SUCCESSFUL STRATEGIES TO CHALLENGE SURVEY ENFORCEMENT ACTION Kenneth L. Burgess, JD

1. SUCCESSFUL STRATEGIES TO CHALLENGE SURVEY ENFORCEMENT ACTION Kenneth L. Burgess, JD Poyner & Spruill, LLP Raleigh, North Carolina Julie Bowman-Mitchell, JD, LLM Health Law Copeland, Cook, Taylor & Bush, PA Ridgeland, Mississippi

2. Successfully Navigating the IDR Process • Lessons from the DAB

3. You had a bad survey… now what? • CMS has certain expectations when it comes to nursing homes and their residents. • Providers must remain in “substantial” compliance with the Medicare/Medicaid program requirements as well as state law. • All deficiencies will be addressed promptly. • Residents will receive the care and services they need to meet their highest practicable level of functioning.

4. You had a bad survey… now what? • 2567 will trigger your appeal rights • Focus on your POC but remember your POC can be used for and against you. • Use a disclaimer • Be careful of false statements

5. Focus on Your POC In order for your POC to be acceptable, it must: • Contain elements detailing how the facility will correct the deficiency as it relates to the individual • Show how the facility will act to protect residents in similar situations • Include measures the facility will take or the systems it will alter to ensure that the problem does not recur. • Indicate how it plans to monitor its performance to make sure that solutions are sustained; and • Provide dates when corrective action will be complete. SOM 7304D

6. Successfully Navigating IDR • What is IDR? • Informal Dispute Resolution (“IDR”) is the process by which facilities can informally dispute regulatory deficiencies cited by the State Survey Agency. It is your one-shot freebie.

7. Successfully Navigating IDR • States are to notify facilities of their right to IDR in the letter transmitting the Official 2567. This notice should inform the facility of its rights and duties in IDR. NOTICE

8. Successfully Navigating IDR • To appeal or not to appeal? • You have a right to appeal. • IDR 42 CFR 488.331 • DAB 42 CFR 498, et. seq.

9. Successfully Navigating IDR • IDR Notice from the State should include: • Right to IDR • Name, address and telephone number of the person the facility must contact to request the IDR • How IDR may be accomplished in that state, e.g., telephone, in writing, or in a face-to-face meeting. • Name and/or position title of the person who will be conducting the IDR, if known.

10. Successfully Navigating IDR • IDR (continued) • A facility may request IDR for each survey that cites a deficiency. Facilities cannot use IDR to challenge any other aspect of the Survey process, including the: • Scope and Severity of the deficiencies, with the exception of SQC and IJ • Remedy(ies) imposed by the enforcing agency • Alleged failure of the survey team to comply with the survey process • Alleged inconsistency of the survey team • Alleged inadequacies or inaccuracy of the IDR process

11. Successfully Navigating IDR • A facility may request IDR based upon the results of a revisit or the previous IDR outcome if: • It is a continuation of the same deficiency or revisit • There is a new deficiency (new or changed facts, new tag) at revisit or IDR • It is a new example of a deficiency (new facts, same tag) • At revisit or IDR if there is a different tag but same facts at revisit or IDR that constitutes substandard quality of care

12. Successfully Navigating IDR • Why IDR? • Nothing to lose • No waiver of discount • Practice • Memory recall • Deficiencies will not be uploaded to Nursing Home Compare until IDR is complete • IJ • Pending or threatened litigation

13. Successfully Navigating IDR • Why not IDR? • Limited time and resources • Can raise new tags • Can create suspect with regard to evidence • IDR is not binding on CMS

14. Successfully Navigating IDR • If you choose IDR • Request must be in writing. • Request must include an explanation of the specific deficiencies that are being disputed. • Request must be made within the same 10 calendar day period the facility has for submitting an acceptable POC.

15. Successfully Navigating IDR • You win! Now what? • The deficiency is deleted, enforcement action resulting from that deficiency should be rescinded, and the s/s should be adjusted. • To get a clean 2567 you must submit a clean POC.

16. Successfully Navigating IDR When a facility is unsuccessful at IDR, the State must provide written notice of the results to the facility.

