Health Care Compliance Associationʹs 18 th Annual Compliance Institute. Medicare Enrollment Application, Revocation and Appeals

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Health Care Compliance Associationʹs 18 th Annual Compliance Institute Medicare Enrollment Application, Revocation and Appeals March 30 April 2, 2014 San Diego, CA Anne Novick Branan, Esq. Attorney Broad and Cassel abranan@broadandcassel.com William (ʺTedʺ) Cuppett Managing Member The Health Group LLC ted.cuppett@healthgroup.com Objectives Learn tips to ensure enrollment success and avoid enrollment deficiencies that can result in denial or revocation of billing privileges Discuss how proposed regulations expanding Medicareʹs authority to deny enrollment and revoke Medicare participation will affect your company Understand appeal rights for enrollment denials and revocations of Medicare privileges. 2 1

Enrollment Basics Submit appropriate version of CMS Form 855 Provider/Supplier Enrollment Application to Medicare Administrative Contractor (ʺMACʺ) or National Supplier Clearinghouse for DMEPOS Suppliers 42 C.F.R. 424.510 Must include complete, accurate and truthful information and all supporting documentation Signed certification statement by person with authority to bind the enrollee Pay fee when required or get hardship exception 3 Enrollment Basics: The CMS 855 Form Use Correct CMS Form 855 CMS 855A For institutional providers (i.e. HHA, hospitals, SNF, Rural Health Clinics) CMS 855B For clinics/group practices, IDTFs, ASCs, and other entities (non individuals billing under Part B), not DMEPOS suppliers CMS 855I For individuals (physicians, NPPs) billing under Part B CMS 855O For registration of ordering/ referring physicians and NPPs. CMS 855R Reassigning benefits under Part B CMS 855S For DMEPOS suppliers 4 2

Enrollment (Contʹd.) Things to know about the 855 forms: Each particular version of 855 has instructions and definitions, some of which are peculiar to that version Instructions are not always instructive regarding item reported The forms are forms and do not fit all situations (particularly complex CHOWs) well. 5 Enrollment Basics (Contʹd.) Things to know about the 855 forms: They can be downloaded from CMSʹs website CMS changes the forms from time to time: If you do not use the right version, your enrollment will be delayed! Important because enrollment is effective beginning on the date that the MAC receives an 855 that can be processed to conclusion, and generally suppliers (and to a lesser extent providers) are not allowed to bill for services furnished before the enrollment date. 6 3

Enrollment Basics (Contʹd.) Update changes to information on CMS Form 855 within required time frames 42 C.F.R 424.516(e) and 42 C.F.R. 424.540(a)(2) Update CHOWs, location, adverse legal actions (i.e. loss of license or certification) within 30 days All other changes within 90 days (non CHOW ownership changes like stock transfers, change in billing services, managing employees) 7 Enrollment Basics (Contʹd.) Complete accreditation, survey or on site review requirements for provider type 424 C.F.R 510(d) (5) and (8) On site review is for purpose of verifying enrollment information is accurate and determining compliance with Medicare enrollment requirements. These onsite reviews do ʺnot affect those site visits performed for establishing compliance with COPs.ʺ 424 C.F.R 510(d) (8) 8 4

Enrollment Basics (Contʹd.) MAC is required to screen all initial applications (including new location and revalidation request responses) based on CMS assessment of risk levels. 42 C.F.R. 424.518 Levels are ʺlimited,ʺ ʺmoderate,ʺ or ʺhigh.ʺ 9 Enrollment Basics (Contʹd.) Examples of ʺlimitedʺ physicians, ASCs, endstage renal disease centers, hospitals, SNFs, pharmacies Verification of licenses & post enrollment verifications Examples of ʺmoderateʺ Ambulances, CMHCs, Hospices, IDTFs, physical therapists, revalidating HHAs and DMEPOS Includes on site review Examples of ʺhighʺ only newly enrolling HHA and DMEPOS in this category Includes fingerprinting/criminal history check 10 5

Enrollment Basics (Contʹd.) PPACA (Section 6401) requires CMS to implement requirements that providers and suppliers establish compliance programs as a condition of enrollment Regulations not yet published Also 6102 of PPACA makes compliance programs mandatory for enrollment of nursing home providers (NF and SNF) Effective March 23, 2013 11 PECOS What is PECOS? Provider Enrollment Chain and Ownership System It is a secure Web site that providers and suppliers can access to submit an application to enroll or change information PECOS can be access at: https://pecos.cms.hhs.gov/pecos/login.do. 12 6

