BILL ANALYSIS Ó SENATE COMMITTEE ON HEALTH Senator Ed Hernandez, O.D., Chair BILL NO: SB 1529 AUTHOR: Alquist AMENDED: March 29, 2012 HEARING DATE: April 18, 2012 CONSULTANT: Bain SUBJECT : Medi-Cal: providers: fraud. SUMMARY : Reduces the legal standard the Department of Health Care Services (DHCS) uses when considering evidence to deny continued enrollment, suspend a provider, or suspend payments to a provider to a "credible allegation of fraud;" requires claims for reimbursement from the Medi-Cal program to identify the ordering or prescribing provider; requires individuals who order, refer or prescribe to Medi-Cal beneficiaries to enroll as Medi-Cal providers; requires individuals enrolling as Medi-Cal providers to submit fingerprints and their date of birth, and requires corporations to submit their taxpayer identification number and all business address locations and post office box addresses; establishes an application fee for a limited number of providers seeking to enroll in the Medi-Cal program; permanently bars providers terminated under Medicare, Medicaid or the Children's Health Insurance Program (CHIP) from the Medi-Cal program; allows DHCS to deactivate a Medi-Cal provider in certain circumstances; requires, if an unannounced site visit is conducted by DHCS of any enrolled provider, the provider to permit access to any and all of their provider locations; requires DHCS to establish a temporary moratorium on enrollment on providers if the federal government has done so to the same group of providers; requires DHCS, at minimum, to utilize federal regulations in determining a provider's or applicant's categorical risk of fraud; and allows DHCS to enter into contracts with one or more eligible Medicaid Recovery Audit Contractors (RACs) under a specified provision of federal law. 1. Overview. State law governing Medi-Cal and federal law and regulations contain provisions to address fraud in the Medicaid program. For example, existing state law requires an applicant or provider seeking to provide services in the Medi-Cal program, to submit a complete application package for enrollment, continuing enrollment, enrollment at a new location or a change in location. In addition, existing law authorizes DHCS, upon Continued--- SB 1529 | Page 2 receipt of reliable evidence of fraud or willful misrepresentation by a provider, among other things, to withhold payment for any goods, services, supplies, or merchandise. Existing law also prohibits DHCS from enrolling any applicant that has been convicted of any felony or misdemeanor involving fraud or abuse in any government program. The Patient Protection and Affordable Care Act (Public Law 111-148), as amended by the Health Care and Education Reconciliation Act of 2010 (Public Law 111- 152) (collectively known as the Affordable Care Act or ACA), makes a number of changes to the Medicare and Medicaid (Medi-Cal in California) programs and CHIP (Healthy Families Program in California) that enhance the provider and supplier enrollment process to reduce fraud, waste, and abuse in the programs. Specifically, the ACA establishes: (1) procedures under which screening is conducted for providers of medical or other services and suppliers in the Medicare program, providers in the Medicaid program, and providers in CHIP; (2) an application fee to be imposed on some providers and suppliers; (3) temporary moratoria that the federal Department of Health and Human Services (DHHS) Secretary may impose if necessary to prevent or combat fraud, waste, and abuse under the Medicare and state Medicaid programs and CHIP; (4) requirements that Medicaid agencies must terminate any provider that is terminated by Medicare or the state's Medicaid program; and, (5) requirements for suspensions of payments pending credible allegations of fraud in both the Medicare and Medicaid programs. This bill is sponsored by DHCS to amend California state law with the ACA-required federal regulations relating to the screening, enrollment, payment suspensions and sanctions of state Medicaid providers. DHCS states it is sponsoring this bill because it does not have the statutory authority to implement the new federal requirements for the provider screening, enrollment, sanctions, payment suspensions and overpayments or underpayments associated with Medicaid providers, and this bill will ensure that DHCS has the legal authority to implement the new measures required by federal regulations. This 55-page bill makes numerous changes. This analysis takes each major policy area affected by this bill, describes existing state law, the related federal requirement (if applicable), the proposed change to state law, and DHCS' rationale for the proposed change. SB 1529 | Page 3 2. Change of standard to credible allegation of fraud in Health & Safety Code. Federal regulations require state Medicaid agencies to suspend all Medicaid payments to a provider after the agency determines there is "a credible allegation of fraud" for which an investigation is pending under the Medicaid program against the individual or entity, unless the agency has good cause not to suspend payments or to suspend payment only in part. A "credible allegation of fraud" is defined in federal regulations as an allegation from any source, including, but not limited to, the following: § Fraud hotline complaints. § Claims data mining. § Patterns identified through provider audits, civil false claims cases, and law enforcement investigations. Allegations are considered to be credible when they have indicia of reliability and the state Medicaid agency has reviewed all allegations, facts, and evidence carefully and acts judiciously on a case-by-case basis. (Indicia of reliability is not defined in the federal regulations, but the Centers for Medicare & Medicaid Services ÝCMS] indicates it expects states to gauge the credibility of allegations after reviewing all allegations, facts, data, and evidence carefully and that state action will be exercised judiciously on a case-by-case basis.) Existing state law contains a higher standard than the new federal standard of "a credible allegation of fraud" for health care programs administered by DHCS. For example, existing state law: § Requires the DHCS Director, when a letter or order of denial of continued enrollment or suspension of any type or duration, based upon fraud or abuse, or when a withholding of payments, based upon "reliable evidence of fraud or willful misrepresentation," is issued by DHCS to a provider, to review the evidence supporting the denial of continued enrollment, suspension, or withholding of payments. § Permits the Director to deny continued