Faculty Disclosures:
Transcription
Faculty Disclosures:
Faculty Disclosures: Billing and Coding in Long Term Care: Miscellaneous Topics Dr. Gelman has disclosed that he has no relevant financial relationship(s). May 19, 2010 presented by Alva S. Baker, MD, CMD An AMDA Webinar Series presented by LEONARD M. GELMAN, MD, CMD ALVA S. BAKER, MD, CMD CHARLES CRECELIUS, MD, PHD, CMD Dr. B D Baker k h has di disclosed l d th thatt h he h has no relevant financial relationship(s). Dr. Crecelius has disclosed that he has no relevant financial relationship(s). Learning Objectives • Discuss various topics related to correct coding and billing, including, but not limited to, NPP services, incident to services, gang visits, and hospice care MEDICARE CLAIMS PROCESSING MANUAL • Discuss correct coding and billing for these services as they relate to fraud and abuse control initiatives in the current health care reform environment CMS Manuals CMS Manuals 100 – cms.hhs.gov Introduction 100-01 Medicare General Information, Eligibility and Entitlement Manual 100-02 Medicare Benefit Policy Manual 100-03 Medicare National Coverage g Determinations ((NCD)) Manual – Look for Regulations and Guidance, Internet Only Manuals 100-04 Medicare Claims Processing Manual 100-05 Medicare Secondary Payer Manual 100-06 Medicare Financial Management Manual 100-07 State Operations Manual 100-08 Medicare Program Integrity Manual 100-09 Medicare Contractor Beneficiary and Provider Communications Manual 1 Medicare Claims Processing Manual Pub.100 Pub.100--04 Chapter 1 - General Billing Requirements Chapter 2 - Admission and Registration Requirements Chapter 3 - Inpatient Part A Hospital Chapter 4 - Part B Hospital (Including Inpatient Hospital Part B and OPPS) Chapter 5 - Part B Outpatient Rehabilitation and CORF Services Chapter 6 - SNF Inpatient Part A Billing Chapter 7 - SNF Part B (Including Inpatient Part B and Outpatient Fee Schedule) Medicare Claims Processing Manual Manual – Chapter 12 –https://www2.cms.gov/manuals/downlo ads/clm104c12.pdf (retrieved 05/18/10) Chapter p 8 - Outpatient p ESRD Hospital, p Independent p Facility, y and Physician/Supplier y pp Claims Chapter 9 - Rural Health Clinics and Federal Qualified Health Centers Chapter 10 - Home Health Agency Billing Chapter 11 - Hospice Chapter 12 - Physician/Practitioner Billing Chapter 13 - Radiology Services Chapter 14 - Ambulatory Surgical Centers Chapter 15 - Ambulance Chapter 16 - Laboratory Services from Independent Labs, Physicians, and Providers Chapter 17 - Drugs and Biologicals Medicare Claims Processing Manual, Pub.100--04, Pub.100 • 30.6.13 - Nursing Facility Services Billing and Coding in Long Term Care: Miscellaneous Topics Start of Today’s Topics A. Visits to Perform the Initial Comprehensive Assessment and Annual Assessments B. Visits to Comply With Federal Regulations (42 CFR 483.40 (c) (1)) in the SNF and NF C. Visits by Qualified Nonphysician Practitioners D. Medically Complex Care 30.6.13 C Visits by Qualified Nonphysician 30.6.13 C Visits by Qualified Nonphysician Practitioners Practitioners • State Regulations, State Scope of Practice – “All E/M visits shall be within the State scope of practice and licensure requirements where the visit is performed and all the requirements for physician collaboration and physician supervision shall be met when performed and reported by qualified NPPs.” – “General physician supervision and employer billing requirements shall be met for PA services in addition to the PA meeting the State scope of practice and licensure requirements where the E/M visit is performed.” • Federally Mandated Visits – SNF (31) – “Following g the initial visit by y the p physician, y , the physician may delegate alternate federally mandated physician visits to a qualified NPP who meets collaboration and physician supervision requirements and is licensed as such by the State and performing within the scope of practice in that State.” 2 30.6.13 C Visits by Qualified Nonphysician MLN MATTERS NUMBER: SE1010 Practitioners • The long-term care regulations at Section 483.40 require that residents of SNFs receive initial and periodic personal visits. These regulations insure that at least a minimal degree g of ppersonal contact between a physician or a qualified NPP and a resident is maintained, both at the point of admission to the facility and periodically during the course of the resident's stay. • Federally Mandated Visits – NF (32) – Per the regulations at 42 CFR 483.40 (f), a qualified NPP, who meets the collaboration and physician supervision requirements, the State scope of practice and licensure requirements, and who is not employed by the NF, may at the option of the State, perform the initial visit in a NF, and may perform any other federally mandated physician visit in a NF in addition to performing other medically necessary E/M visits. 30.6.13 C Visits by Qualified Nonphysician Order to Admit Admission Treatment Orders Initial Comprehen sive Visit Other Required Visits NP & CNS employed by facility N N N Y NP & CNS not a facility employee N N N Y PA regardless of employer N N N Y NP, CNS & PA employed by facility N N N N NP, CNS & PA not a facility employee Y Y Y Y Practitioners • “Questions pertaining to writing orders or certification and recertification issues in the SNF and NF settings shall be addressed to the appropriate State Survey and Certification Agency departments for clarification.” Other Medically Necessary Visits Other Medically Necessary Orders Certification/ Recertification SNF NP & CNS employed by facility Y Y N NP & CNS not a facility employee Y Y Y PA regardless of employer Y Y N NP, CNS & PA employed by facility Y Y Y NP, CNS & PA not a facility employee Y Y Y NF SNF NF Billing and Coding in Long Term Care: Miscellaneous Topics Change in Topic 3 Medicare Claims Processing Manual, Pub.100--04, Pub.100 • 30.6.13 - Nursing Facility Services Slide 20 Regulations for subacute care allow: a. Weekly visits for physicians b. Monthly visits for physicians c. Weekly visits for NPP if not employed by a NF d. Payment for two visits in one day, if medically necessary e. None of the above A. Visits to Perform the Initial Comprehensive Assessment and Annual Assessments B. Visits to Comply With Federal Regulations (42 CFR 483.40 (c) (1)) in the SNF and NF C. Visits by Qualified Nonphysician Practitioners D. Medically Complex Care * 30.6.13 D Medically Complex Care 30.6.13 D Medically Complex Care D. Medically Complex Care D. Medically Complex Care “Payment y is made for E/M visits to p patients in a SNF who are receiving services for medically complex care upon discharge from an acute care facility when the visits are reasonable and medically necessary and documented in the medical record.” “Physicians and qualified NPPs shall report initial nursing facility care codes for their first visit with the patient.” “The p principal p p physician y of record must append pp the modifier “-AI” Principal Physician of Record, to the initial nursing facility care code when billed to identify the physician who oversees the patient’s care from other physicians who may be furnishing specialty care.” Physicians and qualified NPPs shall report E/M visits using the Subsequent Nursing Facility Care, per day (codes 99307 - 99310) for follow-up visits Medicare Claims Processing Manual, Pub.100--04, Pub.100 • 30.6.13 - Nursing Facility Services Billing and Coding in Long Term Care: Miscellaneous Topics E. Incident to Services F. Use of the Prolonged g Services Codes and Other Time-Related Services G. Gang Visits Change in Topic H. Split/Shared E/M Visit I. SNF/NF Discharge Day Management Service 4 60.1 -60.3 - Services of Nonphysician Personnel Furnished Incident to Physician’s Services Slide 25 “Incident to” rules allow: a. Payment to both a NPP and Physician for split services (same patient/same day) b Payment in a nursing home as long as b. Place of Service Code 11 (office) is used c. NPP to bill for a new problem d. NPP to bill under the physician fee schedule, even if the physician is not on site e. The physician to bill with physician UPIN for services performed by a NPP. * “the service can be billed under the Physicians UPIN/PIN, and payment will be made at the appropriate physician fee schedule payment payment.” * 30.6.13 E Incident To Services in the Nursing Home – Where a physician establishes an office in a SNF/NF, the “incident to” services and requirements are confined to this discrete part of the facility designated as his/her office. – “Incident to” E/M visits, provided in a facility setting, are not payable under the Physician Fee Schedule for Medicare Part B. Slide 29 The maximum number of NH visits that a physician can perform in one day is: a. 10 b 20 b. c. 30 d. 40 e. Not defined Billing and Coding in Long Term Care: Miscellaneous Topics Change in Topic Medicare Claims Processing Manual, Pub.100--04, Pub.100 • 30.6.13 - Nursing Facility Services E. Incident to Services F. Use of the Prolonged Services Codes and Other Time-Related Services G. Gang Visits H. Split/Shared E/M Visit I. SNF/NF Discharge Day Management