Healthcare Regulatory Compliance

Companies and professionals engaged in the healthcare industry face a tangled web of state and federal laws and regulations. With Jackson Walker healthcare partners averaging over 25 years of industry experience, we help our healthcare clients understand and manage the complex laws affecting their business.

Our Healthcare practice group offers all facets of legal advice to healthcare industry clients, including entity structure and formation, day-to-day operations, licensing, reimbursement, compliance plan implementation, self-disclosure decisions and defense.  Healthcare regulations, and the internal processes needed to deal with them effectively, are constantly changing. Our attorneys are not only well-versed in existing laws, but remain at the forefront of legislative changes so as to stay ahead of emerging regulations, thus minimizing the risks associated with non-compliance.

Regulatory Compliance

Managing the risks of doing business in the healthcare industry can make the difference between a successful healthcare organization and a failed one. Our attorneys work with clients not only to develop and implement compliance programs that minimize regulatory risk, but programs that strategically manage the cost and effort involved in following necessary procedures and protocols. Our goal is always to help our clients remain compliant without sacrificing their business interests and objectives.

Realizing that the implementation of a strong compliance program is one of the first lines of defense against government allegations, our attorneys can work with clients to design robust compliance programs that can withstand government scrutiny and provide a strong defense to allegations of misconduct. We provide clients a customized compliance solution that considers the size, nature, and capabilities of the organization and is specifically designed to maximize their business objectives while minimizing risk. We try to anticipate regulatory changes before they happen and pride ourselves on real-time responses to regulatory updates. We can also provide training on compliance protocols at all levels of the healthcare organization.

Investigations & Enforcement

Healthcare organizations that have been targeted for inquiries by government agencies and regulators need attorneys who not only understand how the healthcare industry operates and the regulations that it must abide by, but also the strategic realities of adversary proceedings. With one of the most respected healthcare practice groups in Texas, a stellar Investigations team, and highly-regarded litigators, Jackson Walker offers just that.

We assist clients in responding to regulatory investigations and audits at all stages of the process, from meeting with government officials early in an investigation to understand and proactively address their concerns, to conducting full-scale compliance audits and reviews of business activities, to actively litigating complex cases and, when necessary, strategically managing parallel proceedings.

Practice Category

  • Assisted large specialty medical group restore its revoked Medicare certification within one week, with no loss of revenue.
  • Assisted public hospital with potential Stark overpayment claims. By applying alternative analysis using newly adopted regulations, isolated and mitigated improper referral repayments to thousands rather than the original amount in hundreds of thousands.
  • Represented non-profit children’s hospital responding to state OIG Medicaid audits
  • Represented a medical school in responding to HIPAA breach involving a stolen notebook containing medical information.
  • Represented a non-profit hospital in settling an appeal involving a CMS TIPPS review with CMS and the Medicare fiscal intermediary that saved the Hospital over $1,000,000.
  • Represented a teaching hospital making a self-disclosure to the OIG regarding certain issues involving teaching physicians supervision of residents, and negotiated a settlement without civil monetary penalties or the need for a corporate integrity agreement.
  • Represented a non-profit hospital system making a self-disclosure to the OIG regarding certain arrangements with a medical group that employed a physician who was an excluded provider, and negotiated a settlement without penalties or the need for a corporate integrity agreement.
  • Represented a medical school in self-reporting certain issues involving grants and resolving same with the OIG and National Institute of Health.
  • Represented various hospitals and physician groups in internal audits and investigations to identify and resolve billing errors and other compliance issues, and self-reporting such errors to the appropriate Medicare fiscal intermediary and Medicaid carrier, and repayment of amounts in error without penalties.
  • Assisted non-profit mental health provider with internal investigation of coding and billing practices, and self-reporting to state OIG
Jeff Frost with Jackson Walker logo

February 1, 2023
Podcasts

Three Actions Health Systems Should Take Before COVID Blanket Waivers Expire

JW Fast Takes Podcast | ~7 minutes

On Monday, January 30, President Biden announced that the COVID-19 national emergency and public health emergency will end on May 11, 2023. Tune in as Healthcare partner Jeffrey Frost shares three actions health systems should take now to ensure compliance once the emergency declaration expires.

Health charts stethoscope with JW logo

January 4, 2023
Insights

Health Orgs Must Prepare for End of COVID Waivers | Law360 (Subscription Required)

The U.S. Department of Health and Human Services must renew the COVID-19 federal public health emergency determination every 90 days to maintain certain health care flexibilities and waivers.

By Jeffrey Frost

Hospital emergency sign with Jackson Walker logo

December 19, 2022
Insights

Is Your Health System Prepared for the Expiration of the Federal and State COVID-19 Public Health Emergency?

The current extension of the COVID-19 Federal Public Health Emergency (PHE) is set to expire January 11, 2023, and no termination notice has been provided. While the PHE will likely extend through April 11, 2023, it will likely expire sometime in 2023. Here are three steps that health systems and hospitals can take now to ensure compliance should the emergency waivers expire.

