Healthcare ComplianceAdam Law is pleased to represent healthcare organizations and professionals looking for trusted counsel in sensitive compliance inquiries, internal investigations, and payer disputes. Ms. Adam has over 20 years of experience in healthcare compliance, investigations, and litigation. She is a past Chairperson of the Health Law Section of the State Bar of Georgia and a frequent writer and speaker on a range of healthcare topics.
Compliance Policies & Procedures
Corporate Integrity Agreements
Fraud and Abuse Guidance
|Medicare and Medicaid Coverage & Billing
NCD and LCD Compliance
Stark Law Compliance
Adam Law partners with healthcare clients to navigate difficult compliance issues, so that you can maintain focus on your core mission of serving patients and protecting the bottom line. Compliance should not bankrupt your organization. Adam Law delivers value-driven, sensible advice to reduce the disruption and expense of compliance inquiries.
Compliance with the Anti-Kickback Statute and Stark LawViolations of the Anti-Kickback Statute and Stark Law can lead to criminal fines, liability under the False Claims Act, and civil monetary penalties. Ms. Adam investigated and prosecuted violations of the Anti-Kickback Statute as a federal prosecutor, she has served as an expert witness on Anti-Kickback issues, and she has handled investigations and self-disclosures of potential kickback and Stark Law violations as counsel for health systems.
While these laws have admirable goals, compliance with them can be burdensome and costly. The Anti-Kickback Statute and Stark Law serve a common purpose of protecting patients from medical decisions based on improper financial incentives rather than the best interests of patients. The laws also seek to level the playing field for honest healthcare organizations and professionals who are disadvantaged when competitors pay kickbacks to generate referrals or engage in self-dealing by referring patients for services based on personal financial gain.
Congress passed the Anti-Kickback Statute in 1972 and has enhanced it many times since then to curb such abuses in federal healthcare programs. The Anti-Kickback Statute makes it a crime to offer, pay, or accept anything of value to any person if one purpose of the arrangement is to induce a person to refer patients for healthcare services or supplies that are paid for in whole or in part by Medicare, Medicaid, TRICARE, or other federal healthcare programs. See 42 U.S.C. § 1320a-7b(b).
In 2010, Congress strengthened the Anti-Kickback Statute and tied it to the primary whistleblower law, the False Claims Act. The Anti-Kickback Statute now establishes, as a matter of law, that a claim for payment submitted to a federal program such as Medicare that includes “items or services resulting from” a kickback scheme “constitutes a false or fraudulent claim” in violation of the False Claims Act. See 42 U.S.C. § 1320a-7b(g).
A new federal law enacted in 2018, the Eliminating Kickbacks in Recovery Act (EKRA), now makes it a crime to pay kickbacks in the context of commercial health plans, as distinguished from federal programs like Medicare. EKRA prohibits kickbacks to generate a referral of a private-pay patient to a recovery home, clinical treatment facility, or laboratory. This broad new statute has important implications for many healthcare facilities and testing labs.
The Stark Law prohibits physician self-referrals, meaning a physician generally (with many exceptions) may not refer Medicare patients to an entity with whom the physician has a financial relationship. See 42 U.S.C. § 1395nn. Some courts have extended the Stark Law to the Medicaid program. Even technical violations of the Stark Law create a substantial risk of liability for civil monetary penalties and damages under the False Claims Act.
Knowingly engaging in a kickback scheme affecting federal healthcare programs, or participating in a Stark Law violation, creates a risk of liability under the False Claims Act for treble damages and penalties of up to $22,363 for each false claim resulting from the kickback or Stark Law scheme.
Healthcare providers bear the substantial burden of compliance with these laws and the complex regulatory structure that has developed around them. Adam Law can help to alleviate that burden. Ms. Adam assists clients by investigating and addressing potential compliance issues under the Anti-Kickback Statute and Stark Law in an efficient, cost-effective manner.