Service 5 30.6.13 G Gang Visits – “Claims for an unreasonable number of daily E/M visits by the same physician to multiple patients at a facility within a 24hour period may result in medical review to determine medical necessity for the visits.” Billing and Coding in Long Term Care: Miscellaneous Topics Change in Topic – Not quantified Medicare Claims Processing Manual, Pub.100--04, Pub.100 • 30.6.13 - Nursing Facility Services 30.6.13 H Split/Shared Visits • Definition – a medically necessary encounter with a patient where the physician and a qualified NPP each personally perform a substantive portion of an E/M visit face-to-face with the same patient on the same date of service. – The physician and the qualified NPP must be in the same group practice or be employed by the same employer – Can be used for hospital inpatient, hospital outpatient, hospital observation, emergency department, hospital discharge, office and non facility clinic visits, and prolonged visits associated with these E/M visit codes E. Incident to Services F. Use of the Prolonged Services Codes and Other Time-Related Services G. Gang Visits H. Split/Shared E/M Visit • Nursing Facility – I. SNF/NF Discharge Day Management Service • A split/shared E/M visit can not be reported in the SNF/NF setting. Also does not apply to critical care services or procedures Slide 36 Concerning a discharge from a nursing home, all of the following are true except: a. Need a Face-to face encounter b Need to be seen on day of discharge b. c. Can bill for discharge upon death only if death personally pronounced by the provider d. Can cover activities over a period of time e. Billing date is date of actual visit, even if discharge is a different date Billing and Coding in Long Term Care: Miscellaneous Topics Change in Topic * 6 Medicare Claims Processing Manual, Pub.100--04, Pub.100 • 30.6.13 - Nursing Facility Services 30.6.13 I SNF/NF Discharge Day Management – Requires a face-to-face visit E. Incident to Services F. Use of the Prolonged Services Codes and Other Time-Related Services G. Gang Visits H. Split/Shared E/M Visit I. SNF/NF Discharge Day Management Service – Reported for the date of the actual y the p physician y or q qualified visit by NPP even if the patient is discharged from the facility on a different calendar date. – 99315-99316 30.6.13 I SNF/NF Discharge Day Management – Death – “may be reported using CPT code p g on the 99315 or 99316,, depending code requirement, for a patient who has expired, but only if the physician or qualified NPP personally performed the death pronouncement.” Billing and Coding in Long Term Care: Miscellaneous Topics Change in Topic Slide 42 MULTI--SITE SAME DAY VISITS MULTI Medicare pays the same physician on the same date for the following combination of services: a Office visit and initial NH visit a. b. Hospital admission and NH visit c. Hospital discharge and NH discharge d. Hospital discharge and initial NH visit e. Hospital visit and NH visit 7 MULTI--SITE SAME DAY MULTI Office/Outpatient/Emergency Department Visit w/Nursing Facility Admission MULTI--SITE SAME DAY MULTI Nursing Facility Visit w/ Hospital Visit or Admission Same MD, Same date • Medicare does not pay for the office or ED visit • M Medicare di will ill pay only l IInitial iti l N Nursing i F Facility ilit C Care code • Bundle E/M visits on the same date provided in sites other than the nursing facility into the initial nursing facility care code • 30.6.7 - Payment for Office or Other Outpatient Evaluation and Management (E/M) Visits MULTI--SITE SAME DAY MULTI Hospital Discharge Management w/ Nursing Facility Admission Same MD, Same date • Medicare M di d does nott pay ffor th the NH visit i it • Medicare will pay only Initial Hospital Care code • 30.6.9.1 - Payment for Initial Hospital Care Services Visits to Patients in Swing Beds • If the inpatient care is being billed by the hospital as inpatient hospital care: – hospital care codes apply. Same MD,, Same date • Medicare does pay for the Hospital Discharge visit (99238, 99239) • Medicare will also pay Initial Nursing Facility Care code • If the inpatient care is being billed by the hospital as nursing facility care: – nursing facility codes apply. 30.6.9 D- Payment for Inpatient Hospital Visits - General • 30.6.9.2 - Subsequent Hospital Visit and Hospital Discharge Management Physicians in Group Practice 30.6.5 Billing and Coding in Long Term Care: Miscellaneous Topics •Same Group - Same Specialty • Bill and be paid as though they were single MD One e E&M & code pe per day pe per p problem ob e • O • Can combine same day visits and submit appropriate code Change in Topic • Unrelated problems: can submit different bills •Same group – Different Specialty • Bill and be paid without regard to membership in group 8 Medicare Claims Processing Manual Pub.100--04 Pub.100 Chapter 1 - General Billing Requirements Chapter 2 - Admission and Registration Requirements Chapter 3 - Inpatient Part A Hospital Chapter 4 - Part B Hospital (Including Inpatient Hospital Part B and OPPS) Billing and Coding in Long Term Care: Miscellaneous Topics Chapter 5 - Part B Outpatient Rehabilitation and CORF Services Chapter 6 - SNF Inpatient Part A Billing Chapter 7 - SNF Part B (Including Inpatient Part B and Outpatient Fee Schedule) Chapter p 8 - Outpatient p ESRD Hospital, p Independent p Facility, y and Physician/Supplier y pp Claims Chapter 9 - Rural Health Clinics and Federal Qualified Health Centers Chapter 10 - Home Health Agency Billing Chapter 11 - Hospice Change in Topic Chapter 12 - Physician/Practitioner Billing Chapter 13 - Radiology Services Chapter 14 - Ambulatory Surgical Centers Chapter 15 - Ambulance Chapter 16 - Laboratory Services from Independent Labs, Physicians, and Providers Chapter 17 - Drugs and Biologicals Medicare Claims Processing Manual Medicare Claims Processing Manual Pub.100--04 Pub.100 Pub.100--04 Pub.100 Chapter 11 – HOSPICE Chapter 11 – HOSPICE • 40 - Billing and Payment for Hospice Services Provided by a Physician • 40 - Billing and Payment for Hospice Services Provided by a Physician – 40.1 - Types of Physician Services – 40.1 - Types of Physician Services • 40.1.1 - Administrative Activities • 40.1.2 - Patient Care Services • 40.1.3 - Attending Physician Services • 40.1.1 - Administrative Activities • 40.1.2 - Patient Care Services • 40.1.3 - Attending Physician Services • 50 - Billing and Payment for Services Unrelated to Terminal Illness • 50 - Billing and Payment for Services Unrelated to Terminal Illness Medicare Claims Processing Manual Medicare Claims Processing Manual Pub.100--04 Pub.100 Pub.100--04 Pub.100 Chapter 11 – HOSPICE – 40.1 - Types of Physician Services • 40.1.1 - Administrative Activities • Payment for physicians’ physicians administrative and general supervisory activities is included in the hospice payment rates. • These activities include participating in the establishment, review and updating of plans of care, supervising care and services and establishing governing policies. • These activities are generally performed by the physician serving as the medical director (of the Hospice) and the physician member of the interdisciplinary group (IDG). • Nurse practitioners may not serve as or replace the medical director or physician member of the IDG. Chapter 11 – HOSPICE – 40.1 - Types of Physician Services • 40.1.2 - Patient Care Services • Payment (to Hospices) for physicians or nurse practitioner serving as the attending physician, who provide direct patient care services and who are hospice employees or under arrangement with the hospice, is made in the following manner: • Hospices establish a charge and bills the FI (MAC) for these services. 9 Medicare Claims Processing Manual Medicare Claims Processing Manual Pub.100--04 Pub.100 Pub.100--04 Pub.100 Chapter 11 – HOSPICE – 40.1 - Types of Physician Services • 40.1.3 - Attending Physician Services • an “attending physician” means an individual who: Chapter 11 – HOSPICE – 40.1 - Types of Physician Services • 40.1.3 - Attending Physician Services • – Is a doctor of medicine or osteopathy or – A nurse practitioner ; and – Is identified by the individual, at the time he/she elects hospice coverage, as having the most significant role in the determination and delivery of their medical care. Medicare Claims Processing Manual Medicare Claims Processing Manual Pub.100--04 Pub.100 Pub.100--04 Pub.100 Chapter 11 – HOSPICE Chapter 11 – HOSPICE – 40.1 - Types of Physician Services • 40.1.3 - Attending Physician Services • I order In d to t bill M Medicare di as an “attending “ tt di physician:” h i i ” 1. Not employed nor receives compensation by Hospice 2. Professional services only (not technical) 3. Can be in addition to the services of hospiceemployed physicians 4. The professional services of a non-hospice affiliated attending physician for the treatment and management of a hospice patient’s terminal illness are not considered “hospice services.” In order to bill Medicare as an “attending g physician:” y 5. Services are reasonable and necessary for the treatment and management of a hospice patient’s terminal illness 6. Services not furnished under a payment arrangement with the hospice 7. Must be coordinated with any direct care services provided by hospice physicians. 