REPORT OF ADMINISTRATIVE LAW JUDGE

Transcription

1 STATE OF MINNESOTA OFFICE OF ADMINISTRATIVE HEARINGS FOR THE MINNESOTA DIVISION OF HEALTH In the Matter of Proposed Permanent Rules of the Department of Health Governing Hospice Providers, Minnesota Rules Part REPORT OF ADMINISTRATIVE LAW JUDGE Administrative Law Judge Allan W. Klein conducted a hearing on these rules on November 12, 2003, at the Minnesota Department of Health s Snelling Office Park Service Center in St. Paul. In addition to that site, persons participated via two-way videoconference from sites in Slayton and Duluth. The hearing continued until everyone had an opportunity to state his or her views on the proposed rules. The hearing and this Report are part of a rulemaking process governed by the Minnesota Administrative Procedure Act. 1 The legislature has designed the rulemaking process to ensure that state agencies have met all the requirements that Minnesota law specifies for adopting rules. Those requirements include assurances that the proposed rules are necessary and reasonable and that any modifications that the agency made after the proposed rules were initially published do not result in them being substantially different from what the agency originally proposed. The rulemaking process also includes a hearing, when a sufficient number of persons request one. The hearing is intended to allow the agency and the administrative law judge reviewing the proposed rules to hear public comment regarding the impact of the proposed rules and what changes might be appropriate. Wendy Wilson Legge, the Department s Legal Affairs Coordinator, appeared as the attorney for the Division. Other Department personnel participating in the hearing included Assistant Commissioner Carol Woolverton, Mary Absolon, Bonnie Wendt and Kay Herzfeld. They provided information about the proposed rules and answered questions. Approximately 15 members of the public signed the hearing register in St. Paul 2, 28 persons signed in Slayton, and 4 persons signed in Duluth. After the hearing ended, the record remained open for twenty days, until December 2, 2003, to allow interested persons and the Agency an opportunity to submit written comments. 3 During this initial comment period the Administrative Law Judge received several written comments, plus a submission from the Department. The Department s submission contained a number of changes to the proposed staffing rule, 1 Minn. Stat through There were others who attended in St. Paul, but did not sign the register. 3 Minn. Stat , subd. 1.

2 which was the most controversial part of the proposed rules package. Following the initial comment period, the record remained open for an additional five business days to allow interested persons and the Agency the opportunity to file a written response to the comments submitted. The deadline for responses to the comments was December 9, A few responsive comments were received, including a response from the Department. The hearing record closed for all purposes on December 9, NOTICE The Department of Health must make this Report available for review for at least five working days before the department takes any further action to adopt final rules or to modify or withdraw the proposed rules. During that time, this Report must be made available to interested persons upon request. If the Department makes any changes to the rules as proposed, whether or not those changes have been approved or recommended by this Administrative Law Judge, it must resubmit the rules to the Chief Administrative Law Judge for a review of those changes. After adopting the final version of the rules, the Department should inform this Office. This Office will request certified copies of the rules from the Revisor and will file the rules with the Secretary of State. Based upon all the testimony, exhibits, and written comments, the Administrative Law Judge makes the following: Procedural Requirements FINDINGS OF FACT 1. On May 27, 2003, the Department published a Request for Comments on Possible Rules Governing Hospice Providers, and Possible Amendments to Minnesota Rules, Chapters 4668 and 4669, in the State Register, at 27 SR The Department mailed the Request for Comments to those individuals on the Agency s rulemaking mailing list and to a separate mailing list of all licensed hospice providers and other interested persons On August 19, 2003, the Department requested approval of its Additional Notice Plan and asked that a hearing be scheduled for November 12, Administrative Law Judge George A. Beck approved the MPCA s Notice of Hearing and Additional Notice Plan on August 22, Ex Id. 6 Ex. 7. 2

