1. NARHC Technical Assistance Call July 8, 2008 CMS 1910 P2: Medicare Program; Changes in Conditions of Participation Requirements and Payment Provisions for Rural Health Clinics and Federally Qualified Health Centers: Proposed Rule

2. NARHC Technical Assistance Call July 8, 2008 CAPT Corinne Axelrod, MPH, LAc, Dipl.Ac Centers for Medicare & Medicaid Services (CMS) Center for Medicare Management (CMM) Hospital and Ambulatory Policy Group (HAPG) Division of Ambulatory Services (DAS) 410-786-5620 corinne.axelrod@cms.hhs.gov

3. Agenda I. Background II. Highlights of the Proposed Rule III. RHC Location Requirements IV. Proposed RHC Location Exception Criteria

4. I. Background: Rural Health Clinic Services Act of 1977 –Amended the SSA by adding Sec.1861(aa) to extend Medicare and Medicaid entitlement and payment for primary and emergency care services furnished at an RHC by physicians, NPs, and PAs, for services and supplies incidental to their services -Authorized CMS and States to pay qualifying clinics on a cost-related basis for these services -Required that clinics be located in an area that is designated by the Census Bureau as non-urbanized, and designated or certified by HRSA as a shortage area. Contained a “grandfather” clause that enabled an RHC to remain in the program even if it no longer met the location requirements

5. Background: Balanced Budget Act (BBA ) of 1997 Amended Section 1861(aa)(2) of the SSA to apply location requirements to new and existing RHCs and permit exceptions to the location requirements for an existing RHC if the RHC can show that it is essential to the delivery of primary care in the service area (removed the “grandfather” clause)

6. Background: Regulations to Implement BBA Changes February 2000 - Proposed Rule (P1) December 2003 - Final Rule September 2006 – Suspension of Final Rule due to MMA requirement that no more than 3 years could elapse between a proposed and final rule June 2008 – New Proposed Rule (P2)

7. II. Highlights of the Proposed Rule The proposed rule would: Implement location requirements of the BBA and establish exception criteria for existing RHCs Allow RHCs to contract with RHC non-physician providers under certain circumstances Create a one year staffing waiver for existing RHCs

8. Highlights of the Proposed Rule Revise the RHC and FQHC payment methodology Clarify “commingling” policies Require RHCs to establish a Quality Assessment and Performance Improvement Program (QAPI)

9. Highlights of the Proposed Rule Solicit comments on high cost drugs Propose other changes to update the regulations to clarify existing requirements, provide the opportunity to make program improvements, and comply with statutory requirements

10. Highlights of the Proposed Rule Use RUCAs (Rural Urban Commuting Areas) instead of UICs (Urban Influence Codes) - more precise measurement of rurality - consistent with other CMS programs (e.g. hospital and ambulance payment systems)

11. How to Determine the RUCA for Your Area By zip code - http://depts.washington.edu/uwruca/data.html http://depts.washington.edu/uwruca/data.html By census tract - http://www.ers.usda.gov/briefing/Rurality/Rura lUrbanCommutingAreas/ http://www.ers.usda.gov/briefing/Rurality/Rura lUrbanCommutingAreas/ To find out your census tract: http://www.ffiec.gov/Geocode/default.aspx) http://www.ffiec.gov/Geocode/default.aspx

12. III. RHC Location Requirements Two Location Requirements 1. The RHC must be in a non-urbanized area, as defined by the U.S. Census Bureau, and 2. The RHC must be in an area that has been designated or certified by the Secretary within the previous 3 years as having an insufficient number or needed health care practitioners

13. Requirement #1 - U.S. Census Bureau Non-Urbanized Area Urbanized Area (UA) - An area consisting of a central place(s) and adjacent territory with a general population density of at least 1,000 people per square mile of land area that together have a minimum residential population of at least 50,000 people – Does NOT meet this RHC location requirement Urban Cluster (UC) - A densely settled territory that has at least 2,500 people but fewer than 50,000 -Meets this RHC location requirement Neither a UA nor a UC - Meets this location requirement

14. How to Determine if Your RHC is in a Non-urbanized Area Go to http://factfinder.census.govhttp://factfinder.census.gov Tool bar on top -- Select “Search” Tool bar on top -- Select “Geography” Select the option --“Show More Selection Methods” Select – “Address Search” Enter address and zip code, hit “go” Scroll down below county, below congressional district, below metropolitan statistical area, above the 3 digit zip code tabulation If a UA or UC, it will say: Urban Area: (Town) (State) followed by (Urbanized Area OR Urbanized Cluster)

