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Health Law Checkup

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Health Care Mergers at Risk: New Guidelines Enhance Agencies’ Powers to Challenge Mergers

On December 18, 2023, the Federal Trade Commission (“FTC”) and the Antitrust Division of the Department of Justice (“DOJ”) issued a final version of their Merger Guidelines. Initially proposed in July 2023, after five months of public commentary and feedback and two years of work in total, the 2023 Merger Guidelines include 11 enforcement principles to support the Biden administration's more aggressive antitrust enforcement policies. Health care providers contemplating a merger should ensure the merger does not create a presumption of illegality or violate antitrust laws according to the Guidelines. READ MORE

Class Actions Highlight AI-Assisted Payer Denials


As health care payers increasingly rely on artificial intelligence (“AI”) to speed up patient claim adjudication and prior-authorization determinations, providers should be on the lookout for algorithms designed to deny claims with minimal human oversight. READ MORE

OIG Update Modernizes Compliance Program Guidance

Bryan Gray Looney April Kirkley December 1, 2023
Doctor holding tablet

For the first time in 15 years, the Office of Inspector General (OIG) has issued updated compliance program guidance. The release of this guidance is part of the OIG’s two-step approach to modernize its current compliance program guidance. I READ MORE

OCR Issues New Telehealth Guidance

November 2, 2023
A woman talking to a doctor via a telehealth appointment

Last week, the Office for Civil Rights (“OCR") released two new resources designed to assist patients in understanding the privacy and security risks to their health information associated with using telehealth, and steps that can be taken to reduce those risks. READ MORE

Upcoming Changes to Various Federal Laws Impacting the Health Care Industry

A pyramid of blocks featuring health care icons

Pumpkin spice is on all the shelves and the winter holidays are fast approaching. But as we enter into the final few months of 2023, the health care industry should also remember to make note of and prepare for a number of changes that are expected to occur in late 2023 or early 2024. Below we recap just a few of these items. READ MORE

OIG Publishes New “Featured Topic” on Managed Care Oversight

Nicole Jobe Taylor Trippe September 13, 2023

On August 28, 2023, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) published a new “Featured Topic” webpage on managed care oversight. The OIG’s Featured Topics include compilations of the OIG's existing work related to a specific subject matter area and are updated as new material is published. READ MORE

Blog Browse: Get to know the new I-9 requirements

Carlos A. Ortiz August 30, 2023

There have been a number of changes to Form I-9 that employers should know. In a recent article, employment and immigration partner Carlos Ortiz laid out the changes and key dates relevant to Form 1-9 changes. READ MORE

Subjective Intent in False Claims Act: Navigating Ambiguity in Health Care Reimbursement Claims

U.S. Supreme Court

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

Illinois Passes Legislation Requiring Attorney General Notice of Certain Health Care Transactions

Catherine Feorene July 17, 2023
digital caduceus symbol

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

New OIG toolkit: Analyzing Telehealth Claims for Program Integrity Risks

doctor on phone

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

DOJ’s evolving ‘carrot and stick’ approach to increasing health care fraud corporate compliance

March 13, 2023
businessman hand holding carrot on a stick

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

New USAO policy for voluntary self-disclosure in corporate criminal enforcement actions provides greater predictability for health care organizations facing potential fraud or other misconduct

Gavel and scale on a desk

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

DOJ withdraws three long-standing antitrust policy statements, leaving health care organizations in limbo


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

Diagnosing a proposal to eliminate non-competes: Five ways it impacts the health care industry

Nicole Jobe Kevin Kifer February 10, 2023
Two business people negotiating a contract

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

Five considerations for health care providers’ marketing of Medicare Advantage Plans

Drawing of notebook on laptop

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

Mackenzie Wallace discusses the latest trends and challenges facing today's health care market on AHLA podcast

Mackenzie Wallace October 21, 2022
mackenzie wallace

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

CMS seeks stakeholder feedback on COVID-19 waivers in new request for information

Catherine Feorene September 23, 2022

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

Civil Monetary Penalties for non-compliance with the Hospital Price Transparency Rule have arrived

Nicole Jobe August 23, 2022
violation man

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

OIG issues fraud alert warning practitioners of risks with telemedicine arrangements

A woman talking to a doctor via a telehealth appointment

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

Five takeaways from the Amazon/One Medical transaction

Nathan Viehl August 5, 2022

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

Can health care companies create physician programs while avoiding anti-kickback liability?