Results After Filing 855 Follow up Communication Rejection of Application Denial of Enrollment Revocation of Associated Providers Acceptance and Enrollment 13 Results After Filing 855 (Contʹd.) Rejection of Application Reasons Incomplete form Failure to submit requested information within 30 days Failure to pay application fee No appeal rights for rejection of form. Must resubmit new 855 42 C.F.R. 424.525 14 7

Results After Filing 855 (Contʹd.) Denial of Enrollment 42 C.F.R. 424.530 Many reasons, including: Non compliance with enrollment requirements False/misleading information on CMS 855 Current owner, physician or non physician practitioner has an existing overpayment Provider (or owner, managing employee, medical director, supervising physician, authorized/delegated official) conduct excluded, debarred or suspended from federal programs. 15 Denial of Enrollment (Contʹd.) Reasons: Felonies (within 10 years) by provider or any owner (crimes against persons like rape, murder and financial crimes like tax fraud, embezzlement etc.) CMS determines if conduct is ʺdetrimental to best interests of programʺ Current owner, physician or non physician practitioner on Medicare payment suspension Fails on site review (not operational) HHA fails to maintain required initial reserve operating funds 16 8

Results After Filing 855 (Contʹd.) Denial of Enrollment for Overpayment CMS Transmittal 479 (August 1, 2013) CR 8039 revised Program Integrity Manual, Ch. 15 regarding denial of an 855 when an existing or delinquent overpayment exists MAC required to get CMS approval first October 17, 2013 MLN Matters Article MM8039 ʺEnrollment Denials When Overpayment Existsʺ clarified several points with examples of overpayments that would result in denial 17 Results After Filing 855 (Contʹd.) Revocation of Associated Provider Denial or Enrollment can result in adverse action (e.g. revocation) of associated providers (i.e. providers with same manager, owners or authorized officials) 18 9

Results After Filing 855 (Contʹd.) Acceptance Will receive letter from MAC with date of effective enrollment and additional forms, including provider agreement, to sign 19 Revocation of Enrollment and Billing Privileges When enrolled provider fails to comply with condition of continued enrollment 42 CFR 424.535 Many reasons, including many of the reasons for denial, plus: Misuse of billing number (sells, allows another to use) Abuse of billing privileges (beneficiary is deceased, out of country) Failure to report information (i.e. CHOW, changes in location) Medicaid termination by State (exhaust appeals first). 20 10

Revocation of Enrollment and Billing Privileges (Contʹd.) CMS will also terminate Medicare provider agreement if revokes enrollment. 21 Deactivation of Medicare Billing Privileges 42 C.F.R. 424.540 Deactivation means providerʹs billing privileges were stopped, but can be restored upon the submission of updated information 42 C.F.R. 424.502 No effect on providerʹs participation agreement/can reactivate is most cases Reasons Fails to submit claims for 12 consecutive months Fails to report changes to enrollment information HHA 36 month rule related to CHOWs. 22 11

Proposed Enrollment Regulations 78 Fed. Reg. 25013 (April 29, 2013) Dramatically expands CMS authority to deny enrollment and revoke Medicare provider numbers (PTANs) and billing privileges Gives CMS much discretion As of February 2014, rules are still in rulemaking stage; comments were due on June 28, 2013 Many proposed changes 23 Proposed Enrollment Regulations (Contʹd.) Two of the onerous proposals: Denial of enrollment if the enrolling provider, supplier or owner has an existing overpayment (current rules do not apply to all providers and suppliers) Must repay in full or have repayment plan Revocation of Medicare enrollment and billing privileges when the provider or supplier has ʺabusedʺ its Medicare billing privileges 24 12

Proposed Enrollment Regulations (Contʹd.) Revocation for ʺabuseʺ of its Medicare billing privileges Current rule is limited (i.e. deceased beneficiary, out of country) For a ʺpattern or practiceʺ of submitting claims for services that fail to meet the Medicare requirements 25 Proposed Enrollment Regulations (Contʹd.) Revocation for ʺabuseʺ of its Medicare billing privileges Preamble says ʺa common scenario warranting such revocation would be when a provider or supplier is placed on prepayment review and a significant number of claims are denied for failing to meet the medical necessity requirements (78 Fed Reg. at pg. 25022) CMS will use discretion to revoke privileges, including factors such as the reasons for the claims denial, % of denials and length of time over which the pattern has continued. 26 13

