Medicare Advantage and Part D Compliance Training 42 CFR Parts 422.503 and 423.504
Background > As a Medicare Advantage (MA) and Part D (PDP) Plan Sponsor ( Sponsor ), Blue Cross and Blue Shield Northern Plains Alliance (NPA) is committed to following all applicable laws, regulations and guidance that govern the MA and Part D programs Blue Cross Blue Shield Northern Plains Alliance is a trade name of the following independent Blue Cross and Blue Shield Plans: Wellmark Blue Cross and Blue Shield of Iowa*, Blue Cross and Blue Shield of Minnesota*, Blue Cross and Blue Shield of Montana*, Blue Cross and Blue Shield of Nebraska*, Blue Cross Blue Shield of North Dakota*, Wellmark Blue Cross and Blue Shield of South Dakota*, and Blue Cross Blue Shield of Wyoming*. *Independent licensees of the Blue Cross and Blue Shield Association Source: Federal Register, Part V Department of Health and Human Services Centers for Medicare & Medicaid Services 42 CFR 422 and 423, Wednesday, December 5, 2007. 2
Background (cont.) > New regulations at 42 CFR Parts 422 and 423 require, in part, that a Sponsor attests that it will: Develop an effective compliance plan that incorporates measures to detect, prevent, and correct fraud, waste and abuse Establish effective lines of communication between the compliance officer, members of the compliance committee, and the Sponsor s employees, managers, and directors Apply these training and communication requirements to all entities with which they contract to provide benefits or services (first tier, downstream, and related entities) Source: Federal Register, Part V Department of Health and Human Services Centers for Medicare & Medicaid Services 42 CFR 422 and 423, Wednesday, December 5, 2007. 3
Education requirements > NPA plan responsibilities Oversight and monitoring of education and training of first tier, downstream and related entities, May delegate training responsibility to first tier, downstream, and related entities. Produce attestations from their first tier, downstream and related entities to evidence compliance with these requirements Produce copies of training logs as requested 4
Education requirements (cont.) > Your organization may have similar relationships with other Sponsors. If so, you may choose to take this training or training offered by another plan sponsor. With either option: The training must comply with the requirements of 42 CFR Parts 422.504(b)(4)(vi)(c) or 423.504(b)(4)(vi)(c) and Your organization must maintain internal training logs, and submit the required attestation to NPA as documentation of the training 5
Training documentation > All entities are required to complete the Attestation of Training Completion (sample at end of slides) which must be signed by a representative of your organization. > Upon request, your organization will be required to submit copies of training logs demonstrating that employees received compliance training. 6
Training documentation (cont.) > If your organization has contracted with other entities to provide health and/or administrative services on behalf of NPA s Medicare Advantage and Part D members you will need to obtain attestations from those entities that they have completed Compliance training. Upon request, those entities will also need to provide you training logs > The following slides provide you with this training and include information about compliance program requirements 7
What are First Tier, Downstream, and Related entities? First Tier Entity > Any party that enters into a written arrangement, acceptable to CMS, with a sponsor or applicant to provide administrative services or health care services for a Medicare eligible individual under the MA or Part D programs Examples of first tier entities are a Pharmacy Benefits Manager (PBM), contracted hospitals, clinics, and allied providers 8
What are entities (cont.) Downstream Entity > Any party that enters into a written arrangement, acceptable to CMS, with persons or entities involved in the MA or Part D benefit, below the level of the arrangement between a sponsor and a first tier entity. These written arrangements continue down to the level of the ultimate provider of both health and administrative services. Examples include, but are not limited to, pharmacies, marketing firms, quality assurance companies, claims processing firms, and billing agencies 9
What are entities (cont.) Related Entity > Any entity that is related to the sponsor by common ownership or control and: 1.Performs some of the Sponsor s management functions under contract or delegation; 2.Furnishes services to Medicare enrollees under an oral or written agreement; or 3.Leases real property or sells materials to the Sponsor at a cost of more than $2,500 during a contract period. 10
Stakeholder relationship flow chart Source: Prescription Drug Benefit Manual, Chapter 9 Part D Program to Control Fraud, Waste and Abuse (Rev.2, 04-25-2006), Section 40 11
