Medicare Provider Enrollment: When did it become a full contact sport?

1. Medicare Provider Enrollment: When did it become a full contact sport? Don Romano, Foley & Lardner, D.C. Dromano@foley.com Louise M. Joy, Joy & Young, Austin ljoy@joyyounglaw.com

2. Enrollment: Tools of the Trade Provider and Supplier Enrollment Forms – the 855 • CMS 855A -- For institutional providers • CMS 855B – For clinics/group practices, IDTFs, ASCs, and other entities (non-individuals billing under Part B), not including DMEPOS suppliers • CMS 855I – For individuals (physicians, NPPs) billing under Part B • CMS 855O For physician and NPPs for the sole purpose of ordering and referring items and/or services • CMS 855R – For reassigning benefits under Part B • CMS 855S – For DMEPOS suppliers • All new versions effective 7/11—LOTS OF SIGNIFICANT CHANGES!!!

3. Enrollment: Tools of the Trade Other Forms • CMS 588 Electronic Funds Transfer Agreement • CMS 460 Participating provider agreement • CMS 1561 Provider Agreement for Certified Providers • IRS CP-575 Proof of Taxpayer Identification Number (TIN/EIN)

4. Enrollment: The Players • MAC* Enrollment Staff • MAC Enrollment Directors • Part A- Florence Ng (TB) • Part B- Wanda McClatchy (TB) • State Agencies: DSHS/DADS • CMS Regional Office • CMS Baltimore (MAC-Medicare Administrative Contractor-F/K/A Carriers/Fiscal Intermediary (FI))

5. Enrollment: Pointers Essential things to know about the 855 forms • Available On CMS website (or just Google the form number) • Select “Forms” on the left side of the page http://www.cms.gov/CMSForms/CMSForms/list.asp#TopOfPage) • CMS changes the forms from time to time: • Use the right version or enrollment will be rejected! • Part B Enrollment is effective beginning on the date that the contractor receives an 855 that can be processed to conclusion (Part A is different) • Generally suppliers (and to a lesser extent providers) are not allowed to bill for services furnished before the enrollment date • Retrospective Billing Date for Part B is 30 days before enrollment date

6. Enrollment: Essential Facts • 855 Forms come with instructions--each particular version has its own instructions • Submitted form must be complete and accurate (particularly important as it relates to retroactivity) • Enrollment application must be kept current (30/90 days) • 855R must be signed by the individual reassigning the benefits, and completed by the entity (or person) to which/whom the benefits are being reassigned • The forms are forms and not regulations. They are not perfect and they do not fit all situations

7. Enrollment :Essential Facts • The 855S must be submitted with: • a copy of a surety bond in the correct amount (unless the supplier is exempt from the surety bond requirement) • proof of accreditation (for those items for which accreditation is required) • Adverse legal action documentation must be attached • There is a backlog in processing the 855 forms • Backlog varies by contractor and type of provider/supplier • Backlog varies by type of transaction (Trailblazers post average processing times on Provider Enrollment page)

8. Update, Update Update • CMS 855 filings are like extremely delicate gardens that must be maintained: • Weed them to get out old practice locations and managing and controlling persons/entities • Water them and provide all new information about new practice locations, new controlling persons/entities • Feed them to make sure that your provide revalidation information when requested • Watch your calendar for seasonal changes: • 90 day deadlines for less critical information • 30 days deadlines for more critical information • If CMS 855 information is not updated properly, correctly and quickly the garden may die • If the garden dies, you need to immediately attack the problem or you may never get it back

9. Update, Update Update • Watch out for Adverse Action Reporting • Licensure revocations and suspensions require reporting within 30 days • Even if a licensure suspension is rescinded it must be reported. • See CR 2145 – despite licensure suspension being lifted after it was imposed, revocation was appropriate because suspension was not reported in 30 days • See CR 2112 – complex case where TX physician got a board order from TMB but license was revoked in California for failure to respond.

10. NEW 855 CONUNDRUM • Complex Ownership/Control Disclosure for entities and individuals • Required to report mortgage & security interest • Significant level of detail • Exact Percentage ownership/control required to be reported • How do you figure out percentage of management control? • How frequently do you update “exact percentage”? • Separate reporting for physician-owned hospitals: all physician owners must be reported.