8. These services are coded with the GV modifier: “Attending physician not employed or paid under agreement by the patient’s hospice provider” Medicare Claims Processing Manual • – 40.1 - Types of Physician Services • 40.1.3 - Attending Physician Services g physician:” p y Can NOT bill Medicare as an “attending – When services related to a hospice patient’s terminal condition are furnished under a payment arrangement with the hospice by the designated attending physician, the physician must look to the hospice for payment. – In this situation the physicians’ services are hospice services and are billed by the hospice to its FI (MAC). Medicare Claims Processing Manual Pub.100--04 Pub.100 Pub.100--04 Pub.100 Chapter 11 – HOSPICE Chapter 11 – HOSPICE • 40 - Billing and Payment for Hospice Services Provided by a Physician – 40.1 - Types of Physician Services • 40.1.1 - Administrative Activities • 40.1.2 - Patient Care Services • 40.1.3 - Attending Physician Services • 50 - Billing and Payment for Services Unrelated to Terminal Illness • 50 - Billing and Payment for Services Unrelated to Terminal Illness – Any covered Medicare services not related to the treatment of the terminal condition for which hospice care was elected, and which are furnished during a hospice election period, may be billed by the rendering provider to the carrier for non-hospice Medicare payment. – These services are coded with the GW modifier: “service not related to the hospice patient’s terminal condition” 10 Hospice -Summary • Care not related to terminal illness Billing and Coding in Long Term Care: Miscellaneous Topics • Bill Medicare – modifier GW • Care related to terminal illness • MD not associated with hospice Change in Topic • Bill Medicare – modifier GV • MD associated/employed with hospice • Bill Hospice / Contract Care Plan Oversight 99374--5(HH) 99377 99374 99377--8(HOSPICE) 99379--80(NH) 99379 • Medicare does not pay separately for CPO in Nursing Home Billing and Coding in Long Term Care: Miscellaneous Topics • “Bundled” into NH visits • Suggestion : document work done, add into next progress note Change in Topic a potpourri •Not delineated in Manual Place of Service NF Codes Employment and Medicare Billing – “A physician who is employed by the SNF/NF may perform the E/M visits and bill independently to Medicare Part B for payment. – An NPP who is employed by the SNF or NF may perform and bill Medicare Part B directly for those services i where h it iis permitted. itt d – The employer of the PA shall always report the visits performed by the PA. – A physician, NP or CNS has the option to bill Medicare directly or to reassign payment for his/her professional service to the facility.” – 30.6.13 - Nursing Facility Services Facility SNF POS 31 A patient for whom the facility is receiving payment under Medicare Part A (Medicare Stay, Part A Stay) n Non-Facility Non Facility NF POS 32 n Do not have Part A SNF benefits n Patients who are in a Nursing Facility n In a non-covered SNF stay nPOS nPOS 54 (Intermediate Care Facility/Mentally Retarded) 56 (Psychiatric Residential Treatment Center) 31-32 Fee differential lost in 2005 Still need to code appropriately 11 PER DAY SERVICE – “The Nursing Facility Services codes represent a “per day” service.” – “Carriers shall not pay for more than one E/M visit performed by the physician or qualified NPP for the same patient on the same date of service. “ Slide 68 All Evaluation and Management codes require which one of the following: a. A physical exam b A medical b. di l hi history t c. Medical decision-making d. A face-to-face encounter e. C and D – 30.6.13 - Nursing Facility Services Face to Face Encounter vs. Physical Exam • All E&M codes require a face to face contact (Including NF Discharges) • Physical exam not required for all E&M codes • 2 of 3 (Hx, Exam, Medical decision making) for subsequent NF visits Assuming Care from Another Provider • Need to use appropriate E&M code • Usually y 99309 level • Need to document appropriately • Can not use 99304-6 codes unless newly admitted into facility • Still need face to face contact Use of Templates for Visits • Acceptable • Caveat: must perform all items checked or delineated in chart record • Suggestion: have nurses document briefly extent of your visit Slide 72 Medicare pays the physician for which one of the following in the nursing home? a. Care plan oversight b Inpatient b. I ti t consultations lt ti c. Telephone calls d. Specialist care e. Interdisciplinary team meetings 12 Interdisciplinary Team Meetings (old) Medical Team Conferences (new) Telephone Calls • 99361-99362 deleted • Old codes: 99371-99373 -deleted • 99366: MTC w/ face to face • New Codes: 99441-99443 • 99367: MTC w/o face to face w/MD • Medicare does not pay separately for telephone calls • 99368: MTC w/o face to face w/ NPP • Medicare does not pay separately for MTC meetings in NH • “Bundled” into NH visits • Suggestion : document meeting, add into next progress note • “Bundled” into NH visits • Suggestion : document calls, add into next progress note •Not delineated in Manual •Not delineated in Manual • Subacute Care • Medicare does not recognize “Subacute Care” per se • “All All medically necessary visits for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member are covered under Medicare Part B,” if properly documented • 30.6.13 D Medically Complex Care Pressure Ulcers • AHRQ Guidelines: evaluate weekly • Evaluations may be medically necessary especially if types of necessary, treatments are changing • Can not get paid for dressing changes only • Can get paid for debridement Preservice (24hrs)/postservice (7 days) Medical Director Covering of Patient Visits • Regulatory issues – need to have visits performed in timely manner • Emergency care • Liability issues – knowledge of patient, malpractice vs.. administrative? • Payment issues – Medical Director not Attending or “Consultant” • Administrative function covered under contract? 80.3 - Unusual Travel (CPT Code 99082) • In general, travel has been incorporated in the MPFSDB individual fees and is thus not separately payable. • Carriers must pay separately for unusual travel (CPT code 99082) only when the physician submits documentation to demonstrate that the travel was very unusual. 13 210 - Outpatient Mental Health Treatment Limitation • Expenses a beneficiary incurs in connection with the treatment of mental, psychoneurotic, and personality disorders- payment limited to 62.5 percent of the Medicare approved amount for those services 210 - Outpatient Mental Health Treatment Limitation • •The term “mental, psychoneurotic, and personality disorders” is defined as the specific psychiatric diagnoses described in the ICD-9, under the code range 290-319 • • Effective January 1, 2010, through January 1, 2014, the limitation will be phased out Disorders Subject to the Limitation Services Not Subject to the Limitation •1. Diagnosis of Alzheimer’s Disease or Related Disorder •2. Brief Office Visits for Monitoring or Changing Drug Prescription •3. Diagnostic Services The Law Billing and Coding in Long Term Care: Miscellaneous Topics Fraud and Abuse Changes • Anti-Kickback Statute – amended – relax the ‘intent to violate’ proscription – excludes from its definition any remuneration that promotes access to care and poses a low risk of harm to patients and federal healthcare programs • False Claims Act Qui Tam Public Disclosure Bar – the original source (whistleblower) no longer has to have direct knowledge • The Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010 (the Healthcare Reform Law) Law), contains more than 32 sections related to healthcare fraud and abuse and program integrity and makes significant amendments to existing criminal, civil, and administrative anti-fraud statutes. Changes • Overpayments and False Claims Act Liability – identified overpayments must be reported and returned (repaid) within 60 days to the applicable government contractor contractor, intermediary, or carrier – overpayment obligation should be viewed in context with • increased government audits under the Recovery Audit Contractor (RAC) program • the new self-disclosure protocol for Stark Law physician self-referral violations 14 Changes • Stark Law Self-Disclosure Protocol – the Healthcare Reform Law creates a statutory disclosure protocol for violations of the physician self-referral prohibitions, known as the Stark Law – a violation results in an overpayment liability to the government under a strict liability standard without regard to intent – the CMS protocol for self-disclosure will be developed in 2010 Changes • Healthcare Fraud Criminal Statute – the U.S. Sentencing Guidelines are also amended with respect to individuals convicted of healthcare offenses related to any federal healthcare program – the offense level for such individuals is increased anywhere from 20 to 50 percent where the loss involves