value to Medicare and Medicaid Beneficiaries.

Under section 1128A(a)(5) of the Social Security Act (the Act), enacted as part of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), a person who offers or transfers to a Medicare or Medicaid beneficiary any remuneration that the person knows or should know is likely to influence the beneficiary’s selection of a particular provider, practitioner, or supplier of Medicare or Medicaid payable items or services may be liable for civil monetary penalties (CMPs) of up to $10,000 for each wrongful act. For purposes of section 1128A(a)(5) of the Act, the statute defines “remuneration” to include, without limitation, waivers of copayments and deductible amounts (or any part thereof) and transfers of items or services for free or for other than fair market value. The statute and implementing regulations contain a limited number of exceptions.

Prior to issuing this Special Advisory Bulletin, the OIG interpreted the prohibition to permit Medicare or Medicaid providers to offer beneficiaries inexpensive gifts (other than cash or cash equivalents) or services without violating the statute in a 2002 Special Advisory Bulletin.  For enforcement purposes, inexpensive gifts or services were said to be those that have a retail value of no more than $10 individually, and no more than $50 in the aggregate annually per patient.

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