June 23, 2022

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

OCR issues HIPAA guidance on audio-only telehealth services


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

Thinking about leaving private practice? What should physicians do with medical records?

April Kirkley May 26, 2022

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

Keeping clean to reduce M&A antitrust risk: Three tips for clean teams during due diligence

Greg Mennerick May 4, 2022

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

CMS offers new value-based care opportunities as it “REACHES” in a new direction and redesigns GPDC Model for Direct Contracting Entities to create ACO REACH Model

Tonya Oliver Rose March 17, 2022
digital caduceus symbol

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

Updated as of March 17: Should they stay or should they go: Fate of waivers following expiration of the federal PHE

Raquel Boton March 17, 2022
Medical mask and hand sanitizer on an office desk

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

So you’re a health care provider who’s received a civil investigative demand. Now what?

February 2, 2022
magnifying glass rests on a stack of documents

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

DOJ and OIG ramp up enforcement of risk adjustment coding: 5 compliance tips for providers


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

Federal rumblings point to increased interest in limiting non-competes

Kevin Kifer October 12, 2021

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

A new theory of liability under the Anti-Kickback Statute: “File access theory”

Nicole Jobe Kevin Kifer October 8, 2021

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

If you have seen one healthcare deal you have seen… One healthcare deal

September 21, 2021
Two business people negotiating a contract

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

Blog Browse: What can recent FCA decisions tell us about the Seventh Circuit pleading standard for health care billing fraud claims?


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

What you need to know about CMS’s recovery of COVID-19 Accelerated and Advance Payments

Nicole Jobe April 16, 2021

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

Permanent changes finally coming to telehealth

Mackenzie Wallace April 8, 2021
A woman talking to a doctor via a telehealth appointment

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

Fifth Circuit vacates $4.3M HHS enforcement penalty for HIPAA violations

Milada Goturi February 23, 2021

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

HHS provides updated guidance on Provider Relief Fund reporting requirements

Nicole Jobe February 3, 2021
A piggy bank wearing a medical mask on top of coins

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

OIG issues special fraud alert on health care speaker programs

Nicole Jobe December 16, 2020
A podium and microphone at a speaking seminar

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

DOJ continues to pursue health care fraud during COVID-19 pandemic

Nicole Jobe April Kirkley November 24, 2020

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

Additional updates to the Provider Relief Fund

Nicole Jobe October 28, 2020
A jar containing U.S. bills

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

Provider Relief Fund updates: Phase 3 distribution and reporting requirements

Nicole Jobe October 26, 2020

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

State Emergency Declarations: When do they expire and what impact do they have for health care facilities and providers?

September 21, 2020
Illustration of a diverse crowd all wearing medical masks

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

HHS provides update for Provider Relief Fund reporting requirements

Nicole Jobe August 24, 2020
Drawing of notebook on laptop

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

Adding COVID-19 to the informed consent process: A Q&A for health care providers

patients with masks

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

Be on the lookout for frequent changes being made to the CARES Act Provider Relief Fund FAQs

Nicole Jobe June 11, 2020
U.S. capitol dome

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

10 potential benefits for physicians under the CARES Act

Nicole Jobe April 15, 2020
U.S. Capital building at dusk

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

Blog Browse: Federal agencies announce expedited antitrust procedures for COVID-19 public health efforts

Nicole Williams April 2, 2020

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

Follow Up: Impact of Families First Coronavirus Response Act – Who is considered a “health care provider” or “emergency responder”?

Jim Fogle April 2, 2020
A pyramid of blocks featuring health care icons

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

Impact of Families First Coronavirus Response Act: Focus on medical practices and other health care providers

Jim Fogle March 27, 2020
Illustration of magnifying glass examining documents

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

Blog Browse: Coronavirus legislation may impact your paid leave and FMLA obligations

Chuck Poplstein March 18, 2020

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

Population health, care coordination, and HIPAA: Do you need patient authorization or a business associate agreement?

