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Mandatory arbitration agreements in long-term care facilities: A thing of the past...or not?

Nicole Jobe November 14, 2016
Long-Term Care

At the end of November, CMS will prohibit long-term care facilities from using pre-dispute arbitration agreements and only allow arbitration when a dispute arises on a voluntary basis. But a federal judge in Mississippi has already granted a request to bar CMS from implementing the rule. READ MORE

Are you ready for Section 1557’s notice requirements?

April Kirkley October 14, 2016
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Beginning October 16, 2016, most hospitals, health clinics, and insurance insurers must post required nondiscrimination notices on websites, marketing materials, and physical locations, as mandated by Section 1557 of the Affordable Care Act. READ MORE

OCR: No privacy breach is too small

Milada Goturi September 1, 2016
HIPAA folder

Once mainly focused on large data breaches affecting 500 or more individuals, the OCR now intends to increase HIPAA enforcement actions on smaller breaches of unprotected protected health information. READ MORE

Responding to ransomware attacks: A guide for health care providers

Health Law Checkup_default blog

Like all cybersecurity threats, the risk of a ransomware attack cannot be eliminated. But the health care industry is not defenseless. With careful planning and a cybersecurity breach response plan, any lasting damage from an incident can be substantially reduced by planning before a crisis unfolds. READ MORE

8 tips for engaging ACO boards to meet requirements in the Final Waivers

John Howard May 19, 2016
Health Law Checkup_default blog

Given the increased emphasis on the ACO governing body’s work in the Final Waivers, it is paramount that ACO Boards work thoughtfully through this evaluative process, documenting its consideration, analysis, and conclusions in formal Board minutes. READ MORE

Medical devices and cybersecurity: FDA calls for comprehensive risk management programs

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Market growth, along with the growing sensitivity on cyber safety, has caused the FDA to turn its attention to cybersecurity and protecting public health from vulnerabilities presented by the increasing use of software in medical devices. READ MORE

Final Rule on refund of Medicare overpayments: Key requirements to know

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The three key requirements that the Final Rule clarified and which all providers participating in Medicare Part A and Part B must know are: (a) when is an overpayment identified by a provider, (b) what is the required lookback period for returning overpayment, and (c) what process must be used to refund an overpayment. READ MORE

Hospital property tax exemption under attack in Illinois

Nicole Jobe March 8, 2016
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If this ruling stands, not-for-profit hospitals in Illinois could be in danger of losing their property tax exemptions. READ MORE

TCLE webinar to offer overview of medical mobile app regulation

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This webinar, presented by life sciences partner Diane Romza-Kutz and associate Fredric Roth, will provide an overview of mobile medical applications, the attendant regulations and potential enforcement efforts on the part of regulators. READ MORE

Are you covered? Emerging issues for health care providers under cyber risk insurance

Matt Darrough February 3, 2016
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It is critical that cyber risk insurance is designed to both: (1) adequately mitigate future harm to those whose private information is compromised as a result of a data breach; and (2) satisfy the full array of damages sought by such third parties, including damages for future injuries resulting from the anticipated improper use of data. READ MORE

OCR issues new guidance on individuals’ access to PHI: Is your access policy compliant?

Milada Goturi January 19, 2016
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The OCR indicated that based on its enforcement experience, many individuals are having difficulties obtaining such access even as technology evolves, and new treatments make it important for individuals to have ready access to their PHI. READ MORE

Recent HIPAA settlements emphasize importance of robust compliance program

Milada Goturi December 9, 2015
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Two recent HIPAA settlements remind organizations subject to HIPAA of the importance of having a robust HIPAA privacy and security compliance program in place. READ MORE

Top takeaways from 33rd Annual IAHA Annual Meeting

Fredric Roth V November 9, 2015
Health Law Checkup_default blog

On Oct. 27, 2015, the Annual Meeting of the Illinois Association of Healthcare Attorneys was held at Navy Pier in Chicago. Hundreds of health care attorneys attended, including several from Thompson Coburn. The symposium was loaded with high-quality and insightful sessions, and our attorneys identified the following highlights READ MORE

On-demand webinar available – CCJR and mandatory bundled payments

John Howard November 3, 2015
Health Law Checkup_default blog

Health care partner John Howard and Kristi Short, Sr. Vice President of Navvis Healthways, recently provided legal and practical advice on the Centers for Medicare and Medicaid Services' (CMS) proposed mandatory bundled payment program for joint replacement surgeries. READ MORE

