Academic Medical Centers (AMC) Immersion Session

Transcription

1 Academic Medical Centers (AMC) Immersion Session Panel Members Kris West, J.D. Associate Vice President and Director Research Compliance, Emory University Auburn Daily, J.D., M.P.H. Principal Counsel-Health Law Office of General Counsel University of California Lynda Hilliard, MBA, CHC Deputy Compliance Officer University of California C.J.Wolf, MD, CHC, CPC, CPC-H Assistant Systemwide Compliance Officer The University of Texas System 1

2 Immersion Session Agenda Section I: AMC Compliance Overview Regulatory Issues Related to FDA/OHRP Oversight Section III: Regulatory Issues Related to Clinical Trials Billing Regulatory Issues Related to Graduate Medical Education Programs & Reimbursement Summary/Questions and Answers Section I: AMC Compliance Overview 2

3 Section I: AMC Compliance Overview Key Compliance Challenges Budget Constraints Medicare/MediCaid Reductions Increased Government Scrutiny Reimbursement Accuracy Documentation Accuracy Conflicts of Interest Industry Relations Section I: AMC Compliance Overview Key Compliance Concerns Electronic Health Records Research Compliance Researcher Access to Patient Health Records HIPAA Privacy and Security Health Care Reform Initiatives Accountable Care Organizations Lack of Health Care Reform 3

4 Overview of Topics Presented FDA -- New Regulations New IND Safety Reporting Requirements Effective March 28, 2011 On the Horizon Proposed Scientific Misconduct (AKA False Data) Reporting Stepped Up Enforcement Wait There s More! Guidance Galore! FDA IND Exempt Studies 1572s Electronic Source Documentation Central IRBs OHRP Continuing Review (OHRP & FDA) Research with Conditions Subjects who Withdraw 4

5 FDA New Regulations IND Safety Reports Regulations CFR Parts 312 and 320 Effective March 28, 2011 Purpose of Regulations Integrate FDA and International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) reporting rules and guidance FDA New Regulations IND Safety Reports Accompanying Guidance Document: Safety Reporting Requirements for INDs and BA/BE Studies, Sept Draft submitted for public comment But this regulation is for Sponsors, IOs don t need to worry, right? Well... Contains rule for investigator reporting to the Sponsor Sponsor-Investigators Impact on Clinical Trial Agreements. Rule s shortened reporting period for sponsors will impact investigator reporting period. CT agreements may require more IRB reporting 5

6 FDA New Regulations IND Safety Reports Definitions Adverse Event + Serious Addition of Terms Adverse Reaction and Suspected Adverse Reaction Definition of Unexpected Relationship to Investigator Brochure Heavy reliance on Investigator Brochure What if there is no Investigator Brochure? Impact on Sponsor-Investigators FDA New Regulations IND Safety Reports Sponsor Responsorbilities IND Safety Report When: Suspected Adverse Reaction; and Serious; and Unexpected Must report to FDA within 15 Calendar Days of becoming aware of event Evidence must suggest causal relationship between drug and adverse event 6

7 FDA New Regulations IND Safety Reports Determining Causal Relationship Individual Occurrence One or more Occurrences Aggregate Analysis of Specific Events Special Rules for Study Endpoints Un-blinding Requirements FDA New Regulations IND Safety Reports Investigator Reporting Obligations to Sponsor Immediately Report All Serious Adverse Events Whether or not considered drug related Even if listed in investigator brochure or protocol Include assessment of whether there is a reasonable probability drug caused event Of special interest to Sponsor-Investigators Collecting and analyzing information from other investigators Analysis of findings from other studies regardless of who conducted them Includes findings from animal studies and in vitro testing Still want to do multi-site Sponsor- Investigator IND Trials? 7

