RHC Compliance Update - Georgia Rural Health Association

RHC Compliance Update Georgia Rural Health Association May 1, 2019 Patty Harper, CEO/Principal InQuiseek Consulting So, what are we going to talk about? Georgia RHC Trivia

Types of CMS Regulations/Guidance Appendix G/Appendix Z Top Survey Deficiencies for 2018 Compliance Challenges & Successes Georgia RHC Trivia RHCs in Georgia 88 per QCOR, April, 2019 www.inquiseek.com Terminated RHCs 2017-2019** Terminated Rural Health Clinics Calendar Year

Georgia Nationwide 2017 2018 2 163 2 108 2019 YTD 0 10

All closures were Voluntary Closures or Mergers/Change of Ownership. Difficult from the QCOR data to distinguish between independent and provider-based status because it is by ownership type in the database. www.inquiseek.com New RHCs** 2017-2019 New Rural Health Clinics Calendar 2017 2018 2019 Year YTD Georgia 0 4 0

Nationwide 261 292 26 No net change in # of RHCs from 1/1/2017 to 4/29/2019 www.inquiseek.com Georgia RHC Survey Statistics 2017-2019** Survey Activity for Georgia Calendar Year Georgia Georgia: Complaint National National: Complaint

2017 2018 12 or 13.3% 6 or 9.5% 0 or 0.0% 0 or 0.0% 814 or 18.7% 814 or 18.0% 32 or 0.6% 34 or 0.7% No surveys YTD in 2019 as of 4/29/2019 Georgia RHC Survey Statistics 2017-2019**

Total Survey Deficiency Count Calendar Year 2017 2018 2019 YTD Georgia 0.0% 100 % 0.0%

National 38.9% 55.7% 5.4% No surveys YTD in 2019 as of 4/29/2019 Georgia RHC Survey Statistics 2017-2019 RHCs Overdue for Survey as of April 29, 2019 Calendar Year Georgia National

# of Clinics % of Clinics 70 2,324 79.6% 52.5% **Data Source S&C's Quality, Certification and Oversight Reports (QCOR) https://qcor.cms.gov/main.jsp Survey data and statistics are available on this site

for all CMS certified facility types. www.inquiseek.com How or why do I get a survey deficiency ? When a surveyor cannot find evidence (written proof, observation, interviewing, inspection, auditing, etc.) that the certification standards are being met, you receive a

deficiency. Each survey tag or standard is tied back to the 42 CFR 491 conditions for RHC certification. Each deficiency is referenced to a regulation subpart, tag or AO standard because it has not been evidenced. Are all surveyors the same? Is a surveyor a surveyor regardless? Surveyors are people who come to the task from different

backgrounds and perspectives. Even though they have the same standards or conditions to evaluate and the same regulation to govern their surveying, its not always as objective or as much of a science as you would think it would be. Should I use the state to survey my RHC or should I use an Accreditation Organization?

RHC can be surveyed for initial or subsequent certification by either the state agency or by one of the two deemed AOs. States do not currently have federal funding to conduct initial surveys. Georgia is also currently behind on RHC recertification surveys. Using an AO gets you surveyed quicker but there is a cost for the service. The deemed authorities are also accreditors so they evaluate RHCs at a higher level. RHC Accreditation Organizations https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCerti

ficationGenInfo/Downloads/MPD-RHCs-FQHCs.pdf Accreditation Organizations with CMS-Approved RHC Deemed Status Programs Currently there are two: American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF) https://www.aaaasf.org/ The Compliance Team https://thecomplianceteam.org/ Federal Regulations and Guidance for Medicare & Medicaid Providers www.inquiseek.com

Types of Guidance Regulatory Federal State Local Sub-Regulatory Paper-based Manuals Internet-only Manuals Transmittals, Program Memoranda & Change Requests MLN Matters Articles National and Local Coverage Determinations Other CMS Publications, Tools and FAQ MAC Information Federal Register The daily publication of the United States government. CMS Adopts Regulations in the Federal Register.

