CMS Solicits Comments on How to Impose Penalties for Failure to Comply with the MSP Act’s Reporting Requirements

Posted by Health Law Informer Author on December 19, 2013
Medicaid, Medicare / No Comments

On December 11, 2013 the Centers for Medicare & Medicaid Services (CMS) published an advance notice of proposed rulemaking concerning the circumstances under which civil money penalties may be imposed for failure to comply with Medicare Secondary Payer Act (the “MSP Act”) Section 111 reporting requirements.  Section 111 of the Medicare, Medicaid, and SCHIP Extension Act of 2007 amended the MSP Act by establishing  mandatory reporting requirements for certain group health plans (GHPs) and for liability insurance (including self-insurance) no fault insurance and workers compensation (collectively NGHPs) arrangements.  The Section 111 amendments require GHPs and NGHPs to notify CMS when they pay a claim on behalf of a Medicare beneficiary.  Failure to comply with the reporting requirements resulted in a civil monetary penalty of $1,000 for each day of noncompliance.

The Strengthening Medicare and Repaying Taxpayers Act of 2012 (the “SMART Act”) amended the penalty provision of the Section 111 reporting requirements by stating that applicable plans that fail to comply with the reporting requirements may be subject to a civil monetary penalty of up to $1,000 per day of non-compliance.  Thus, the SMART Act made the penalty discretionary instead of mandatory and allowed for penalties below $1,000.  As a result,  CMS is soliciting public comments and proposals on the practices for which civil monetary penalties may or may not be imposed.  Specifically, CMS is seeking comments on how to define “noncompliance” with reporting requirements; what mechanisms and criteria should be used to evaluate whether a civil money penalty can be imposed; what methods should be used to determine the dollar amount of such a penalty; and what actions on the part of a primary payer would constitute a “good faith effort” to identify a Medicare beneficiary for purposes of reporting under the MSP Act.  Comments can be submitted to CMS until February 10, 2014.

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Ruminations on Observation: OIG Report Highlights Inpatient vs. Observation Status

Posted by Health Law Informer Author on August 22, 2013
Medicaid / No Comments

On July 29, 2013, the OIG released a memorandum report finding that Medicare paid more on average for short inpatient stays than for observation stays in 2012.  The report, Hospitals’ Use of Observation Stays and Short Inpatient Stays for Medicare Beneficiaries, OEI-02-12-00040, touches on observation versus inpatient status, which has been and continues to be a hot button issue.

Background

Medicare beneficiaries receiving care at a hospital are classified as either inpatients or observation patients.  Observation patients are outpatients who receive treatments and assessments to determine whether they require further treatment as inpatients or can be discharged.  CMS policy provides that observation services are usually needed for 24 hours or less.   Continue reading…

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THE CLOCK IS TICKING: Covered Entities, Business Associates and Subcontractors Have Until September 23, 2013 to comply with Updated HIPAA Regulations

Posted by Health Law Informer Author on June 27, 2013
HIPAA, HITECH / No Comments

As we’ve discussed in previous articles,[1] and as you are no doubt aware by now, the Health Insurance Portability and Accountability Act (HIPAA) recently received a significant facelift.  In addition to extending direct liability to business associates and subcontractors, the updated HIPAA regulations (Updated Regulations), which were authorized by the Health Information Technology for Economic and Clinical Health Act (HITECH), contain many new provisions to address growing privacy concerns for the increasing amount of protected health information (PHI) stored on electronic media.  Covered entities and their business associates and subcontractors must comply with the Updated Regulations by September 23, 2013.  In order to help you prepare for the September 23, 2013 compliance deadline, this article (1) explains the difference between two important compliance deadlines contained in the Updated Regulations, (2) suggests a 5-step process to efficiently update and/or create compliant HIPAA policies and procedures, and (3) discusses a few observations we’ve made as we’ve helped our clients prepare for the September 23, 2013 compliance deadline. Continue reading…

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Screen Early, Screen Often: OIG Updates its Advice on How to Avoid Liability for Employing or Contracting with Individuals Excluded from Participation in Federal Health Care Programs

Posted by Health Law Informer Author on June 03, 2013
Fraud and Abuse, Medicaid, Medicare / No Comments

On May 8, 2013, the Office of Inspector General (“OIG”) of the Department of Health & Human Services issued an updated Special Advisory Bulletin (the “Updated Bulletin”)[1]  on the effect of exclusion from participation in Medicare, Medicaid and other Federal health care programs (collectively “FHPs).  The Updated Bulletin, which replaces and supersedes guidance originally provided by OIG in a 1999 Special Advisory Bulletin (the “1999 Bulletin”), details OIG’s broad interpretation of the scope and effect of its exclusion authority under the Civil Monetary Penalties Law (“CMPL”).[2]  The Updated Bulletin addresses many of the questions OIG has received about exclusions and purports to convey insight gained from resolving self-disclosure cases since publishing the 1999 Bulletin. Continue reading…

