At the intersection of law and business, ambiguity can present significant challenges. But one thing seems apparent under the False Claims Act (“FCA”) for health care entities submitting reimbursement claims to the government: if you subjectively believe that your claims are or might be false, you likely have the requisite intent to violate the FCA. And this principle may hold true even if there is technically some ambiguity about the facts underlying the representations inherent in presenting your claim to the government. READ MORE

The Illinois legislature recently passed new antitrust legislation (“HB2222”) that will require advance notice to the Attorney General for health care facilities and health care provider entities engaging in certain covered transactions. If signed by the Governor, the new legislation will go into effect January 1, 2024. READ MORE

On April 20, 2023, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) published a new toolkit titled “Analyzing Telehealth Claims to Assess Program Integrity Risks” designed to analyze claims data for telehealth services and identify program integrity risks to Federal healthcare programs (“Toolkit”). READ MORE

The carrot or the stick … which motivates compliance conduct more? Consider it a Prior to that, the Department also reminded the public about the significant consequences of finding your business weighed down by DOJ scrutiny in reporting a record year of False Claims Act (“FCA”) settlements and recoveries from the federal government’s previous fiscal year, ending September 30, 2022. READ MORE

On February 22, 2023, the Department of Justice (DOJ) announced a new Voluntary Self-Disclosure Policy establishing uniform, transparent guidelines for how United States Attorneys’ Offices (USAOs) will determine whether a company has made a voluntary self-disclosure and the benefits to the company for doing so. READ MORE

On February 3, 2023, the Antitrust Division of the U.S. Department of Justice (DOJ) withdrew three health care policy statements, which have provided antitrust enforcement guidance to various segments of the health care industry for the past few decades. READ MORE

On January 5, 2023, the Federal Trade Commission ("FTC") proposed an all-encompassing new rule to bar employers from including non-compete clauses in contracts with their employees. READ MORE

During the Medicare Advantage (MA) annual enrollment period, health care providers may be looking to inform their patients of their MA options. Below are five considerations to keep in mind when sharing information related to MA organizations with patients. READ MORE

Thompson Coburn partner Mackenzie Wallace was the featured guest on a recent episode of AHLA's Speaking of Health Law Podcast, where she sat down with Bob Paskowski, Consulting Principal, PYA, to discuss the latest trends and challenges facing the provider and payer in today's health care market. READ MORE

On September 6, 2022, the Centers for Medicare & Medicaid Services (CMS) released a Request for Information (RFI) seeking public input to assess the impact of the waivers and flexibilities provided in response to the COVID-19 Public Health Emergency. READ MORE

The Hospital Price Transparency Rule (the “Rule”) became enforceable as of January 1, 2021 and is designed to make it easier for Americans to compare the costs of care before going to the hospital by requiring hospitals to make certain information about prices publicly available. While enforcement has been slow to take off, as of June 2022, two hospitals – Northside Hospital Atlanta and Northside Hospital Cherokee, both part of the same system in Georgia – now face $883,180 and $214,320, respectively, in civil monetary penalties under the Rule. READ MORE

On July 20, 2022, the OIG released a Fraud Alert encouraging practitioners to exercise caution when entering into arrangements with telemedicine companies, given the various fraud and abuse risks associated with such arrangements, including an increased risk of fraudulent claims to Medicare, Medicaid, and other federal healthcare programs. READ MORE

On July 21, 2022, the most high-profile acquisition in the health care space in recent memory was announced, when Amazon publicized the acquisition of One Medical, a primary care organization, for $3.9 billion. Amazon’s interest in the massive US health care industry has been no secret in recent years, but this is undoubtedly their biggest bet to date. READ MORE

Prompted by aggressive enforcement of the Anti-Kickback Statute, many pharmaceutical and medical device companies are reconsidering physician-related programs to avoid potential liability. But while DOJ enforcement remains high, you can create programs that accomplish your company’s goals without running afoul of the statute. READ MORE