Tonya Oliver Rose March 5, 2020
Stethoscope over a laptop computer keyboard

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

Top considerations for structuring health care mergers and acquisitions

January 7, 2020
Three puzzle pieces fitting together

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

10 cybersecurity tips for a safe holiday season

December 16, 2019
Illustration of security shield on computer

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

HHS proposes significant changes to Stark, Anti-Kickback and CMP regulations

Milada Goturi October 11, 2019
Stethoscope and gavel

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

Comments due to CMS by September 27 on proposed changes to Stark Law advisory opinion process

April Kirkley September 5, 2019
A pyramid of blocks featuring health care icons

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

CMS issues final rule on pre-dispute arbitration agreements with long-term care facilities

arbitration agreement with gavel and pen poised to sign it

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

Blog browse: Credit for cooperation: What you need to know about the DOJ’s new guidelines for FCA investigations

Claire Schenk August 5, 2019
magnifying glass rests on a stack of documents

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

OCR reminds business associates of direct liability for noncompliance with HIPAA Rules

Milada Goturi June 10, 2019

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

CMS draft guidance on co-location arrangements: What hospitals and health care entities need to know

Milada Goturi May 29, 2019
health care waiting room

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

New law expands kickback liability for laboratories, recovery homes, and clinical treatment facilities

Nicole Jobe May 10, 2019
Stethoscope and gavel

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

CMS provides more hints at future Stark Law modifications

March 25, 2019

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

Blog browse: Highlights from the Missouri Department of Health’s first medical cannabis forum

February 26, 2019
Marijuana buds spilled on a table next to a medicine bottle

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

HIPAA breach notification deadline is March 1

February 12, 2019
Illustration of security shield on computer

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

Health care hot topics for 2019

Nicole Jobe January 30, 2019
A pyramid of blocks featuring health care icons

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

HHS issues voluntary health care cybersecurity guidelines

Milada Goturi January 17, 2019
Stethoscope over a laptop computer keyboard

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

OCR seeks public input on potential modifications to the HIPAA Rules

January 4, 2019
Doctor holding tablet

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

Missouri insurers to face new requirements for audits, compliance reporting in 2019

December 10, 2018
Illustration of business tools

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

7 facts employers and employees should know about HIPAA and the opioid crisis

Lori Jones September 21, 2018
Opioid pills and needle

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

DOJ continues to investigate, seek recoveries over compounding pharmacy fraud

Claire Schenk August 8, 2018
Pill bottle next to pharmacist using pestle

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

CMS seeks public comment on potential Stark Law modifications

August 2, 2018
gavel and stethoscope

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

AT&T rings Justice's bell: What the AT&T-Time Warner merger decision means for health care

June 22, 2018

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

Blog Browse: National Right to Try Act passes U.S. House

April 19, 2018

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

HIPAA reports of 2017 small-scale breaches due March 1, 2018

February 27, 2018

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

Relaxation of SAMHSA laws intended to align with advances in health care delivery

Nicole Jobe February 20, 2018
pills and a needle

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

CMS announces new voluntary episode-payment program: BPCI Advanced

January 10, 2018
Medical money

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

CMS revises CJR program, cancels cardiac bundles

August 22, 2017
Medical money

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

Escobar case limits False Claims Act liability for providers

July 18, 2017
U.S. Supreme Court

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

Are you subject to MIPS reporting requirements in 2017?

June 13, 2017
stethascope and chart

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

CMS finalizes additional delay for episodic payment programs

June 9, 2017
digital caduceus symbol

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

CMS changes the SRDP process effective June 1, 2017

June 2, 2017
Health Law Checkup_default blog

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

Blog browse: Is mobile targeting a ‘secret weapon’ for good or ill?

Mark Sableman May 1, 2017

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

CMS mandates new Stark Self-Referral Disclosure Protocol form

Milada Goturi April 10, 2017
Health Law Checkup_default blog

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

Blog browse: FDA bans powdered gloves in human, animal medicine

January 18, 2017
medical exam glove

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

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
An Affordable Care Act booklet with stethascope

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

June 8, 2016
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

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

March 30, 2016

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

Milada Goturi March 18, 2016

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

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

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

Matt Darrough February 3, 2016

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

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

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

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

Record-breaking FCA settlements underscore importance of Stark Law compliance

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

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

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

September 3, 2015

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

August 27, 2015

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

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

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

June 9, 2015

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

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

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

“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
Health Law Checkup_default blog

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

April 13, 2015

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

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

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)

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

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

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
Health Law Checkup_default blog

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

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

July 17, 2014

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

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

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

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
Health Law Checkup_default blog

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

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

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

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

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

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 Health Law Checkup, the blog of Thompson Coburn's health care practice group

February 11, 2014
Health Law Checkup_default blog

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

EHR Donation Exception and Safe Harbor Modified and Extended through 2021

January 6, 2014

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
Health Law Checkup_default blog

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
Health Law Checkup_default blog

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
Health Law Checkup_default blog

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