DIA COMPLIANCE OVERVIEW FOR HOME HEALTH AGENCIES Mary Spracklin RN, M.S.N Rosemary Kirlin RN, M.S.N September 30, 2014 ROLE OF THE STATE AGENCY (SA) The Centers for Medicare and Medicaid Services (CMS) contracts with an agency in every to state to conduct survey and certification work in that state on behalf of CMS. In Iowa, the Department of Inspections and Appeals (DIA) is the contracted state agency (SA). Therefore, all home health surveys in Iowa are Medicare (Federal) surveys. 2 STATE OPERATIONS MANUAL (SOM) The State Operations Manual is the manual written by CMS to instruct state agencies on how to conduct survey and certification activities on behalf of CMS. It is not a manual written by the State of Iowa. 3 1
TOP 11 DEFICIENCIES HOME HEALTH SURVEYS FFY2014 10/1/13 9/30/14 4 G121 COMPLIANCE WITH ACCEPTED PROFESSIONAL STANDARDS & PRINCIPLES 484.12(c) Standard: Compliance With Accepted Professional Standards and Principles The HHA and its staff must comply with accepted professional standards and principles that apply to professionals furnishing services in an HHA. 5 G158 CARE FOLLOWS A WRITTEN PLAN/REVIEWED BY A PHYSICIAN 484.18 Care follows a written plan of care established and periodically reviewed by a doctor of medicine, osteopathy, or podiatric medicine. 6 2
G159 PLAN OF CARE COVERS ALL PERTINENT DIAGNOSES AND IS ACCURATE & COMPLETE 484.18(a) Standard: Plan of Care The plan of care developed in consultation with the agency staff covers all pertinent diagnoses, including mental status, types of services and equipment required, frequency of visits, prognosis, rehabilitation potential, functional limitations, activities permitted, nutritional requirements, medications and treatments, any safety measures to protect against injury, instructions for timely discharge or referral, and any other appropriate items. 7 G172 RN REGULARLY RE EVALUATES THE PATIENT S NURSING NEEDS 484.30(a) regularly re evaluates the patient s nursing needs, 8 G224 ASSIGNMENT & DUTIES OF THE HOME HEALTH AIDE 484.36(c)(1) Written patient care instructions for the home health aide must be prepared by the registered nurse or other appropriate professional who is responsible for the supervision of the home health aide under paragraph (d) of this section. 9 3
G225 ASSIGNMENT & DUTIES OF THE HOME HEALTH AIDE 484.36(c)(2) The home health aide provides services that are ordered by the physician in the Plan of Care and that the aide is permitted to perform under State law. 10 G229 ON SITE SUPERVISORY VISITS (USUALLY WITHOUT AIDE PRESENT) EVERY 14 DAYS 484.36(d)(2) The registered nurse (or another professional described in paragraph (d)(1) of this section) must make an on site visit to the patient s home no less frequently than every 2 weeks. The expected outcome for this high priority standard is that the aide supervisory visits occur no less frequently than every 14 days. 11 G236 CLINICAL RECORDS MAINTAIN IN ACCORDANCE WITH PROFESSIONAL STANDARDS. (EHR & PAPER CLINICAL RECORDS STANDARDS/ REQUIREMENTS ARE THE SAME) 484.48 A clinical record containing pertinent past and current findings in accordance with accepted professional standards is maintained for every patient receiving home health services. 12 4
G236 CLINICAL RECORDS MAINTAIN IN ACCORDANCE WITH PROFESSIONAL STANDARDS. (EHR & PAPER CLINICAL RECORDS STANDARDS/ REQUIREMENTS ARE THE SAME) continued In addition to the plan of care, the record contains appropriate identifying information; name of physician; drug, dietary, treatment, and activity orders; signed and dated clinical and progress notes; copies of summary reports sent to the attending physician; and a discharge summary. This includes authentication of clinical records. 13 G334 COMPLETION OF THE COMPREHENSIVE ASSESSMENT 484.55(b)(1) The comprehensive assessment must be completed in a timely manner, consistent with the patient s immediate needs, but no later than 5 calendar days after the start of care. 14 G337 DRUG REGIMEN REVIEW COMPREHENSIVE ASSESSMENT MUST INCLUDE REVIEW OF ALL MEDS THE PATIENT IS CURRENTLY TAKING 484.55(c) Standard: Drug Regimen Review The comprehensive assessment must include a review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. 15 5
G339 UPDATE OF THE COMPREHENSIVE ASSESSMENT FOLLOW UP ASSESSMENT CONDUCTED WITHIN LAST 5 DAYS OF EVERY 60 DAYS BEGINNING WITH START OF CARE DATE, TRANSFER, CHANGE IN CONDITION, OR DISCHARGE AND RETURN DURING A 60 DAY EPISODE 16 G339 continued 484.55(d)(1) The last 5 days of every 60 days beginning with the start of care date, unless there is a: (i) Beneficiary elected transfer; (ii) Significant change in condition; or (iii) Discharge and return to the same HHA during the 60 day episode. 17 Top 7 Conditions of Participation in order of frequency cited 42 CFR 484.55 Comprehensive Assessment of Patients cited 11 times in FFY 2014 42 CFR 484.18 Acceptance of Patients, Plan of Care, and Medical Supervision cited 10 times in FFY 2014 42 CFR 484.36 Home Health Aide Services cited 8 times in FFY 2014 42 CFR 484.48 Clinical Records cited 5 times in FFY 2014 18 6