15. What to Do if Your RHC is Located in an Urbanized Area (UA) If the RHC is in a UA and meets the eligibility criteria for an exception, submit an application to be considered an Essential Provider within 90 days from the effective date of the final rule to the appropriate Regional Office

16. Essential Provider An RHC that does not meet one of the location requirements may be considered an Essential Provider if primary care services would otherwise be unavailable in the geographic area served by the clinic

17. Eligibility Criteria for UA Location Exception To apply for this exception, the RHC must Be in a level 4 or higher RUCA, and Demonstrate that at least 51% of its patients reside in an adjacent non-urbanized area, and Have a current shortage area designation

18. Questions? Questions on the Urbanized Area Requirement?

19. Requirement #2 - Designated/Certified Areas Requirement #2 - Designated/Certified Areas The RHC must be in an area that has been designated or certified by the Secretary within the previous 3 years as having an insufficient number of needed health care practitioners

20. Designation Applications Designation applications are usually prepared by the State (not the RHC) List of State Primary Care Offices available at: http://hrsa.gov/grants Designation applications are submitted to HRSA http://bhpr.hrsa.gov/shortage/hpsapply.htm

21. Designation Types Acceptable for this RHC Location Requirement 4 types of designations satisfy this RHC location requirement: Geographic Health Professional Shortage Area (HPSA) Population-group HPSA Medically Underserved Area (MUA) Governor-designated and Secretary-Certified (GDSC) Shortage Area

22. Designation Types NOT Acceptable for RHC Location Requirements Designations NOT ACCEPTABLE: Medically Underserved Population designations (MUP) Automatic HPSA designations Safety-net facility designations Dental or mental health HPSA designations State designations (different from the GDSC designation) Any others that are not among the 4 acceptable designations

23. How to Determine if Your RHC is in a Designated HPSA (Geo or Pop) Go to http://hpsafind.hrsa.govhttp://hpsafind.hrsa.gov Above the blue boxed area, click on “Advanced Search by…” Select “State”, “County”, and “Primary Care” Under “Metro”, select “All” Under “Status”, select “Designated” Under ‘Types”, select “Geographic Single County and Service Area” and “Population Groups”

24. HPSA Screen HPSA name Parts included in the designation (whole county, townships, census tracts, etc.) HPSA identification number Status (designated) Type (geographic, population group, etc.) FTE Degree of shortage Score Date of the last update

25. How to Determine if Your RHC is in a Designated MUA 1.Go to: http://muafind.hrsa.govhttp://muafind.hrsa.gov 2. Select your state and county, then “Find MUAs/MUPs”

26. How to Determine if Your RHC is in a GDSC Shortage Area Governor-designated and Secretary-Certified Shortage Area Call HRSA’s Shortage Designation Branch 301- 594-0816

27. HRSA’s Proposed Rule Proposes changes to the methodology to determine designations Does not affect the requirement that an RHC be in a designated area Tier I and Tier II designations will be accepted More RHCs are in areas that retain their designation under the proposed method than the current method When finalized, many areas will be automatically designated (no application needed)

28. What to Do if Your RHC is Not in a Currently Designated Area Contact your State Primary Care Office to determine if an application to update the designation of the RHC’s area has been submitted If HRSA has received a designation application (new or update) for the area where the RHC is located before the end of the 3 year period since the last designation, no action needed

29. When to Apply for an Exception to this Location Requirement If the RHC is not in a UA and 1)HRSA has not received an application to designate or update the area before the end of the 3 year period, or 2) HRSA received an application to update the designation but determined that the area no longer qualifies for one of the designation types accepted for RHC certification

30. When to Apply for An Exception to This Location Requirement Submit an application for an exception to the appropriate Regional Office within 90 days from the date the designation is no longer current or within 90 days of the effective date of the regulation, whichever is later RO’s have 90 days to review the application for an exception to the location requirements Denial of exception request can be appealed per Part 498.3(b)(5)

31. Decertification RHCs are protected from decertification if HRSA has received an application to update the designation before the end of the 3 year period A clinic that is decertified as an RHC may apply to become another type of Medicare provider who would then bill Medicare using the fee for service system

32. Decertification Decertification would be effective on the last day of the month in which the 180 day limit was met Advantageous for an RHC to submit their request for an exception as soon as possible for planning purpose

33. Decertification A provider-based clinic that does not meet the location requirements and does not qualify for an exception and has submitted to CMS an application to be another type of Medicare provider that requires a state survey for certification would have a 120 day extension of their status as an RHC while their application is being processed

34. Example #1 RHC located in area designated as a geographic primary care HPSA on 1/2/06 Deadline for application to HRSA to update the designation for RHC certification is 1/2/09 Scenario 1 – Application received by HRSA before 1/2/09, application approved, area’s designation is updated, no action necessary by the RHC for 3 years from the date of the designation update.

