Category Archives: Compliance

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Kickoff Call: 340B Drug Pricing Program Covered Entity Coalition

Foley has scheduled a call on Thursday, September 24, 2015 at 8am PST/10am CST/11am EST to convene 340B Program covered entities that may be interested in forming a “coalition” to develop a response to HHS/HRSA’s recently proposed comprehensive 340B Program guidance, beginning with (but not necessarily limited to) the preparation of comments on the guidance. Interested … Continue reading this entry

Omnibus 340B Guidance Raises New Issues for Covered Entities

The Department of Health and Human Services (HHS) released its proposed 340B Drug Pricing Program Omnibus Guidance (Omnibus Guidance) on August 28, 2015. The Omnibus Guidance offers comprehensive – and, in some cases, new – guidance for 340B Drug Pricing Program (340B Program) covered entities (including providers such as disproportionate share hospitals, critical access hospitals, … Continue reading this entry

Another Delay for the Two-Midnight Rule

The Centers for Medicare and Medicaid Services (CMS) announced, on August 12, 2015, that it has extended the enforcement delay of the controversial two-midnight rule governing short hospital stays until the end of the year. As set forth in the FY 2014 IPPS Rule, the two-midnight rule imposes financial penalties for services that recovery auditors deem … Continue reading this entry

New Report Highlights Period of Transformation for the Medicaid Program, Urges Greater Federal Oversight

Obama Announces Affordable Care Act Enrollment Crosses the 8 Million Mark
The U.S. Governmental Accountability Office (GAO) has issued a new report to Congress identifying key issues facing the Medicaid program and urging greater federal oversight. The report comes at a time of significant transformation for the Medicaid program, which is currently celebrating its 50th year. Following its historic expansion as a result of the Affordable … Continue reading this entry

Fasten Your Seat Belts: District Court Says “Failure to Act Quickly Enough” May Violate 60-Day Refund Rule

A New York Federal District Court issued an Opinion and Order, on August 3, 2015, in a closely-watched False Claims Act (FCA) case, Kane v. Healthfirst, Inc. The Court refused to dismiss the whistleblower complaint in which both the federal government and the State of New York have intervened. As important to this discussion, the … Continue reading this entry

Recent OIG Audits of Home Health and Hospice Surveys May Signal Increased Scrutiny on Worker Qualifications

Recent audits by the Department of Health and Human Services Office of Inspector General (“OIG”) conclude that state survey agencies in a number of states and a leading national accrediting agency serving the home health and hospice industry failed to identify a significant number of deficiencies related to worker qualifications. Based on these findings, OIG … Continue reading this entry

CMS Proposes Major Update to Medicaid Managed Care Regulations

The Centers for Medicare and Medicaid Services (“CMS”) released, on May 26, 2015, the a far-ranging proposal for revising the Medicaid managed care regulations (“Proposed Rule”).  The number of individuals enrolled in Medicaid managed care plans has increased to over 40 million. Federal Medicaid managed care regulations have not been substantially revised since they were issued … Continue reading this entry

The Medicaid Fraud Control Units: Fiscal Year 2014 Report

The Department of Health and Human Services (HHS) Office of Inspector General (HHS-OIG) has released its Fiscal Year (FY) 2014 Annual Report (Report) on the performance of the Medicaid Fraud Control Units (MFCUs) (OEI-06-15-00010, April 2015). Although the MFCUs reported another strong year in civil recoveries, criminal recoveries were significantly lower than last year, when … Continue reading this entry

OIG Releases Compliance Guidance for Health Care Governing Boards

Compliance
The Office of Inspector General (“OIG”) of the U.S. Department of Health and Human Services (“DHHS”) released new compliance guidance for health care governing boards, attorneys, compliance officers and internal auditors on April 20, 2015. The guidance was developed in collaboration with the Association of Healthcare Internal Auditors, the American Health Lawyers Association, the Health Care … Continue reading this entry

Supreme Court Holds Providers Cannot Sue States to Challenge Low Medicaid Rates

The Supreme Court ruled, on March 31, in a 5-4 decision, that hospitals and all other providers cannot sue to force a state to pay higher Medicaid rates. The name of the case is Armstrong v. Exception Child Center. In Armstrong, the plaintiffs were a group of Idaho providers that furnish “habilitation services.” These are … Continue reading this entry

CMS Releases Stage 3 Meaningful Use Proposed Rule

The Centers for Medicare & Medicaid Services (“CMS”) released the Stage 3 proposed rule to the Medicare and Medicaid Electronic Health Records Incentive Programs (“Proposed Rule”) on March 20, 2015. To provide context, eligible professionals (“EPs”) and hospitals must attest to demonstrating meaningful use of certified electronic health record (“EHR”) technology to qualify for incentive payments … Continue reading this entry