11. New Issues • Application Fees • New Enrollments, New Locations, Reenrollment/Revalidations (not CHOWs) • PayPal for government (Pay.gov) • No paper checks • Accreditation Standards for Advanced Imaging (1/1/2012) • Applies to TC by IDTF/MD/DO/DDS/OMFS/Grps • Hospitals are exempt • Nuclear Medicine, MRI, and CT

12. New Issues • DNF Initiative • Instead of revoking providers for returned mail; MACs now must contact providers to see if there was a USPS error. • Revalidation of all providers by 3/23/2013 • Watch out for 60-day deadlines • Application Fees must be paid • Scary given what happened with Ordering/ Referring Initiative • Bets on whether the deadline moves?

13. Revalidation Effort • First Trailblazers letters sent on 9/30/2011 • Providers not in PECOS (thru 12/31/2011) • Thereafter random selections • Huge undertaking; much larger than the Ordering/Referring initiative • AMA has tried to get it pared down. • No revocations this time; • After 60 days to submit, provider is deactivated • Potential gap in reimbursement from deactivation

14. Special Rules for DME and Home Health

15. DURABLE MEDICAL EQUIPMENT : DME MEANS WAR • Put on your flack jacket and then pay watch out for 26 separate land mines • DME has extremely strict rules of engagement • If you are out of compliance with any of the 26 standards, the DME company or practice runs the risk of revocation. • Watch out in particular for: • Posting of hours • Telephone lines • CMS 855S –frequent updates

16. HHA 36-Month Rule • Generally, in a CHOW of a provider, the new owner assumes the provider agreement of the old owner (unless the new owner expressly declines) • Special rule for HHAs in certain changes of ownership that take place within 36 months after the effective date of the HHA’s enrollment in Medicare. • Where the rule applies, HHA must enroll as a new provider and must be re-surveyed or re-accredited prior to enrollment in Medicare • Rule due to CMS’s concerns about owners “flipping” HHAs instead of operating HHAs.

17. HHA 36-Month Rule • CY 2011 HH PPS rule clarifies the 36-Month Rule is triggered when there is a “change in majority ownership” • “change in majority ownership” does not include an indirect change in ownership (stated only in preamble) • CY 2010 rule provided that 36-Month Rule was applicable where there was any “change in ownership” • “change in majority ownership” or “change in ownership” is not synonymous with a CHOW (as defined in 489.18) • includes the acquisition of a majority ownership (more than 50%) in a HHA through the cumulative effect of asset sales, stock transfers, consolidations, or mergers during the 36-month period after Medicare billing privileges are conveyed or the 36-month period following the HHA’s most recent change in majority ownership

18. HHA 36-Month Rule: Exceptions-- 424.550(b)(2)) • HHA submitted two consecutive years of full cost reports • low utilization or no utilization cost reports do not qualify as “full cost reports” • HHA's parent company is undergoing an internal corporate restructuring, such as a merger or consolidation • Owners of an existing HHA are changing the HHA's existing business structure and the owners stay the same • Corporation to Partnership; LLC to Corp; Partnership to LLC • An individual owner of an HHA dies

19. Deactivations – 424.540 • Deactivations are done for providers/suppliers that have not submitted claims for more than 12 months, or that have not reported changes timely on an applicable 855 • Rules indicate intent to protect the supplier/provider from abuse by others • Deactivation can lead to loss of income (CR 2394) • Concerns about groups operating in more than one payment locality-(Big problem in Texas) • Imposition of deactivation is not appealable administratively • But can you appeal directly to court?

20. Revocations -- 424.535 • Effective retroactively or prospectively • Enrollment bar 1-3 years • Causes: • Failure to revalidate • “Drive by shooting” (practice location not operational) • Telephone contact not operational • Letters returned to contractor • and many more . . .