enrollment, suspend, or withhold payments to the provider with respect to those other health care programs if, in the opinion of the Director, the evidence shows "a pattern or practice of fraud, abuse, or willful misrepresentation" that, if replicated in any other health care program administered by DHCS, could cause either fiscal loss to the state or harm to any participant. SB 1529 | Page 4 § Permits the Director to deny the application of an applicant or provider to participate in any health care program administered by DHCS when, based upon fraud or abuse, the applicant or provider has been denied continued enrollment in, or suspended from, any health care program administered by DHCS, or has had payments withheld based upon reliable evidence of fraud or willful misrepresentation in connection with any health care program administered by DHCS, and remains ineligible to participate. This bill : § Reduces the legal standard the DHCS Director uses when considering evidence to deny continued enrollment, suspend providing Medi-Cal services, or suspend payments to a provider from a "pattern or practice of fraud, abuse, or willful misrepresentation" to a "credible allegation of fraud." In addition, this bill deletes the requirement in existing law that the Director consider that the fraud, if replicated in other programs administered by DHCS, could cause either fiscal loss to the state or harm to any participant when deciding whether to deny enrollment, suspend providing Medi-Cal services, or withhold payment. § Reduces the legal standard the DHCS Director uses when deciding whether to deny an application of an applicant or provider to participate in any health care program administered by DHCS based upon fraud or abuse when the provider has been denied continued enrollment or suspended, from one based on "reliable evidence of fraud or willful misrepresentation in connection with any health care program administered by DHCS" to "a credible allegation of fraud." § Delete references to "withholding of payments," and replaces that phrase with "suspension of payments" throughout the bill to conform to language used in federal regulations. Note: DHCS indicates the purpose of the above-described changes is to comply with the regulations implementing the ACA and to mirror the language in the ACA. Changing "withholding" and "withholding of payments" to "suspension" and "payment suspension" is not intended as a substantive change and conforms to language used in the ACA regulations. 1. Change of standard to credible allegation of fraud specific to Medi-Cal. Existing law authorizes DHCS, upon receipt of reliable evidence that would be admissible under the administrative adjudication provisions of the Administrative Procedure Act (APA) of fraud or SB 1529 | Page 5 willful misrepresentation by a provider under the Medi-Cal program or the commencement of a suspension, to take specified actions, including collecting overpayments identified through an audit or examination and withholding payment This bill changes the legal standard from "reliable evidence that would be admissible under the APA of fraud or willful misrepresentation" to "a credible allegation of fraud." This bill requires the provider to be temporarily placed under payment suspension, unless it is determined there is a good cause exception, as defined, not to suspend the payments or to suspend them only in part. Existing state law authorizes DHCS to withhold payment for any goods, services, supplies, or merchandise. Existing law requires DHCS to notify the provider within five days of any withholding of payment under this provision. This bill allows DHCS to delay notification to the provider by 30 days if it is requested to do so in writing by any law enforcement agency, which can be renewed in writing up to two times and in no event, may exceed 90 days. This bill changes references to "payment withholding" to "payment suspension" and revises the wording of the notice to the provider. This bill allows DHCS to lift a payment suspension when a resolution of an investigation for fraud or abuse occurs. This bill requires an allegation of fraud to be considered credible by DHCS if it exhibits indicia of reliability as recognized by state or federal courts or by other law sufficient to meet the constitutional prerequisite to a law enforcement search or seizure of comparable business assets. This bill requires the Department of Justice (DOJ) and any other law enforcement agency that has accepted referrals for investigation from DHCS to submit a report on a quarterly basis to DHCS listing each referral and stating whether the referral continues to be under investigation and whether it involves a credible allegation of fraud. This bill allows DHCS, if DOJ or a law enforcement agency fails to submit a report, to request the report from DOJ or the law enforcement agency on no more than a quarterly basis. This bill requires DOJ or the law enforcement agency, as applicable, to provide the report within 30 days of the request. SB 1529 | Page 6 This bill exempts from public disclosure under the California Public Records Act a report, request, or notification submitted, but permits these records to be disclosed to law enforcement agencies or other government entities that execute a specified agreement. This bill revises the definition of "provider" and would define "good cause exception" as a reason determined by DHCS that falls under a specified provision of federal regulations. This bill defines "law enforcement agency" to include any agency employing peace officers, as defined in existing law. Note: DHCS indicates the purpose of the above-described changes is to comply with the regulations implementing the ACA. DHCS indicates in the previous 12 months, its Medical Review Branch has issued 35 Payment Withhold (Payment Suspension) sanctions. 