1. What practical purpose is served by the safe harbors, advisory opinions, and special fraud alerts issued by the Office of the Inspector General (OIG) in the Department of Health and Human Services (DHHS)?
2. Pick three of the Anti-Kickback Statute safe harbors and briefly describe what an individual or organization must do to earn their protection.
3. The Anti-Kickback Statute safe harbors describe circumstances under which a transaction that otherwise would violate the statute will be considered safe and legal. In contrast with that, what is the function of a Special Fraud Alert?
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Safe Harbors, Advisory Opinions, and Special Fraud Alerts
Differences among Safe Harbor, Special Fraud Alert, and Advisory Opinion
Practical legal effect of a Safe Harbor
Protection details of each of 24 Safe Harbors
OIG purpose in issuing Special Fraud Alerts
Submit recommendation for new Safe Harbor or Special Fraud Alert
Purpose and application of Advisory Opinion
Process for requesting an Advisory Opinion
The federal agencies responsible for enforcing fraud and abuse laws publish numerous regulations and other documents to help individuals understand and obey the laws.
Foremost among these are
advisory opinions, and
special fraud alerts
Exceptions Under the Anti-Kickback Statute (AKS)
Statutory exceptions to AKS prohibitions:
Properly disclosed discounts/price reductions
Payments to bona fide employees
Certain risk-sharing arrangements with managed care organizations
Certain payments to group purchasing organizations
Certain coinsurance waivers for Medicare services
Safe Harbors Under the Anti-Kickback Statute (I)
If a transaction fits exactly within an OIG-defined safe harbor, it will not be prohibited or prosecuted.
Rental of space and equipment
Personal services and management contracts
Sale of practice
Safe Harbors Under the Anti-Kickback Statute (II)
Group purchasing organizations
Waiver of beneficiary coinsurance & deductible
Increased coverage, reduced cost-sharing, or reduced premium offered by health plans
Price reductions offered by health plans
Safe Harbors Under the Anti-Kickback Statute (III)
Obstetrical malpractice insurance subsidies
Investments in group practices
Cooperative hospital service organizations
Ambulatory surgical centers
Referral arrangements for specialty services
Prices reductions offered to eligible managed care organizations
Safe Harbors Under the Anti-Kickback Statute (IV)
Price reductions offered by contractors with substantial financial risk to managed care organizations
Electronic prescribing items and services
Electronic health records items and services
Typical Terms of a Safe Harbor
Arrangement is written and signed by the parties
Fully describes the services, space, or equipment that are subject of arrangement
Term of arrangement is at least one year
Dollar amounts set in advance, consistent with FMV, and not based on volume of referrals
Special Fraud Alerts (I)
Occasionally issued on topics of heightened legal concern to the OIG. In 10 years, it has issued 12 alerts on these topics:
Joint venture relationships
Routine waiver of copayments or deductibles under Medicare Part B
Hospital incentives to referring physicians
Prescription drug marketing schemes
Special Fraud Alerts (II)
Arrangement for clinical laboratory services
Home health fraud
Provision of medical services in nursing facilities
Nursing home arrangements with hospices
Provision of services in nursing facilities
Special Fraud Alerts (III)
Physician liability in certification of medical equipment and supplies and home health services
Rental of office space in physicians’ offices
Telemarketing by DME suppliers
Typical Terms of a Special Fraud Alert
Describes potential problems from a risky or prohibited arrangement or behavior
Details of the arrangement or behavior
Extent of a person’s or organization’s liability for engaging in the arrangement or behavior
Advisory Opinions (I)
An OIG Advisory Opinion is a legal opinion issued to a requesting party about the application of fraud and abuse laws to an existing or proposed business arrangement.
It is legally binding on DHHS and the requesting party, but no one else.
Advisory Opinions: Examples
Proposal for a website to display coupons and advertising from health care providers and suppliers.
Proposal by a radiology group to offer free insurance pre-authorization services to physicians and patients.
Online referral service for care providers to receive requests from hospitals for post-discharge care.
Advisory Opinions (II)
Topics on which Advisory Opinions will not be issued.
An AO request must be based on current facts or a proposed transaction that is very likely to be implemented if the opinion is favorable.
Information included in an AO request.
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