Record-breaking FCA settlements underscore importance of Stark Law compliance

Christina Randolph November 3, 2015
Health Law Checkup_default blog

With the continued focus of the government on investigating and prosecuting matters involving compliance with the Stark Law, health care systems entering into compensation arrangements with referring physicians must have robust processes in place to ensure that the compensation arrangements – at the time that they are structured and during the course of the arrangement – don’t run afoul of the Stark Law. READ MORE

IRS releases final forms for health care reform reporting

October 5, 2015
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With required reporting under the Affordable Care Act (ACA) looming, employers should be aware of the latest guidance from the IRS. READ MORE

DOJ issues new guidance on individual accountability for corporate wrongdoing

Milada Goturi September 28, 2015
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The DOJ Guidance makes clear that fighting corporate misconduct is the DOJ’s top priority and indicates that one of the most effective ways to fight corporate misconduct is by holding accountable the individuals who perpetrated the wrongdoing. READ MORE

FDA Update: New guidance released on mobile medical devices, medical devices data systems

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In the newly updated Guidance, the FDA stresses, in particular, the purposes of the two platforms as well as the difference between the hardware on which they are run. In the case of an MMA, the software in question is run on a handheld device, such as a cell phone, tablet or similar device. READ MORE

Comprehensive Care for Joint Replacement: CMS adopts mandatory approach to payment reform

John Howard August 27, 2015
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Hospitals affected by the CCJR model proposal will need to address a number of opportunities and challenges rather quickly. READ MORE

Cybersecurity is once again a hot topic as Illinois undergoes PIPA update

July 23, 2015
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Cybersecurity is a hot topic at both the state and federal level. Specifically, Illinois is in the process of amending its Personal Information Protection Act (“PIPA”). READ MORE

Insufficient protection of PHI leads to HIPAA settlement

Milada Goturi July 16, 2015
Health Law Checkup_default blog

The latest settlement between the U.S. Department of Health and Human Services, Office for Civil Rights and St. Elizabeth’s Medical Center, a tertiary care Massachusetts hospital, is a reminder that having a strong and functioning HIPAA compliance program is imperative for organizations subject to HIPAA. READ MORE

Patients poised to record doctor's visits?

A. Jay Goldstein June 26, 2015
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Like many complex issues in the healthcare industry, there are pros and cons associated with patients recording discussions and certainly opinions on both sides of the debate. Physicians continue to grapple with how best to convey information and advice to patients, as well as recommendations and instructions about medication or healthy living. READ MORE

OIG Updates 2015 Work Plan: New Medicare initiatives for hospitals, DMEPOS suppliers, clinical labs, GPOs

Christina Randolph June 9, 2015
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As the health care industry continues to reform its delivery of care models and payment structures, the OIG reaffirmed its continued focus on certain risk areas which pose significant management and performance challenges for HHS. READ MORE

Insurance Holding Company Laws: What providers need to know as they dive into insurance market waters

Joy Harris Hennessy June 8, 2015
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As a provider contemplates the move into the insurance market, it is important to consider the impact the reporting requirements set forth in the applicable states’ insurance holding company laws may have on the provider’s operations. READ MORE

Why health care entities should pay attention to the Federal Priority Act

Claire Schenk June 4, 2015
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Since the government has used the Federal Priority Act in the health care setting to recover sums owed to the government after a health care organization or physician group becomes insolvent, health care organizations should be familiar with the exposure they may face under the FPA. READ MORE

Introducing Tracking Cannabis, a legal blog by Thompson Coburn

May 22, 2015
Health Law Checkup_default blog

Our interdisciplinary cannabis practice group will use this blog to provide updates and insights on the latest developments in the cannabis industry. READ MORE

$125k HIPAA settlement for small, single-location pharmacy

Nicole Jobe April 29, 2015
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“Regardless of size, organizations cannot abandon protected health information or dispose of it in dumpsters or other containers that are accessible by the public or other unauthorized persons,” said OCR Director Jocelyn Samuels. READ MORE

Illinois joins growing list of states to adopt anti-markup legislation; statute impacts all payors

April 20, 2015
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One issue giving rise to the law was physicians’ practice of making arrangements with laboratories to mark up below the reimbursement level of many commercial insurers, so insurers were unaware of the extent of the practice. However, insurers have typically denied these mark-ups when claims are submitted with any type of disclosure. READ MORE

CMS establishes Health Care Payment Learning and Action Network

John Howard April 13, 2015
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HCPLAN is intended, in part, to “identify areas of agreement” for new payment models and reporting methods. More generally, it would seem, HCPLAN has the challenge of working to define value for healthcare delivery, to determine how to measure value and then how to pay for that value. This is no small task/ READ MORE