2. Claims for reimbursement. Existing state law requires each claim for reimbursement from the Medi-Cal program to identify the place of services and the rendering provider. Federal regulations require the state Medicaid agency to require all claims for payment for items and services that were ordered or referred to contain the National Provider Identifier (NPI) of the physician or other professional who ordered or referred such items or services. This bill requires that each claim for reimbursement from the Medi-Cal program to identify the ordering or prescribing provider (in addition to the rendering provider). In addition, this bill deletes the statutory requirement that Medi-Cal issue provider numbers. Note: DHCS indicates the purpose of the above-described changes is to comply with the regulations implementing the ACA, and to delete an obsolete requirement that Medi-Cal issue provider numbers, as it no longer does so. 3. Provisions requiring additional providers to enroll as Medi-Cal providers. Existing state Medi-Cal law defines a "provider" and an "applicant" and requires applicants and providers seeking to SB 1529 | Page 7 enroll in Medi-Cal who are licensed under the Business and Professions Code, such as physicians, dentists, pharmacists, optometrists, nurse practitioners, and physician assistants (or a corporation of such health care providers), to be enrolled as either an individual provider or as a rendering provider in a provider group. Existing law does not specifically include ordering, referring or prescribing individuals within the definition of applicant or provider. Federal regulations require state Medicaid agencies to require all enrolled providers to be screened, and require all ordering or referring physicians or other professionals providing services under Medicaid to be enrolled as participating providers. In meeting this requirement, states can rely on the results of the provider screening performed by Medicare contractors, or other states' Medicaid agencies or CHIP. This bill expands the definitions of "provider" and "applicant" to include "ordering, referring or prescribing individuals" within the definition of "provider" and "applicant." Note: DHCS indicates the purpose of the above-described changes is to comply with the regulations implementing the ACA. The practical effect of this change and the NPI requirement described previously are to require providers who order, refer or prescribe to a Medi-Cal beneficiary to enroll as a Medi-Cal provider through the DHCS' Provider Enrollment Division (PED). An example of an ordering or prescribing provider would be a physician who orders or prescribes prescription medication, durable medical equipment (DME), lab work, or diagnostic imaging. An example of a referring physician would be when a patient is evaluated by an ear, nose and throat specialist (a physician) who determines that patient needs to be evaluated for hearing aids and refers that patient to audiologist for those services. When the audiologist submits a claim for their services, the claim form must include the enrolled NPI of the ear, nose and throat physician who referred the patient to the audiologist. Under the federal regulations, in order for the audiologist, pharmacist, DME provider, lab or imaging provider to be reimbursed by Medi-Cal, the ordering, referring or prescribing provider must also be enrolled as a Medi-Cal provider. This provision is likely to increase the number of providers enrolling through PED. SB 1529 | Page 8 4. Medi-Cal provider application information requirements. State law requires, in order to be enrolled as a Medi-Cal provider, or for enrollment as a provider to continue, an applicant or provider may be required to sign a provider agreement and to disclose all information as required in federal Medicaid regulations and any other information required by DHCS. Federal regulations require specified disclosures, including the date of birth and Social Security Number (in the case of an individual) or other tax identification number (in the case of a corporation), with an ownership or control interest in the disclosing entity (or fiscal agent or managed care entity) or in any subcontractor in which the disclosing entity (or fiscal agent or managed care entity) has a five percent or more interest. This bill requires applicants, providers, and persons with an ownership interest to submit their date of birth, and would requires corporations with an ownership or control interest, as defined in federal Medicaid regulations, to submit their taxpayer identification number and all business address locations and post office box addresses. Note: DHCS indicates the purpose of the above-described changes is to comply with the regulations implementing the ACA. 5. New provider application fee for a limited number of providers. Existing state law does not require an enrollment fee as part of its Medi-Cal provider enrollment process. Federal regulations require states, beginning on or after March 25, 2011, to collect the applicable application fee prior to executing a provider agreement from a prospective or re-enrolling provider. There are several exemptions in the federal regulations from paying the fee, including the following: § Individual physicians or non-physician practitioners. § Providers enrolled in either Medicare or another states' Medicaid program or CHIP who have paid the applicable application fee to either a Medicare contractor or another state. This bill requires DHCS to collect a Medi-Cal application fee SB 1529 | Page 9 for enrollment, revalidation of enrollment, enrollment at a new location, or a change in location. This bill would prohibit the application fee from being collected from individual physicians or non-physician practitioners, from providers that are enrolled in Medicare or another state's Medicaid or CHIP, from providers that submit proof that they have paid the applicable fee to a Medicare contractor or to another state's Medicaid program, or pursuant to an exemption or waiver pursuant to federal law. This bill requires the application fee collected to be in the amount calculated by the federal CMS in effect for the calendar year during which the application for enrollment is received by DHCS. Note: DHCS indicates the purpose of the above-described changes is to comply with the regulations implementing the ACA. DHCS indicates the application fee for 2012 is $523, and this amount is updated annually by the federal government. The application fee is collected upon enrollment or re-enrollment, or when an application is submitted to enroll a new location or to request a change in location. The fee is a one-time fee (unless the provider relocates), and a provider who has paid the fee for another state's Medicaid program, another state's CHIP program or Medicare does not have to pay the fee. DHCS' preliminary estimate is that it expects to collect minimal revenue from the fee, likely less than $600,000. 