8 FDA Proposed Regulation on Scientific Misconduct Reporting 75 Federal Register 7412, Feb. 19, 2010 Comment Period Ended May 20, 2010 Effective 90 days after publication of final rule Proposed Rule: Sponsor must report to FDA within 45 days after becoming aware of information that: Any person has, or may have, engaged in the falsification of data In reporting study results In proposing or designing research In supervising or reviewing studies conducted for sponsor or on which sponsor relies FDA Proposed Regulation on Scientific Misconduct Reporting Definition of Falsification of Data Data changed so they don t represent what actually happened Data created for events that never happened Data altered Data recorded or altered in a way that doesn t reflect what happened Omitted data Has or may have standard No evidence of intent necessary, although errors such as typos and transposed numbers are excluded No investigation required to: Determine if data was definitively falsified If person suspected of falsification had any intent to do so 8

9 FDA Proposed Regulation on Scientific Misconduct Reporting Contents of Notice Name of suspected falsifier Last known contact information Study affected Information suggesting that falsification occurred Description of falsification Information will be used by FDA to investigate Food for Thought Covers everyone involved in study, e.g., coordinators, lab techs, etc. On-going requirement applies before study starts and after study ends Remember those Sponsor-Investigators? How does this rule work with PHS and NSF process for investigating and reporting possible research misconduct in PHS/NSF funded studies if those studies also are FDA regulated? FDA Proposed Regulation on Scientific Misconduct Reporting Other unanswered questions: What happens to a person who is falsely accused? Restoration of reputation? For PHS/NSF funded studies, does report to FDA trigger report to those agencies? When is IRB reporting triggered? What about ambiguous reports? Should any investigation be done? What about reports received anonymously? What Clinical Trial Agreement provisions can sites expect? 9

10 FDA STEPPED UP Enforcement August 2009 FDA Announcement of enforcement initiative 700 more inspectors hired Inspections Warning letters 25% increase FY 2009 FDA STEPPED UP Enforcement Trouble Spots: Investigation not conducted in accordance with 1572 or protocol Failure to maintain or prepare adequate case histories Poor drug accountability drug diaries Informed consent failures Reporting failures sponsor and IRB Once again sponsor-investigator trials Be prepared if they come a knockin Time sink 15 working days to provide response to 483 Fall out for Investigator Fall out for Institution 10

11 Guidance Galore: IND Exempt Studies -- FDA Guidance for Industry: Investigational New Drug Applications (INDS) Determining Whether Human Research Studies Can be Conducted Without an IND (DRAFT, Oct. 2010) IND Necessary When: New Drug + Clinical Investigation + No IND Exemption IND Exemptions Investigation not intended to be reported to FDA as well controlled study in support of new indication or change in labeling; and If drug is prescription, investigation is not intended to support change in advertising; and Investigation does not involve route of administration, dosage level, use in patient population or other factor that significantly increases risks or decreases acceptability of risks associated with use of drug; Investigation is conducted with IRB review and informed consent requirements in 21 CFR Parts 50 & 56. Guidance Galore: IND Exempt Studies -- FDA Investigator s Favorite Factor: No intent to report investigation to FDA as well controlled study... Application to Investigator Initiated Studies: Certain investigator initiated studies have the potential to influence labeling or promotion of drug notwithstanding the investigator s intent in initiating the study. For example: Pharma company provides drug and/or funding and results are good. Effectiveness studies sponsored by the federal government. FDA recommends INDs for these studies. 11

12 Guidance Galore: IND Exempt Studies -- FDA Challenge Agents Not therapeutic, but affect structure or function of body IND required Dietary Supplements Evaluating effect on structure or function of body no IND required Evaluate potential to treat, diagnose, mitigate disease or condition IND required Study has non-commercial intent Irrelevant, IND may be requires "Grandfathered Drugs Ask FDA Guidance Galore: 1572s -- FDA Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs: Frequently Asked Questions Statement of Investigator (Form FDA 1572), May 2010 Form 1572 Form signed by Investigator for clinical investigation of new drugs; evidences investigator s commitment to proper conduct of investigation. Numerous Questions About Who Should Sign and How to Complete 12