On June 13, 2022, the U.S. Department of Health and Human Services, Office for Civil Rights (“OCR”), issued guidance on how covered entities and business associates can use remote communication technologies for audio-only telehealth in a HIPAA-compliant manner following the end of the national COVID-19 public health emergency (“PHE”). READ MORE

Recent trends indicate that more physicians are considering retirement or selling their private practice to a health care system or other physician practice. If you are one of these physicians, then it is important to think about and understand medical record retention requirements. READ MORE

Increased consolidation in the healthcare sector continues to draw media attention and antitrust scrutiny from a variety of regulators including the Federal Trade Commission, the Antitrust Division of the Department of Justice and state attorneys general. READ MORE

On February 24, 2022, the Centers for Medicare & Medicaid Services (“CMS”) announced a redesign of the Global Professional Direct Contracting (“GPDC”) Model for Direct Contracting Entities (“DCEs”). The revamped model will be known as the Accountable Care Organization (“ACO”) Realizing Equity, Access, and Community Health (REACH) Model. READ MORE

In response to the COVID-19 pandemic, the Centers for Medicare & Medicaid Services (CMS) issued almost 200 “blanket” waivers which automatically apply to health care providers including hospitals, other healthcare facilities, and healthcare professionals. These blanket waivers are effective through the duration of the federal Public Health Emergency (PHE) declared by the Secretary of the US Department of Health and Human Services (HHS), which has been extended for 90-day periods since the onset of the pandemic and is currently extended through April 16, 2022. READ MORE

Getting any communication from the U.S. Department of Justice can be a bit unnerving. That’s particularly true for medical providers receiving a Civil Investigative Demand (CID) for documents and testimony. If you’re not sure what to do in response, keep reading and we’ll answer many of the questions you may be asking or should be asking. READ MORE

Medicare Advantage plans and providers need to be aware of the recent increase in government enforcement of risk adjustment coding issues. In the past few years, the Office of the Inspector General (OIG) and the Department of Justice (DOJ) have focused on risk adjustment coding as an area susceptible to fraud which will likely continue into 2022. See below for an overview of risk adjustment coding, recent enforcement examples, and five tips for providers to help ensure accurate coding. READ MORE

On July 9, 2021, President Biden signed an “Executive Order on Promoting Competition in the American Economy” (EO 14036). The EO sets forth a number of priorities and initiatives of the Biden administration aimed at protecting competition in light of the market consolidation that has taken hold in many segments of the American economy over the past several decades, including in health care markets READ MORE

In June, the U.S. District Court for the Northern District of Illinois held that a medical management company (MPI) violated the Anti-Kickback Statute (AKS), False Claims Act, and Illinois False Claims Act by paying a community care organization (HCI) for access to the personal information of HCI clients in order to market Medicare-reimbursed healthcare services to those clients. READ MORE

This will seem like an odd admission for a legal blog, but the success of a negotiation does not depend solely upon the legal acumen of the parties involved. It depends upon the ability of the parties, including their negotiators, to understand each other, establish a rapport, build a relationship, and nurture trust. While I have seen transactions occur in the absence of these factors, I have never seen one work well over time under those circumstances. READ MORE

Can a whistleblower successfully allege Medicaid/Medicare fraud if the whistleblower lacked direct access to records related to the alleged fraud? While the appellate circuits are still split on this issue, we look at recent decisions that indicate a possible shift in the Seventh Circuit’s pleading standard. READ MORE

In March of 2020, CMS expanded the COVID-19 Accelerated and Advance Payments Program to additional Medicare Part A providers and Part B suppliers in response to the COVID-19 pandemic. READ MORE

CMS has finalized a rule that expands Medicare coverage for telehealth services. This final rule, along with other new rules and waivers by the federal government, state governments and private payors, has significantly expanded access to and coverage of virtual health care services in response to the public health emergency. READ MORE