What is a Compliance program? > A Compliance program is a series of internal controls and measures to ensure that a sponsor is following all applicable laws and regulations that govern the programs in which it participates. > A comprehensive compliance program is required of all MA and Part D plan sponsors. The elements of a compliance program include: Written Standards of Conduct: development and distribution of written Standards of Conduct and Policies & Procedures (P&Ps) that promote the Sponsor s commitment to compliance and that address specific areas of potential fraud Designation of a Compliance Officer: designation of an individual and a committee charged with the responsibility and authority of operating and monitoring the compliance program Sources: OIG s Compliance Program Guidance for Medicare+Choice Organizations Offering Coordinated Care Plans (Federal Register, Vol. 64, No. 219, HHS Office of Inspector General, Monday, November 15, 1999); 42 CFR 422.503(b), 42 CFR 423.504(b) 12
What is a Compliance program? (cont.) Effective Compliance Training: development and implementation of regular, effective education and training for all affected employees. This training must be provided at both time of hiring and annually thereafter to the following: New employees and all staff involved with the administration or delivery of the product benefits must receive general training. All staff with specific duties must receive specialized training based on job function (i.e. Marketing). 13
What is a Compliance program? (cont.) Effective Lines of Communication: Sponsors must have effective lines of communication between the Compliance Officer and the organization s employees, contractors, agents, directors, and members of the compliance committee This includes having a system in place to receive, record, and respond to compliance questions, or reports of potential or actual non-compliance from employees, contractors, agents and directors while maintaining confidentiality, allowing anonymity if desired (e.g. through telephone hotlines or mail drops), and ensuring nonretaliation against callers. First tier, downstream, and related entities must report compliance concerns and suspected or actual misconduct involving the MA or Part D programs to the Sponsor contact Source: CMS Prescription Drug Benefit Manual, Section 50.2.4 14
What is a Compliance program? (cont.) Internal Monitoring and Auditing: use of risk evaluation techniques/audits to monitor compliance and assist in the reduction of identified problem areas Disciplinary Mechanisms: development of policies to (1) consistently enforce standards and (2) address dealing with sanctioned individuals Procedures for Responding to Detected Offenses and Corrective Action Development of policies to respond to detected offenses and to initiate corrective action to prevent similar offenses Perform a timely, reasonable inquiry Sources: OIG s Compliance Program Guidance for Medicare+Choice Organizations Offering Coordinated Care Plans (Federal Register, Vol. 64, No. 219, HHS Office of Inspector General, Monday, November 15, 1999). CMS Prescription Drug Benefit Manual, Section 50.2.7. 15
What are fraud and abuse? > Fraud: to purposely bill for services that were never given or to bill for a service that has a higher reimbursement than the service provided. May involve billing for services that were never rendered or billing for services at a higher rate than is actually justified. May also involve deliberate misrepresentation of services provided to members, resulting in unnecessary cost to the program, improper payments to providers, or overpayments. > Abuse: payment for items or services that are billed by mistake by providers, but should not be paid for by Medicare. This is not the same as fraud. Source: CMS Medicaid State Agency Guide to Medicare Operations May 2002 16
Who commits fraud and abuse? > Many individuals and organizations involved in the health care system may potentially commit fraud or abuse. Here are some examples: Beneficiaries Physicians, nurses, and other health care providers Pharmacies Laboratories Pharmaceutical manufacturers Medical equipment suppliers Hospitals Pharmacy benefit managers (PBMs) Employees of health plans Home health agencies 17
Fraud, waste and abuse (FWA) laws: False Claims Act > The False Claims Act, in part, prohibits any person from: Knowingly presenting, or causing to be presented, to an officer or employee of the United States Government a false or fraudulent claim for payment or approval; Knowingly making, using, or causing to be made or used, a false record or statement to get a false or fraudulent claim paid or approved by the Government; or Conspiring to defraud the Government by getting a false or fraudulent claim allowed or paid. A violator may be liable to the United States Government for a civil penalty of not less than $5,000 and not more than $10,000, plus 3 times the amount of damages which the Government sustains because of the act of that person. 18
