Presentation on theme: "Office of Compliance Brody School of Medicine ECU HIPAA Privacy Office"— Presentation transcript:
1 Office of Compliance Brody School of Medicine ECU HIPAA Privacy Office Compliance 101: What you Need to Know to Protect Yourself and Your PracticeOffice of ComplianceBrody School of MedicineECU HIPAA Privacy Office
2 Top Compliance Risk Areas Documentation and BillingFederal False Claims ActFederal Anti-kickback StatutePhysician Relationships with VendorsStark Law
4 Documentation and Billing Teaching Physician Documentation RulesGenerally need evidence of physician presence during key portion of procedure or exam and review of medical management with resident.Primary Care Exception ClinicsFamily Medicine Clinic; General Internal Medicine Clinic, Geriatrics Clinic, General Pediatrics Clinic; General OB/GYN ClinicTeaching Physician needs to document that case was reviewed and examined with residentTeaching Physician does not have to examine patient unless billing at a higher level (level 4 or 5)
5 Documentation and Billing Electronic Medical Record IssuesSharing of passwords prohibitedCutting and pasting may be problematic (i.e. may be difficult to demonstrate medical necessity)If you cut and paste, make sure you also review and edit
6 Documentation and Billing Billing and ReimbursementBilling for services not performed (or underperformed)Ordering/billing for medically unnecessary servicesImproper billing and documentation for teaching physician servicesDouble billingUpcoding/Downcoding
7 Documentation and Billing Recent OIG and DOJ Settlements related to billing:$25.1M Pediatrix Medical GroupBilling for critical care services when infant’s condition did not substantiate critical careOccurred over 3-year time period$1.25M Carlinville Area HospitalCoded for diagnoses involving gram negative pneumonia, septicemia, and acute renal failure when documentation did not support such codes.$493K University of Rochester Strong Memorial Hosp.Teaching physician documentation problems$900M Tenet HealthcareExcessive outlier paymentsUpcodingFederal Anti-kickback Statute violations
9 Federal False Claims Act Background Federal False Claims Act:False Claims Act (FCA) prohibits anyone from “knowingly” submitting a false or fraudulent claim for payment“Claim” is generally defined as a CMS standard paper claim form“Knowingly” means (i) actual knowledge; (ii) acts in deliberate ignorance of the truth or falsity of the information; or (iii) acts in reckless disregard of the truth or falsity of the information.No proof of specific intent to defraud is required; liability is proven by evidence of deliberate ignorance or reckless disregard of truth of the claim
10 Federal False Claims Act Background Federal False Claims Act (Cont’d):Damages: Triple damages and penalties of $5,500 to $11,000 per false claim for submission or causing submission of false claim.May result in imposition by the government of a “corporate integrity agreement”Typically lasts for 5 years and includes requirements such as: develop written standards and policies; establish a confidential disclosure program, provide annual reports to OIG on status of entity’s compliance activities
11 Federal False Claims Act Background: Qui Tam ActionsThe FCA allows a private person (a “qui tam relator”) to bring a civil action in the name of the United States.Qui tam relators share in any money recovered (including settlements).If government joins in action, relator is entitled to 15% to 25% of proceeds depending on relator’s contribution to case.If government does not join in action, court may award relator not less than 25% and not more than 30% of proceeds.
13 Federal Anti-kickback Statute Forbids any knowing and willful conduct involving the solicitation, receipt, offer or payment of any kind of remuneration in return for referring an individual or for recommending or arranging the purchase, lease or ordering of an item or service that may be paid for under a federal health care program.Criminal and civil liability for failure to comply.
14 Federal Anti-kickback Statute Regulatory Safe HarborsNot a “per se” violation of law to be “outside” of a safe harborMost important consideration is “fair market value”Affects many physician contractual relationshipsLeases with referral sources (space or equipment), employment and recruitment agreements, and joint ventures, for example, may implicate the Federal Anti-kickback Statute.