CMS Delays Publication of Final Rule Regarding Reporting and Returning of Medicare Overpayments

One of the most challenging compliance changes brought about by the Affordable Care Act (ACA) is the provision mandating the reporting and refunding of Medicare and Medicaid overpayments within 60 days of the date they are identified, or the date that the corresponding cost report is due, if applicable. See ACA Section 6402(a); Section 1128J(d) … Continue reading this entry

Takeaways From the FTC/DOJ Workshop on Health Care Competition

The Federal Trade Commission and Department of Justice Antitrust Division held their second public workshop on health care competition on February 24-25, 2015. The workshop is part of the FTC and DOJ’s commitment to periodically “step back” from the work of day-to-day antitrust enforcement to take in a broader perspective of trends in the health care … Continue reading this entry

State Medicaid Programs May Be Leaving Revenue From Drug Rebates on the Table

The recent release of a New York State Office of the State Comptroller audit report serves as an example of state Medicaid programs that may not be maximizing their collection of revenue from drug rebates for Medicaid managed care enrollees. This report indicated that the New York Medicaid program did not collect as much as $119.3 … Continue reading this entry

Happy Holidays!

Thank you for reading, subscribing and being a part of our blog community in 2014. We hope you have a happy holiday season and a wonderful new year! – The Health Care Law Today Team We will be back with new posts the week of January 5.… Continue reading this entry

Federal Prosecutors Charge NECC Employees with Second Degree Murder: A Shot Across the Bow to Healthcare Companies Navigating Uncertain Regulatory Environments

Research
Federal prosecutors charged the head pharmacist and the president of New England Compounding Center (NECC), a now-bankrupt Massachusetts compounding pharmacy, with second-degree murder and racketeering in the U.S. District Court District of Massachusetts on Tuesday, December 16. The charges relate to NECC’s 2012 distribution of contaminated steroid injection vials in twenty states. The contaminated vial … Continue reading this entry

OIG Releases Fiscal 2014 Report to Congress

The Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (DHHS) released its Semiannual Report to Congress (Report) last week summarizing health care fraud investigation activities for the second half of fiscal year 2014 and the full year’s achievements. OIG reported expected recoveries of over $4.9 billion for fiscal year … Continue reading this entry

How to Prepare Your Hospital or Medical Practice for a Meaningful Use Audit

New York Office of the Medicaid Inspector General Releases 2014-2015 Work Plan
For the past several years, the Centers for Medicare and Medicaid Services (“CMS”) has incentivized hospitals and eligible professionals to adopt and make “meaningful use” of certified electronic health records (“EHR”) technology through the Medicare and Medicaid Meaningful Use programs. Since the inception of these programs, over $16.6 billion in Medicare incentive payments and $8.6 … Continue reading this entry

Happy Thanksgiving!

The Health Care Law Today team is thankful for you, our readers and subscribers. Thank you all for reading, contributing to, and sharing our blog. We hope you have a safe and happy holiday. Have a great weekend!… Continue reading this entry

Ebola Preparedness: Employee Education Is Key

In the wake of the world’s largest Ebola Virus Disease (EVD) outbreak in history, Americans have been inundated with media hype surrounding the disease, and the government and employers’ perceived inadequacy in their response. While the threat of a widespread EVD outbreak in the United States is minimal, healthcare providers in particular, but also airlines and … Continue reading this entry

Legal Preparedness – Are You Ready for Ebola?

With confirmed Ebola Virus Disease (EVD) patients in the United States, health care facilities and providers should review whether they are compliant with existing laws and recommendations for emergency preparedness. Providers should take the time during non-emergency circumstances to identify issues, make advance legal decisions, and focus on training and education. There is a misperception that liability … Continue reading this entry

Hospice Industry Will Face Stricter Scrutiny Under New Law Aimed at Post-Acute Care Data Standardization

Compliance
President Obama signed the “Improving Medicare Post-Acute Care Transformation Act of 2014” or the IMPACT Act of 2014 (the Act) on October 6, 2014. The new law is broadly focused on requiring all post-acute care providers to adopt standardized data protocols for patient assessment, quality of care and resource use data so as to allow for … Continue reading this entry

Transitional Compliance Period for Business Associate Agreements Expiring September 23, 2014

If they have not already done so, covered entities and business associates have until September 23, 2014, to update their business associate agreements to comply with the January 2013 changes to the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) and the Health Information Technology for Economic and Clinical Health Act (“HITECH Act”).… Continue reading this entry

CMS Says: Let's Make a Deal

In the hours before everyone began enjoying Labor Day Weekend, the Centers for Medicare & Medicaid Services (CMS) issued an important inpatient hospital review update. To expedite the appeals process and reduce the volume of inpatient status claims currently pending, “CMS is now offering an administrative agreement to any hospital willing to withdraw their pending … Continue reading this entry