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Articles Posted in Compliance

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Due to the high volume of tips and complaints the Department of Health and Human Services (HHS) Office of Inspector General (OIG) receives – approximately 115,000 each year – the need for an efficient means of capturing these complaints was vital for OIG. Released to the public November 14, 2019, the newly redesigned OIG Hotline website is now the preferred method for users to submit tips or complaints.

The site has been completely revamped to include user-friendly updates such as guided questions and options for users to provide supplementary documentation for their submission. Furthermore, the addition of mobile compatibility for the site increases the options for access individuals previously had.

“The Hotline is the public face of the Health and Human Services Inspector General,” said Nenette Day, Assistant Special Agent in Charge, Office of Investigations.

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In the recently released CY 2020 Outpatient Prospective Payment System (OPPS) proposed rule, the Centers for Medicare & Medicaid Services (CMS) introduced policies that, if finalized, would require hospitals to post a list of standard charges for items and services provided. This proposed rule updates the requirements set forth in the FY 2015 Inpatient Prospective Payment System (IPPS)/Long-Term Care Hospital (LTCH) final rule, which aimed to improve the transparency of hospital prices by requiring either standard charges to be posted online or compliance with patient requests for same. This rule was finalized on August 2, 2018 and came into effect on January 1, 2019. HLP previously wrote about the FY 2015 IPPS/LTCH rule here.

Following a June 24, 2019 Executive Order and several listening sessions and CMS-solicited comments, CMS offered numerous updates to its policy in the 2020 OPPS proposed rule. These changes would include defining several standard terms used in the policy, requiring the posting of 300 “shoppable services” to the hospital’s website, asking for payer-specific information, and penalizing noncompliant hospitals.

In order to ensure every hospital operating in the U.S. and in U.S. territories complies, CMS seeks to broadly define “hospital” as an institution in any State in which State or applicable local law provides for the licensing of hospitals and is either: licensed as a hospital pursuant to such law or, approved, by the agency of such State or locality responsible for licensing hospitals as meeting the standards established for such licensing. CMS does note that the rule would not apply to ambulatory surgical centers or nonhospital sites offering laboratory or imaging services but does encourage these facilities to comply with the policy. Furthermore, the rule would not apply to federally owned or operated hospitals, such as the U.S. Department of Veterans Affairs or hospitals operated by an Indian Health Program.

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By Adrienne Dresevic, Esq. of The Health Law Partners, P.C., Olivia Dresevic JD expected 2020

On June 1, 2019, Joanne Chiedi assumed the role of Acting Inspector General at the U.S. Department of Health and Human Services (HHS) following Daniel R. Levinson’s resignation. Ms. Chiedi recently sat down with the Compliance Perspectives Podcast to speak on key issues she addressed at the 2019 Compliance Institute. This article will highlight some of Ms. Chiedi’s insight regarding how healthcare providers can maintain successful compliance and oversight considering the rapid innovative changes occurring in Healthcare.

Innovation and Technology in the world of Healthcare

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As of April 30, 2019, the maximum penalties for violations of the Health Insurance Portability and Accountability Act (HIPAA) have new annual limits. These updated penalties will be based on the level of culpability associated with the violation, according to the Department of Health and Human Services (HHS). Organizations that have taken measures to meet HIPAA’s requirements now face a smaller maximum potential penalty than organizations who are found neglectful.

The level of culpability associated with a HIPAA violation is based on four tiers, described in the Health Information Technology for Economic and Clinical Health (HITECH) Act. In order to address “apparently inconsistent language” in HITECH’s penalty scheme, which outlines the minimum and maximum HIPAA enforcement penalties, HHS published a notice of enforcement discretion that further defines the updated fines for the four tiers:

  1. The person did not know (and, by exercising reasonable diligence, would not have known) that the person violated the provision – $100 to $50,000 per violation, capped at $25,000 per year the issue persisted
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The New York State Office of the Medicaid Inspector General (OMIG) maintains a Certification Program to ensure Medicaid providers are continuing proper compliance. This program works to eliminate any environment in a Medicaid provider’s system that may encourage fraud, waste, or abuse, as well as ensuring errors have the potential for self-correction if mistakes are located before the Medicaid program is billed. Providers who meet OMIG’s requirements must submit a certification at the time of enrollment and every December thereafter. This includes any Medicaid providers who have submitted $500,000 in Medicaid claims or those who may reach that goal in any consecutive 12-month time period, regardless of calendar year.

OMIG has identified seven compliance areas that must be covered by the Compliance Program:

  • Billings
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June 2018 – On June 19, 2018, the Centers for Medicare & Medicaid Services (“CMS”) issued a Request for Information (“RFI”) seeking public input on how to address any undue impact and burden of the physician self-referral law, 42 U.S.C. § 1395nn (the “Stark Law”).

By way of background, the Stark Law addresses the concern that health care decision making can be unduly influenced by a profit motive and when physicians have a financial incentive to refer patients for health care services, overutilization in medical services may result. To counter such concerns, the Stark Law, subject to certain exceptions: (1) prohibits physicians from making referrals for certain designated health services (“DHS”) payable by Medicare to an entity with which the physician (or an immediate family member) has a financial relationship; and (2) prohibits the entity from filing claims with Medicare (or billing another individual, entity, or third-party payer) for those referred services.

In response to a prior RFI published by CMS requesting comments on improvements that can be made to the health care delivery system that reduce unnecessary burdens, the commenters identified compliance with the Stark Law and its regulations as one of the top areas of burden. In response to these concerns, CMS is now requesting additional information. Specifically, CMS is interested in thoughts on issues that include the structure of arrangements between parties that participate in alternative payment models or other novel financial arrangements, the need for revisions or additions to exceptions to the Stark Law and terminology related to alternative payment models and the Stark Law.

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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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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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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 New York State Office of the Medicaid Inspector General (OMIG) issued guidance on its requirements for Medicaid compliance, effective October 26, 2016.  This Compliance Program Review Guidance (“Guidance”) will assist the Medicaid Required Provider (“Required Provider”) community in developing and implementing compliance programs that meet the requirements of Social Services Law Section 363-d (“SSL 363-d”) and title 18 New York Codes of Rules and Regulations Part 521 (“Part 521”).

For the purposes of this Guidance, “Required Provider” means a provider meeting any of criteria listed: (a) persons subject to the provisions of articles twenty-eight or thirty-six of the public health law; (b) persons subject to the provisions of articles sixteen or thirty-one of the mental hygiene law; or (c) other persons, providers or affiliates who provide care, services or supplies under the medical assistance program or persons who submit claims for care, services, or supplies for or on behalf of another person for which the medical assistance program is or should be reasonably expected by a provider to be a substantial portion of their business operations.

The comprehensive Guidance addresses all requirements under each of the eight program elements. Invariably in compliance program guidance there are seven key elements of an effective compliance program which are as follows: written policies and procedures, compliance oversight, effective training/ education, effective communication, internal monitoring and auditing, enforcement of standards and corrective action with the OMIG Guidance adding an eight element in the form of a policy on non-intimidation and non-retaliation.

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