more than a million • See attached handout from Morgan, Lewis & Bockius LLP Changes • Healthcare Fraud Criminal Statute – the Healthcare Reform Law amends the intent requirement contained in the healthcare fraud criminal statute • now now, provides that proof of actual knowledge of the healthcare fraud statute or specific intent to violate the statute is not required • definition of healthcare offense is also amended to include violations of the AKS, the Food Drug and Cosmetic Act, and certain ERISA provisions Summary • Discussed various topics related to correct coding and billing, including NPP services, incident to services, gang visits, hospice care and a variety of others • Discussed correct coding and billing for these services as they relate to fraud and abuse control initiatives in the current health care reform environment Slide 90 Billing and Coding in Long Term Care: Miscellaneous Topics Some Final Thoughts The CPT codes are made by a. CMS b. AMDA c. Medicare Carriers d. AMA e. An act of Congress f. An act of God 15 EXERCISE 6 • You are asked by staff to sit in on a care plan meeting about a 82 year old patient who is not present with a recent CVA who is not progressing well in physical rehabilitation. Slide 93 Which of the following are required to bill a 99306? a. Physical b History b. Hi t c. Medical decision making d. Face to face service time e. all of the above EXERCISE 13 • Telephone call by nursing to assess patient with chronic atrial fibrillation with an abnormal Prothrombin time of INR 3.8, no bleeding noted, no other symptoms noted Slide 92 Which of the following is NOT required to bill 99305? a. Moderate to high medical decision making b. Comprehensive exam c. Complete history d. New MDS e. Face to face encounter Slide 94 Which criterion does not fulfill a requirement in order to bill 99316 a. Less than 30 minutes service time b Final b. Fi l exam c. Instructions for continuing care d. Preparation of discharge records e. Prescriptions Slide 96 Which of the following are required to bill a 99310? a. Physical b History b. Hi t c. Medical decision making d. a and b and c e. none of the above 16 Slide 97 What elevates medical decision making from a moderate to a high level? a. acute uncomplicated illness b. 3 or more self-limited or minor problems c. Prescription meds d. 4 or more stable chronic problems e. Acute threat to life EXERCISE 21 • 92 year old woman with history of dementia, ASCVD, and DM who was a DNR and was found by the nursing staff without pulse or respirations at the time you were in the nursing i h home. * EXERCISE 29 • Family of a 91 year old patient admitted to the facility one week ago with progression of dementia requests a meeting to review patients status and medications. EXERCISE 33 • A patient who was seen on Monday for a discharge on Friday, develops pneumonia on Thursday, you call in treatment and have the discharge cancelled. 17 Healthcare Reform Law: Healthcare Fraud and Abuse and Program Integrity Provisions March 31, 2010 The Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010 (the Healthcare Reform Law), contains more than 32 sections related to healthcare fraud and abuse and program integrity and makes significant amendments to existing criminal, civil, and administrative anti-fraud statutes. The new program integrity provisions impose substantial requirements that will compel updates and enhancements to business operations, commercial transactions, and compliance policies in every sector of the health industry. These provisions establish fundamental expectations for regulatory compliance, disclosure, transparency, and quality of care and are matched by extraordinary enforcement provisions that could greatly increase potential legal exposure. Healthcare entities should reinforce their broad and sustained commitment to compliance to successfully implement these provisions. This alert presents a brief summary of the major fraud and abuse provisions in the Healthcare Reform Law as well as an overview of the program integrity provisions. Morgan Lewis has also prepared a detailed chart1 outlining the fraud and abuse and program integrity provisions in the Healthcare Reform Law, many of which we note became effective on the date of enactment, March 23, 2010, and will require prompt compliance attention. These provisions will also significantly impact government audit, investigation, and litigation resources and the structure for intra-agency cooperation. To address the impact on key program integrity and law enforcement agencies, the Healthcare Reform Law provides for the HIPAA Fraud and Abuse Control Program and the Medicare Integrity Program to receive total funding of $100 million for FY 2011 through 2020 under the March 23, 2010 legislation and an additional $250 million for FY 2011 through 2016 under the Reconciliation legislation, for a total of $350 million. Morgan Lewis will continue to monitor and report on developments in healthcare fraud and abuse and program integrity matters. I. FRAUD AND ABUSE PROVISIONS A. Anti-Kickback Statute. The fraud and abuse amendments that may have the greatest impact on the healthcare industry in a direct and daily fashion are the amendments to the federal Anti-Kickback 1 This chart is also available at http://www.morganlewis.com/pubs/FraudAbusePrgmIntegrityProvisions.pdf. For AMDA webinar, this chart is appended to this document. 1 Statute (AKS). Healthcare arrangements and transactions directly and indirectly related to federal healthcare programs are regulated by the criminal and administrative provisions of the AKS. Violations of the AKS have resulted in significant False Claims Act liability for many healthcare entities. The amendments to the AKS will impact fraud and abuse counseling and liability evaluations in criminal and civil government investigations and judicial proceedings. Under the Healthcare Reform Law, the AKS is amended to relax the specific intent requirement judicially recognized in U.S. v. Hanlester Network v. Shalala, 51 F.3d 1390 (9th Cir. 1995). The amendment provides that an AKS violation may be established without showing that an individual knew of the statute’s proscriptions and intended to violate the statute. This new standard will impact transaction and arrangements counseling and could potentially create significant criminal and civil fraud exposure for transactions and arrangements where there is no intent to violate the statute. The AKS is further amended to explicitly provide that a violation of the statute constitutes a false or fraudulent claim under the False Claims Act. This amendment may have its most significant impact on downstream liability scenarios involving manufacturers and other entities that do not themselves submit claims to the government under the “caused the submission of a false claim” liability provisions of the False Claims Act. Interestingly, in Section 6402 of the Healthcare Reform Law, the definition of remuneration, the touchstone for the general application of the statute, is amended for the beneficiary inducement provisions under the civil monetary provisions of the AKS’s Section 1320a-7a, to exclude from the definition, among other things, any remuneration that promotes access to care and poses a low risk of harm to patients and federal healthcare programs. The beneficiary inducement statute does not apply directly to manufacturers but does apply to providers, practitioners, suppliers, health plans and other healthcare services entities. This definitional change is potentially significant as many health industry activities may come within this broad exclusion and will require thoughtful assessment in fraud and abuse transaction counseling. B. False Claims Act Qui Tam Public Disclosure Bar. The Healthcare Reform Law makes a significant change to the jurisdictional bar that has historically served as a strong protector of health and other industries from parasitic and opportunistic qui tam suits that do not advance the public interest in the context of Department of Justice declined whistleblower qui tams. The False Claims Act previously contained a “public disclosure” jurisdictional element that required dismissal of a qui tam suit pursued by the private citizen (relator) where the allegations had been publicly disclosed in a criminal, civil, or administrative proceeding; a congressional, administrative, or GAO report, hearing, audit, or investigation; or in the news media. The scope of this bar had been judicially extended to include state proceedings and this expansion was affirmed by the U.S. Supreme Court in Graham County Soil & Water Conservation District v. U.S. ex rel. Wilson (No. 08-304), issued March 30, 2010, after the enactment of the Healthcare Reform Law. The False Claims Act is now amended to provide that the public disclosure bar is not jurisdictional and does not require dismissal if the government opposes dismissal. Public disclosure is also now limited to federal criminal, civil, and administrative proceedings in which the government or its agent is a party; and federal reports, hearings, audits, or