13 Guidance Galore: 1572s -- FDA Co-Investigators Not an explicitly defined term in FDA regulations. Definition Person who is responsible for the conduct of the study. Investigator equivalent. Multi-Site Trial: Co-Investigator should be available at each site to conduct or supervise investigation. Each signs Form Same Site: For large, complex study, may have more than one Investigator at one site. Each signs Form Sub-investigator: Not the same as a coinvestigator. Definition When investigation is conducted by a team of individuals, the Investigator is the responsible leader of the team and any other members who assist the investigator in the conduct of the investigation are sub-investigators. Guidance Galore: 1572s -- FDA Should nurses, residents, fellows or hospital staff be listed as subinvestigators on 1572? Do they make a direct and significant contribution to the clinical data? Do they have a more than occasional role? Should pharmacists or research coordinators be listed? Direct and significant contribution? Research coordinators should generally be listed. : Not the same as a co-investigator Financial disclosures must be collected for Investigators AND Sub-investigators. 13

14 Guidance Galore: Electronic Source Documents -- FDA Guidance for Industry: Electronic Source Documentation in Clinical lnvestigations (DRAFT, December 2010) Remember 21 CFR Part 11? Does not replace other FDA Guidance on electronic records. Recognizes that most clinical investigation sites use a combination of electronic and paper records. Guidance Galore: Electronic Source Documents -- FDA Focuses on: Electronic case report forms (ecrf) Data elements as basic information unit of ecrf Validating information about data element and its creation, modification, transmission, and storage Investigator responsibilities for reviewing and archiving data 14

15 Guidance Galore: Electronic Source Documents -- FDA 3 Information Tiers Tier 1 Data Entry Tier 2 Data Review Tier 3 Data Processing and Transmission Focus on Who Can Originate What Data Data Delegation of Duties Log Investigator must review and sign-off on ecrf Guidance Galore: Central IRBs OHRP OHRP Recent support for use of central IRBs in multi-site trials Prior FDA Support Guidance for Industry: Using a Centralized IRB Review Process in Multicenter Clinical Trials (March 2006) Can have both IRBs review; reliance on 1 IRB; or apportionment of duties between IRBs. Central IRB process useful to avoid duplicative review. IRBs must have written agreement. IRBs must have written procedures that address qualification of central IRBs; handling of local context; site assessment. 15

16 Guidance Galore: Central IRBs FDA & OHRP OHRP Correspondence of April 30, 2010 posted on OHRP website specifies support of FDA Guidance However, even in the absence of new regulation, OHRP is taking steps to address institutions concerns about relying on an IRB external to the institution. For example, as you indicated, we have archived prior guidance documents that suggested OHRP favors local IRB review over review by a non-local IRB, a position that OHRP no longer holds. (The reviewing IRB should nonetheless have appropriate knowledge of the local context.) Also, in our recent compliance evaluations, we have taken into consideration whether a single central IRB external to the institution was responsible for any identified regulatory noncompliance with 45 CFR part 46. In cases where an external central IRB is found to be responsible for any identified regulatory noncompliance with 45 CFR part 46, we will continue to clearly indicate this in our compliance determination letters and will communicate directly with the external IRB as appropriate. Guidance Galore: Continuing Review OHRP & FDA OHRP: Guidance on IRB Continuing Review, November 10, 2010 FDA: Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Continuing Review After Clinical Investigation (DRAFT, January 13, 2010) 16

17 Guidance Galore: Continuing Review OHRP Continuing review to determine if elements necessary for initial approval continue to be met. Review of Progress of Research Enrollment overenrollment and underenrollment may pose problems Procedural Requirements for Continuing Review at Full Committee v. Expedited Review Determining Dates for Continuing Review Guidance Galore: Research with Conditions -- OHRP Guidance on IRB Review of Research with Conditions, November 10, 2010 When is approval with conditions permitted? What verification procedures are needed to ensure that conditions have been fulfilled? Once again, that effective date thing... 17