FWA Laws: Anti-Kickback Statute > The Anti-Kickback Statute makes it a criminal offense knowingly and willfully to offer, pay, solicit, or receive any remuneration to induce or reward referrals of items or services reimbursable by a Federal health care program. Where remuneration is paid purposefully to induce or reward referrals of items or services payable by a Federal health care program, the anti-kickback statute is violated By its terms, the statute ascribes criminal liability to parties on both sides of an impermissible kickback transaction > For purposes of the anti-kickback statute, remuneration includes the transfer of anything of value, directly or indirectly, overtly or covertly, in cash or in kind. Source: 42 U.S.C. 1320-7b(b). CMS Medicare Fraud & Abuse Brochure, October 2007. 19
FWA Laws: Physician Self-Referral Prohibition Statute ( Stark Law ) > The Physician Self-Referral Prohibition Statute, commonly referred to as the Stark Law, is set forth at 1877 of the Social Security Act, (42 U.S.C. 1395nn). This statute prohibits physicians from referring Medicare patients for certain designated health services (DHS) to an entity with which the physician or a member of the physician s immediate family has a financial relationship unless an exception applies. It also prohibits an entity from presenting or causing to be presented a bill or claim to anyone for a DHS furnished as a result of a prohibited referral Source: 42 U.S.C. 1320-7b(b). CMS Medicare Fraud & Abuse Brochure, October 2007. 20
Examples of Potential FWA: Prescriber > Illegal Remuneration Schemes Prescriber is offered, or paid, or solicits, or receives unlawful remuneration to induce or reward the prescriber to write prescriptions for drugs or products > Script Mills Provider writes prescriptions for drugs that are not medically necessary, often in mass quantities, and often for patients that are not theirs. These scripts are usually written, but not always, for controlled drugs for sale on the black market, and might include improper payments to the provider. > Theft of Prescriber s DEA Number or Prescription Pad Prescription pads and/or DEA numbers can be stolen from prescribers. This information could illegally be used to write prescriptions for controlled substances or other medications often sold on the black market. Source: Prescription Drug Benefit Manual, Chapter 9 Part D Program to Control Fraud, Waste and Abuse (Rev.2, 04-25-2006), Section 70.1.4 21
Examples of Potential FWA: Wholesaler > Counterfeit and Adulterated Drugs through Black and Grey Market Purchases This includes but is not limited to fake, diluted, expired, and illegally imported drugs > Diverters Brokers who illegally gain control of discounted medicines intended for places such as nursing homes, hospices and AIDS clinics. Diverters take the discounted drugs, mark up the prices, and rapidly move them to small wholesalers. In some cases the pharmaceuticals may be marked up six times before being sold to the consumer. > Inappropriate Documentation of Pricing Information Submitting false or inaccurate pricing or rebate information to or that may be used in any Federal health care program Source: Prescription Drug Benefit Manual, Chapter 9 Part D Program to Control Fraud, Waste and Abuse (Rev.2, 04-25-2006), Section 70.1.5 22
Examples of Potential FWA: Pharmaceutical Manufacturer > Illegal Off-label Promotion Illegal promotion of off-label drug usage through marketing, financial incentives, or other promotion campaigns > Illegal Usage of Free Samples Providing free samples to physicians knowing and expecting those physicians to bill the federal health care programs for the sample > Kickbacks, Inducements, or Other Illegal Remuneration Inappropriate marketing and/or promotion of products reimbursable by Federal health care programs Inappropriate discounts, inappropriate educational grants Source: Prescription Drug Benefit Manual, Chapter 9 Part D Program to Control Fraud, Waste and Abuse (Rev.2, 04-25-2006), Section 70.1.6 23
Examples of Potential FWA: Beneficiary > Identify Theft Perpetrator uses another person s Medicare card to obtain prescriptions > Resale of Drugs on Black Market Beneficiary falsely reports loss or theft of drugs or feign illness to obtain drugs for resale on the black market > Doctor Shopping Beneficiary or other individual consults a number of doctors for the purpose of inappropriately obtaining multiple prescriptions for narcotic painkillers or other drugs. Doctor shopping might be indicative of a underlying scheme, such as stockpiling or resale on the black market. Source: Prescription Drug Benefit Manual, Chapter 9 Part D Program to Control Fraud, Waste and Abuse (Rev.2, 04-25-2006), Section 70.1.7 24