investigations. State proceedings and private litigation (for example, employment, shareholder suits) are not qualifying public disclosures. Importantly, news media reports, and by logical extension social media, remain a qualified public disclosure. Where there has been a public disclosure, the relator may only proceed with the action if he or she is the original source of the information. Prior to the amendments contained in the Healthcare Reform Law, to 2 qualify as an original source, the relator had to have direct and independent knowledge of the allegations. The original source exception is now amended to eliminate the direct knowledge requirement and provides that to qualify as an original source (1) the relator must provide the information to the government prior to the public disclosure, and (2) the information must be independent of and materially add to the publicly disclosed allegations. Unlike the 2009 False Claims Act amendments, which contained express retroactivity provisions, the 2010 public disclosure amendments contain no retroactivity provision. Courts generally have found that False Claims Act amendments, including the 2009 amendments, are not retroactive. In Graham County, the majority opinion, authored by Justice Stevens, noted that because the 2010 False Claims Act amendments contain no retroactivity provisions, the public disclosure amendments are not retroactive. This means that 2010 False Claims Act amendments do not apply to cases pending on or before March 23, 2010. While the public disclosure bar remains an important check on abusive qui tam suits, the amendments add significant litigation complexity and cost to declined qui tam actions and ensure that the Department of Justice has a prominent role in determining a relator’s status to proceed with the declined qui tam action. To avoid abusive suits that do not advance the public interest, it will be critical that DOJ develop fair and balanced objective criteria to assess its now mandatory role in declined qui tams that involve pubic disclosure issues. It will be necessary for qui tam defense counsel to assess public disclosure issues well in advance of the government’s intervention decision to positively impact both DOJ’s and the trial court’s consideration of this important legal defense. C. Overpayments and False Claims Act Liability. Section 6402 of the Healthcare Reform Law provides that identified overpayments must be reported and returned (repaid) within 60 days to the applicable government contractor, intermediary, or carrier. The retention of any overpayment after the 60-day period constitutes an “obligation” under the False Claims Act. Under the 2009 amendments to the False Claims Act, the definition of “obligation” was expanded to expressly include “retention of overpayments.” The concept of “identified” overpayments in the Healthcare Reform Law is not defined. There are a host of duplicative and confusing statutory concepts between Section 6402 and the current version of the False Claims Act that it will be necessary to work through in providing compliance guidance. What is clear, however, is that the government’s position will be that any delay in processing a known overpayment creates the potential for False Claims Act liability—a potential that has always existed in healthcare fraud enforcement and has been the basis for numerous False Claims Act settlements over the last 20 years. Healthcare providers, suppliers, and health plans should ensure compliance with the new overpayment provision by putting in place robust auditing and refund processing structures. The overpayment obligation should be viewed in context with increased government audits under the Recovery Audit Contractor (RAC) program for federal healthcare programs, as well as with the new self-disclosure protocol for Stark Law physician self-referral violations, which should provide an opportunity for reasonable overpayment settlements under the identified criteria. D. Stark Law Self-Disclosure Protocol. The Healthcare Reform Law creates a statutory disclosure protocol for violations of the physician self-referral prohibitions, known as the Stark Law. Under the Stark Law, a violation results in an overpayment liability to the government under a strict liability 3 standard without regard to intent. 42 U.S.C. § 1395nn(g)(2) and 42 C.F.R. § 411.353(d). Because the Stark Law imposes extraordinary financial liability for technical violations, there was an industry need for a fair and principled process to disclose and resolve Stark Law violations with CMS. Significantly, the new protocol will provide for agency discretion to resolve Stark violations and authorizes HHS to reduce the amount due and owing for all violations under the Stark Law, considering such factors as the nature and extent of the improper practice, timeliness of the disclosure, cooperation, and other factors in the agency’s discretion. The Stark self-disclosure process will be critical to both the healthcare community and HHS in reasonably and fairly managing the expected discovery of technical Stark violations from enhanced compliance reviews. The CMS protocol for self-disclosure will be developed in the next six months. Healthcare providers and suppliers need to assess disclosure efforts in context with the new overpayment provision in Section 6402, which is effective now. There will continue to be a significant potential for False Claims Act exposure for Stark Law violations through qui tam whistleblower suits. E. Expanded Recovery Audit Contractor Activities (RAC). RAC audits of providers will increase and also expand to the Medicare Part D and Medicare Advantage healthcare programs. RAC auditors are compensated, in part, through a bounty process that includes a percentage of any amounts recovered through the audit. Healthcare providers and health plans will need to resource both internal audit activities as well as responses to RAC requests. Because RACs operate on behalf of the government, and may make program integrity and fraud referrals to law enforcement, it is necessary to structure audit responses to RACs with the same degree of diligence as a direct government request, including documenting interactions with RAC representatives. F. Healthcare Fraud Criminal Statute. The Healthcare Reform Law amends the intent requirement contained in the healthcare fraud criminal statute, 18 U.S.C. § 1347. That statute now provides that proof of actual knowledge of the healthcare fraud statute or specific intent to violate the statute is not required. The definition of healthcare offense, 18 U.S.C. § 24(a), is also amended to include violations of the AKS, the Food Drug and Cosmetic Act, and certain ERISA provisions. The U.S. Sentencing Guidelines are also amended with respect to individuals convicted of healthcare offenses related to any federal healthcare program. The offense level for such individuals is increased anywhere from 20 to 50 percent where the loss involves more than a million. In a highly regulated industry, with a myriad of complex regulations, these provisions effectively increase exposure for a broad array of business and regulatory activities where there is no specific intent to violate the provisions of the statute. II. PROGRAM INTEGRITY PROVISIONS The Healthcare Reform Law contains a host of program integrity provisions that will impact business operations and require enhanced procedures and policies in all health industry sectors. Some of these provisions, if violated, may comprise a basis for overpayment or fraud liability. These provisions include new employee and vendor screening requirements, new financial disclosure requirements, the requirement of face-to-face physician and patient encounters for DME and home health services, and new price reporting requirements in the 340B program. Of special note in the program integrity provisions is the requirement that Medicare and Medicaid providers and suppliers, effective January 1, 2011, include their national provider identifier on all program applications and claims. If you have any questions or would like more information on any of the issues discussed in this LawFlash, please contact the authors of this LawFlash, Kathleen McDermott (202.739.5458; 4 [email protected]) and Meredith S. Auten (215.963.5860; [email protected]), or any of the following key members of our cross-practice Healthcare Reform Law resource team: FDA & Healthcare Practice Joyce A. Cowan Washington, D.C. Kathleen M. Sanzo Washington, D.C. 202.739.5373 202.739.5209 [email protected] [email protected] Employee Benefits & Executive Compensation Practice Andy R. Anderson Chicago 312.324.1177 Steven D. Spencer Philadelphia 215.963.5714 [email protected] [email protected] Antitrust Practice Thomas J. Lang Scott A. Stempel [email protected] [email protected] Washington, D.C. Washington, D.C. 202.739.5609 202.739.5211 Business & Finance Practice – Mergers & Acquisitions, Securities, Emerging Business & Technology Marlee S. Myers Pittsburgh 412.560.3310 [email protected] Scott D. Karchmer San Francisco 415.442.1091 [email