18 Guidance Galore: Subjects Who Withdraw OHRP & FDA FDA: Guidance for Sponsors, Clinical Investigators, and IRBs: Data Retention When Subjects Withdraw from FDA- Regulated Clinical Trials FDA regulated research must inform subjects that data collected about them up to time of withdrawal will remain in the trial database and be used in data analysis Relation to HIPAA Privacy Rule Guidance Galore: Subjects Who Withdraw OHRP & FDA OHRP: Guidance on Withdrawal of Subjects from: Data Retention and Other Related Issues HHS, non-fda regulated research Must inform subjects that if they revoke authorization in writing for continued use or disclosure of his or her PHI that was already obtained in the research, analysis of that PHI will continue only to the extent necessary to protect the integrity of the research study. HHS, non-phi, non-fda research: Should inform subjects whether the investigator intends to either: (1) retain and analyze already collected data relating to the subject up to the time of subject withdrawal; or (2) honor a research subject s request that the investigator destroy the subject s data or that the investigator exclude the subject s data from any analysis. What about subjects who request a copy of their data? 18

19 Section III: Clinical Trials Billing Section III: Clinical Trials Billing I. Regulatory overview II. Strategic thoughts III. Could it get more complicated? We will be referencing some documents which were made available as Appendix A. 19

20 Section III: Clinical Trials Billing After it self-disclosed conduct to the OIG, Tenet Healthcare Corporation and Tenet HealthSystem KNC, Inc., (collectively Tenet), California, agreed to pay $1.9 million for allegedly violating the Civil Monetary Penalties Law. The OIG alleged that Tenet submitted claims to the Federal health care programs for clinical research-related items or services rendered at a hospital that were billed to or reimbursed by the Federal health care programs, including: 1) items or services that were paid for by clinical research sponsors or grants under which the clinical research was conducted; 2) items or services that were indicated as free of charge in the research informed consent; 3) items or services that were for research purposes only and not for the clinical management of the patient; and/or 4) items or services that were otherwise not covered under the Centers for Medicare and Medicaid Services Clinical Trial Policy Section III: Clinical Trials Billing NCD for Routine Costs in Clinical Trials (310.1) =ncd%3a310%2e1%3a2%3aroutine+co sts+in+clinical+trials routine costs qualifying clinical trial 20

21 Medicare Claims Processing Manual, Chapter 32, sections 68 and 69 Section III: Clinical Trials Billing ds/clm104c32.pdf Devices Modifiers Medical documentation requirements Split billing ICD-9 code Condition code CMS Office of Financial Management memo (May 26, 2010) Devices--Sample Medicare Administrative Contractor (MAC) Section III: Clinical Trials Billing TrailBlazer Health Enterprises, LLC (J4 MAC) es/devices/default.aspx?domainid=1 Pre-Approval Submission Checklist FDA-Approved IDE Part A Billing Instructions FDA-Approved IDE Part B Billing Instructions Humanitarian Use Devices (HUD) Investigational Device Exemption 21

22 Section III: Clinical Trials Billing Billing issues likely to expand beyond Medicare PPACA and clinical trial coverage Section (effective 2014) Routine Patient Costs Qualified Individual Approved Clinical Trial Life-Threatening Senior-Level Ownership Section III: Clinical Trials Billing Clearly defining roles and responsibilities can assist institutions in fulfilling their legal responsibility to comply with Department requirements, removing any uncertainty as to the precise responsibility of all individuals involved in the research enterprise. Draft OIG Compliance Program Guidance for Recipients of PHS Research Awards, U.S. Department of Health and Human Services, Office of Inspector General, Federal Register, Vol. 70, No. 227, Monday, November 28, 2005, page

23 P.I. Skin in the Game Section III: Clinical Trials Billing Clinical trials that meet the qualifying criteria will receive Medicare coverage of routine costs after the trial's lead principal investigator certifies that the trial meets the criteria. Should CMS find that a trial's principal investigator misrepresented that the trial met the necessary qualifying criteria in order to gain Medicare coverage of routine costs, Medicare coverage of the routine costs would be denied... In the case of such a denial, the Medicare beneficiaries enrolled in the trial would not be held liable (i.e., would be held harmless from collection)... Where appropriate, the billing providers would be held liable for the costs and fraud investigations of the billing providers and the trial's principal investigator may be pursued. NCD for Routine Costs in Clinical Trials (310.1) Excessive residuals may be a sign Section III: Clinical Trials Billing Some institutions have policies with the intent to avoid (1) financial recruitment incentives (2) inappropriate billing to third parties Some have thresholds, 50%, 25%, $5000, etc. 23