In FY 2020, the U.S. Department of Justice recovered over $1.8 billion under the False Claims Act based on alleged violations of healthcare laws and regulations.
Corporate Integrity AgreementsAfter litigating a False Claims Act case, a provider sometimes resolves the case by entering into a settlement agreement with the U.S. Department of Justice and a Corporate Integrity Agreement (CIA) or Integrity Agreement (IA) with the U.S. Department of Health and Human Services.
Complying with a CIA or IA can be challenging and enormously costly, even for the most sophisticated providers. Ms. Adam knows the value of developing a trusting relationship with the Government monitor, retaining the right Independent Review Organization (IRO), and promptly resolving issues over the scope and implementation of the CIA or IA. These measures can reduce costs over the long run. She also has experience preparing for and responding to IRO reports and reporting potential breaches and overpayments to the Government. Adam Law offers experienced counsel to protect the organization’s interests at these important junctures of compliance with integrity agreements.
Enforcement Hot TopicsAnti-Kickback Statute
COVID Pandemic Relief Fraud
Medically Unnecessary Lab Tests
Medically Unnecessary Physician Services
Risk Adjustment Scores (Medicare Advantage Plans)
Speaker Programs (Pharmaceutical Manufacturers)
Therapy Services for Skilled Nursing Patients
Having represented health systems and large physician practices for many years, Ms. Adam has substantial experience with conducting internal investigations and providing effective, pragmatic compliance advice on a range of coding and billing topics. Ms. Adam’s experience includes, among other issues, the following areas:
Medicare and Medicaid Coverage & Billing
- Evaluation and Management (E/M) Coding
- Patient Status (inpatient, outpatient, observation billing)
- Medical Necessity of ICD and CRT-D procedures (implantable cardioverter defibrillators and cardiac resynchronization therapy)
- Medicare Conditions of Coverage, including CMS National Coverage Determinations and Local Coverage Determinations
- Overpayments by Medicare and Medicaid, including Medicare Advantage and Medicaid Care Management Organizations
- Midlevel Billing (Nurse Practitioners, Physician Assistants)
- Medicare Secondary Payer Act
Overpayment issues have been front and center for compliance officers at least since the Affordable Care Act was adopted in March 2010. Overpayments happen. Most are handled with routine refunds. When non-routine issues crop up, Adam Law can help. Ms. Adam assists providers to strengthen overpayment policies and to identify, quantify, report, and return overpayments in an efficient, methodical manner.
An Overpayment is any amount of money that a provider, supplier, Medicaid managed care organization, Medicare Advantage organization, or Prescription Drug Plan sponsor receives or retains from Medicare or Medicaid and is not entitled to keep. See 42 U.S.C. § 1320a-7k(d)(4)(B).
Overpayments and Self-Disclosure
In other words, an Overpayment is taxpayer money to be returned to the Government. An Overpayment must be reported and returned to the applicable healthcare program within 60 days of when the Overpayment is identified, or the date when the corresponding cost report is due.
When an Overpayment is not refunded in a timely fashion, a provider can face potential liability under the False Claims Act and Civil Monetary Penalties statute. Partnering with experienced and knowledgeable counsel is critical for the organization seeking to mitigate the risks associated with non-routine Overpayment issues. Ms. Adam’s experience in this area helps clients to resolve Overpayment issues efficiently and with confidence.
Payer DisputesAdam Law believes that healthcare providers are entitled to fair reimbursement for the important services they deliver to their patients, and Ms. Adam is on your side in payer disputes. Federal healthcare programs and commercial managed care plans seem to squeeze providers at every turn, and the Medicare Advantage program is growing, meaning providers will see more and more of their Medicare patients covered by managed care plans in the future.
Payer disputes can be draining. Adam Law can help. Ms. Adam’s strong healthcare litigation experience prepares her to understand the issues quickly and to successfully challenge the plans and payers that arbitrarily deny coverage, unfairly recoup payments, or improperly reduce the reimbursement owed to her healthcare provider clients.