protected] Randall B. Sunberg Princeton 609.919.6606 [email protected] Business & Finance Practice – Insurance Regulation David L. Harbaugh Philadelphia 215.963.5751 [email protected] Labor & Employment Practice Joseph J. Costello Philadelphia John F. Ring Washington, D.C. 215.963.5295 202.739.5096 [email protected] [email protected] Life Sciences Practice Stephen Paul Mahinka 202.739.5205 [email protected] 213.612.7375 215.963.4824 215.963.5892 215.963.5103 [email protected] [email protected] [email protected] [email protected] Washington, D.C. Litigation Practice – Commercial & Products Liability Kathleen M. Waters Los Angeles John P. Lavelle, Jr. Philadelphia Coleen M. Meehan Philadelphia Brian W. Shaffer Philadelphia Litigation Practice – Corporate Investigations & White Collar Practice Lisa C. Dykstra Philadelphia 215.963.5699 Jack C. Dodds Philadelphia 215.963.4942 Eric W. Sitarchuk Philadelphia 215.963.5840 [email protected] [email protected] [email protected] Tax Controversy & Consulting Practice Gary B. Wilcox Washington, D.C. Barton W. Bassett Palo Alto [email protected] [email protected] 202.739.5509 650.843.7567 Washington Government Relations & Public Policy Practice Fred F. Fielding Washington, D.C. 202.739.5560 [email protected] 5 About Morgan, Lewis & Bockius LLP With 22 offices in the United States, Europe, and Asia, Morgan Lewis provides comprehensive transactional, litigation, labor and employment, regulatory, and intellectual property legal services to clients of all sizes—from global Fortune 100 companies to just-conceived startups—across all major industries. Our international team of attorneys, patent agents, employee benefits advisors, regulatory scientists, and other specialists—more than 3,000 professionals total—serves clients from locations in Beijing, Boston, Brussels, Chicago, Dallas, Frankfurt, Harrisburg, Houston, Irvine, London, Los Angeles, Miami, Minneapolis, New York, Palo Alto, Paris, Philadelphia, Pittsburgh, Princeton, San Francisco, Tokyo, and Washington, D.C. For more information about Morgan Lewis or its practices, please visit us online at www.morganlewis.com. This LawFlash is provided as a general informational service to clients and friends of Morgan, Lewis & Bockius LLP. It should not be construed as, and does not constitute, legal advice on any specific matter, nor does this message create an attorney-client relationship. These materials may be considered Attorney Advertising in some states. Please note that the prior results discussed in the material do not guarantee similar outcomes. © 2010 Morgan, Lewis & Bockius LLP. All Rights Reserved. 6 Fraud and Abuse and Program Integrity Provisions PROVISION SUMMARY OF REQUIREMENT (Section of Healthcare Reform Law and Related Laws) EFFECTIVE DATE FRAUD AND ABUSE 1 Overpayments Sec. 6402 (42 U.S.C. § 1301 et. seq.) Overpayments must be reported and returned within 60 days of identity or the date a corresponding cost report is due, which ever is later. Repayments may be made to the carrier, contractor, or intermediary. March 23, 2010 Any overpayment retained after the 60-day deadline is considered an obligation for purposes of the False Claims Act. 2009 False Claims Act amendments provided an expanded definition of obligation. 31 U.S.C. 3729(b)(3). 2 Medicare SelfReferral Disclosure Protocol Sec. 6409 Establishes a self-referral disclosure protocol (SRDP) for healthcare providers and suppliers to disclose an actual or potential violation of the Federal Physician Self-Referral Law (Stark Law). Authorizes HHS discretion to reduce the amount due and owing for all violations under the Stark Law to an amount less than that specified in the statute. In establishing the amount due, the following factors may be considered: Nature and extent of the improper or illegal practice Timeliness of such self-disclosure SRDP procedures to be established no more than six months from the date of enactment, March 23, 2010 Procedures to be established in consultation with the OIG. Cooperation in providing additional information related to the disclosure Such other factors as the Secretary considers appropriate 3 4 Medicare/ Medicaid AntiKickback Statute (AKS) Amendments. Sec. 6402 (42 U.S.C. § 1320a7b) A claim that includes items or services resulting from a violation of the AKS constitutes a false or fraudulent claim for purposes of the False Claims Act. AKS CMP Remuneration Definition Amended Sec. 6402 (42 U.S.C. § 1320a- Relevant to the beneficiary inducement provisions, remuneration does not include: March 23, 2010 A person need not have actual knowledge of the AKS nor specific intent to commit an AKS violation. Any remuneration which promotes access to care and poses a low risk of harm to patients and federal healthcare programs. Offer or transfer by a retailer of coupons, rebates, or March 23, 2010 PROVISION SUMMARY OF REQUIREMENT (Section of Healthcare Reform Law and Related Laws) 7a(i)(6)) 5 6 7 EFFECTIVE DATE other rewards if certain conditions are met. Offer or transfer of items or services for free or less than fair market value by a person to an individual in financial need if certain conditions are met. After January 1, 2011, the waiver by a PDP sponsor MA organization of any copayment for an enrollee’s first fill of a covered part D generic drug. Expansion of Recovery Audit Contractor (RAC) Program Sec. 6411 (42 U.S.C. § 1396a(a)(42)) Mandates the expansion of the RAC program into Medicaid by requiring states to contract by December 31, 2010 with one or more RACs to identify underpayments and overpayments and recoup overpayments for Medicaid services. Sec. 6411 (42 U.S.C. § 1395ddd(h)) Mandates the expansion of the RAC program to Medicare Parts C and D by requiring HHS Secretary to contract with RACs to, among other things, ensure that each Part C MA plan and each Part D prescription drug plan has an antifraud plan in effect and to review the effectiveness of such anti-fraud plan. Sec. 6411 Requires CMS to submit an annual report to Congress regarding the effectiveness of the RAC program under Medicare and Medicaid. Medicaid State Plans – Additional Requirements Sec. 6501 (42 U.S.C. § 1396a(a)(39)) Mandatory Medicaid termination if an individual or entity is terminated by Medicare or another Medicaid program. Sec. 6502 (42 U.S.C. § 1396a(a)) Mandatory Medicaid exclusion of individuals or entities that own, control, or manage an entity that (1) has unpaid overpayments determined to be delinquent; (2) is suspended, excluded, or terminated from participation; or (3) is affiliated with a suspended, excluded, or terminated individual or entity. Sec. 6503 (42 U.S.C. § 1396a(a)) Mandatory registration by agents, clearinghouses, or other alternate payees that submit claims on behalf of healthcare providers with the state and the HHS Secretary. Sec. 6505 (42 U.S.C. § 1396b(a)) Bars Medicaid payments for items or services to any financial institution or entity located outside the United States. False Claims Act-Public Public disclosure no longer an issue of jurisdiction but amendments do subject declined qui tam actions to 2 March 23, 2010 January 1, 2011, unless state legislation is required. March 23, 2010 PROVISION SUMMARY OF REQUIREMENT (Section of Healthcare Reform Law and Related Laws) Disclosure Bar to Qui Tam Actions Sec. 10104(j) (31 U.S.C. § 3730(e)(4)) EFFECTIVE DATE dismissal if allegations are publicly disclosed and relator is not original source. DOJ may oppose dismissal of action where allegations are publicly disclosed and relator is not original source. Limits public disclosures to federal criminal, civil, or administrative hearings in which the government is a party and to federal reports, hearings, audits or investigations. State proceedings and private litigation are not qualifying disclosures. News media reports remain a qualifying disclosure to bar qui tam suits Expands definition of “original source” to include (i) an individual who discloses to the government the information on which the claims are based prior to the public disclosure and (ii) an individual who provides independent knowledge that adds materially to the publicly disclosed information to the government before filing an action. 8 Healthcare Fraud Offense Sec. 10606 (18 U.S.C. § 1347; 18 U.S.C. § 24(a)) Amends 18 U.S.C. § 1347 criminal healthcare fraud statute to reduce intent required to establish a healthcare fraud offense violation. Knowing and willful standard does not require proof of actual knowledge of healthcare fraud statute or specific intent to violate the statute. Similar amendment to anti-kickback statute. Sec. 6402 (42 U.S.C. § 1320a-7b). Changes definition of healthcare fraud offense in 18 U.S.C. § 24(a) to include violations of the anti-kickback statute, FDCA and certain ERISA provisions. 