OIG: Exclusive laboratory arrangement may violate Anti-kickback Statute and result in exclusion for excessive charges

Milada Goturi March 31, 2015
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The Office of Inspector General (“OIG”) issued Advisory Opinion 15-04, which found that an exclusive arrangement between a laboratory and its referring physician practices could violate the Federal Antikickback Statute and constitute grounds for permissive exclusion from participation in Federal healthcare programs. READ MORE

Timeline tightens for provider, supplier responses to MAC and ZPIC requests starting April 6, 2015

Christina Randolph March 25, 2015
Health Law Checkup_default blog

Effective April 6, 2015, in response to a pre-payment review and additional documentation request issued by a MAC or ZPIC, providers and suppliers will be limited to a 45 calendar day timeframe to produce the requested documentation and should no longer have any expectation that a request for an extension of time will be granted. READ MORE

Concealed carry triggers physician office questions on gun-toting patients

A. Jay Goldstein February 16, 2015
Health Law Checkup_default blog

If a physician or physician’s group owns the building where the practice is located, this is a straightforward analysis: Post the approved sign and obtain compliance from law-abiding patients. What happens, however, if the physician is just renting space in a medical office building and is not the property owner? READ MORE

Hospital financial assistance policies: IRS gives new guidance on complying with Section 501(r)

Christina Randolph February 2, 2015
Health Law Checkup_default blog

Are you responsible for ensuring that your hospital financial assistance policies are compliant with IRS section 501(r) requirements? Then you will want to know that the IRS recently finalized its regulations to section 501(r), which include new requirements for 501(c)(3) organizations regarding their financial assistance policies, READ MORE

Possible hospital malpractice exposure in Missouri for non-employed physicians

Nicole Jobe January 12, 2015
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Based on a recent Missouri Court of Appeals case, hospitals need to be aware that they could be liable for the acts or omissions of any physician on their medical staff, if such physician is considered an “employee” of the hospital according to common-law principles of agency. READ MORE

IRS provides interim guidance for ACO participation in Medicare Shared Savings Programs and expands safe harbors for management contracts

Christina Randolph November 12, 2014
Health Law Checkup_default blog

Private business use can occur if a qualified user enters into a management contract or other type of exclusive service contract with a for-profit party (a “non-qualified user”). Rev. Proc. 97-13 sets forth certain safe harbors for these types of management contracts, which can include exclusive service contracts. READ MORE

OIG proposes favorable changes to the anti-kickback and CMP regulations

Nicole Jobe October 15, 2014
Health Law Checkup_default blog

On October 3, 2014, the Office of Inspector General (OIG) published a favorable proposed rule that would make changes to the anti-kickback and civil monetary penalties (CMP) regulations. READ MORE

Patients now have the right to access laboratory reports directly from the laboratory

Nicole Jobe October 9, 2014
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According to the final rule, these changes are intended to provide patients with “a greater ability to access their health information, empowering them to take a more active role in managing their health and health care.” READ MORE

September 22, 2014: Quickly approaching deadline to amend business associate agreements

Milada Goturi September 9, 2014
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The HIPAA Omnibus Rule, enacted last year, made a number of changes to the HIPAA privacy, security and breach notification rules. Some of these changes affected business associate provisions of the HIPAA privacy and security rules. READ MORE

OIG issues special fraud alert on laboratory payments to referring physicians

Christina Randolph July 17, 2014
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In this Special Fraud Alert, the OIG focuses on two trends which it has identified as presenting a “substantial risk of fraud and abuse” under the federal Anti-Kickback Statute (AKS). READ MORE

FDA issues social media guidance

June 26, 2014
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Earlier this month, the FDA released proposed two-part Guidance on Internet and social media intended to assist prescription drugs and medical device manufacturers to accurately communicate online about their products. READ MORE

New OIG guidance issued on independent charity patient assistance programs

Milada Goturi June 3, 2014
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The OIG explained that if donor contributions to PAPs are made to induce the PAP to recommend the donor’s Federally reimbursable items or if a PAP’s grant of financial assistance to the patient is made to influence the patient to purchase certain items, the Antikickback Law is implicated. READ MORE

CMS updates hospital conditions of participation for the medical staff and governing body

Nicole Jobe May 22, 2014
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The Final Rule addresses (1) the composition of the medical staff and governing body, (2) required consultation between the governing body and medical staff, and (3) requirements for a unified and integrated medical staff for multi-hospital systems. READ MORE

Litigation and enforcement under Civil False Claims Act: An upcoming national program