1. Fingerprint requirement. Existing state law does not require DHCS to deny a Medi-Cal provider enrollment application for failure to submit fingerprints. Federal regulations require state Medicaid agencies to terminate or deny enrollment if the provider, or any person with a five percent or greater direct or indirect ownership interest in the provider, fails to submit sets of fingerprints in a form and manner to be determined by the Medicaid agency within 30 days of a CMS or a state Medicaid agency request, unless the state Medicaid agency determines that termination or denial of enrollment is not in the best interests of the Medicaid program and the state Medicaid agency documents that determination in writing. This bill requires DHCS to deny an application package for failure to submit fingerprints as required by federal SB 1529 | Page 10 regulations. This bill requires DHCS to deactivate a provider and all business addresses of an applicant or provider whose application is denied because of failure to submit fingerprints, and requires DHCS to remove the applicant or provider from enrollment in the Medi-Cal program. Note: DHCS indicates the purpose of the above-described changes is to comply with the regulations implementing the ACA. 2. Resubmitted Medi-Cal provider applications. Existing state law requires DHCS, if a Medi-Cal application package that was noticed as incomplete is not resubmitted with all requested information and documentation within 60 days of the date on the DHCS notice, to deny the application package. Existing law allows the applicant or provider to reapply by submitting a new application package that is required to be reviewed de novo (starting over as a new application). Existing state law makes a provider subject to deactivation of the provider's number and all of the business addresses used by the provider if the failure to resubmit is by a provider applying for continued enrollment. This bill allows DHCS to deactivate the provider's number and all of the business addresses used by the provider in the circumstances described above. In addition, this bill allows DHCS to deactivate any currently enrolled provider, and not just providers applying for continued enrollment. Note: DHCS indicates the purpose of this change and the change to background checks described below is to implement an ACA requirement and to provide DHCS discretion in implementing that requirement so that DHCS would not have to deactivate an existing provider with multiple locations (such as a chain pharmacy that is opening a new store) when the provider fails to complete an application for a new location. DHCS indicates federal regulations give DHCS discretion in these situations based on a DHCS determination that the deactivation would not be in the best interest of the Medi-Cal program. 3. Background checks, inspections or visits. Existing state law requires DHCS, if DHCS exercises its authority to conduct background checks, pre-enrollment inspections, or unannounced visits, to provide the applicant or provider with notice from DHCS after the conclusion of the background check, pre-enrollment inspection, or unannounced visit of either of the following: SB 1529 | Page 11 § The applicant or provider is granted provisional provider status for a period of 12 months, effective from the date on the notice. § Discrepancies or failure to meet program requirements, as prescribed by DHCS, have been found to exist during the pre-enrollment period. The notice is required to identify the discrepancies or failures, whether remediation can be made, and if so, the time period within which remediation must be accomplished. Failure to remedy discrepancies and failures, or notification that remediation is not available, results in denial of the application. The applicant or provider may reapply by submitting a new application package that is required to be reviewed de novo. Existing state law makes a provider subject to deactivation of the provider's number and all of the business addresses used by the provider if the failure to remedy is by a provider applying for continued enrollment. This bill would bill instead allow DHCS to deactivate the provider's number and all of the business addresses used by the provider, instead of making the provider subject to deactivation. In addition, DHCS would be allowed to deactivate any currently enrolled provider, and not just providers applying for continued enrollment. 1. Provider termination based on termination in Medicare or another state's Medicaid or CHIP program. Federal regulations require the state Medicaid agency to deny enrollment or terminate the enrollment of any provider that is terminated on or after January 1, 2011, under Medicare, or the Medicaid program or CHIP of any other state. This bill prohibits DHCS from enrolling providers in the Medi-Cal program if it is discovered that a provider has been terminated under Medicare, or under Medicaid or a CHIP program of another state. This bill requires DHCS to terminate such a provider. This includes deactivation of the provider's numbers and all business addresses used to obtain reimbursement from the Medi-Cal program. Existing state law prohibits an applicant or provider from reapplying for enrollment or continued enrollment in the SB 1529 | Page 12 Medi-Cal program, or for participation in any health care program administered by DHCS or its agents or contractors, for a period of three years from the date an application package is denied or provisional provider status is terminated. Under existing law, there are exceptions to this three-year bar that permanently prevent a provider from enrollment. This bill allows a provider terminated under Medicare, Medicaid or CHIP to reapply to be a Medi-Cal provider only when a temporary suspension is lifted after a resolution of an investigation for fraud or abuse occurs. Note: DHCS indicates the purpose of the above-described changes is to comply with the regulations implementing the ACA. 2. Temporary suspension. Existing law requires, if it is discovered that a provider is under investigation by DHCS or any state, local, or federal government law enforcement agency for fraud or abuse, that provider to be subject to temporary suspension from the Medi-Cal program. This includes temporary deactivation of the provider's number, including all business addresses used by the provider to obtain reimbursement from the Medi-Cal program. Existing state law requires the DHCS Director to notify the provider in writing of the temporary suspension and deactivation of the provider's number, which takes effect 15 days from the date of the notification. This bill allows DHCS to lift a temporary suspension when a resolution of an investigation for fraud or abuse (as defined below) occurs. Note: DHCS indicates in the previous 12 months, its Medical Review Branch has issued 77 temporary suspensions. 