21. Death by Lack of Notice • Revalidation Requests lead to revocation • Request never received • Lacking letter never received • Lacking letter did not identify real problem • Ordering/Referring Practitioner nightmare • Originally 4/2009 to be effective 10/2009 • Now postponed indefinitely

22. Enrollment Tools: Revocation Repair Kit • Corrective Action Plan (CAP) • Request for Reconsideration (RfR) • Request for Hearing to Departmental Appeals Board • Contacts at CMS Central Office • Your Congressional Representative or Senator

23. Corrective Action Plan (CAP) • Must be submitted within 30 days (not a month) • For some contractors (e.g., Trailblazers), party must use the form on the contractor website • Identify what was wrong and how it was corrected • Submit a new 855 or related form to address problem • Effective date might leave a gap unless the CAP can make clear that it was a simple error and/or problem relates to contractor error

24. Corrective Action Plan (CAP) These are discretionary in terms of review and processing CAPs do not work in all situations. CAPmay cure a prospective issue but the provider/supplier may still face retroactive claims issues. Carefully consider how you "agree to improve" something without agreeing that you are at fault There is no appeal of a CAP rejection. Get to know the people processing your CAP

25. Appeals Process – 42 CFR 498 Four steps are: • Reconsideration before the MAC • ALJ Hearing • DAB Review • District Court Unwritten step: Informal “reconsideration”before CMS---either RO or CMS Central Office.

26. Request for Reconsideration • 60-day deadline (not 2 months) • Identify error made by contractor • Should be corrected retroactively to original date • Must be signed by authorized representative or legal representative • documentation cannot be submitted past the recon stage unless good cause for not submitting it earlier

27. Request for Hearing • Hearing request is submitted to DAB • Include copy of MAC letter regarding the adverse action • Deadline set by date of decision for request for reconsideration • Deadlines may be extended for good cause • Good option if provider revoked with no correspondence from MAC

28. Request for Hearing • DAB sends out prehearing order within about 10 days after the request is filed • CMS Regional Counsel has 30 days put their case together • The CMS attorneys have been reasonable to deal with and settle many of the cases • Cases are now handled by ALJ Susann • Some of the cases that are tried to decision have been favorable to the practitioners • Question about new 1 year claims deadline – If you win the ability to bill claims that are more than 1 year old, what have you won? Does administrative error doctrine apply?

29. DAB Decisions Appealing the Effective Date of Enrollment Section 489.3(b) includes as an “initial determination” … (15) The effective date of a Medicare provider agreement or supplier approval. • Preamble language states the purpose of the regulation is to make “existing appeals procedures available to entities that are dissatisfied with any effective date determination” 62 Fed. Reg. at 43934 (August 18, 1997) (emphasis supplied) • CMS’s interpretation of the regulatory history of the regulation is that section 489.3(b)(15) should be understood to restrict appeals to those providers and suppliers subject to survey and certification or accreditation • Split in ALJ Decisions • DAB, in Eugene Rubach, M.D., DAB CR 2125 (2010), found that issue is appealable

30. DAB Decisions Real Party In Interest Some ALJ decisions have held that entity to which a physician has reassigned benefits cannot bring an appeal concerning unfavorable enrollment action directly related to physician • Romeo Nillas, M.D., DAB CR2069 (2010) • Victor Alvarez, M.D., DAB CR 2070 Entity, can, however, prosecute the appeal as the representative of the physician or other supplier

31. DAB Decisions Defective Notice of Revocation Samuel T. Houston, M.D., CR 2071 (2010) -- ALJ finds that notice was defective because it cited only the regulations without explaining how they related to the petitioner, but because the ALJ’s review is de novo, and because CMS’s brief provided “ample notice” of reasons for revocation, and because the petitioner was afforded the opportunity to respond, there was no prejudice to the petitioner Entity with contractual arrangement denied enrollment as an IDTF US Ultrasound, CR 1982 (2010) -- DAB upholds denial of enrollment, because US Ultrasound did not meet definition of supplier, because a supplier is an entity that “furnishes health care services under Medicare,” and here US Ultrasound would contract with another entity that would own the equipment and be responsible for its the maintenance and calibration, and would perform the TC and PC of the tests

32. DAB Decisions Revocation for Failure to be Operational E&I Medical Supply Services, Inc., CR 2363 (2011) – DAB upheld ALJ’s decision that found CMS failed to provide any “credible or persuasive evidence supporting its revocation determination.” • Direct contradiction between the testimony of the supplier’s employees (and others in building) who say the employees were present and accounted for and the business operational, and the testimony of the NSC investigator who said that he went to the supplier’s place of business on 6 separate occasions during posted business hours and found the office to be closed • ALJ found the NSC investigator’s testimony to be not credible