24 Plans to monitor details Section III: Clinical Trials Billing Do bragging points about how many patients on clinical trials match up with use of V70.7 on claims (how about condition code, modifiers, etc.)? What about certain diseases that might have high enrollment in clinical trials (e.g., leukemia)? Devices did someone jump through the appropriate hoops? High residuals when approaching completion or certain milestones Can it get more complicated? Section III: Clinical Trials Billing Personalized Medicine Biomarkers This is the present and future of clinical trials at academic medical centers (especially cancer trials) 24

25 Section III: Clinical Trials Billing As the leaders of the National Institutes of Health (NIH) and the Food and Drug Administration (FDA), we have a shared vision of personalized medicine and the scientific and regulatory structure needed to support its growth. Margaret A. Hamburg, M.D., Commissioner FDA Francis S. Collins, M.D., Ph.D., Director NIH The Path to Personalized Medicine, NEJM 363:4, July 22, 2010 Section III: Clinical Trials Billing 25

26 Section III: Clinical Trials Billing MEDCAC Meeting 1/27/ Pharmacogenomic Testing in Cancer kiesupport=1 Tumor genetic factors as markers and predictors to tumor growth and response to anti-cancer agents Currently, Medicare does not have a National Coverage Determination for using such tests for diagnosis or treatment of cancer. CMS seeks guidance from the panel to inform future coverage determinations Section III: Clinical Trials Billing CYP2D6 for breast cancer patients who are candidates for tamoxifen UGT1A1 for colon cancer patients who are candidates for irinotecan HER2/neu for breast cancer patients who are candidates for trastuzumab BCR-ABL for CML patients who are candidates for imatinib KRAS for metastatic colorectal cancer patients who are candidates for cetuximab or panitumumab 26

27 Section III: Clinical Trials Billing The use of therapeutic innovations for a specific patient is contingent on or guided by the results from a diagnostic test that has not been independently reviewed for accuracy and reliability by the FDA. (2006) FDA granted approval to rituximab (Rituxan) for use as part of first-line treatment in patients with certain cancers. Subsequently, a lab markets a test with the claim that it can identify the approximately 20% of patients who are more likely to have a response to the drug. Margaret A. Hamburg, M.D., Commissioner FDA Francis S. Collins, M.D., Ph.D., Director NIH The Path to Personalized Medicine, NEJM 363:4, July 22, 2010 LCD Examples Section III: Clinical Trials Billing LCD for MammaPrint Test - Breast Cancer Prognosis (L30376) (Palmetto GBA) LCD for Oncotype DX Test - Breast Cancer Prognosis (L28287) (Palmetto GBA) LCD L Loss-of-Heterozygosity Based Topographic Genotyping with PathfinderTG (Highmark Medicare Services) LCD L Cytogenetic Analysis (Highmark Medicare Services) LCD for GENETIC Testing (L24308) (Noridian) 27

28 Section III: Clinical Trials Billing See CPT code ranges: CPT Manual Appendix I (Genetic Testing Code Modifiers) 28

29 Presentation Roadmap I. GME Background: Overarching Principles II. Changes to Definition of Resident III. Health Care Reform GME Changes A. Counting Resident Time Spent in Non- Provider Settings B. Counting Resident Time Spent for Research and Didactic Activities C. Redistribution of Unfilled Residency Positions D. Preserving Slots from Closed Hospitals IV. Other Key GME Compliance Issues Relevant GME Background: Overarching Principles Medicare regulates payment, not operations GME payments have been available since 1965 (start of Medicare) and used to be cost-based Medicare views residents more like nurses than doctors reimbursed under Medicare Part A (hospitals), not Part B (physicians) Teaching physicians can include resident services in their own billing in certain circumstances 29