Last month, the US Court of Appeals for the Fifth Circuit issued a ruling vacating a $4.3 million dollar civil monetary penalty against the University of Texas MD Anderson Cancer Center by the US Department for Health and Human Services for alleged violations of the HIPAA Privacy and Security Rules. READ MORE

On January 15, 2021, the Department of Health and Human Services announced it has amended the reporting timeline for those who received Provider Relief Fund payments exceeding $10,000 in the aggregate. Additionally, pursuant to the Coronavirus Response and Relief Supplemental Appropriations Act of 2021, HHS revised the methodology for calculating lost revenues. READ MORE

Last month, the Department of Health and Human Services Office of Inspector General issued a Special Fraud Alert regarding fraud and abuse concerns related to speaker programs offered by pharmaceutical and medical device companies. The OIG provided a list of factors that could potentially indicate a program is in violation of the anti-kickback statute. READ MORE

Despite the pandemic, the DOJ is continuing to investigate allegations of health care fraud. A recent settlement from Wheeling Hospital serves as a reminder to hospitals to review their physician compensation arrangements to ensure that they are within fair market value and considered commercially reasonable. READ MORE

On October 22, HHS updated its reporting guidance to revise the methodology for calculating lost revenue and expanded the eligibility requirements for the Phase 3 distribution. This blog updates our blog posted earlier this week on these topics. READ MORE

The Department of Health and Human Services has opened the portal for Phase 3 of Provider Relief Funds, which will include an additional $20 billion in distributions. The distributions will be made available to an expanded group of providers. READ MORE

In response to the COVID-19 pandemic, states across the country have issued emergency declarations or disaster proclamations. It is important to track the expiration of a state’s emergency declaration to ensure appropriate compliance with various legal requirements. READ MORE

Recipients of aid from the Provider Relief Fund are required to submit reports detailing how the funds were used, but detailed instructions and a data collection template have not yet been released. This article outlines what we know about the reporting deadlines while recipients await further guidance. READ MORE

To minimize their risk should a patient be exposed to COVID-19 while seeking medical care, health care providers should consider supplementing their informed consent process to include information about COVID-19 risks. READ MORE

The Department of Health and Human Services has updated its FAQs regarding the Provider Relief Fund contained in the CARES Act. It is important to monitor these changes because HHS has changed its position on certain issues and such changes could impact a provider’s ability to retain the funds. READ MORE

The CARES Act, signed into law on March 27, 2020, provides emergency assistance and health care response for individuals, families and businesses affected by the 2020 coronavirus pandemic. The CARES Act includes several provisions that could provide relief to physicians as a result of the pandemic. READ MORE

On March 24, 2020, the Federal Trade Commission and the U.S. Department of Justice Antitrust Division — the two federal agencies responsible for enforcement of federal antitrust laws — issued a joint statement recognizing that dealing with the COVID-19 crisis will require “unprecedented cooperation…among private businesses.” The joint statement details procedures and guidance aimed at collaborations of businesses working to protect the health and safety of Americans during the COVID-19 pandemic. READ MORE

Previously, we discussed the impact of the Families First Coronavirus Response Act on medical practices and health care providers. Specifically, the Act allows medical practices and other health care entities to exclude any employees who are “health care providers” or “emergency responders” from the new emergency provisions. In follow-up guidance, the Department of Labor recently clarified the definition of “health care provider.” READ MORE

The Families First Coronavirus Response Act establishes new emergency medical and sick leave benefit requirements for employers with 500 or less employees. However, health care entities have the right to exclude their some of their employees, with certain stipulations. READ MORE

The Families First Coronavirus Response Act we first reported on earlier this week has now passed the Senate after technical corrections by the House of Representatives and has been sent to the President for signature. This bill creates several significant paid leave requirements for employers. Even employers not usually covered by the Family and Medical Leave Act (FMLA) may be required to offer FMLA leave and paid sick time for employees who must miss work for coronavirus-related reasons. READ MORE