Top 7 Conditions of Participation in order of frequency cited, continued 42 CFR 484.14 Organization, Services, and Administration cited 4times in FFY 2014 42 CFR 484.30 Skilled Nursing Services cited 4 times in FFY 2014 42 CFR 484.52 Evaluation of the Agency s Program cited 4 times in FFY 2014 19 Other Conditions of Participation cited one time 42 CFR 484.12 Compliance with Federal, State & local laws and accepted professional standards cited 1 time in FFY 2014 42 CFR 484.16 Group of Professional Personnel cited 1 time in FFY 2014 42 CFR 484.20 Reporting OASIS Information cited 1 time in FFY 2014 42 CFR 484.32 Therapy Services cited 1 time in FFY 2014 20 CHART OF HOME HEALTH G TAGS AND ABBREVIATED IDENTIFIERS Level 1 standards are highlighted in green Level 2 standards are highlighted in yellow The following slide will be provided to you as a full size handout. 21 7
22 23 INFORMATION REQUIRED DURING RECERTIFICATION SURVEYS The agency s organizational chart The agency s current authorized geographic service area map Many other documents may be required during a survey 24 8
G123 ORGANIZATIONAL STRUCTURE (CHART) 484.14 Organization, services furnished, administrative control, and lines of authority for the delegation of responsibility down to the patient care level are clearly set forth in writing and are readily identifiable. The following slide contains an example of an organizational chart for a HHA. This document will also be presented to you as a full size handout. 25 26 GEOGRAPHIC SERVICE AREA We need a copy of your current approved geographic service area: During each recertification survey; If you request to change the agency s geographic service area; or If you request to provide services to a patient residing outside the agency s geographic service area you must provide a map of the agency s service area and additional requested information prior to accepting an out of area patient. 27 9
AN ACCEPTABLE PLAN OF CORRECTION SHOULD INCLUDE Step by step description of the method(s) used to correct the system level problem which caused the deficiency. The plan of correction must provide information which assures the intent of the regulation, as evidenced by the examples, is corrected. A statement that correction has been made for the specific examples cited is not acceptable. 28 AN ACCEPTABLE PLAN OF CORRECTION SHOULD INCLUDE State the method(s) to be used to maintain and monitor compliance. Indicate the person(s) responsible for monitoring the correction to prevent the deficiency s reoccurrence by position title(s). State your anticipated frequency of monitoring for continued compliance. Include a realistic date of correction/compliance for each deficiency by month, date, and year. 29 AN ACCEPTABLE PLAN OF CORRECTION SHOULD NOT INCLUDE Any proper names except the name of the person signing the plan of correction. The surveying agency will consider evidence arguing the existence of a deficiency, but will not consider documentation that argues the seriousness of a deficiency. An accepted plan of correction will be displayed on the DIA website 90 days after the end of the survey, additional exhibits or attachments will not be displayed. 30 10
REPORTABLE CHANGES To maintain an active enrollment status in the Medicare program, you must submit updates and changes to your enrollment information in accordance with specified timeframes. Reportable changes that need to be submitted to the state agency (SA) and the MAC include, but are not limited to: Change of legal name or doing business as (D/B/A) name; Change of practice location, for parent and/or branch offices; Change of administrator or authorized/delegated officials; or Final adverse legal actions, including felony convictions, license suspensions or revocations of a health care license, an exclusion or debarment from participation in Federal or State health care program, or a Medicare revocation by a different Medicare contractor. 31 REPORTABLE CHANGES (continued) Change of Ownership (CHOW) Asset transfers of more than 5% of the certified entity s assets Stock transfers, mergers, and management structure reorganizations Changes of ownership for HHAs certified less than three years may result in a revocation of the agency s Medicare certification. Approval by the MAC for reportable changes is final pending approval by the CMS Regional Office or the SA on behalf of the CMSRO. 32 REPORTABLE CHANGES THAT REQUIRE AUTHORIZATION BY THE SA & THE RO PRIOR TO Relocation of a HHA parent office or branch office Change in geographic service area (GSA) Addition or deletion of a practice location Voluntary termination of Medicare certification 33 11
REPORTABLE CHANGES FOR THE MAC Revalidations do not address changes in an agency s Medicare information unless the agency notifies the MAC what specifically has changed in the cover letter for the revalidation. Contact provider enrollment at the MAC for your agency for specific information on their reporting requirements and billing information. 34 NEW HHA ALTERNATIVE SANCTIONS Was originally published in December, 2013 Alternative sanctions officially took effect 7/1/14 We have not imposed alternative sanctions on any HHAs in the State of Iowa yet. 35 CMS EXPECTATIONS OF THE REGULATIONS First Expectation: Providers remain in substantial compliance with Medicare program requirements as well as State law. The regulation emphasizes need for continued rather than cyclical compliance. The enforcement process require that policies and procedures be established to correct deficient practices & to ensure that correction is lasting. That HHAs take the initiative for continuously monitoring their own performance to sustain compliance. 36 12