30 Relevant GME Background: Overarching Principles Now, GME is prospective and includes two key payment streams: 1. Direct graduate medical education ( DGME ) Payment of Medicare s proportionate share of direct costs of GME activities Calculation = FTE count x per resident amount x Medicare patient load Paid through the Medicare cost report FTEs can be counted in all areas of the hospital and hospital complex and in non-hospital sites that meet statutory/cms requirements Relevant GME Background: Overarching Principles (cont d) 2. Indirect graduate medical education ( IME ) Payment for the indirect costs that teaching hospitals incur (e.g., payment for the higher case mix of the teaching hospital patient population) Calculation comprised of: A multiplier (set by Congress); An interns/residents-to-beds ratio (a measure of teaching intensity); and A logarithmic equation. Paid on a per-claim basis Payment is available for training in the acute care part of the hospital and the outpatient department, as well as certain non-hospital sites (but not excluded units such as psych, rehab, etc) 30

31 Relevant GME Background: Overarching Principles (cont d) Rules Applicable to FTE Counts: DGME and IME counts are capped at the FTE count for cost reporting period ending on or after 12/31/96 Separate IME cap on interns and residents to bed ratio Three year rolling average Hospitals that did not have residents in 1996 have a cap of 0 Changes to Definition of Resident (FY 2011 IPPS Final Rule; 75 Fed. Reg. at ) Determining Whether an Individual is a Resident or Physician: Two key inquiries: 1. Does the individual actually need the training in order to meet board certification requirements in that specialty? AND 2. Is the individual formally participating in an organized, standardized, structured course of study? Must be able to answer both in the affirmative resident An individual who participates in training after the completion of an accredited residency program is not a resident (and must bill as a physician under the MPFS) 31

32 Changes to Definition of Resident (cont d) Revision of Definition of Resident : Effective for cost reporting periods on or after 10/1/10, in order to be considered a resident, the individual must: 1. Be formally accepted and enrolled in the training program; AND 2. Be fully participating in that training Mere participation in an otherwise approved residency program is insufficient Revised definition carries specific documentation requirements (e.g., letters from program sponsor; employment contract) Changes to Definition of Resident (cont d) Revision to Chief Resident Policy: Effective for cost reporting periods on or after 10/1/10, individuals acting as chief residents after they have completed the accredited program and satisfied minimum requirements for board certification are not considered residents for GME/IME payment purposes Surgical chief residents will continue to be considered residents 32

33 Changes to Definition of Resident (cont d) Clarification Regarding Extended & Unaccredited Training: Effective for cost reporting periods on or after 10/1/10, individuals training in a program that extends beyond the minimum accredited length are not considered residents (as to the period of time beyond the minimum length) An individual participating in unaccredited training is categorized as a physician, not a resident, even if the training at issue is ultimately accepted by the relevant board as fulfilling certification requirements Counting Resident Time Spent in Non-Provider Setting Historical statutory requirements: o In order for hospitals to count FTE residents, for purposes of GME and IME payments, in connection with residents time spent in nonprovider settings: Time had to be spent on patient carerelated activities; and Hospital had to incur all or substantially all costs of the training in the non-hospital site o Significant variation in CMS interpretation of this provision 33

34 Counting Resident Time Spent in Non-Provider Setting (cont d) PPACA ( 5504) changes to the SSA: Defines all or substantially all to mean just the costs of residents salaries and fringe benefits So What? A hospital may count all the time a resident trains in activities related to patient care in a non-provider setting so long as the hospital incurs the costs of the resident s salary and fringe benefits for the time the resident spends training in the non-provider site No longer have to incur supervisory physician costs As of When? IME: for discharges after 7/1/10 DGME: for cost reporting periods beginning on or after 7/1/10 Counting Resident Time Spent in Non-Provider Setting (cont d) What if more than one hospital incurs costs of residency training in the same non-provider setting? Multiple hospitals can count time proportionally, so long as there is a written agreement in place Agreement must have a reasonable basis for allocating time Agreement must include payments being made to the non-provider site that, in the aggregate, equal the sum of the residents salaries and fringe benefits (for the amount of time residents are training in that site) Payments must be broken out by program 34