As more health care entities implement population health and care coordination initiatives, questions arise concerning the application of HIPAA to such efforts. Although HIPAA applies to protected health information used and shared by covered entities in connection with population health activities, in many circumstances HIPAA permits the use and sharing of such PHI without patient authorization or business associate agreements. READ MORE

As a new year starts, health care organizations looking to grow or sell their businesses in the upcoming months will need to tackle the key question of which transaction structure is the best fit based on significant financial, business and operational considerations. READ MORE

Don’t let a cybersecurity incident ruin your holiday season. Follow these tips to help keep both your company-issued and personal devices and data safe during your holiday travels. READ MORE

On October 9, 2019, the DHSS proposed significant amendments to the Stark Law, Anti-Kickback Law and Civil Monetary Penalty Law. These proposed amendments are intended to modernize and clarify these laws, encourage value-based arrangements and care coordination and reduce some of the key burdens these laws impose on health care providers. READ MORE

In August 2019, the Centers for Medicare & Medicaid Services released proposed changes to its Stark Law advisory opinion process. CMS intends for these proposed changes to reduce limitations and restrictions that may be unnecessarily serving as an obstacle to a more robust advisory opinion process. READ MORE

On July 18, 2019, CMS published a rule that finalized certain requirements for long-term care facilities using pre-dispute arbitration agreements with residents. The final rule is scheduled to go into effect on September 16, 2019. READ MORE

In May 2019, the U.S. Department of Justice issued new guidelines regarding cooperation and remedial efforts with False Claims Act investigations. The guidelines, 4-4.112, detail the credits individuals and entities may receive during investigations. These guidelines do not change an entity’s or individual’s right to not cooperate with a government investigation. READ MORE

The HHS Office for Civil Rights has issued a new fact sheet addressing direct liability of business associates for violations of HIPAA Rules. The fact sheet serves as a reminder that business associates have direct liability under HIPAA and are subject to enforcement for Rule violations. READ MORE

On May 3, 2019, CMS issued long-awaited draft guidance addressing co-location arrangements, providing some clarification on how a hospital can share space, services, staff and emergency services and still demonstrate independent compliance with the Medicare Conditions of Participation for hospitals (“COPs”). READ MORE

Under the Eliminating Kickbacks in Recovery Act of 2018, kickback liability has expanded to non-governmental payors. Clinical laboratories, recovery homes, and clinical treatment facilities should take note of what is prohibited and allowed under EKRA. READ MORE

After years of provider feedback, CMS has indicated significant changes to the Stark Law could arrive in 2019. The updated regulations will seek to spur care coordination in an era of increasing use of value-based payment models. READ MORE

On February 13, 2019, the Missouri Department of Health and Senior Services held a forum to hear suggestions regarding the drafting of preliminary medical cannabis regulations. Suggestions covered quality control and testing, fees and profits, startup logistics, distribution issues, and more. READ MORE

Per the HIPAA Breach Notification Rule, organizations that discovered a HIPAA breach in 2018 that affected fewer than 500 people have until March 1 to report the breach to the Office for Civil Rights. Organizations with more than one breach are required to complete a report for each incident. READ MORE

The end of 2018 saw major developments in some of health care’s key areas, from cybersecurity to medical cannabis. As another year begins, here are some of the significant developments over the past year that are likely to impact health care providers in 2019. READ MORE

The latest cybersecurity guidelines published by the Department of Health and Human Services, developed in response to a mandate of the Cybersecurity Act of 2015, provide healthcare organizations of all types and sizes with information on cybersecurity practices. READ MORE

The Office of Civil Rights has asked for public input how the agency might modify the HIPAA Privacy, Security and Breach Notification Rules in a Request for Information. The 50 questions in the RFI reveals notable insights for the OCR’s future plans to improve care coordination and reduce regulatory burdens. READ MORE

Effective January 1, 2019, Missouri insurers must comply with new legislation regarding internal audit requirements and the submission of new annual disclosure reports. These new requirements stem from model laws issued by the National Association of Insurance Commissioners. READ MORE