First published as Proposed Rules with a comment period and then published as Final Rules. CMS publishes notices and links to the Federal Register on their website. States have a Register or Similar Publication. Code of Federal Regulations The CFR is a complete volume of all federal regulations for all sectors and is legally binding. The annual edition is updated every Oct 1st . eCF is more up-to-date. Title 42 applies to Public Health Chapter I: Department of Health & Human Services Chapter IV: Centers for Medicare & Medicaid Services, HHS Chapter V: Office of Inspector General, HH First published as Proposed Rules with a

comment period and then published as Final Rules. CMS publishes notices and links on their Links to the Federal Register and the eCFR Federal Register https://www.federalregister.gov/ eCRF- Title 42 https://gov.ecfr.io/cgi-bin/ECFR Main Federal Regulations Medicare Program 42 CFR 405 Federal Healthcare for the Aged and Disabled 42 CFR 420

Program Integrity-Medicare 42 CFR 455 Program Integrity- Medicaid Main Federal Regulations Critical Access Hospitals 42 CFR 485 Subpart F Conditions of Participation Main Federal RHC/FQHC Regulations 42 CFR 405, Subpart X 42 CFR 491 Conditions for certification 42 CFR 413.65

Provider Based Status 42 CFR 413.65 RHCs as Provider-Based Facilities Less than 50 Beds Relationship Between the Parent Hospital and RHC PB Attestation Voluntary 42 CFR 491 Title Subpart Regulatory 42 CFR 491

RHC Certification Requirements Location Compliance Staffing/Personnel/HR Physical Plant/Environment Provision of Services Emergency Preparedness Medical Management Annual Evaluation Emergency Preparedness 42 CFR 491:1 THRU 491:12 These section contains all the regulations concerning the conditions of certification and recertification of Rural Health Clinics. This is where the certification and accreditation standards originate. However, the subregulatory sources of information are often easier to interpret and more user-friendly. The CFR is legally binding. Sub-regulatory guidance must be taken into consideration by Medicare Contractors and Administrative

Law Judges and they must explain rulings to the contrary, but they are not obligated to uphold sub-regulatory guidance. Be mindful of published and effective dates when referring to regulations and sub-regulatory guidance. A Google search can result in an outdated publication. Text in red indicates the updated portions of the publications. RHC and FQHC guidance are often in the same documents. Use caution. Sub-regulatory CMS Internet-Only Manuals Policy Benefit Manual, Chapter 13 https://www.cms.gov/Regulations-and-Guidance/Gui dance/Manuals/Downloads/bp102c13.pdf Claims Processing Manual, Chapter 9 https://www.cms.gov/Regulations-and-Guidance/Gui dance/Manuals/Downloads/clm104c09.pdf

Sub-regulatory State Operations Manuals Sub-regulatory Sub-regulatory The State Operation Manuals which apply to RHCs are: Appendix G--Guidance for Surveyors: Rural Health Clinics 42 CFR 491.1 through 491.11 https://www.cms.gov/Regulations-and-Guidance/Guidance/Manual s/downloads/som107ap_g_rhc.pdf Appendix ZEmergency Preparedness for all Provider Types, Interpretive Guidance 42 CFR 491.12 https://www.cms.gov/Regulations-and-Guidance/Guidance/Manual

s/downloads/som107ap_z_emergprep.pdf Top RHC Deficiencies for 2018 Top 25 RHC Survey Deficiencies Nationwide in 2018** Tag Deficiency % of Surveys # Cited J0043

Drug Storage and Handling 19.1% 161 J0123 Provider Review of Policies 11.2% 95 J0042

Preventative Maintenance 10.9% 92 J0160/ Annual Program Eval 8.5% (S) J0161 Condition or Standard 4.8 % (C) J0044 Environment Clean and Orderly 8.4% 72 (S) 41 (C) 71 Top 25 RHC Survey Deficiencies

Nationwide in 2018** Tag Deficiency % of Surveys # Cited E0037 EPP Training 8.2% 69