35 Counting Resident Time Spent in Non-Provider Setting (cont d) Hospital cost reports are not to be reopened unless a jurisdictionally proper appeal was pending on the issue as of 3/23/10 Creates additional recordkeeping and reporting requirements to allow comparison of non-hospital training against the base year training level Base Year = first cost reporting period beginning on or after 7/1/09 No direct implication on GME payments Counting Resident Time Spent for Research & Didactic Activities I. Research 2002 regulations interpreted to exclude from IME FTE count time spent in research activities not related to diagnosis/treatment of a particular patient PPACA ( 5505) solidifies CMS position: as of 10/1/01, research not associated with diagnosis or treatment of a particular patient is to be excluded from the FTE count for both: (1) IME; and (2) time spent in non-hospital settings o o Includes activities focused on developing new medical treatments, evaluating medical treatments for safety or efficacy, etc No one workday exception for research activities 35

36 Counting Resident Time Spent for Research & Didactic Activities (cont d) II. Didactic Activities FFY 2007 rule: CMS clarified that its policy excluding time related to non-patient care-related activities extended beyond research to include didactic activities (e.g., seminars, journal club) for IME and, in non-hospital settings, DGME PPACA ( 5505) allows didactic activities to be included in FTE count for both IME and, in nonhospital settings, for IME and DGME o o Non-hospital site must be primarily engaged in furnishing patient care (even if activity is not) Effective: cost reporting periods ending on or after 7/1/09 for DGME; from 1/1/83 for IME Counting Resident Time Spent for Research & Didactic Activities (cont d) II. Didactic Activities (cont d) Cost reports can be reopened if there is a jurisdictionally proper appeal in place Medical and dental schools are not primarily engaged in patient care activities didactic activities in a medical/dental school must be excluded o BUT, didactic activities that occurred in the school clinics are properly included (with proper documentation) Termination of the one workday rule for didactic time, effective for cost reporting periods beginning on or after 1/1/11 36

37 Counting Resident Time Spent for Research & Didactic Activities (cont d) III. Leaves of Absence PPACA ( 5505) includes time associated with vacation, sick leave and other approved leave (e.g., jury duty) in the IME and DGME FTE counts, provided it does not prolong the normal duration of the resident program o Effective 1/1/83 When a resident is training at 2 hospitals, hospital to which resident is assigned when vacation/leave is taken counts the FTE time (or, without any assignment, hospitals make a pro rata allocation based on total time for that FTE) Counting Resident Time Spent for Research & Didactic Activities (cont d) Resident Time Counted vs. Not Counted DGME Hospital Patient Care Vacation/Sick Didactic Research Non-Hospital Patient Care Vacation/Sick Didactic (7/1/09 +) NOT Research IME Hospital Non-Hospital Patient Care Patient Care Vacation/Sick Vacation/Sick Didactic NOT Didactic (1/1/83 +) NOT Research NOT Research (1/1/01 +) 37

38 Redistribution of Unfilled Residency Slots PPACA ( 5503) amends the SSA to provide for reductions in the statutory FTE resident caps for GME and IME in certain hospitals and authorizes a redistribution of those FTE slots to other hospitals Effective July 1, 2011, a hospital s FTE cap will be permanently reduced if its reference resident level (e.g., FTE count for a given cost reporting period) is less than its otherwise applicable resident limit (e.g., a hospital s statutorilyestablished FTE cap as adjusted by Section 422) for any of the 3 most recent settled or submitted cost reports for cost reporting periods ending before 3/23/10 Reduction = 65% of unused FTE slots Redistribution of Unfilled Residency Slots (cont d) Will CMS reduce your FTE cap? 1. Do you meet an exception? (If yes to any, no reduction) Rural hospital with < 250 beds Voluntary reduction plan participants (National VRRP, NY Medicare GME Demo, and Utah Medicare GME Demo) who submit, by 1/21/11, a plan to fill the slots by 3/23/12 (see 75 Fed. Reg. at 72150) MLK replacement facility New teaching hospitals in their 3-year cap building period Low utilization hospitals without a cap 2. Are you at or over your cap for all three years? (If yes, no reduction) 3. If no exception and not at/over cap in all 3 years, your cap will be reduced 38