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UPDATE: Congress Drafts Legislation that would Expand the FDA’s Role in Regulating Compounding Pharmacies

Posted by Health Law Informer Author on May 02, 2013
Food and Drug Law, Pharmacy / No Comments

UPDATE

The Senate Health, Education, Labor, and Pensions (HELP) committee approved a bill on May 22 that largely tracks the Draft Legislation.  As outlined below, the bill would create a new category for large-scale compounders – known as “compounding manufacturers” – and give the FDA greater authority over compounding pharmacies. Continue reading…

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Are You Prepared? The ACA’s Compliance Program Mandate for All Health Care Providers

Posted by Health Law Informer Author on April 15, 2013
Affordable Care Act, Medicare / No Comments

While the implementation of compliance programs to encourage the development and use of internal controls to monitor adherence of the health care industry to applicable statutes, regulations, and program requirements has long been considered a best practice, the Patient Protection and Affordable Care Act (“ACA”) has made them mandatory. Continue reading…

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Highlights of the Omnibus HIPAA/HITECH Final Rule

Posted by Health Law Informer Author on March 12, 2013
Affordable Care Act, HIPAA, HITECH / No Comments

On January 25, 2013, the Office of Civil Rights (OCR) of the Department of Health & Human Services (HHS) published the long-awaited omnibus final regulation governing health data privacy, security and enforcement (Omnibus Rule).[i]  The Omnibus Rule is a group of regulations that finalizes four sets of proposed or interim final rules, including changes to the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules mandated by the Health Information Technology for Economic and Clinical Health (HITECH) Act[ii] and proposed in 2010;[iii] changes to the interim final breach notification rule;[iv] modifications to the interim final enforcement rule; and implementation of changes to the Genetic Information Nondiscrimination Act of 2008 (GINA).  The Omnibus Rule goes into effect on March 26, 2013, and compliance is required by September 23, 2013.  As expected, the Omnibus Rule did not finalize the May 31, 2011 proposed regulation regarding accounting for disclosures. Continue reading…

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The SMART Act: A Bipartisan Attempt to Make the MSP Act Workable

Posted by Health Law Informer Author on January 23, 2013
Uncategorized / No Comments

On January 10, 2013, President Obama signed into law H.R. 1845, which includes the Strengthening Medicare and Repaying Taxpayers Act of 2011 (SMART Act).[1] The SMART Act,  amends several portions of the Medicare Secondary Payer (MSP) Act that apply to non-group health plans, including liability (including self-insurance) and no-fault insurance and workers’ compensation plans (together, NGHPs).  Although the SMART Act makes significant substantive and procedural amendments to the MSP Act, many practical issues will continue to bedevil parties who are trying to settle a personal injury claim. Continue reading…

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Business Associates Face Challenges on All Fronts

Posted by Health Law Informer Author on December 10, 2012
Uncategorized / No Comments

Since the implementation of the privacy and security regulations of the Health Insurance Portability and Accountability Act (“HIPAA”) in 2003 and 2005 respectively, business associates (“BAs”) – those entities that perform services for or on behalf of covered entities – had been a weak link in the overall protection of protected health information (“PHI”).   BAs were not directly subject to HIPAA, but were only indirectly subject to its requirements through the business associate agreements – which were generally boilerplate – that covered entities were required to maintain as a condition of sharing PHI.  Thus, under the original regulatory structure, the only risk for a BA was for a breach of contract. Continue reading…

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Taking Aim in 2013: The Government Points Two Barrels at Preventing and Punishing Healthcare Fraud and Abuse

Posted by Health Law Informer Author on November 16, 2012
Affordable Care Act, Fraud and Abuse, HIPAA, HITECH, Medicaid, Medicare / No Comments

A few weeks ago we posted on this Blog an article highlighting the “gathering storm” surrounding HIPAA enforcement and predicted an ominous future for hospitals and other providers who fail to develop and maintain adequate HIPAA compliance policies.  While there is no doubt the future is bleak for those unwilling to abide by HIPAA’s mandate, the forecast for providers who commit healthcare fraud is equally devastating.  This is because, in 2013, the federal government will attack healthcare fraud from two angles. First, the Office of Inspector General (“OIG”), per the terms of its 2013 Work Plan (“Work Plan”), will review many of the government’s anti-fraud efforts to maximize recovery of Medicare and Medicaid overpayments.  Second, many of the new anti-fraud provisions in the Affordable Care Act (“ACA”) will kick into high gear now that the result of the presidential election has guaranteed the law’s survival. Continue reading…

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