Ilah Naudasher Kettering Health Network Chris Bennington - INCompliance Consulting Shannon DeBra Bricker & Eckler LLP

Transcription

1 Ilah Naudasher Kettering Health Network Chris Bennington - INCompliance Consulting Shannon DeBra Bricker & Eckler LLP How we Got Here Culture Clash Onboarding Risk Assessment Billing Issues Legal Issues 2 1

2 Hospitals/Health Systems rapidly buying physician practices Expand referral networks Reimbursement declines for some physician specialties looking for income stability Physician quality of life Cost of malpractice and adopting new technologies (EHRs) Improve quality of care Prepare for population health management Launching own managed care plans Drive/Capture hospital admissions, especially in specialties 3 4 2

3 Culture From small, independent to corporate with formal policies/procedures Comprehensive compliance program Stark Law becomes more relevant Integration into existing systems resistance to change Human Resources issues benefits, retirement, seniority 5 Notices of Change of Ownership CLIA Contracts assignment/assumption? Incident to rule Going Provider-based? State-specific issues to consider 6 3

4 Staff recruitment, retention, training Exclusion checking Ensure your new employees are not excluded (OIG s LEIE and GSA SAM List) before adding to payroll system Medical staff privileges IS/Billing system/ehr integration/roll-out Policies/Procedures/Training Notification to Payors, State agencies, etc. 7 Conduct proactive claims audits specifically for practices in which a full acquisition is desired To identify any potential improper payments due to incorrect coding/billing Identify coding knowledge/needs prior to start date Obtain and verify proper licensure, etc. (change of address, change of ownership and discontinuing business forms are applicable in some States): Prescriptive Authority for midlevel providers State specific Board of Pharmacy for dangerous drugs Controlled Substance reporting-state specific CLIA Radiology OIG and State Medicaid exclusions 8 4

5 Physician and office staff orientation. Use this time to orient yourself and your compliance program to the new physicians and their staff. Topics in your orientation should be informative and educational such as: How to report a compliance concern New patient E/M coding 1:1 coding education Audit plans Licensure requirements 9 All providers should be audited within days of onboarding to your network. All audit results should be shared with the provider Re-audits should be conducted if high error rate or trends are identified Every audit should include a training/education element 1:1 E/M coding education by a certified coder to the physician 10 5

6 Patient Name, Record Number, Dates of Service CPT Codes Billed Global Surgical Period E/M Level Correct? E/M level suggested based on documentation E/M comments Procedure codes correct? Modifiers correct? Place of Service correct? Billed? Paid or denied? Compliant? Comments? Practice Agrees? Practice Comments? 11 Key to identifying risks and issues internally Provides an outlet for leadership and employees to provide, in confidence compliance risks affecting the organization Findings should used to determine audit plans, education, etc. for upcoming year Risk assessments should be conducted routinely, this shouldn t be a one and done type of project Ensure all newly acquired practices are added to your risk assessment 12 6

7 Risk assessments can be used to help identify changes needed to the entire compliance program or portions of the program Trend and score responses by determining factors such as likeliness to occur, consequence if occurred, etc. Can be done via 1:1 interviews Electronically (and anonymously, such as using survey monkey) 13 Are you familiar with the policies, federal and state regulations that specifically affect your department or area? If not, why not? Do you feel that there are adequate controls to ensure your department s compliance with those policies and federal regulations that affect you? In your opinion, what are the 3 greatest risks to the entire organization? Can you recommend controls that would alleviate those risks? Are there mechanisms in place to evaluate the quality of each contracted service and to ensure it is provided safely and as expected? Are there processes in place to properly screen medical staff members and to assure services are provided appropriately? 14 7

8 Are there adequate processes in place to identify improper payments? When overpayments are identified, are overpayments promptly reported and repaid? Do you have any concerns regarding auditing and/or reporting of financial information, such as the cost report? What information security and privacy (HIPAA) challenges do you think the facility has now or will have in the future? Do employees receive adequate and timely compliance education and/or training? 15 Are employees, including physicians, aware of the conflict of interest policy? Do you have any concerns regarding the governance and/or leadership at the facility? Do you have any concerns about ethical issues or compliance related practices? Do you have any risks/concerns with the EMR? Do you feel employees are challenged to always do the right thing? Do you feel that there might be retaliation by supervisors or managers for reporting suspected wrongdoing internally? 16 8