39 Redistribution of Unfilled Residency Slots (cont d) How much will your FTE cap be reduced? Example: Look at the single year with the highest resident count CMS will reduce your cap by 65% of the difference between your cap and your FTE count in the year with the highest count Year DGME Count DGME Cap FY FY FY Highest count is 14 (use FY 2008, representing smallest difference between cap & count) DGME cap is reduced by 65% of 1 slot =.65 FTE Repeat same process for IME slots Redistribution of Unfilled Residency Slots (cont d) CMS will estimate the number of slots likely to be available for redistribution (by 5/16/11) What if your hospital is part of a GME affiliation agreement or emergency affiliation agreement (and shares cap slots with other hospital(s))? (As of 12/9/10) CMS must look first at the affiliated group as a whole (as the agency did under Section 422) to see if the entire group has exceeded its aggregate cap; if affiliated group is over its cap no reduction of individual hospitals resident caps 39

40 Redistribution of Unfilled Residency Slots (cont d) What if your hospital has merged? If the merger occurred on or after 3/23/10: CMS will treat hospitals separately, and will combine any cap reductions If merger occurred during any year of the 3- year look-back period: CMS will treat hospitals as if they had merged during all 3 years Redistribution of Unfilled Residency Slots (cont d) Where will the redistributed slots go? Per PPACA: 70% of slots To states with resident-to-population ratios in the lowest quartile 30% of slots To states that are in the top 10 states in terms of population in HPSAs Rural hospitals Max of 75 new slots per hospital 40

41 Redistribution of Unfilled Residency Slots (cont d) CMS Final Lists (for 70% and 30% categories) 13 States with Lowest Residentto-Population Ratios ( Res-Pop List ) 10 States with Highest Proportion of Population Living in a HPSA ( HPSA List ) Montana Idaho Louisiana Alaska Wyoming Mississippi South Dakota Nevada Puerto Rico North Dakota Mississippi New Mexico Indiana Puerto Rico South Dakota Florida Georgia D.C. Arizona Montana North Dakota Wyoming Alabama Redistribution of Unfilled Residency Slots (cont d) What if you don t fit into either (70% or 30%) category? You are ineligible to apply for redistributed slots (e.g., if you are not located in one of the states identified on the previous slide and are not a rural hospital, you will not receive any additional slots) Rigorous evaluation process; applications were due January 21, 2011 What if slots remain after CMS goes through the prioritization and distribution process? New round of applications will take place 7/1/11; CMS will establish criteria for that second round 41

42 Redistribution of Unfilled Residency Slots (cont d) 5 year Restrictions on Use of Redistributed Slots: 5 year period begins 7/1/11 Post-distribution, the # of primary care residents cannot be less than the average during the 3 most recent cost reports submitted by March 23, 2010 Must use 75% of additional slots for primary care or general surgery NEW: auditor can look at average performance over cumulative years (75 Fed. Reg. at 72199) and there is no judicial review Lose slots permanently if requirements not met (and slots then redistributed) Preserving Cap Slots from Closed Hospitals PPACA ( 5506) permanently redistributes resident caps from hospitals that close on or after March 23, 2008 Closed hospital defined to mean: Hospital terminates Medicare provider agreement, and Cap slots of closed hospital no longer exist as part of any other hospital s permanent resident cap See 75 Fed. Reg. at for list of hospitals (> 700 slots) Does not include: hospitals that declared bankruptcy; closure of a residency program only; and merger (where no provider agreement is retired) 42

43 Preserving Cap Slots from Closed Hospitals (cont d) First application deadline (for closure between 3/23/08 and 8/31/10): April 1, 2011 Complicated distribution and prioritization process; hospitals must demonstrate likelihood of filling new slots within 3 years Other Key GME Compliance Issues Treatment of fellows in unapproved fellowship programs Resident duty hours: new ACGME standards effective July 1, 2011 Operational issues presented by resident moonlighting FICA: Supreme Court upheld 2005 IRS regulation that excluded residents from student exemption MedPAC recommendations 43

44 Questions and Answers For More Information: Question and Answers Auburn Daily Kristin West CJ Wolf Lynda Hilliard