9 CMS Civil Monetary Penalties (CMP) Sec. 6402, Sec. 6408 (42 U.S.C. § 1320a-7a(a)) Expands CMS liability for the following activities: Ordering or prescribing a medical or other item or service during a period in which the person was excluded from a federal healthcare program, if the person knows or should have know that a claim for such medical or other item or service will be made. Knowingly making or causing to be made any false statement, omission, or misrepresentation of a material fact in any federal healthcare program application, bid or contract (Penalty: $50,000 penalty and 3 times total amount claimed). Knowing retention of an overpayment and not reporting and returning such overpayment. Knowingly making, using, or causing to be made or 3 March 23, 2010 PROVISION SUMMARY OF REQUIREMENT (Section of Healthcare Reform Law and Related Laws) EFFECTIVE DATE used, a false record or statement material to a false or fraudulent claim for payment for items and services furnished under a federal healthcare program (Penalty: $50,000, for each false record or statement). Failing to grant timely access, upon reasonable request, to the HHS Inspector General for audits, investigations, evaluations, or other statutory functions of the HHS Inspector General (Penalty: $15,000 per day). 10 Beneficiary Fraud Sec. 6402 (42 U.S.C. § 1301 et. seq.) Imposes appropriate administrative penalties on those beneficiaries who knowingly participate in a federal healthcare fraud offense or a conspiracy to commit a federal healthcare fraud offense. March 23, 2010 11 Expanded HHSOIG Subpoena Authority Sec. 6402 (42 U.S.C. § 1320a7(f)) Extends HHS testimonial subpoena authority to program exclusion investigations and authorizes HHS Secretary to delegate such subpoena authority to the HHS Inspector General. March 23, 2010 12 Obstruction of Program Audits Sec. 6408 (42 U.S.C. § 1320a7(b)(2)) Authorizes permissive exclusion for obstructing an investigation or audit. Prior provision applied only to obstructing criminal investigations. January 1, 2010 13 Evidentiary Privilege of Inter-Agency Correspondence Related to Any Investigation Sec. 6607 (29 U.S.C. § 1134(d)) Secretary of Labor may promulgate a regulation that provides an evidentiary privilege for, and provides for the confidentiality of communications between or among, certain federal and state agencies (including State AG, DOJ, DHHS). Any privilege that is established must apply to communications related to any investigation, audit, examination, or inquiry conducted or coordinated by any of the agencies. Corresponding regulations must be promulgated before privilege becomes effective. 14 Data Sharing Sec. 6403 (42 U.S.C. § 1320a7e; 42 U.S.C. § 1396r-2) Mandates a national healthcare fraud and abuse data collection program for the reporting of certain final adverse actions and to furnish the information collected to the National Practitioner Data Bank. First day after the final day of the transition period. Mandates states have in effect a system for reporting information with respect to formal licensing proceedings or final adverse actions. Mandates termination of the Healthcare Integrity and Protection Data Bank and mandates transfer of all data collected therein to the National Practitioner Data Bank. 4 PROVISION SUMMARY OF REQUIREMENT (Section of Healthcare Reform Law and Related Laws) EFFECTIVE DATE Transition period is from date of enactment to the later of one year after enactment or the effective date of regulations related to this requirement. Authorizes the Department of Veteran Affairs to have access to the National Practitioner Data Bank. Sec. 6402 (42 U.S.C. § 1301 et. seq.) Mandates the Integrated Data Repository of the Centers March 23, 2010 for Medicare & Medicaid Services include claims and payment data from a variety of programs, including Medicare, Medicaid, Veterans Affairs, and the Indian Health Service, so that data from such programs can be matched with data in the HHS system for the purpose of identifying potential Medicare and Medicaid fraud, waste and abuse. Mandates access by the HHS Inspector General and the Attorney General to claims and payment databases for purposes of conducting law enforcement and oversight activities. 15 Sec. 6402 (42 U.S.C. § 1396b(i)) Prohibits federal matching payments to states for medical assistance to those individuals for whom the state does not report enrollee encounter data to Medicaid Management Information Systems (MMIS) in a timely manner. March 23, 2010 Sec. 6504 (42 U.S.C. § 1396b(r)(1)(F) and 42 U.S.C. § 1396b(m)(2)(A) (xi)) Mandates states submit expanded data elements under Applies to data submitted, and contract years beginning, on or after January 1, 2010. Uniform Fraud and Abuse Referral Format Sec. 6603 (42 U.S.C. § 300gg93) Mandates HHS request that the National Association of Insurance Commissioners develop: MMIS as necessary for program integrity, program oversight, and administration. Mandates state contracts with Medicaid managed care organizations provide for the provision of patient encounter data to the state. March 23, 2010 A model uniform report form for private health insurance issuer seeking to refer suspected fraud and abuse to responsible state agencies for investigation; and Recommendations for uniform reporting standards for such referrals. 16 17 U.S. Sentencing Guidelines (USSG) Sec. 10606 (Federal Sentencing Guidelines) Transparency Amends Federal Sentencing Guidelines to provide an increase of between two and four levels for federal healthcare offenses involving $1 million or more. March 23, 2010 There are significant transparency requirements for applicable manufacturers of 5 PROVISION SUMMARY OF REQUIREMENT (Section of Healthcare Reform Law and Related Laws) Requirements for Health Industry Sectors EFFECTIVE DATE covered devices, drugs, biologics and medical supplies, pharmacy benefit managers, hospitals, physicians, and skilled nursing facilities. These transparency requirements are contained in Morgan Lewis’s March 29, 2010 LawFlash, “Healthcare Reform Law Delivers New Transparency Requirement to the Health Industry” (available online at http://www.morganlewis.com/pubs/WashGRPP_FDATransparencyRequirements_LF_29mar10.pdf). Sec. 6001 (Physician and Hospital Disclosures on Physician Ownership and Investment) Sec. 6002 (Manufacturer and Group Purchasing Organization Reporting of Physician Ownership and Investment) Sec. 6003 (Physician Disclosure Requirements for In-Office Ancillary Services) Sec. 6004 (Manufacturer and Distributor Reporting on Prescription Drug Samples) Sec. 6005 (Pharmacy Benefit Manager Transparency Requirements) Sec. 6101 (Nursing Facility and Skilled Nursing Facility Disclosure of Ownership and Additional Information) Sec. 6104 (Nursing Facility Staffing Information) 18 19 Suspension of Payments Pending Investigation Sec. 6402 (42 U.S.C. § 1395y; 42 U.S.C. § 1396b(i)(2)) Fraud and Abuse Enforcement Funding Sec. 6402 and Reconciliation Sec. 1303 (42 U.S.C. § 1395i(k)) Medicare and Medicaid payments may be suspended pending investigation of a credible allegation of fraud, unless HHS determines there is good cause not to suspend payments. March 23, 2010 The Healthcare Reform Law appropriates to the Health Care Fraud and Abuse Control Account an additional $100 million for FY 2011 through 2020 and the Reconciliation Law appropriates $250 million for FY 2011 through 2016 to cover the costs of the administration and operation of the healthcare fraud and abuse control program and the Medicare Integrity Program. March 23, 2010 PROGRAM INTEGRITY 20 Provider Screening and Other Enrollment Requirements Under Medicare, Medicaid and Mandates establishment, for new Medicare, Medicaid and CHIP providers, of screening procedures, which must include licensure checks and may include criminal background checks, fingerprinting, database inquiries and site visits Screening must occur within one year of enactment for 6 March 23, 2010, unless otherwise noted. PROVISION SUMMARY OF REQUIREMENT (Section of Healthcare Reform Law and Related Laws) Children’s Health Insurance Program (CHIP) Sec. 6401 (42 U.S.C. § 1395cc(j); 42 U.S.C. § 1396a(a)) 21 22 23 OIG Authority to Obtain Information from Providers and Suppliers Sec. 6402 (42 U.S.C. § 1301 et. seq.) National Provider Identifier Sec. 6402 (42 U.S.C. § 1301 et. seq.) Physician EFFECTIVE DATE new providers and suppliers and within two years of enactment for current providers and suppliers. Mandates establishment of procedures to provide for a period (greater than 30 days and up to one year) of enhanced oversight (e.g., prepayment review and payment caps) for new providers and suppliers New providers and suppliers must disclose current or past affiliations with any provider or supplier with uncollected debt, suspended payments or exclusion from a federal healthcare program, or revoked billing privileges. HHS may deny enrollment if such affiliations pose undue risk of fraud, waste, or abuse. HHS may satisfy past due obligations of a provider or supplier by adjusting payments to providers or suppliers with the same tax identification number as the provider or supplier with the past due obligation. HHS may impose a moratorium on enrollment of new providers or suppliers if necessary to combat fraud, waste, or abuse and provided that there would be no adverse impact on beneficiaries. Establishment of a compliance program with core elements