3. Definition of "resolution of an investigation for fraud or abuse." Existing state law does not define "resolution of an investigation for fraud or abuse." Federal regulations define "resolution of an investigation" to state that an investigation of credible allegations of fraud will be considered resolved when legal action is terminated by settlement, judgment, or dismissal, or when the case is closed or dropped because of insufficient evidence to support the SB 1529 | Page 13 allegations of fraud. This bill defines "resolution of an investigation for fraud or abuse" to mean there is no documentation to indicate either that a charge or accusation has been filed against the provider and either (1) the investigation has not been active at any time during the previous 12 months; or (2) DHCS has been unable, for a period of 12 months, to contact an investigator or responsible representative of any agency investigating the provider. Note: DHCS indicates the purpose of including this proposed definition is to provide clarity on when it would lift a sanction upon closure of a case without making a finding or taking action. The proposed definition includes a 12-month limit (which is not included in the federal regulations or state law). The 12-month limit was included in the proposed definition for two reasons: (1) to limit DHCS' broad authority so it could end a withhold, suspension or deactivation of a provider; and (2) because the vast majority of cases are closed by the Medi-Cal Fraud Control Unit (MFCU) within 355 days. 4. Categorical risk levels. Existing state law does not designate providers based on their level of risk. Federal regulations require a state Medicaid agency to screen all initial applications, including applications for a new practice location, and any applications received in response to a re-enrollment or revalidation of enrollment request based on a categorical risk level of ''limited,'' ''moderate,'' or ''high.'' This bill states that provider types are designated as "limited," "moderate," or "high" categorical risk by the federal government pursuant to a specified provision of federal regulations. This bill requires DHCS, at minimum, to utilize the federal regulations in determining a provider's or applicant's categorical risk. This bill requires DHCS, if DHCS designates a provider as a "high" categorical risk, to conduct a criminal background check and to require submission of a set of fingerprints in accordance with a specified provision of the Penal Code. This bill requires, if fingerprints are required, providers and any person SB 1529 | Page 14 with a five-percent direct or indirect ownership interest in the provider to submit fingerprints in a manner determined by the DHCS within 30 days of the request.This bill requires DHCS, in accordance with a specified provision of federal regulations, to designate a provider as a "high" categorical risk if any of the following occur: § DHCS imposes a payment suspension based on a credible allegation of fraud, waste, or abuse. § The provider has an existing Medicaid overpayment. § The provider has been excluded by the federal Office of the Inspector General or another state's Medicaid program within the previous 10 years. § CMS lifted a temporary moratorium within the previous six months for the particular provider type submitting the application, the applicant would have been prevented from enrolling based on that previous moratorium, and the applicant applies for enrollment as a provider at any time within six months from the date the moratorium was lifted. Note: DHCS indicates the purpose of the above-described changes is to comply with the regulations implementing the ACA. 1. Discrepancies during pre-enrollment period affects all of provider's business locations. Existing state law allows DHCS, if discrepancies are found to exist during the pre-enrollment period, to conduct additional inspections prior to enrollment. Under existing law, the failure to remedy discrepancies as prescribed by the Director may result in denial of the application for enrollment. This bill allows DHCS, if a provider failed to remediate discrepancies as prescribed by the Director, to deactivate all of the provider's business addresses. Note: DHCS indicates the purpose of the above-described changes is to comply with the regulations implementing the ACA. 2. Moratorium on enrollment of providers. Existing state law permits DHCS to implement a 180-day moratorium on the enrollment of providers in a specific provider service category, on a statewide basis or within a geographic area when the Director determines this action is necessary to safeguard public funds or to maintain the fiscal integrity of the program. Existing law authorizes DHCS to extend or repeat moratorium when the Director determines this action is necessary SB 1529 | Page 15 to safeguard public funds or to maintain the fiscal integrity of the program. Existing law prohibits a moratorium from being implemented on the enrollment of licensed and unlicensed clinics, and individuals who are health care providers licensed or certified under the Business and Professions Code, such as physicians, pharmacists, physician assistants, optometrists, and chiropractors. Federal regulations require Medicaid agencies to impose temporary moratoria on the enrollment of new providers, or provider types identified by the Secretary of DHHS as posing an increased risk to the Medicaid program. The Medicaid agency is not required to impose such a moratorium if the Medicaid agency determines that imposition of a temporary moratorium would adversely affect beneficiaries' access to medical assistance. If a Medicaid agency makes such a determination, the Medicaid agency must notify the Secretary of DHHS in writing. Federal regulations authorize Medicaid agencies to impose temporary moratoria on enrollment of new providers, or impose numerical caps or other limits that the Medicaid agency identifies as having a significant potential for fraud, waste, or abuse and that the Secretary of DHHS has identified as being at high risk for fraud, waste, or abuse. Before implementing the moratoria, caps, or other limits, the Medicaid agency must determine that its action would not adversely impact beneficiaries' access to medical assistance. Federal regulations require the federal Secretary of DHHS to consult with any affected Medicaid agency regarding imposition of temporary moratoria on enrollment of new providers or provider types prior to imposition of the moratoria. The Medicaid agency must notify the Secretary in writing in the event the Medicaid agency seeks to impose such moratoria, including all details of the moratoria, and obtain the Secretary's concurrence with the imposition of the moratoria. The Medicaid agency must impose the moratorium for an initial period of six months, and can extend the moratorium in six-month