J0152 Complete Medical Records 8.2% 69 E0004 Developing EPP 8.0% 68

J0136 Emergency Care/Kit 7.4% 63 J0135 Required RHC laboratory services 7.1% 60

Top 25 RHC Survey Deficiencies Nationwide in 2018 Tag Deficiency (paraphrased) % of Surveys # Cited J0039 EPP Testing 6.7%

57 J0124 Written Patient Care Policies 6.3% 53 E0036 EPP Training and Testing Program 6.3%

53 E0001 All Elements of EPP Not Evidenced 6.3% 53 E0009 EPP Collaboration 6.1%

52 Top 25 RHC Survey Deficiencies Nationwide in 2018** Deficiency % of Surveys # Cited Plan Based on All Hazard Risk Assessment Clinic safe and adequate space Physician Review of Charts

6.0% 51 5.6% 47 5.2% 44 E0032 EPP Alternate Means of Communication

5.2% 44 E0024 EPP Volunteers 4.5% 38 Tag E0006 J0041 J0101

(paraphrased) Top RHC Survey Deficiencies Nationwide in 2018** Tag Deficiency % of Surveys # Cited E0022

EPP Written Policies and Procedures 4.4% 37 E0029 EPP Communication Plan 4.4% 37 E0020

EPP Evacuation 4.0% 34 E0013 EPP Written Policies and Procedures 4.0% 34 EPP Requirements

38 Common Administrative Deficiencies No written organization structure or policies No organizational chart No Disclosure of Ownership No Disclosure of Medical Directorship No Disclosure of Provider-Based Relationship with Parent Hospital Failure to update 855A and CMS 29 forms when changes in key personnel or ownership occur.

Clinic not held out or represented as entity enrolled in Medicare Multi Use Vials : Not labeled/dated Not left in patient care areas Common Drug Storage, Handling and Administration Deficiencies Single Use Vials: Should not be labeled, used only once. No Unsecured Sharps or Needles in patient care areas.

No reuse of single use items-sterile packing, sterile water Expired Drugs (have inventory system) Sample Drugs logged by patient with lot # Controlled Drugs Storage and Reconciliation Emergency Kit Common Medical Record Deficiencies Records do not contain all elements found in 491.10 Physician review of NP charts not evidenced

No audits of records per 491.10 Incomplete records for nursing home patients No General Consent to Treatment No Informed Consent to Treatment (procedures) Other Common RHC Deficiencies No Annual Program Evaluation conducted within 12 months. Not all elements of annual program evaluation included in

annual program. No NP/PA staffing at least 50% of the patient care hours. Providers not in clinic during all posted patient care hours. No posted hours Employee/provider files not complete OIG Excluded Party Database Checked PRIOR to hire; periodically thereafter. Check all alias, AKA, maiden, previous married names Georgia Medicaid requires monthly checks. Medicaid Provider Responsibilities Any provider participating or applying to participate in the Georgia Medicaid program, including managed care entities, must search the Georgia Medicaid Exclusion List, in addition to the List of Excluded Individuals and Entities (LEIE) and the System for

Award Management (SAM) on a monthly basis to determine if any existing employee or contractor has been excluded from participation in the Georgia Medicaid program and/or has been excluded, on a national level, from the Medicare and/or Medicaid program. Furthermore, any provider participating or applying to participate in the Georgia Medicaid program must search all above-referenced lists prior to hiring staff to ensure that any potential employees or contractors have not been excluded from participating in the Medicare and/or Medicaid program. https://dch.georgia.gov/georgia-oig-exclusions-list First, always ask: Is what we want to do going to cause a compliance problem? Always assume that it might until you know it wont. Examples: Rebranding or renaming the clinic Moving or rearranging space in the clinic

Adding visiting specialists or non-RHC services Use of social media/web site discrepancies What are your biggest compliance challenges? Knowing the RHC regulations Finding Information and Updates

Culture that is not compliance-driven Policies and Procedures that arent actually being followed Keeping evidence updated Knowing what to do when Provider Buy-in/Pushback Little fish in a big pond? Staff turnover or burnout Share how you have had a compliance success What has worked? What hasnt? Follow-up questions or comments can be directed to: Patty Harper InQuiseek Consulting

318.243.2687 [email protected] www.inquiseek.com

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