determined by HHS, in consultation with HHS OIG, is a condition of enrollment. CMS must establish a process for making available to each state agency responsible for administering a state Medicaid plan or a CHIP plan the name, national provider identifier, and other identifying information for any Medicare or CHIP provider or supplier who is terminated from participation within 30 days of termination. HHS Inspector General may obtain information from any individual (including beneficiaries) or provider, supplier, grant recipient, contractor, manufacturer, distributor, or other entity, for purposes of protecting the integrity of Medicare and Medicaid, including supporting documentation necessary to validate Medicare and Medicaid payments. March 23, 2010 All Medicare and Medicaid providers and suppliers must include their national provider identifiers on all program applications and claims. January 1, 2011 Section 6001 places new restrictions on the Stark Law‘s whole-hospital 7 PROVISION SUMMARY OF REQUIREMENT (Section of Healthcare Reform Law and Related Laws) Ownership Sec. 6001 (42 U.S.C. § 1395nn) EFFECTIVE DATE exception, as well as requiring additional transparency. Among other things, Section 6001: Prohibits physician-owned hospitals that do not have a provider agreement from participating in Medicare. Physician-owned hospitals with a provider agreement could participate under prescribed conditions. Requires hospitals to submit annual reports to HHS containing a detailed description of each physician owner or investor (and any other owners or investors) of the hospital and the nature and extent of all ownership and investment interests. HHS will publish such information on the CMS website. Requires hospitals to implement procedures requiring physician owners and investors to disclose to patients referred to the hospital the physician’s ownership or investment interest. Requires hospitals to disclose the fact that the hospital is partially owned or invested in by physicians on the hospital’s public website and in any public advertising by the hospital. 24 DME and Home Health Services Sec. 6405 (42 U.S.C. § 1395m(a)(11)(B)) Limits ordering of DME or home health services for Medicare beneficiaries to Medicare enrolled physicians or eligible professionals. Authorizes HHS to extend these requirements to other Medicare items and services. Sec. 6406 (42 U.S.C. § 1395u(h) , 42 U.S.C. 1395cc, 42 U.S.C. § 1320a-7(b)(11)) Authorizes HHS to revoke enrollment, for not more than one year for each act, of a Medicare physician, supplier, or provider who fails to maintain and provide access to documentation relating to written orders or requests for payment for DME, certifications for home health services or referrals for other items and services. Applies to orders, certifications, and referrals made on or after January 1, 2010. Sec. 6407 (42 U.S.C. § 1395f(a)(2)(c); 42 U.S.C. § 1395m(a)(11)(B)) Requires physician or other permitted professional to have a face-to-face encounter with a patient prior to issuing a certification for home health services or written order for DME. Applies to home health certification, after January 1, 2010. Applies to Medicare and Medicaid. Permits HHS to apply this requirement to other Medicare items and services based upon a finding that doing so would reduce the risk of fraud, waste, or abuse. 25 Applies to written orders and certifications made on or after July 1, 2010. Surety Bonds Sec. 6402 (42 U.S.C. 1395m(a)(16)(B); 42 U.S.C. §1395x(o)(7)(C); Surety bonds for DME and home health agencies must be commensurate with volume of billing. 8 Applies to written orders for DME upon enactment. March 23, 2010 PROVISION SUMMARY OF REQUIREMENT (Section of Healthcare Reform Law and Related Laws) EFFECTIVE DATE 42 U.S.C. 1395y) 26 27 28 Application of Fraud and Abuse Laws to Private Exchange Insurers Sec. 1313 (31 U.S.C. § 3729 et seq.) See also Sec. 10104 (striking § 1313(a)(6)(B)) Requires HHS to provide for the efficient and non- Medicare Advantage (MA) or Part D Plan Sec. 6408 (42 U.S.C. § 1395w27(g)(2)(A); 42 U.S.C. § 1395w27(g)(1)) Establishes penalties for Medicare Advantage and Multiple Employer Welfare Arrangements (MEWAs) under ERISA Sec. 6601 (29 U.S.C. § 1149) Provides criminal penalties for any person, in connection with a MEWA, that knowingly makes a false statement or false representation of fact in connection with the marketing or sale of the MEWA in regard to the: January 1, 2014 discriminatory administration of Exchange activities and implement any measure or procedure appropriate to reduce fraud and abuse. Subjects payments made by, through, or in connection with an Exchange to the False Claims Act if those payments include any federal funds. January 1, 2010 Medicare Part D plans that misrepresent or falsify information of up to the amount claimed by the plan or plan sponsor in connection with the misrepresentation or falsified information. Authorizes sanctions and penalties for MA and Part D plans that enroll individuals in a plan without their consent; transfer an individual from one plan to another to generate commissions or fees; fail to comply with marketing restrictions related to approval of marketing materials and prohibited marketing activities; or employ or contract with an individual or entity who engages in conduct for which intermediate sanctions may be imposed. March 23, 2010 Financial condition of the MEWA; Benefits provided by the MEWA; Regulatory status of the MEWA under any federal or state law governing collective bargaining, labor management relations, or internal union affairs; or Regulatory status of the MEWA regarding exemption from state regulatory authority under ERISA. Sec. 6604 (29 U.S.C. § 1150) Authorizes Secretary of Labor, for the purpose of identifying, preventing, or prosecuting fraud and abuse, to adopt regulations that would prevent MEWAs from claiming federal preemption as a defense under state law and would subject MEWAs to the laws of the states in which the MEWA 9 Corresponding regulations must be promulgated before preemption PROVISION SUMMARY OF REQUIREMENT (Section of Healthcare Reform Law and Related Laws) 29 EFFECTIVE DATE operates. change becomes effective. Sec. 6605 (29 U.S.C. § 1151) Allows Secretary of Labor to issue a “cease and desist” order if it appears that the alleged conduct of a MEWA (i) is fraudulent, (ii) creates an immediate danger to the public safety or welfare, or (iii) is causing or can be reasonably expected to cause significant, imminent, and irreparable public injury. Authorizes the seizure of MEWA assets if it appears that the MEWA is in a financially hazardous condition. March 23, 2010 Sec. 6606 (29 U.S.C. § 1021(g)) Mandates MEWAs register with the Secretary and make annual reports regarding their operations. March 23, 2010 Section 340B Program Integrity Measures Sec. 7102 (42 U.S.C. § 256b(d); 42 U.S.C. 256b(a)) Requires manufacturers to submit quarterly reports of March 23, 2010 340B ceiling prices and the components used to calculate them to the Secretary. Requires the Secretary to provide certain improvements in 340B compliance by manufacturers in order to prevent overcharges and other violations of the 340B discounted pricing requirements. Establishes civil monetary penalties not to exceed $5,000 for each instance of overcharging a covered entity. Requires the Secretary to provide certain improvements in 340B compliance by covered entities in order to prevent diversion and violations of the duplicate discount provision and other 340B requirements. Requires the Secretary to promulgate regulations, within 180 days of the effective date, to establish and implement an administrative process for the resolution of (i) claims by covered entities that they have been overcharged for drugs purchased under 340B and (ii) claims by manufacturers after an audit has been conducted. 30 Medicare and Medicaid Integrity Programs Sec. 6402 (42 U.S.C. § 1395ddd; 42 U.S.C. § 1396u6(c)(2)) Entities contracting with the Medicare Integrity Program and Medicaid Integrity Program must agree to provide performance statistics to HHS and HHS Inspector General. HHS must conduct evaluations of contracting entities every three years and must submit an annual report to Congress. 10 March 23, 2010 PROVISION SUMMARY OF REQUIREMENT (Section of Healthcare Reform Law and Related Laws) 31 32 Time Period to Submit Medicare Claims Sec. 6404 (42 U.S.C. § 1395f(a)(1); 42 U.S.C. § 1395u (b)(3)(B); 42 U.S.C. § 1395n(a)) Medicaid Coding Sec. 6507 (42 U.S.C. § 1396b(r)) Reduces the period of submission of Medicare claims EFFECTIVE DATE January 1, 2010 from three calendar years following the year in which services were furnished to one calendar year after the date of service. Applies to services furnished on or after January 1, 2010. For services furnished before January 1, 2010, a bill or request for payment must be filed not later than December 31, 2010. Mandates states use compatible methodologies of the National Correct Coding Initiative for Medicaid claims. 11 Effective for claims filed on or after October 1, 2010.