17. Successfully Navigating IDR • Things to note: • Failure to complete IDR will not delay enforcement, nor will it toll your time for an ALJ hearing. • Imposition of remedies will not be tolled by a pending IDR process

18. Successfully Navigating IDR • When IDR is done with the state rather than CMS, CMS is not bound by the result. • CMS’s findings of noncompliance take precedence over state agency’s findings of compliance.

19. Successfully Navigating IDR • Mistaken reliance on possibly misleading information from state agency is not good cause for failing to file a formal ALJ hearing request while IDR is ongoing. OOPS!

20. Successfully Navigating IDR • Federal IDR • Same as states • Disclaimer is given to facility that IDR is informal and in no way to be construed as a formal evidentiary hearing. • Counsel may accompany facility at a face-to-face meeting. • CMS will verbally relay decision with written decision to follow.

21. Successfully Navigating IDR • All states must offer IDR in compliance with 7212 of the SOM. • CMS Memorandum June 12, 2003 • CMS Memorandum December 16, 2004

22. LESSONS FROM THE DAB Departmental Appeals Board Departmental Appeals Board

23. Lessons from the DAB • Petition/Complaint • Plead everything in your formal appeal in detail: • Each citation and Tag number challenged • Challenge to overall finding of noncompliance • Each remedy challenged • Duration of remedies if can be legitimately argued • Any findings of substandard quality of care • Level of CMPs

24. Lessons from the DAB • Petition/Complaint • Unchallenged deficiencies are deemed final • Substantial noncompliance with only one participation requirement can support the imposition of a penalty

25. Lessons from the DAB • Petition/Complaint • Summary disposition may be issued even without holding an in-person hearing where the facility fails to provide facts to dispute those facts offered by CMS in its 2567

26. Lessons from the DAB • Right to a Hearing • You have 60 days from receipt of notice from CMS to timely file your request for an ALJ hearing. • Failure to timely file your request will bar your right to appeal… except where you can make a showing of “good cause”. • Human error is NOT good cause • Filing a plan of correction does not toll your 60 days • IDR does not toll your 60 days

27. Lessons from the DAB • Right to a Hearing • If you feel the facility is in substantial compliance with participation requirements, you must come forward with something to show this compliance. • CMS has no burden of producing facts showing a continuing state of noncompliance after an initial finding of same; a presumption of noncompliance is established.

28. Lessons from the DAB • Right to a Hearing • If you have no right to a hearing, the ALJ may dismiss the hearing request. • CMS must actually impose a proposed remedy to grant a right to a hearing; mere citation of a deficiency is not enough. • You may withdraw your hearing request at any time prior to the hearing.

29. Lessons from the DAB • Burden of Proof and Evidence in Appeals • CMS has the initial burden of making a prima facie case of a regulatory violation.

30. Lessons from the DAB • Burden of Proof and Evidence in Appeals • CMS must show causal connection between alleged regulatory violation and the harm or potential for harm upon which it relies to support a deficiency. • Once CMS establishes the presence of a deficiency, they have no additional burden to prove scope and severity.

31. Lessons from the DAB • Allegations of New Deficiencies by CMS During Appeals • CMS may add a new deficiency during an appeal, under a different regulatory provision and tag number, to the deficiencies identified in the CMS 2567 survey report • The new alleged deficiency must be based upon facts relied upon by CMS which you have ample notice of via the 2567

32. Lessons from the DAB • CMS’s Right to Impose CMPs for Any Noncompliance • CMS has the discretion to impose CMPs for any instance of noncompliance, defined as any deficiency which poses the potential for more than minimal harm. • Regulations direct CMS to impose CMPs to remedy level "F" or higher level deficiencies, but CMS may also impose CMPs for substantial deficiencies, level “D" or higher

33. Lessons from the DAB • CMS’s Right to Impose CMPs for Any Noncompliance • You must focus on disproving the existence of the deficiency, the level of the deficiency or the duration of the deficiency and cannot simply challenge the right of CMS to impose a CMP because the deficiency did not involve the existence or allegation of “actual harm.”

34. Lessons from the DAB • CMS’s Right to Impose CMPs for Any Noncompliance • Substantial noncompliance with only one participation requirement can support the imposition of a penalty, i.e. challenge all deficiencies that may result in CMPs in the initial request for hearing.