Appeals of Enrollment Actions Covered by 42 CFR Part 498 but also see 42 CFR Part 405 Subpart H Triggered by an unfavorable ʺinitial determinationʺ related to enrollment 42 CFR 498.3(h) 27 Denial or Revocation of Enrollment: The Appeals Process Four steps: Reconsideration before the MAC Also Corrective Action Plan ALJ Hearing Departmental Appeals Board (DAB) Review District Court/Judicial Review 28 14

Appeals Process Reconsideration Must be requested within 60 days of receipt of Initial Determination For list of ʺInitial Determinationsʺ that can be appealed see 42 C.F.R. 498.3 Request for reconsideration must identify any error made by MAC 42.C.F.R. 498.22 29 Corrective Action Plan (CAP) Submit when provider receives notice that CMS will revoke its billing privileges Must be submitted within 30 days (not a month) Use in addition to Request for Reconsideration For some MACs, provider must use the form on the MAC website 30 15

Corrective Action Plan (CAP) (Contʹd.) MAC/CMS required to process within 60 days. Much discretion in terms of review, approval and processing Get to know the people processing your CAP. Rejection of CAP is not appealable (Medicare Program Integrity Manual CMS 100 08, Ch. 15 25 1.1.B.) 31 Corrective Action Plan (CAP) (Contʹd.) To correct deficiencies that resulted in the proposal to revoke Identify what was wrong and how it was corrected Carefully consider how you ʺagree to improveʺ something without agreeing that you are at fault Provider must establish that it is in compliance with Medicare requirements 32 16

Corrective Action Plan (CAP) (Contʹd.) Submitting a CAP does not substitute for submitting a request for reconsideration and does not toll the time for submitting a request for reconsideration. If you choose to submit a CAP and miss the appeal deadline, you are out. File reconsideration request at same time you file CAP, but it may not be processed at same time. 33 Appeals Process ALJ Hearing 42.C.F.R. 498.40 Request for hearing must be made within 60 days of notice of reconsideration determination ALJs are bound by statute, regulations and CMS Rulings (but not manual instructions) DAB sends out prehearing order within about 10 days after the request is filed. 34 17

Appeals Process ALJ Hearing (Contʹd.) OGC Regional Counsel has 30 days put case together OGC attorneys generally have been reasonable to deal with and settle many of the cases Better chance of favorable ruling at ALJ level than below 35 Appeals Process ALJ Hearing (Contʹd.) The ALJ hearing is an adversarial process. Parties may present oral arguments, question and cross examine witnesses, and file briefs or other written statement. The ALJ, upon his or her own motion or at the request or a party, may issue subpoenas. 36 18

Appeals Process DAB Review Either party may request DAB review of the ALJʹs decision or dismissal. 42 C.F.R. 498.80; 42 C.F.R. 498.82 60 day deadline 37 Appeals Process DAB Review The DAB may grant, deny or dismiss a request for review. Upon request by the DAB, the parties will be permitted to file briefs or other written statements and (rarely) an opportunity to present to the DAB oral arguments and evidence. 38 19

Appeals Process ALJ Hearing (Contʹd.) Upon taking review, the DAB may issue a decision, or it may remand the case back to the ALJ either for a hearing and decision or for a recommended decision (in which case, the final decision will be issued by the DAB). 39 Appeals Process District Court Following a final decision by the Secretary ʺmade after a hearingʺ a party can seek review in the district court This generally means that one must receive a DAB ʺdecision,ʺ or an ALJ ʺdecisionʺ (if the DAB declines review) A ʺdismissalʺ does not count one must have a ʺdecisionʺ in order to get into court Exhaustion of remedies generally required, but if no right to administrative appeal (e.g., deactivation), there may be federal question jurisdiction. See Bowen v. Michigan Academy of Family Physicians, 476 U.S. 557 (1986). 40 20

Another Type of Enrollment: Ordering and Referring Physicians/Practitioners Affordable Care Act requires that physicians and ʺother eligible professionals (OEP)ʺ be enrolled in Medicare to order or refer certain items or services for Medicare beneficiaries. ʺOEPsʺ are: Physician Assistants Clinical Nurse Specialists Nurse Practitioners Clinical Psychologists Interns, Residents, and Fellows Certified Nurse Midwives Clinical Social Workers 41 Ordering and Referring Physicians/Practitioners For claims from: Part A HHAs Clinical Laboratories for ordered tests Suppliers of DMEPOS Imaging Centers (Technical portion only) 42 21