Nick Diamond with Jackson Walker logo

September 15, 2022
Speaking Engagements

Nick Diamond Speaks on Vaccine Development at National Vaccine Law Conference

Nick Diamond presented two sessions at the National Vaccine Law Conference held at George Mason University’s Antonin Scalia Law School. The first session, “International Vaccine Law,” covered international structures for the development, regulation, and distribution of vaccines. The second session, “The Bright Future of Vaccine Development,” discusses regulatory issues for the collective pipeline.

Health charts stethoscope with JW logo

August 18, 2022
Insights

Next Steps for Healthcare and the Inflation Reduction Act

By Nicholas J. Diamond

The Inflation Reduction Act of 2022 has been signed into law. This article explores key healthcare provisions in the IRA, including prescription drug pricing, inflationary rebates, Medicare Part D benefit resign provisions, and vaccine coverage.

August 8, 2022
Insights

Digital Health Implications of Recent HHS Anti-Discrimination Proposed Rule

By Nicholas J. Diamond

The Department of Health and Human Services issued a new proposed rule on Section 1557 of the Affordable Care Act (ACA) that will impact digital health, including the proposed extension of Section 1557 to “clinical algorithms” and telehealth services.

Laptop and stethoscope for healthcare

July 27, 2022
Insights

FDA Releases Draft Guidance on Remote Regulatory Assessments

By Nicholas J. Diamond

The U.S. Food and Drug Administration has indicated in its draft guidance that it intends to continue to use remote tools to support oversight activities, including a hybrid approach for inspections that combines both onsite and remote modalities, beyond the COVID-19 pandemic.

Jeff Drummond with Jackson Walker logo

January 17, 2022
Mentions

Patient Blocks Exam Elements? Work With Them Before Turning Them Away | Part B News (Subscription Required)

Providers are usually obliged by contract and allowed by HIPAA to communicate an insured patient’s medical information to insurers. But, Jeff Drummond says, such patients may avail an exception in the HITECH Act that he calls the “hide rule,” by which “a patient may request that a health care provider not provide information relating to a particular service or treatment to an insurer for payment or health care operations purposes, so long as the patient has paid for the service or treatment in full, out of pocket, prior to making the request,” he says.

Department of Justice with Jackson Walker logo

September 29, 2021
Insights

What to Know About the Department of Justice’s Nationwide Crackdown on Healthcare Fraud

By Laura Cordova, Erica Giese, & Daniela Mondragón

The Department of Justice (DOJ) has identified over $1 billion in fraud-related losses to government-funded healthcare programs and private insurers. In its recent announcement, the DOJ highlighted enforcement actions targeting four major categories of alleged fraud: telemedicine; COVID-19 relief funds; substance abuse treatment facilities, or “sober homes”; and illegal prescription and/or distribution of opioids.

Laptop and stethoscope for healthcare

August 18, 2021
Podcasts

Navigating Potential COVID Relief and Healthcare Fraud Issues

~10 minutes | With a dense thicket of regulations to comply with, businesses may trigger a governmental investigation if they are not familiar with the complex and changing rules and regulations surrounding COVID relief funds, particularly in the healthcare sector. In this interview about the Department of Justice’s crackdown on fraud, Arthur Gollwitzer discusses how businesses can protect themselves and what to do when approached by the authorities.

More Healthcare Regulatory Compliance News

  • Compliance with and defense against alleged violations of Federal regulations including:
    • Medicare/Medicaid accreditation and reimbursement requirements
    • Anti-kickback Statute
    • Stark Statute
    • Sunshine Act
    • Food, Drug, and Cosmetic Act
    • False Claims Act and state counterparts
    • Good manufacturing practices regulations
  • Compliance with and defense against alleged violations of state regulations including:
    • State licensing
    • Corporate practice of medicine compliance
    • Consumer fraud and deceptive practices statutes
    • Disclosure issues in private placements and public offerings
    • Insurance prompt pay and other provider contracting and payment issues
    • State Anti-kickback and False Claims laws, including OIG investigations
    • State Comptroller taxation issues
  • Representation of clients in administrative hearings and appeals of government regulatory actions
  • Representation of clients on antitrust matters, including representation before the FTC and Department of Justice
  • Representation of providers before State regulators and licensing boards, including the Texas Health and Human Services Commission, Department of Aging and Disability Services, Texas Medical Board, Texas Board of Nursing and the Texas State Board of Pharmacy
  • Assistance with Recovery Audit Contractor (RAC) audits and appeals
  • Design and implementation of proactive and responsive internal investigations
  • Resolution of government and commercial payor audits and disputes
  • Resolution of regulatory and legislative issues with the CMS, OIG, NIH, and Congress
  • Development of pre-charging presentations to the government
  • Negotiation of administrative, civil and criminal settlements
  • Preparation and presentation of self-disclosures
  • Preparation of clients for government interviews or grand jury testimony
  • Presentation of findings to boards of directors and other stakeholders
  • Responses to alleged physician self-referral (Stark Law) violations
  • Responses to search warrants and government subpoenas
  • Prepare and assist in implementing corporate compliance programs
  • IRS compliance and reporting for taxable and tax-exempt organizations
  • HIPAA compliance

Practice Category