CMS EXPECTATIONS OF THE REGULATIONS Second Expectation: All deficiencies will be addressed promptly. The standard for program participation mandated by the regulation is substantial compliance. Substantial compliance is compliance with all condition level requirements, as determined by CMS and the SA. The SA and the CMSRO will take steps to bring about compliance quickly. In addition to termination of the HHA s provider agreement, sanctions such as civil money penalties, suspension of payment for all new admissions, temporary management, directed plans of correction, directed in service training. 37 CMS EXPECTATIONS OF THE REGULATIONS Third Expectation: Individuals under the care of the HHA will receive the care and services they need to attain and maintain their highest practicable functional capacity. The processes detailed in these sections provides incentives to HHAs for the continued compliance needed to enable these individuals to reach these goals. 38 AVAILABLE SANCTIONS Civil Money penalties; Suspension of payment for all new admissions; Temporary management of the HHA; Directed plan of correction; and Directed in service training. 39 13
FACTORS TO BE CONSIDERED IN SELECTING SANCTIONS The extent to which the deficiencies pose immediate jeopardy to patient health and safety. The nature, incidence, manner, degree, and duration of the deficiencies or non compliance. The presence of repeat deficiencies, the HHA s overall compliance history and any history of repeat deficiencies at either the parent or branch location. The extent to which the deficiencies are directly related to a failure to provide quality patient care. The extent to which the HHA is part of a large organization with performance problems. An indication of any system wide failure to provide quality care. Other factors including, but not limited to, the history of the HHA s compliance with the CoPs, specifically with reference to the cited deficiencies. 40 NOTIFICATION TO A HHA OF ALTERNATIVE SANCTIONS AFTER A SURVEY CMS has adopted the following elements to be incorporated in all cases involving deficiencies cited as a result of Federal survey. They are designed to clarify and expedite the resolution process. Notice to the HHA will indicate that the IDR, including any face to face meetings, constitutes an informal administrative process that in no way is to be construed as a formal evidentiary hearing. Notice to the HHA will indicate that counsel may accompany the HHA. If the HHA chooses to be accompanied by counsel, then it must indicate that in its request for IDR, so that CMS/SA may also have counsel present. CMS will verbally advise the HHA of CMS s decision relative to the informal dispute, with written confirmation to follow. 41 INFORMAL DISPUTE RESOLUTION Section 488.745 offers HHAs, upon their receipt of the official Form CMS 2567, the option to request an informal opportunity to dispute condition level survey findings warranting a sanction. An HHA s initiation of the IDR process or failure of CMS or the State, as appropriate, to complete an IDR will not postpose or otherwise delay the effective date of any enforcement action. 42 14
INFORMAL DISPUTE RESOLUTION, continued Upon their receipt of the official Form CMS 2567, agencies must be offered one informal opportunity, if they request it in writing, to dispute condition level deficiencies. Deficiencies cited at the standard level are not subject to the IDR process. 43 INFORMAL DISPUTE RESOLUTION, continued Agencies may not use the IDR process to delay the formal imposition of sanctions or to challenge any other aspect of the survey process, including: The severity assessment of a deficiency(ies) at the standard level that constitutes substandard care or immediate jeopardy; Sanctions imposed by the enforcing agency; Alleged failure of the survey team to comply with a requirement of the survey process; Alleged inconsistency of the survey team in citing deficiencies among agencies; and Alleged inadequacy or inaccuracy of the IDR process. 44 INFORMAL DISPUTE RESOLUTION, continued HHAs must be notified of the availability of IDR in the letter transmitting the official Form CMS 2567. The letter should inform the agency of the following: It may request the opportunity for IDR, and that if it requests the opportunity, the request must be submitted in writing; The written request must include an explanation of the specific deficiencies that are being disputed; The written request must be made within the same 10 calendar day period the HHA has for submitting an acceptable plan of correction to the surveying entity; The name and address, e mail and phone number of the person to contact in order to request the IDR; The IDR process that is followed in the State, e.g., telephone conference, written communication, or face to face meeting; and The name and or position title of the person who will be conducting the IDR, if known. 45 15