15 Federal Anti-Kickback Statute Recent OIG and DOJ Settlements related to anti-kickback:$311M four orthopedic device manufacturersCompanies bribed surgeons to recommend their hip and knee surgical implant products by awarding physicians with vacations, gifts and annual “consulting fees” as high as $200k.$650k one orthopedic surgeonPaid to resolve allegations that the surgeon accepted payments from device manufactures to use their hip and knee implants
16 Federal Anti-Kickback Statute Recent OIG and DOJ Settlements related to anti-kickback:Serono ($567M):Admitted to providing physicians trips to France in exchange for certain number of prescriptions for new drugTAP ($875M) and AstraZeneca ($355 M): Federal anti-kickback statute implicated for marketing practices“educational grants” to encourage use of productFree trips, funding office holiday parties, lavish mealsPayment for inconsequential drug studiesCash payments for small record-keeping tasksBristol-Myers Squibb ($328M)BMS paid kickbacks to doctors in the form of bogus consulting fees to induce them to purchase BMS’s drugs; off-label marketing of its drug, Abilify; kickbacks to wholesalers and retail pharmacies to induce purchases of generic products.Zimmer, Inc.; Depuy Orthopedics, Inc.; Biomet Inc., and Smith & Nephew, Inc. ($311M)Companies used consulting agreements with orthopedic surgeons to induce the purchase of their devices. Firms paid surgeons hundreds of thousands of dollars a year for consulting contracts and provided lavish trips and other expensive perks in exchange for using the companies’ products exclusively.
18 Physician Relationship with Vendors Free SamplesIt is legal to give free samples to patients for free but it is illegal to sell the samples and/or bill MedicareConsulting AgreementsKey questions to ask:1) Does vendor really need a physician’s particular expertise or input?;2) Does the amount of money offered seem fair, appropriate, and commercially reasonable for what physician is being asked to do?;3) Is it possible the company is paying physician for their loyalty so that they will prescribe its drugs or use its devices?
19 Physician Relationship with Vendors TransparencyAlthough free lunches, subsidized trips and gifts may not seem like they affect medical judgment, research shows that this can influence prescribing practices.The Patient Protection and Affordable Care Act of 2012 will require drug, device, and biologic companies to publicly report nearly all gifts or payments they make to physicians beginning in 2013.Conflict of Interest DisclosuresDisclosure required even if relationship is legal
20 Physician Relationship with Vendors Continuing Medical EducationDrug and device manufacturers sponsor many educational opportunities for physiciansImportant to distinguish between CME sessions that are educational in nature and sessions that constitute marketing by a vendorIndustry satellite program that occurs concurrently with a society meeting are generally promotional, even if the primary speaker is a well known physician in the fieldBe wary about a discussion that focuses on a particular drug or device as opposed to all treatment alternatives for a specific condition
21 Physician Relationship with Vendors Off-label UsesFederal Food, Drug, and Cosmetic Act prohibits promotion for off-label usesA physician may prescribe drugs for off-label uses however it is illegal for a drug manufacturer to promote off-label uses of drugsRecent OIG and DOJ Settlements related to off-label uses:In 2004, Pfizer paid $430 million to settle allegations it marketed the epilepsy drug Neurontin for pain and psychiatric illnesses (some say this was a mere “slap on the wrist” since sales of the drug reached $2.7 billion in 2003).Schering was ordered to pay $435 million to settle allegations related to illegal promotion of Temodar and Intron A for the treatment of certain cancers without approval.
22 Federal Prohibition on Physician Self-Referral (Stark Law)
23 Federal Prohibition on Physician Self-Referral (Stark Law) Governs most financial relationships between physicians and referral sources (even members of same group practice)Space and equipment leases, any type of ownership or compensation relationship, employment arrangements, independent contractor arrangements between an entity and a referral sourceExamples of requirements:Written agreementsTerm of one yearCompensation “set in advance”Compensation cannot vary with volume or value of referralsFair market value for services/equipment
25 BSOM Compliance Program Wide range of activities to help prevent, detect, and avoid fraud and abuseBSOM Compliance officer, BSOM compliance committee, risk assessment, monitoring, education, recommendation of disciplinary action, reporting system for potential incidents of non-complianceBSOM contracts review process to help maintain compliance with Stark law and Federal Anti-kickback law, among othersMonitoring program for provider documentationRandom and targeted reviewsAlways provide follow-up review and education for provider
26 BSOM Compliance Program BSOM Code of ConductAll employees required to signCarefully read and understand termsCondition of employmentAnnual attestation required
27 BSOM Reporting Incidents of Potential Non-compliance Encouraged to use supervisors, administrators as the first line of reporting of any known incidents of noncomplianceBSOM Compliance HotlineAvailable 24 hours a day, 7 days a weekCan be anonymousToll freeNo retaliation for good faith reporting of incidents of noncomplianceAll good faith reports will be fully investigatedConfidentiality maintained to the fullest extent possiblePhysicians and staff have a professional duty to report potential problems.
28 BSOM Office of Compliance Serves as a resource to all faculty, learners, and staffContact information:Kenneth De Ville, PhD, JDInterim Chief Compliance Officer