increments if necessary. Each time the moratorium is extended, the Medicaid agency must document in writing the necessity for extending the moratorium This bill requires DHCS, if the Secretary of the DHHS establishes a temporary moratorium on enrollment as described in SB 1529 | Page 16 federal regulations, to establish a corresponding moratorium covering the same period and provider types, even if those provider types would not ordinarily be subject to a moratorium under existing state law, unless DHCS determines that the imposition of the moratorium will adversely impact beneficiaries' access to medical assistance. This bill prohibits a federal moratorium adopted under this provision from being subject to any provision of existing state law requiring a Director's determinations regarding safeguards of public funds and program integrity or other prerequisites that are necessary to implement a state-initiated moratorium. Note: DHCS indicates the purpose of the above-described changes is to comply with the regulations implementing the ACA. DHCS currently has three moratoria that have been administratively imposed: Non-pharmacist owned, non-chain pharmacies in Los Angeles County; DME providers in four counties (Los Angeles, Riverside, Orange and San Bernardino counties) and out-of-state; and all clinical labs. 3. Unannounced visits. Existing state law allows DHCS to make unannounced visits to any applicant or to any provider for the purpose of determining whether enrollment, continued enrollment, or certification is warranted, or as necessary for the administration of the Medi-Cal program. At the time of the visit, the applicant or provider is required to demonstrate an established place of business appropriate and adequate for the services billed or claimed to the Medi-Cal program, as relevant to his or her scope of practice, as indicated by, but not limited to, the following: § Being open and available to the general public. § Having regularly established and posted business hours. § Having adequate supplies in stock on the premises. § Meeting all local laws and ordinances regarding business licensing and operations. § Having the necessary equipment and facilities to carry out day-to-day business. Unannounced visits are prohibited for some providers, including licensed and unlicensed clinics, health facilities (hospitals, skilled nursing facilities) and individuals who are certified health care providers licensed or certified under the Business and Professions Code (such as physicians, pharmacists, physician SB 1529 | Page 17 assistants, optometrists, chiropractors) unless DHCS has reason to believe that the provider will defraud or abuse the Medi-Cal program or lacks the organizational or administrative capacity to provide services under the program. Federal regulations require Medicaid agencies to conduct pre-enrollment and post-enrollment site visits of providers who are designated as ''moderate'' or ''high'' categorical risks to Medicaid. The purpose of the site visit is to verify that the information submitted to the Medicaid agency is accurate and to determine compliance with federal and state enrollment requirements. Under the regulations, states must require any enrolled provider to permit CMS, its agents, its designated contractors, or the Medicaid agency to conduct unannounced on-site inspections of any and all provider locations. This bill requires enrolled providers, if an unannounced site visit is conducted by DHCS, to permit access to any and all of their provider locations. This bill requires DHCS, if a provider fails to permit access for any site visit, to deny the provider's application, and requires the provider to be subject to deactivation. Note: DHCS indicates the purpose of the above-described changes is to comply with the regulations implementing the ACA. 1. Appeals. Existing state law requires any applicant whose application for enrollment as a provider is denied, or any provider who has been denied continued enrollment, denied for a new location, temporarily suspended, has had payments withheld, has had one or more business addresses deactivated, has been terminated, or who has had a civil penalty imposed can appeal this action by submitting a written appeal, including any supporting evidence, to the Director or the Director's designee. Under existing law, if the appeal relates to withholding of payment, the appeal to the Director or the Director's designee is required to be limited to the issue of the reliability of the evidence supporting the withhold, and is prohibited from encompassing fraud or abuse.This bill requires the appeal for a suspension of payment to be limited to the credibility of the allegation supporting the payment suspension, and prohibits it from encompassing an SB 1529 | Page 18 investigation or adjudication of the allegation. DHCS indicates the intent of existing law and the proposed changes are to keep the provider focused on information relevant to the appeal, and to make the standard of review clearer for the hearing officer (DHCS indicates many of the hearing officers are auditor staff without formal legal training). DHCS indicates the system is intended to be user-friendly to small businesses and health care providers proceeding without a lawyer. 2. Authority for DHCS to implement specified provisions through provider bulletins or similar instructions. Existing state law allows the DHCS Director, in consultation with interested parties, through regulation, to adopt, readopt, repeal, or amend additional measures to prevent or curtail fraud and abuse. Regulations adopted, readopted, repealed, or amended under this provision are deemed to be emergency regulations in accordance with the APA. Existing law deems these regulations as an emergency, and existing law exempts these regulations from review by the Office of Administrative Law. Existing law allows the Director, without taking regulatory action under the APA, to implement, interpret, or make specific specified provisions of existing law dealing with Medi-Cal provider enrollment, including by means of a provider bulletin or similar instruction. In doing so, DHCS is required to notify and consult with interested parties and appropriate stakeholders in implementing, interpreting, or making specific those provisions, including all of the following: § Notifying provider representatives of the proposed action or change, including providing notice at least 10 business days prior to the meeting described below. § Scheduling at least one meeting with interested parties and appropriate stakeholders to discuss the action or change. § Allowing for written input regarding