3 3. On September 4, 2003, the MPCA mailed the Notice of Hearing and a copy of the Proposed Rules to all persons and associations who had registered their names with the agency for the purpose of receiving such notice, and to the persons and groups identified in the Additional Notice Plan. 4. On September 8, 2003, the Notice of Hearing and the proposed rules were published at 28 State Register On the day of the hearing, the Division placed the following documents into the record: a. Request for Comments as published at 27 State Register 1716 on May 27, 2003, along with related mailing lists; 8 b. Proposed Permanent Rules Relating to Home Care and Hospice Service (dated August 13, 2003); 9 c. Statement of Need and Reasonableness (dated August 27, 2003); 10 d. Certificate of Mailing the Statement of Need and Reasonableness to the Legislative Reference Library (letter dated September 4, 2003); 11 e. Notice of Hearing as published at 28 State Register 235 on September 8, 2003; 12 f. Certificate of Mailing the Notice of Hearing to the Division s Rulemaking Mailing List (September 4, 2003) 13, to persons pursuant to the Additional Notice Plan (September 4, 2003) 14 and to certain legislators (also September 4, 2003); 15 g. Certificate of Accuracy of the Mailing List (September 2, 2003); 16 h. Approval of Notice of hearing and Additional Notice Plan by the Office of Administrative Hearings (dated August 22, 2003); 17 i. All comments received prior to publication of the Notice of Hearing on September 8, 18 and all comments received after publication of the Notice; 19 j. Summary of Meeting with Stakeholders (October 28, New Ulm) 20 and written comments received in response to that meeting; 21 k. Changes proposed by the Division (Memorandum of November 12, 2003) Ex Ex Ex Ex Ex Ex Ex Exs. 7,7a, 7b, 7c, and 7d. 15 Ex. 6a. 16 Ex Ex Ex Ex. 8b. 20 Ex Ex. 9a. 3

4 6. The Administrative Law Judge finds that the Department has met all of the procedural requirements under the applicable statutes and rules. Background and Nature of the Proposed Rules 7. The Department has licensed hospices since 1993, when there were 59 hospice providers in the State. By March 15, 2003, there were a total of 76 licensed hospice providers in the State, six of which were licensed to operate a residential hospice facility. 8. For historic reasons, the regulatory pattern since 1993 has been less than a perfect fit to the realities of current hospice practice. Therefore, during the 2002 session, the Legislature adopted a new hospice statute, but stayed its effectiveness until the Department had adopted rules which the new statute mandated. 23 These rules are the Department s response to that legislative mandate. Legal Requirements for Rulemaking 9. The Administrative Procedure Act requires an agency adopting rules to consider seven factors in its Statement of Need and Reasonableness. 24 The first factor requires: (A) A description of the classes of persons who probably will be affected by the proposed rule, including classes that will bear the costs of the proposed rule and classes that will benefit from the proposed rule. The Department lists hospice providers, hospice volunteers, hospice patients and state agency enforcers as persons who are likely to be affected by the proposed rule. The Department asserts that patients or their family members who pay for hospice services, the Medicaid program, and state taxpayers are persons that will bear the cost of the proposed rule. The Department asserts that the rules provide minimal standards for the protection of hospice patients, as well as some basic education for providers regarding appropriate services. Both patients and providers are likely beneficiaries of the proposed rules. (B) The probable costs to the agency and to any other agency of the implementation and enforcement of the proposed rule and any anticipated effect on state revenues. The Department does not expect to incur additional costs to implement the proposed rules because it is already implementing similar rules for hospice providers. The Department will have to provide some education on the new rules for hospice 22 Ex With one exception, not important for this discussion. 24 Minn. Stat (2003). 4