35. Example #2 Scenario 2 – Application to update the designation is not submitted to HRSA by 1/2/09. RHC has until 4/2/09 (90 days) to submit request to the RO for an exception RHC does not submit application for an exception to RO by 4/2/09 RHC is decertified July 31, 2009

36. Example #3 Scenario 3 – Application to update the designation is not submitted to HRSA by 1/2/09. RHC has until 4/2/09 (90 days) to submit request to the RO for an exception RHC submits exception application to RO by 4/2/09 RO has up to 90 to review the exception application and make a determination RO approves the exception, no action needed for 3 years from the date of notification.

37. Example #4 Scenario 4 – Application to update the designation is not submitted to HRSA by 1/2/09. RHC has until 4/2/09 (90 days) to submit request to the RO for an exception RHC submits exception application to RO by 4/2/09 RO has up to 90 to review the exception application and make a determination RO disapproves the exception request, RHC is decertified 90 days from the date of notification, effective the last day of the month

38. Questions? Questions on the Designation Requirement?

39. IV. Proposed RHC Location Exception Criteria Sole Community Provider Major Community Provider Specialty Clinic Extremely Rural Community Provider

40. Exceptions Criteria “Participating primary care provider” means another RHC, FQHC, or primary care provider that is actively accepting and treating Medicare beneficiaries, Medicaid recipients, low ‑ income patients, and the uninsured (regardless of their ability to pay)

41. Sole Community Provider The RHC meets either of the following requirements: The RHC is at least 25 miles from the nearest participating primary care provider; or The RHC is at least15 miles but less than 25 miles from the nearest participating primary care provider and can demonstrate that it is more than 30 minutes from the nearest primary care provider based on local topography, predictable weather conditions, or posted speed limits

42. Major Community Provider The RHC meets both the following requirements: Has a Medicare, Medicaid, low-income, and uninsured patient utilization rate greater than or equal to 51 percent, or a low-income patient utilization rate greater than or equal to 31 percent; and Is actively accepting and treating a major share of Medicare, Medicaid, low-income and uninsured patients (regardless of their ability to pay) compared to other participating primary care providers that are within 25 miles of the RHC.

43. Specialty Clinic: Obstetrics/Gynecology (Ob/Gyn) or Pediatrics The RHC meets all of the following requirements: Exclusively provides ob/gyn or pediatric health services (as applicable) and Is actively accepting and treating Medicare, Medicaid, low-income, and uninsured patients and Has a Medicare, Medicaid, low-income patient and uninsured utilization rate greater than or equal to 31 percent, and Provides ob/gyn (including prenatal care) or pediatrics services onsite to clinic patients, and

44. Specialty Clinic: Obstetrics/Gynecology (Ob/Gyn) or Pediatrics Is the sole or major source of ob/gyn or pediatrics for Medicare (where applicable), Medicaid, and uninsured patients (regardless of their ability to pay) and is either of the following: - At least 25 miles from the nearest participating provider of ob/gyn or pediatric services or - At least 15 miles but less than 25 miles from the nearest participating provider of ob/gyn or pediatric services, and can demonstrate that it is more than 30 minutes from the nearest participating primary care provider providing these services based on local topography, predictable weather conditions, or posted speed limits

45. Extremely Rural Community Provider The RHC meets both the following requirements: Is located in a frontier county (6 or less persons per square mile) or in a RUCA code 10, and Is actively accepting and treating Medicare, Medicaid, low-income, and uninsured patients (regardless of their ability to pay)

46. Mental Health Specialty Clinics Was included in the 2003 Final Rule as a Specialty Clinic Statute prohibits an RHC from being a facility which is primarily for the care and treatment of mental diseases

47. Mental Health Specialty Clinics Since the statute imposes a “ceiling” on mental health services, is it still appropriate to include RHCs that provide mental health services for purposes of an exception to the location requirement? If so, what should the minimum level of mental health services be in order to qualify for an exception?

48. Questions? Questions on the Exception Criteria?

49. Additional Information Next NARHC TA Call – RHC Proposed Regulation - Staffing - Payment Requirements - Health, Safety, & Quality Next CMS Rural Open Door Forum July 29, 2008 2:00 pm – 3:00 pm EST Special RHC Open Door Forum August 5, 2008 2:00 p.m. – 4:00 pm EST CMS Regional Rural Health Coordinators

50. RHC Final Rule Comment period closes 5:00 p.m. on August 26, 2008 All comments will be addressed and considered for the Final Rule Provisions of the rule will be effective 60 days after publication of the Final Rule

51. Thank you!