INFORMAL DISPUTE RESOLUTION, continued Failure to complete IDR timely will not delay the effective date of any enforcement action against the agency. When an HHA is unsuccessful during the process at demonstrating that a deficiency should not have been cited, the SA must notify the agency in writing that it was unsuccessful. When an HHA is successful during the IDR process at demonstrating that a deficiency should not have been cited or should be revised: The deficiency citation should be marked deleted, or revised as appropriate, and signed and dated by a supervisor of the surveying entity; and Any enforcement action(s) imposed solely because of that deleted or revised deficiency citation should be rescinded. 46 INFORMAL DISPUTE RESOLUTION, continued The HHA has the option to request a clean (new) copy of the Form CMS 2567. However, the clean copy will be the releasable copy only when a clean (new) plan of correction is both provided and signed by the agency. The original Form CMS 2567 is disclosable when a clean plan of correction is not submitted and signed by the agency. An agency may request IDR for each survey that cites condition level deficiencies. However, if IDR is requested for deficiencies cited at a subsequent survey, an HHA may not challenge the survey findings of a previous survey for which the HHA either received IDR or had an opportunity of it. Condition level deficiencies that are not corrected and that are carried forward on a subsequent survey are not eligible for the IDR process. Condition level deficiencies identified on a subsequent survey that are new are eligible to be reviewed through the IDR process. 47 IMMEDIATE JEOPARDY SITUATIONS If CMS or a SA determines that the HHA s condition level deficiencies immediately jeopardize the health or safety of its patients, then CMS must take immediate action to notify the HHA of the jeopardy situation and the HHA must correct the deficiencies. If the IJ is not removed because the HHA is unable or unwilling to correct the deficiencies, CMS will terminate the HHA s provider agreement, and may impose one or more specified alternative sanctions, including but not limited to civil money penalties and suspension of all Medicare payments before the effective date of termination. The purpose of enforcement sanctions if to ensure prompt compliance with program requirements in order to protect the health and safety of individuals under the care of an HHA. 48 16
DETERMINATION OF SANCTIONS A determination of sanctions would be based on condition level deficiencies or repeat deficiencies found in an HHA during a survey. Determination on deficiencies would not be limited to findings from the mandated surveys specified in the statue or the regulations. Deficiency findings that are based on other reporting or evaluative programs, procedures, or mechanisms, such as OASIS reporting and validated complaints, would be sufficient to determine whether Medicare requirements are met. The survey agency (the SA) makes a recommendation to the RO on which sanction(s) may be effective in prompting the HHA to return to compliance. The RO considers the SA s recommendations and makes a determination to agree with or impose a different sanction(s) for the HHA. 49 EFFECT OF SANCTIONS ON DEEMED HHAS SAs conduct validation and complaint investigation surveys of accredited providers only when specifically authorized to do so by the RO. A deemed HHA loses its deemed status when a condition level finding is cited on a complaint or a validation survey. When this occurs the RO returns oversight of the accredited HHA back to the SA until the HHA can demonstrate compliance with the CoPs. During the time the SA has jurisdiction over the HHA, the SA not the AO, will follow the procedures for recommending the imposition of sanctions, if appropriate. Once the HHA returns to compliance with the Medicare CoPs and has not been terminated, the RO will restore its deemed status and will return oversight to the AO. 50 GUIDANCE FOR THE USE OF INDIVIDUAL SANCTIONS The guidance on the implementation of the various sanctions is too lengthy to go into in this presentation. However, all of the information available to the SA is also available to HHAs in Chapter 10 of the State Operations Manual sent to you prior to this presentation. We are unable to answer any hypothetical questions during a presentation because the answers are not applicable to specific situations which vary from survey to survey and agency to agency. *Remember the State Operations Manual is a CMS publication and is not a State of Iowa publication. 51 17
QUESTIONS???? 52 CONTACT INFORMATION Mary Spracklin RN, M.S.N, Medicare Services Bureau Chief 515 281 0286 mary.spracklin@dia.iowa.gov Rosemary Kirlin RN, M.S.N, Program Coordinator 515 281 4120 rosemary.kirlin@dia.iowa.gov Iowa Department of Inspections and Appeals Health Facilities Division Lucas State Office Building, 3 rd Floor 321 E 12 th Street Des Moines, IA 50319 0083 Main Phone #515 281 4115 Fax #515 242 5022 53 18