As the opioid crisis continues, the Department of Health and Human Services has provided information to help health care providers know what they can and cannot disclose to concerned family members trying to help addicted loved ones. READ MORE

Since 2015, health care providers have paid more than $200 million in enforcement actions due to fraud and abuse relating to compounding pharmacies. In this post, we’ve summarized several recent enforcement actions to underscore how important it is for health care providers to monitor closely their practices and policies for compounding pharmacies. READ MORE

The broad scope of CMS’s recent Request for Information gives health care providers an opportunity to voice their concerns on a variety of Stark Law provisions, and may demonstrate an interest within the administration to modify the regulations implementing this statute. READ MORE

U.S. District Judge Richard Leon's decision in the AT&T-Time Warner merger has set a precedent regarding antitrust scrutiny in large mergers. The decision demonstrates how vertical mergers may lead to less scrutiny—and that likely goes for the health care industry as well. READ MORE

The concept of a “Right to Try” has been spreading through the U.S. over the last four years, beginning with the first passing of such laws in Colorado in 2014. Most recently, President Trump has echoed support for a federal Right to Try law in his State of the Union address. READ MORE

Covered entities that discovered small-scale HIPAA breaches during calendar year 2017 must file notice of such breaches with the Office of Civil Rights by March 1, 2018. READ MORE

The final rule governing changes to the Substance Abuse and Mental Health Services Administration (SAMHSA) regulations became effective February 2, 2018. The changes are intended to facilitate information exchange within new health care models while addressing the privacy concerns of patients seeking treatment for a substance use disorder. READ MORE

On Jan. 9, 2018, the Centers for Medicare and Medicaid Services (CMS) announced a new voluntary episode-payment program, Bundled Payments for Care Improvement Advanced, which allows health care providers to accept risk for the cost of care associated with a clinical episode “based on how successfully they manage resources and total costs.” READ MORE

In August, CMS issued a proposed rule seeking to reduce mandatory participation requirements in the CJR program and eliminate the episode payment models and CR incentive payment model before their scheduled effective date. READ MORE

Now that False Claims Act liability is no longer predicated on the government’s decision to identify a particular provision as a condition of payment under the Supreme Court's decision in Escobar, it will be important for health care providers to monitor how courts apply this more demanding standard of materiality. READ MORE

More than 800,000 clinicians have been notified by the Centers for Medicare and Medicaid Services that this year they will be exempt from complying requirements for CMS's Merit-based Incentive Payment System. READ MORE

After earlier delays, the Centers for Medicare and Medicaid Services has set the start date for cardiac episode payment models and revisions to the Comprehensive Care for Joint Replacement to Jan. 1, 2018. READ MORE

If you are in the process of drafting a Self-Referral Disclosure Protocol submission, you must use CMS' new SRDP forms or risk the agency not accepting the disclosure into the protocol. READ MORE

A recent Massachusetts case highlights the tension inherent in geo-location targeted ads— the ability to target customers through their mobile devices, right to down to where they are and what they are doing — as well as special concerns that crop up when advertisers target consumers using health care metrics. READ MORE

The Centers for Medicare and Medicaid Services has issued new SRDP Forms for use by providers of services and supplies when disclosing actual or potential violations of the Stark Law under the SRDP. READ MORE

As of Jan. 18 2017, powdered gloves are now considered adulterated medical devices under the Food Drug and Cosmetic Act. Health care facilities and providers should document the removal of these banned gloves and document their replacement. READ MORE

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Hospitals affected by the CCJR model proposal will need to address a number of opportunities and challenges rather quickly. READ MORE

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

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

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

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

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

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

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

“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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Welcome to www.healthlawcheckup.com, Thompson Coburn’s newly launched health care law blog. Our Health Care Practice Group plans to use this blog to provide updates and insights on the latest developments in the health care industry. READ MORE

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

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

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

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

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

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

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