Ordering and Referring Physicians/Practitioners (Contʹd.) Effective January 6, 2014, CMS turned on the edits to deny Part B clinical lab and imaging, DMEPOS, and Part A HHA claims that fail the ordering/referring provider edits. MLN Matters SE 1305 Revised (November 6, 2013); and MLN ʺMedicare Enrollment Guidelines for Ordering/Referring Providersʺ ICN 906223 (December 2013). 43 How to Check Enrollment Record Providers & suppliers may check the Ordering Referring Report or Internet based PECOS to verify their enrollment records The Ordering Referring Report is published by CMS Report shows all physicians & OEPs who have an approved record in PECOS to order and refer and those who have an application that has been received and is pending approval Report is available at: http://www.cms.gov/medicareprovidersupenroll /06_MedicareOrderingandRefering.asp#TopOfPa ge 44 22

APPENDIX OF STATUTORY AND REGULATORY AUTHORITIES 45 Enrollment Authorities Provider and Supplier Enrollment Regulations 42 CFR Part 424, Subpart P (the 424.500ʹs) establishing and maintaining Medicare billing privileges (including rules for denying, revoking and deactivating billing privileges, and special rules on HHA changes in majority ownership) 424.57 DMEPOS supplier standards 424.58 DMEPOS accreditation procedures 410.33 IDTF Standards 42 CFR, Part 498 appeals procedures (see also 42 CFR Part 405, Subpart H (the 424.800ʹs)) Manual Provisions Medicare Program Integrity Manual (Pub. 100 08 Chapter 15 available at http://www.cms.gov/manuals/om/list.asp PECOS Guide ʺGetting Started With Internet based Provider Enrollment, Chain and Ownership System (PECOS)ʺ available at: http://www.cms.gov/medicareprovidersupenroll/downloads/internetbasedpecos%e2%80%93gettingstartedguidefordmepossuppliers.pdf 46 23

Enrollment: Recent Final Rules April 27, 2012 final rule in furtherance of May 5, 2010 interim final rule with comment period (see below), on enrollment requirements for ordering/referring physicians and NPI requirements (77 FR 25284) March 14, 2012 further changes to DMEPOS supplier standards, including changes to patient anti solicitation provision (77 FR 14989) 47 Enrollment: Recent Final Rules (Contʹd.) February 2, 2011 implementing provision of PPACA on screening requirements, application fees, temporary enrollment moratoria, payment suspensions, and Medicaid terminations of providers and suppliers that have been terminated or that had their billing privileges revoked (76 FR 5682) August 27, 2010 additional DMEPOS supplier standards (75 FR 166). 48 24

Enrollment: Recent Final Rules (Contʹd.) May 5, 2010 implementing provisions of PPACA to require all providers and suppliers that qualify for an NPI to include their NPI on all applications to enroll in the Medicare and Medicaid programs and on all claims for payment submitted under the Medicare and Medicaid programs (75 FR 24437) January 2, 2009 surety bond requirement for DMEPOS suppliers (74 FR 166) 49 Enrollment: Recent Final Rules (Contʹd.) November 19, 2008 established the reenrollment bar of 1 to 3 years on providers and suppliers that have had their billing privileges revoked, and placed limitations on retroactive billing by providers and suppliers (73 FR 69726) June 27, 2008 ʺAppeals of CMS or CMS Contractor Determinations When a Provider or Supplier Fails to Meet the Requirements for Medicare Billing Privilegesʺ (73 FR 36448). 50 25

Enrollment: Recent Final Rules (Contʹd.) November 27, 2007 changes to IDTF provisions in 410.33 (72 FR 66222) December 1, 2006 established performance standards for IDTFs (71 FR 69624) April 21, 2006 ʺRequirements for Providers and Suppliers to Establish and Maintain Medicare Enrollment,ʺ implementing section 1866(j)(1)(A) of the Act (71 FR 20754) October 11, 2000 additional standards for DMEPOS suppliers (65 FR 60366). 51 Q U E S T I O N S??? Doc #4816 1341 2120v1 52 26