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.
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.
- 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
September 11, 2023
September Signals Start of College Football Season and Texas Medical Debt Billing Reforms Under S.B. 490
By Jeffrey H. Frost
As of September, any individual or facility licensed or certified to provide healthcare services in Texas must provide an itemized bill of charges for healthcare services or related supplies provided to a patient prior to requesting payment for such services or related supplies from the patient.
August 9, 2023
JW Fast Takes Podcast | ~7.5 minutes
Congress in late 2022 largely expanded the U.S. Food and Drug Administration’s authority to regulate cosmetics companies. In this episode, Nick Diamond discusses key provisions of the Modernization of Cosmetics Regulation Act and what the new law means for the cosmetics industry and consumers.
July 13, 2023
By Jeffrey H. Frost
HB 3359 amends Chapter 1301 of the Texas Insurance Code. Chapter 1301 sets forth the legal requirements and obligations of a “preferred provider benefit plan”. A “preferred provider benefit plan” is a benefit plan in which an insurer provides, through its health insurance policy, for the payment of a level of coverage that is different from the basic level of coverage provided by the health insurance policy if the insured person uses a preferred provider.
July 10, 2023
By Nicholas J. Diamond
In March, the FDA launched the new Dietary Supplement Ingredient Directory. The directory is intended to be a resource to help consumers, manufacturers and retailers quickly find relevant FDA materials, federal regulations and FDA enforcement actions — e.g., warning letters — for specific dietary ingredients.
May 10, 2023
Coronavirus (COVID-19) Public Health Emergency Termination Compliance Checklist (Hospital and Health Systems) l Practical Guidance
By Jeffrey H. Frost
After more than three years, the COVID-19 federal Public Health Emergency (PHE) (effective January 31, 2020) will expire on May 11, 2023. This checklist will assist hospitals and health systems, including critical access hospitals (CAHs), prepare for the return of numerous healthcare regulations that were in place pre-pandemic.
April 4, 2023
Jackson Walker partner Jeffrey H. Frost will join a panel discussion covering the end of the public health emergency (PHE) and the associated waivers. Jeff will be joined by fellow panelists Rick L. Hindmand (McDonald Hopkins) and Matthew K. Loughran (Reed Smith).
February 1, 2023
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.
January 4, 2023
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
December 19, 2022
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.
September 15, 2022
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.
- 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