the action or change. § Providing at least 30 days' advance notice of the effective date of the action or change. This bill allows DHCS to implement the application fee and provider classification based on fraud risk provisions of this bill through provider bulletins or other similar instructions without taking regulatory action under the APA. SB 1529 | Page 19 Note: DHCS indicates the use of provider bulletins instead of regulations allows for a more efficient and expeditious process, and public comment is required under that process under existing law. 1. Meet and confer. Existing law requires DHCS to develop, in consultation with provider representatives, including, but not limited to, physician, pharmacy, and medical supplies providers, a process that enables a provider to meet and confer with the appropriate DHCS officials within 30 days after the issuance of a letter notifying the provider of a withholding of payment or a temporary suspension for the purpose of presenting and discussing information and evidence that may impact DHCS' decision to modify or terminate the sanction. This bill deletes the 30-day requirement. This bill change references from "withhold of payments" to "payment suspension." Note: DHCS indicates this provision is clean-up to the "meet and confer" language that would no longer require the provider to notify DHCS within 30 days that the provider wishes to meet and confer. DHCS indicates requiring DHCS to meet and confer within 30 days of the sanction implies that the provider must make the request in some time less than 30 days. Were DHCS to implement this provision, DHCS indicates it would have to promulgate regulations giving providers a deadline to submit a request that would leave DHCS sufficient time to organize the meet and confer before the statutory deadline. DHCS' states that, many providers wait to file their requests in order to retain counsel and perform internal fact-finding, and while DHCS welcomes promptly-filed requests and is willing to meet promptly, DHCS sees no need to force providers into a shorter timeframe. 2. Recovery audit contractors. Existing state law does not specifically authorize DHCS to enter into contracts with RACs. Existing federal law requires states, not later than December 31, 2010, to establish a program under which the state contracts with one or more RAC for the purpose of identifying underpayments and overpayments and recouping overpayments under the Medicaid State Plan. The state must provide assurances satisfactory to the Secretary that, under such contracts, SB 1529 | Page 20 payment must be made to such a contractor only from amounts recovered, and from the amounts recovered, payments are required to be made on a contingent basis for collecting overpayments, and may be made in such amounts as the state may specify for identifying underpayments. This bill permits DHCS to enter into contracts with one or more eligible Medicaid RACs under the above described provision of federal law. This requirement takes effect January 1, 2012. In implementing this provision, DHCS would be exempt from a specified provision of law that limits personal service contracts. Note: DHCS indicates this provision is to comply with the ACA, and the RAC program will mirror what Medicare is doing where a contractor is hired via a Request for Proposal procurement to perform parallel audit services along with state audit efforts. DHCS indicates it needs an exemption from the personal service contract requirement because the federal regulation requires it to secure a "third-party" contractor to perform audit services (separate from state efforts). California submitted a RAC State Plan Amendment (SPA) in December 2010, which was approved in February 2011. 3. Note on conditional operation of specified provisions of this bill. The Medicaid State Plan is the officially-recognized document describing the nature and scope of state Medicaid programs and is required under federal law. Changes to the Medicaid State Plan are known as SPAs and are submitted by the state to DHHS for approval. This bill contains language in certain sections of this bill that the amendments to those code sections become operative on the effective date of the SPA necessary to implement the change and a declaration by the DHCS Director that states that this approval has been obtained with the effective date of the SPA. The affected existing code sections that this bill amends would, in effect, sunset and be replaced when the changes made by this bill take effect. FISCAL EFFECT : This bill has not been analyzed by a fiscal committee. COMMENTS : SB 1529 | Page 21 1.Author's statement. According to the author, SB 1529 would conform state Medi-Cal fraud law to provisions within the federal Affordable Care Act. By conforming state law to federal law in the areas of screening, enrollment, and sanctions of Medi-Cal providers, DHCS will have more tools to address and curb Medi-Cal fraud. If California does not comply with federal regulations, there is the potential loss of federal financial participation program wide. 2.Medi-Cal Payment Error Study. DHCS has conducted five payment error studies (known as Medi-Cal Payment Error Study or MPES). The most recent study from 2009 found that 94.55 percent of payments to fee-for-service Medi-Cal providers in 2009 were billed appropriately and paid accurately. In terms of dollars, the projected potential losses in 2009 totaled $1.07 billion. The potential provider fraud rate, which is a part of the overall payment error rate, has also declined significantly, from 3.23 percent in 2005, to 1.16 percent in 2009. In terms of dollars, the potential losses from fraud have dropped from $542 million cited in MPES 2005 (total Medi-Cal budget in 2004-05 was $31 billion) to $228 million cited in MPES 2009 (total Medi-Cal budget in 2008-09 was $40 billion). The 2009 MPES findings are based upon a random sample of 1,149 Medi-Cal fee-for-service claims paid during the fourth quarter of 2009 (October 1 through December 31) and is organized by provider type. 3.Support. This bill is sponsored by DHCS to align California's state law with the ACA-related changes to federal regulations, as it relates to screening, enrollment, payment suspensions, overpayment recovery and sanctions of Medi-Cal providers. DHCS states this bill would provide DHCS with the authority to establish procedures for California to comply with ACA provisions required by federal regulations. DHCS states CMS believes the new screening requirements will move Medicare and Medicaid from a "pay and chase" model to one that will prevent fraudulent providers from enrolling as