Examples of Potential FWA: Pharmacy > Inappropriate Billing Practices Billing for non-existent prescriptions Billing for brand when generics are dispensed Billing for non-covered prescriptions as covered items > Prescription Drug Shorting Providing less than the prescribed quantity but billing for the fully-prescribed amount >Dispensing Expired or Adulterated Drugs Dispensing drugs that are expired, or have not been stored or handled in accordance with manufacturer and FDA requirements Source: Prescription Drug Benefit Manual, Chapter 9 Part D Program to Control Fraud, Waste and Abuse (Rev.2, 04-25-2006), Section 70.1.3 25
Examples of Potential FWA: Pharmacy Benefits Manager (PBM) > Prescription Drug Switching The PBM receives a payment to switch a beneficiary from one drug to another or influence the prescriber to switch the patient to a different drug. > Prescription Drug Splitting or Shorting PBM mail order pharmacy intentionally provides less than the prescribed quantity and does not inform the patient or make arrangements to provide the balance but bills for the fullyprescribed amount. Splits prescription to receive additional dispensing fees. Source: Prescription Drug Benefit Manual, Chapter 9 Part D Program to Control Fraud, Waste and Abuse (Rev.2, 04-25-2006), Section 70.1.2 26
Examples of Potential FWA: Sponsor > Payments for excluded drugs > Marketing schemes Offering beneficiaries a cash payment as an inducement to enroll in Part D Unsolicited door-to-door marketing Use of unlicensed agents Enrollment of beneficiary without their knowledge or consent Stating that a marketing agent/broker works for or is contracted with the Social Security Administration or CMS Misrepresenting the product being marketed as an approved Part D Plan when it actually is a Medigap policy or non- Medicare drug plan Source: Prescription Drug Benefit Manual, Chapter 9 Part D Program to Control Fraud, Waste and Abuse (Rev.2, 04-25-2006), Section 70.1.1 27
FWA Resources > The following Federal government websites are sources of information regarding fraud, waste and abuse detection, correction and prevention: Department of Health and Human Services Office of Inspector General: http://oig.hhs.gov/fraud.asp Centers for Medicare & Medicaid Services (CMS): http://www.cms.hhs.gov/mdfraudabusegeninfo/ CMS Information about the Physician Self Referral Law: www.cms.hhs.gov/physicianselfreferral 28
Reporting Potential Fraud or Abuse > Report issues or concerns to your NPA Blue Plan Compliance Officer or hotline: Minnesota > Fraud Hotline 1-800-382-2000 ext 28363 North Dakota > Fraud Hotline (877) 537-2830 > Mail to: Compliance, PO Box 242, West Fargo, ND 58078 Iowa and South Dakota > Special Investigations Unit (515) 248-5695 Nebraska > Susan Rainey-Biler, Special Investigations Unit (402) 398-3676 > Fraud Hotline (877 ) 632-2583 29
Reporting Potential Fraud or Abuse (cont.) > Reporting issues (cont.): Wyoming > John McBride, Chief Legal Counsel, john.mcbride@bcbswy.com > Fraud Hotline (800) 442-2376 > Mail to: Attn: Fraud Reporting, PO Box 2266, Cheyenne WY 82003. Montana > Fraud Hotline (800) 621-0992 or email fraud@bcbsmt.com > Mail to: BCBS of Montana, Internal Audit/Special Investigation Unit, PO Box 4309, Helena, MT 59604-4309 > You may also report to 1-800-MEDICARE or the Regional Compliance Hotline (866) 311-4216 > You may remain anonymous 30
Attestation of Training Completion > Congratulations! You ve completed the Compliance Training. What should you do next? > A representative of your organization should complete the Attestation of Training Completion and submit to your local BCBS Plan for your organization. > A samples training log and links to the attestation form are on the next slides. 31
Sample Attestation of Training Completion > As a first tier, downstream or related entity, (Name of Organization) attests that it has conducted appropriate education and training to identify, correct and prevent potential fraud, waste and abuse, as required by the final rule issued in the Federal Register for 42 CFR Parts 422 and 423 of the Medicare Program on 12/5/07. > Please select the method of education and training that your organization chose to comply with the final rule requirement: [ ] Reviewed this training and education provided by the Northern Plains Alliance [ ] Reviewed training and education provided by another Medicare Advantage and Part D sponsor or another source. > By signing below, you also attest that your organization will furnish training logs upon request to your local Plan to validate that training was completed. Print Name Title Signature Date Organization Name Tax ID Street Address City, State, Zip Code 32
Sample Training Log Employee Name Title of Training Course Date Employee Signature 33
Attestation of Training Completion > Click the your local plan link to access the attestation. Wellmark Blue Cross and Blue Shield of Iowa Blue Cross and Blue Shield of Minnesota Blue Cross and Blue Shield of Montana Blue Cross and Blue Shield of Nebraska Blue Cross Blue Shield of North Dakota Wellmark Blue Cross and Blue Shield of South Dakota Blue Cross Blue Shield of Wyoming 34
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