9 Provider-Based If the newly acquired practice will now be treated as provider (hospital) based - Must meet all requirements of 42 CFR , including: Physicians working in the hospital-based space must have privileges at main hospital Medical records must be integrated with main provider Financial integration costs appear on hospital cost report Public awareness must be held out as part of hospital, not a physician office patients must know Additional requirements if off-campus (see 42 CFR (e) Must treat all Medicare patients as hospital outpatients for billing purposes even if they have another insurer that doesn t treat clinic visits as a hospital service 17 Site of Service Make sure the physicians are billing the correct site of service If hospital-based, physicians must bill site of service code 22 (outpatient hospital), not 11 (office) Coding Make sure physician coding is compliant with payor guidelines (audit?) Any pending audits by government or commercial payors? Examine physician documentation to ensure documentation matches codes billed Teaching Physicians? Make sure they know how to document and what is required to bill 18 9

10 Incident-to Billing Allows for non-physician practitioner to be reimbursed at 100% of physician fee schedule instead of 85% Must be integral part of physician s services Physician must have initially provided health care services to the patient to initiate an ongoing course of treatment Direct supervision require that physician be immediately available (in same office suite) Change in chief complaint or problem requires physician to see the patient again or NPP cannot bill incident-to NO INCIDENT-TO BILLING IN HOSPITAL SETTING (INCLUDES PROVIDER-BASED CLINICS) Split/shared care may be used if criteria is met in a hospital department 19 Billing for services incident to can only be used when the following criteria are met: D: O: N: E: Direct Supervision Office setting (POS 11)-cannot be used in a hospital outpatient department No new patient, no new conditions or symptoms Established patients, with established plans of care from the physician ONLY 20 10

11 Physician supervision if hospital-based clinic now Diagnostic Services Check the required level of supervision for the test Medicare Physician Fee Schedule (PFS) Relative Value File Direct Supervision: Physician must be present on the same campus and immediately available to furnish assistance and direction throughout the performance of the procedure The supervisory physician must have, within State scope of practice and hospital-granted privileges, the knowledge, skills, ability, and privileges to perform the service or procedure (more than just emergency response). Supervising physician should know on duty Can be in a physician office or other nonhospital space that is not officially part of the hospital campus where the services are being furnished as long as he or she remains immediately available 21 Physician supervision if hospital-based clinic now Therapeutic Services Services and supplies (including the use of hospital facilities and drugs and biologicals that cannot be self-administered) which are not diagnostic services, are furnished to outpatients incident to the services of physicians and practitioners and which aid them in the treatment of patients. These services include clinic services, emergency room services, and observation services. Unless indicated otherwise, CMS requires direct supervision by an appropriate physician or NPP Direct Supervision: Physician must be present on the same campus and immediately available to furnish assistance and direction throughout the performance of the procedure Can be in a physician office or other nonhospital space that is not officially part of the hospital campus where the services are being furnished as long as he or she remains immediately available Supervising physician should know he/she is on duty as supervisor 22 11

12 Supervision Requirements Is supervision of non-physician staff required, and if so, what level of supervision is necessary? Medicare Claims Processing Manual Vaccines Pneumonia/flu (no supervision requirement; Secs and ) vs. Hepatitis (supervision required; Sec ) Injections Payment for Codes for Chemotherapy Administration and Non-Chemotherapy Injections and Infusions Supervision required (Sec. 30.5) 23 Coding new vs. established patient E/M codes If in the same specialty/sub-specialty and same Tax ID# and patient has been seen within the past 3 years, you cannot code a new patient E/M code Create edits to assure these are caught, in large networks, it is hard to identify who has been seen by other physicians, and could create an overpayment 24 12

13 Incident to and State-specific physician supervision requirements are not synonymous-be careful not to interchange these requirements Be sure to understand State requirements regarding prescriptive authority before billing services provided by mid-levels 25 It is important to determine while onboarding if the physician intends to be a teaching physicianadditional education regarding teaching physician requirements would then be necessary Training for the residents is necessary as well Some State regulations are more strict than CMS in terms of teaching physician requirements-e.g., Ohio requires for billing the teaching physician to be physically present for the medical decision making Due to recent settlements across the country, auditing teaching physician documentation is imperative 26 13