Medicare and Medicaid providers. DHCS continues that the intent of this bill is to prevent fraud from occurring in the Medi-Cal program, and the federal regulations require states to implement these measures and ensure compliance. Currently, California statutes provide authority to DHCS and other state departments to take actions to protect the fiscal integrity of the Medi-Cal program but the new federal regulatory requirements are not provided for in existing California statutes or regulations. Therefore, California statute must be amended in order for the state to SB 1529 | Page 22 have the necessary legal authority and comply with federal requirements. DHCS states this bill would make only the minimally-required amendments to existing law to gain the statutory authority to carry out the federal requirements. Given California has had standards of participation more rigid than the federal requirements in the past, minimal changes to California codes are necessary for a majority of the new requirements established by the regulations. As the state Medicaid agency, if DHCS does not comply with the regulations, there is the potential loss of federal financial participation program-wide. 4.Oppose unless amended. The California Medical Association (CMA) writes it is opposed to this bill unless it is amended. CMA writes that it understands that the bulk of the content of this bill was contained in the ACA and its implementing regulations, and that it is necessary to make changes to California statute to comport with these new federal requirements. CMA states that, though it supports efforts to stem fraud, if these efforts are overly punitive, could severely impact the financial solvency of a medical practice, and CMA urges they be used sparingly and with the utmost discretion. CMA indicates there appears to be some room in the ACA's provisions that allow some flexibility for states in their interpretation of the code, and CMA is currently drafting amendments to ensure that the bill's requirements are as targeted as possible in order to avoid the unintended but potentially significant impacts this bill could have on individual physician offices seeing a high volume of Medi-Cal and Medicare patients. 5.Author's amendments. a. This bill deletes the word "temporary" from two sections of law (Sections 14043.2 and 14043.7) dealing with the "temporary deactivation" of a provider number. DHCS indicates this deletion was made inadvertently and the author intends to propose amendments to restore this word. In addition, DHCS would like to include the word "referring" (as in "referring provider") to Section 14043.15(b)(3). b. This bill also narrows the definition of "provider" and "applicant" in the Health and Safety Code Section 100185.5 to limit their applicability to only Medi-Cal providers and applicants, and not to providers and applicants to other health care programs administered by DHCS, as is required under existing law. The author intends to offer amendments SB 1529 | Page 23 to continue to apply these revised definitions to other programs administered by DHCS. 6.Policy issues. a. Bill drafting. This bill is intended to align California's state law with federal regulations relating to the screening, enrollment, payment suspensions, overpayment recovery and sanctions of Medi-Cal providers. DHCS states this bill would amend California statute to provide DHCS with the authority to establish procedures for California to comply with these ACA provisions and related federal regulations. However, the requirements of this bill in state law are not drafted contingent upon a requirement in federal law or regulations, and would remain in effect if the ACA is struck down. If this bill were not implementing federal requirements, the Legislature, individuals representing Medi-Cal beneficiaries, and Medi-Cal health care providers would likely have a different view of some of the requirements of this bill. One way to address this issue would be to include language in this bill that makes its ACA-related changes contingent upon a requirement in federal law or regulation, either as an amendment now, or following the results of the Supreme Court decision expected later this year. b. Credible allegation of fraud. In Section 1, this bill amends the Health and Safety Code to implement federal requirements for a payment suspension based on a "credible allegation of fraud." However, the language in this bill using the legal standard of "credible allegation of fraud" appears to apply more broadly than the federal requirement that it apply to a payment suspension. For example, this bill would apply the "credible allegation of fraud" standard to the denial of continued enrollment, the suspension of providing services, and the denial of an application, which seems to go beyond the federal regulations. In addition, this section of law applies to other health care programs administered by DHCS, and not just the Medi-Cal program. To clarify the intent of DHCS to have this bill implement the ACA and its related regulations, committee staff recommends amendments to either delete this provision of this bill or to limit the "credible allegation of fraud" standard to the ACA SB 1529 | Page 24 requirement. c. Applicability of bill to Medi-Cal managed care health care providers. One of the questions raised by health care provider associations whose members provide services to Medi-Cal beneficiaries is whether this bill applies to managed care health care providers (in addition to fee-for-service ÝFFS] Medi-Cal health care providers). DHCS indicates it is still evaluating the full impact of the ACA on managed care and how the regulations apply to managed care providers. However, DHCS indicates this bill does not impact managed care providers because the enrollment statutes that are being amended are specific to FFS providers. DHCS indicates the conflicting information from CMS is in regard to whether an ordering, referring, or prescribing provider is required to be on a FFS claim when that claim is a carved-out service for a managed care beneficiary (a carved-out service is reimbursed outside of managed care). Based on January 2012 discussions with CMS, DHCS states that if a managed care enrolled beneficiary were to be referred by, or were to receive an order for carved-out goods or services from a Medi-Cal managed care network provider, that provider would not have to be enrolled in Med-Cal as an ordering/referring provider. SUPPORT AND OPPOSITION : Support: Department of Health Care Services (sponsor) California Advocates of Nursing Home Reform Oppose: California Medical Association (unless amended) -- END -