35. Lessons from the DAB • Appealing the Amount of CMPs • ALJs may find CMP levels to be excessive and reduce them, particularly where one or more deficiencies are overturned by the ALJ, or are found to be at a lower level than cited by CMS • ALJs do not, however, have authority to overturn CMS’s decision to select a CMP as the remedy of choice if a deficiency is upheld

36. Lessons from the DAB • Appealing the Amount of CMPs • CMS is not required, as part of its case in chief, to present evidence on any or all of the factors or to explain its reasoning process in determining the amount of CMP to impose.

37. Lessons from the DAB • Appealing the Amount of CMPs • If you want to challenge the amount of CMPs, you must actually make that specific challenge up front. • Merely disputing the basis for CMPs, and failing to challenge whether or not the amount is reasonable based on the factors that CMS and the ALJ must consider, is not enough.

38. Lessons from the DAB • Appealing the Duration of CMPs • You may challenge duration of noncompliance or deficiency • However, if you do not offer an argument or evidence to challenge the alleged duration of noncompliance, CMS’s determination is deemed administratively final

39. Lessons from the DAB • Competence of Surveyors as Clinical Witnesses • Facilities attacking the competence of surveyors to assess a clinical issue must show specific evidence of a lack of knowledge, training or other basis for clinical expertise to successfully rebut CMS’s clinical witnesses • You cannot rebut CMS’s prima facie case by showing that a surveyor has been “off the floor” for a period of time

40. Lessons from the DAB • Standard of Care • The standard of care is “substantial compliance”, NOT “strict liability”. • You must provide care and services to maintain highest practicable well-being of facility residents • You will not be punished for unavoidable outcomes or untoward events that could not be reasonably foreseen.

41. Lessons from the DAB • Immediate Jeopardy (IJ) • IJ exists if a facility’s noncompliance has caused or is likely to cause “serious injury, harm, impairment, or death to a resident” • Actual harm is not required • Key is whether a resident in that condition could have been injured

42. Lessons from the DAB • Immediate Jeopardy • CMS may determine whether IJ existed even if state survey agency did not make that determination or impose remedies • ALJ is permitted to rely on past events to determine whether noncompliance existed at the time of a survey

43. Lessons from the DAB • Comprehensive Assessments • Comprehensive assessments are part of the care and services necessary to maintain highest practicable well-being of residents • Resident’s right to refuse treatment does not excuse you from performing comprehensive assessments or offering appropriate services

44. Lessons from the DAB • Plan of Correction (POC) Must Actually Be Implemented • You cannot overcome CMS’s prima facie case simply by referring to a POC submitted to the state agency. • A POC is merely a representation of what you intend to do to correct a deficiency; it is the implementation of the POC that actually corrects deficiencies.

45. Lessons from the DAB • Hydration • The regulations and the SOM do not specify what assessments and care plans are to look like or how detailed they are to be • A survey is a result-oriented process; if alleged dehydration is observed, presumption arises that inaction or deficient action by the facility was the cause, and CMS has made its prima facie case

46. Lessons from the DAB • Elopement/Wandering • There is an unstated presumption that all elopements are preventable • While you are only required to have in place procedures and policies to prevent wandering, when wandering occurs, the ALJs and the DAB virtually always find the facility had ineffective procedures in place to prevent resident wandering

47. Lessons from the DAB • Elopement/Wandering • Actual harm is unnecessary for a resident’s elopement to constitute “immediate jeopardy” • Based more on whether a resident in that condition could have been injured; likelihood of potential for more than minimal harm • The duty to protect goes beyond the walls of the facility

48. Lessons from the DAB • Elopement/Wandering • Care-planning alone is not enough to constitute having “effective procedures in place” • You must do all the facility reasonably can to protect residents from foreseeable risks of harm due to elopement • However, you can sometimes prevail in wandering/elopement cases where the facility has taken a full range of preventive measures and documented them

49. Lessons from the DAB • Elopement/Wandering • CMS is increasingly citing providers in wandering/elopement cases under both the accident prevention tag and for failing to administer the facility in a manner that enables residents to attain or maintain the highest practicable well-being of each resident

50. Lessons from the DAB • Accidents • You are only required to have in place procedures and policies to prevent accidents • Policies and procedures and subsequent interventions must be effective in the particular circumstances to prevent resident accidents • Potential interventions must be implemented in a systematic, reliable manner