14 If there is no documentation of the teaching physician s physical presence, the only documentation that can count towards the E/M code is from the teaching physician Train/educate the residents as well as the teaching physicians on the documentation/coding/billing requirements Use EMR templates to help guide providers to document physical presence 27 Patient Name/Acct Number, DOS, Payer, CPT Code Billed Resident Name GC Modifier Present on Claim? GC = Service has been performed in part by a Resident under the direction of a teaching physician Is Resident listed as servicing provider? Approved signature of resident? Documentation to prove teaching physician was present during critical portions of visit? 28 14

15 Did resident document which portions of visit teaching physician was present? Did teaching physician document which portions of resident s visit she was present for? Approved signature of physician? Does documentation support billing under teaching physician? Is E/M level correct based solely on physician s documentation? Is the place of service correct? 29 HIPAA Privacy and Security Records Retention / EMR Issues Prescription Drugs ensuring practices comply with state and federal laws Teaching Physicians Supervision compliance Stark Law/Anti-Kickback - Fair market value purchase price, employment compensation Exclusion physicians and staff 30 15

16 31 Organized Health Care Arrangement Essential Documents Notice of Privacy Practices Policies and Procedures Business Associate Agreements Authorizations and Other Forms Implementation of Policies and Procedures Individual Rights Documentation Notice of Privacy Practices Breach Log Business Associate Agreements Training 32 16

17 Walkthroughs Training Mobile Device Review EMR Review (Same name, high profile) Document Review Secret Shoppers 33 Looking Forward: Compliance with System s retention policy and applicable laws Looking Back: Dealing with records created pre-acquisition Where maintained? How long maintained? Archive or move to live EHR? Need access to records for malpractice cases 34 17

18 35 Make sure provider is appropriately trained on EMR before they open/start their practice More documentation does not equal better documentation Often times templates are not set up as the provider thought or wanted-which may lead to documentation issues Educate on appropriate use of copy/paste/cloning functionality within the EMR 36 18

19 It is imperative to understand your State specific regulations of prescription drugs Some States require increased licensure and regulatory requirements once a practice is no longer considered a solo practitioner Provide proactive auditing of prescription drugs in practices, including samples, drugs administered, etc. Audits are conducted to assure proper security, access to drugs by licensed professionals, inventory and recordkeeping of prescription drugs. 340B compliance if the newly acquired practices will be hospital-based and your hospital participates in 340B program 37 If the practice has samples or administers medications, do they have their State license (Ohio- TDDD) signed and readily retrievable? Does the practice have the proper category of license? Is the practice conducting a controlled substance inventory as required by State law (even if zero)? Are physicians registered with the State s prescription drug reporting system to prevent drug-seeking behavior? Are physicians reporting personally furnished controlled substances as required by law?? Are physicians personally furnishing controlled substances? 38 19

20 Are prescription pads stored in a secure location? Is EMR prescription paper stored in a secure location? Are hypodermics, needles, and syringes, etc. stored in a secure location? Are sharps containers and used sharps secure? Is the medication storage area secure except when there is a licensed professional present (including Oxygen)? Is the medication refrigerator in a secure location? 39 Does the medication refrigerator have a thermometer? Is there a temperature log kept for the medication refrigerator and freezer? Is there a process for verifying temperature of the medication refrigerator and freezer at night, on the weekends, and on holidays? Samples: Is there a separate sheet in the inventory log for each medication and dosage (for meds being audited)? Samples: Are there inventory logs on file for 7 years? Samples: Does the actual medication inventory match the log (for meds being audited)? 40 20

21 Samples: Are the inventory logs and patient records Positive ID compliant (prescriber signature along with explanation of samples given)? Other Meds: Is there a separate sheet in the inventory log for each medication and dosage (for meds being audited, including Oxygen)? Other Meds: Are there inventory logs on file for 7 years? Other Meds: Does the actual medication inventory match the log (for meds being audited)? Other Meds: Are the inventory logs and patient records Positive ID compliant (prescriber signature along with explanation of medications given)? 41 Does the practice have a process that they are following for tracking the Beyond Use Date (BUD) when multi dose vials (MDVs) are opened? Is the current inventory of all opened MDVs within the 28- day timeframe? Is the current inventory of all opened immunizations within their expiration date or manufacturer recommended date? Samples: Are expired medications segregated from other medications? Other Meds: Are expired medications segregated from other medications? Does the practice have a process to dispose of waste or expired meds that includes rendering the drug useless or disposing to an approved wholesaler or charity? 42 21