May 19, 2014
Health Law Checkup_default blog

Our colleague Claire Schenk, a business litigation partner and veteran of the U.S. Department of Justice, will be a featured speaker at the event. In her June 5 session, “Recent Developments on Damages and Penalties,” panelists will focus on the calculation and proof of FCA damages, particularly in cases where the damages are not easily ascertainable, as well as the assessment of civil penalties. READ MORE

An update on open payments

May 8, 2014
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Since our report last week, “Next steps under open payments,” the Centers for Medicare & Medicaid Services (“CMS”) has released additional information on the time frame for registration on CMS’ Enterprise Portal for physicians and teaching hospitals. READ MORE

Next steps under open payments

Joy Harris Hennessy April 30, 2014
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As manufacturers and group purchasing organizations (“GPOs”) get ready for Phase 2 of Open Payments (formerly, the Physician Payments Sunshine Act), physicians and teaching hospitals should be aware that a voluntary registration process to enable them to review data submitted by manufacturers and GPOs through Open Payments will soon follow. READ MORE

New DHHS guidelines on third-party premium assistance reinforce concerns with provider premium assistance

April 1, 2014
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The Department of Health and Human Services (DHHS) recently clarified a long-running question of who may provide premium relief to certain insurance beneficiaries and when insurers must accept such relief. READ MORE

How to respond to a data breach

Milada Goturi March 12, 2014
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The list of organizations affected by data breaches grows daily. It is now clear that a data breach can affect virtually any type of organization and can result in many negative and costly consequences. READ MORE

Part one of Florida Stark Law case settled for $85 million

Nicole Jobe March 10, 2014
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On March 3, 2014, Halifax Health, a 582-bed hospital in Daytona Beach, Fla., announced it tentatively settled alleged violations of the Stark Law with the federal government for $85 million. READ MORE

Responding to search warrants: 10 steps to prepare

Nicole Jobe February 25, 2014
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A government investigation is something for which every health care provider should be prepared. Of course, the first line of defense is an effective compliance program. Issues can still arise, though, so every company should have a policy and procedure in place for responding to search warrants. READ MORE

EHR Donation Exception and Safe Harbor Modified and Extended through 2021

January 6, 2014
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On December 27, 2013, the Centers for Medicare & Medicaid Services and the Office of the Inspector General, both of the Department of Health and Human Services, issued closely coordinated rules (“Final Rules”) extending the original sunset of the current Stark exception and Anti-Kickback safe harbor for certain arrangements involving the donation of electronic health records (“EHR”) items and services. READ MORE

Marketplace plans not subject to anti-kickback statute

November 5, 2013
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On October 30, 2013, the Secretary of the Department of Health and Human Services (DHHS), Kathleen Sebelius (“Secretary”), released a letter to Congressman Jim McDermott (D-WA) answering the question of whether qualified health plans (QHPs) purchased through the Affordable Care Act’s (ACA) marketplaces are subject to the Anti-Kickback Statute. READ MORE

Illinois Providers - Don't Forget Prior Approval of Medicaid Non-Emergency Ambulance Services Required as of October 1, 2013

September 24, 2013
Health Law Checkup_default blog

If you arrange for non-emergency ambulance services for Medicaid patients in Illinois, prior approval by the State is required as of October 1, 2013. Effective October 1, 2013, the prior approval for non-emergency ambulance services requirement will be in Phase 2 and fully implemented. READ MORE

PHI on photocopier hard drives… Is your organization at risk?

August 19, 2013
Health Law Checkup_default blog

This settlement demonstrates how PHI may be electronically stored in locations that are easily overlooked. Has your organization considered PHI stored on photocopier hard drives in its risk analysis? READ MORE

OCR scrutiny continues – Are you ready for the September deadline?

May 23, 2013
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On May 21, 2013, the U.S. Department of Health and Human Services (HHS) released details regarding a $400,000 settlement with Idaho State University (ISU) for alleged violations of the HIPAA Security Rule. The settlement involves the breach of unsecured electronic protected health information (ePHI). READ MORE

Updated OIG bulletin on effect of exclusion from federal health care programs

May 14, 2013
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This Bulletin reiterates the OIG’s long standing position on the far reaching consequences of exclusions, emphasizes harsh sanctions the OIG may take if a provider bills Federal health care programs for services provided by or at the direction of excluded persons and advises providers to adopt best practices for exclusion screenings. READ MORE

CMS and OIG propose changes to the Electronic Health Records Exception and Safe Harbor

April 24, 2013
Health Law Checkup_default blog

On April 10, 2013, the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services Office of Inspector General (OIG) published parallel proposed rules revising, respectively, the Stark exception and Anti-Kickback safe harbor concerning electronic health record (EHR) items and services READ MORE