22 The Stark Law Stark Law Regulates hospital relationships with referring physicians a. Purpose to ensure that physician decisionmaking isn t skewed by the financial relationships the physicians have b. Requires every financial relationship (interpreted VERY broadly) to fit within an exception or else the physician cannot refer patients to the hospital, and the hospital may not bill Medicare for the services provided to patients referred by the physician. 1. Purchase of practice 2. Employment of physician 43 The Stark Law Stark Law Regulates hospital relationships with referring physicians (cont d) c. Strict liability law meaning no intent required. This law requires perfection. d. There are several possible relevant exceptions. 1. Isolated Transactions 2. Bona Fide Employment Arrangement 3. Group Practice 4. Fair Market Value e. Penalty Hospital must refund all Medicare payments; also subject to fines, exclusion, treble damages if included as basis for False Claims Act liability 44 22

23 The Anti-Kickback Statute Anti-Kickback Statute Regulates relationships with referral sources (any referral source, not just physicians) a. Purpose: To protect patients from medical decisionmaking skewed by financial considerations b. Applies to relationships with all referral sources and to all individuals and entities you make referrals to c. Criminal and Civil Penalties d. Requires intent to induce or reward referrals of federal health care business e. If one purpose of an arrangement is to induce or reward referrals, the arrangement is tainted. 45 Purchase of Physician Practice Concern: Remuneration paid for physician practice is intended to induce referrals to the hospital acquiring the practice Important to establish FMV of consideration paid for the practice stock/assets. Important to document the intent behind the acquisition of the practice. Repurchase provisions OIG cautions against paying for anything more than hard assets could be viewed as payment for referral stream Goodwill, noncompetes, value of ongoing business unit, patient lists, patient records 46 23

24 Concern: FMV of purchase price of practice Stark Exception: Isolated Transaction Must be in writing (signed by parties) No other transaction for 6 months (unless fit in another exception, and except certain post closing adjustments) FMV; Not related to volume or value of referrals Must be commercially reasonable Installment Payments Aggregate payment must be set before first payment is made (some post-closing adjustments OK); not take into account volume or value of referrals 47 Concern: FMV of purchase price of practice AKS Safe Harbor: Sale of Practice Most acquisitions won t fit Date from agreement to closing is not more than 3 years Seller will not be in a professional position to make referrals post-closing Practice must be in a HPSA for that specialty Purchaser must engage in recruitment activities that: (i) may reasonably be expected to result in recruitment of new practitioner to take over the acquired practice within one year; and (ii) will satisfy the conditions of the practitioner recruitment safe harbor 48 24

25 Concern: FMV of Employment Compensation Concern: Payments With No Contract Look for payments from DHS entities and identify written agreements Concern: Real Estate Leases Space owned by now-employed physician Lease must fit into Rental of Office Space exception if hospital now considered tenant and physician is landlord must be FMV rent 49 FMV Get a valuation from independent appraiser for purchase of practice FMV Get appraisal or use survey data to set employment compensation post-acquisition Have a provision to adjust income if postacquisition productivity not same as what was represented ensure your compensation methodology really is FMV as applied Due Diligence 50 25

26 OIG and State specific Medicaid exclusion checking should be conducted during the new provider onboarding process and monthly thereafter Develop an internal policy on exclusions and communicate the policy and regulatory requirements to physicians and office staff All employees and physicians should be educated and informed on exclusions Medical staff credentialing should also be validating exclusions during credentialing and recredentialing 51 Communicate upfront with the new provider what to expect, i.e. audits, exclusions, etc. Collaborate with physician leadership to keep up to date with issues, audit findings, trends, etc. Always obtain the provider s insight on audit findings Be empathetic-but firm! Change takes time, often times compliance is new to providers, especially those coming from a solo/small practice Communicate to the providers and staff that you are here to help, it is better if you find errors vs. the government! Create a culture of compliance first! 52 26

27 53 27