5 providers, but there are licensing fees available to help with that cost. Due to the limited number of licensees, the Department expects a de minimus impact on state revenues and expenses. (C) A determination of whether there are less costly methods or less intrusive methods for achieving the purpose of the proposed rule. The Department could not identify any less costly methods or less intrusive methods for achieving the legislative goals. Minimizing the cost and intrusion was one of the goals of the Department and its work group during the formulation of these rules. (D) A description of any alternative methods for achieving the purpose of the proposed rule that were seriously considered by the agency and the reasons why they were rejected in favor of the proposed rule. The Department considered a number of different proposals, particularly in the area of minimum staffing requirements. In the SONAR, the Department sets forth a lengthy history of these proposals, and explains why the Department settled upon the one which it recommended in the rules as published. 25 (E) The probable costs of complying with the proposed rule, including the portion of the total costs that will be borne by identifiable categories of affected parties, such as separate classes. The Department noted that during the process of writing the rule, it dropped two out of the three areas that had been identified (by a work group) as new cost drivers. The remaining item was staffing, and the rule s cost impact would be felt primarily by one currently licensed residential hospice which would not be in compliance with the staffing requirements in the rule as originally proposed. The Department also noted relatively minor additional costs for training. The Department did point out that there are a number of costs which are set forth in the statute, but not in the rule. These include compliance with physical plant standards and the imposition of some additional licensure fees. 26 (F) The probable costs or consequences of not adopting the proposed rule, including those costs or consequences borne by identifiable categories of affected parties, such as separate classes of government units, businesses, or individuals. 25 SONAR, at pp SONAR, at pp

6 A current rule, pt , subp. 1, requires certain documentation and paperwork from providers. The proposed rule will eliminate much of that burden. Providers estimated that this change would save the industry approximately $2 million in administrative costs per year. [There would also be a minor cost savings from eliminating the requirement for a class B supervised living facility license for physical plant standards.] But the major change is derived from reduction of the paperwork requirements. (G) An assessment of any differences between the proposed rule and existing federal regulations and a specific analysis of the need and reasonableness of each difference. The Legislature directly addressed conforming to Federal Regulations when it wrote the 2002 law. The new law prohibits the Commissioner from enforcing these new rules against a Medicare certified program when that program provides an equivalent federal law or regulation relating to the same subject matter. In the proposed rule, the Commissioner has identified those parts which are deemed to be equivalent to provisions of federal Medicare certification requirements. 10. The Department has satisfied the requirements of Minn. Stat (2003), which requires it to ascertain the above information to the extent the Department can do so through reasonable effort. Performance Based Rules 11. The Administrative Procedure Act also requires an agency to describe how it has considered and implemented the legislative policy supporting performancebased regulatory systems. 27 A performance-based rule is one that emphasizes superior achievement in meeting the agency s regulatory objectives and maximum flexibility for the regulated party and the agency in meeting those goals The Department asserts that one of the objectives of the rule is to establish goals to be achieved, but not specify exactly how they must be achieved. It points, for example, to the rule that requires individual patient assessment, but does not mandate a specific type of tool that must be used. It also points to rules that require certain minimum standards, but encourage providers to exceed those. Finally, the Department points to the provision for waivers or variances to allow for innovations and new developments. The Department has met its obligation to support performancebased rules. Additional Notice 13. In addition to the mailed and published notice required by statute, the Department also mailed a copy of the notice and proposed rules to all administrators of 27 Minn. Stat Minn. Stat

7 licensed hospice providers, members of the hospice rules work group, and a variety of organizations such as consumer advocacy groups, the Minnesota Partnership to Improve End of Life Care, the Minnesota HomeCare Association, and persons who had contacted the Department with questions or comments during the development of the rules. A copy of the notice, the proposed rules and the SONAR were also published on the Department s web page. Rulemaking Legal Standards 14. Under Minn. Stat , subd. 2, and Minn. Rule , in a rulemaking proceeding, the Administrative Law Judge must determine whether the agency has established the need for and reasonableness of the proposed rule by an affirmative presentation of facts. In support of a rule, an agency may rely on legislative facts, namely general facts concerning questions of law, policy and discretion, or it may simply rely on interpretation of a statute, or stated policy preferences. 29 The Department prepared a Statement of Need and Reasonableness in support of the proposed rules. At the hearing, the Department primarily relied upon the SONAR as its affirmative presentation of need and reasonableness for the proposed amendments. The SONAR was supplemented by exhibits and comments made by the Assistant Commissioner and other agency representatives at the public hearing and in written post-hearing submissions. 15. The question of whether a rule is reasonable focuses on whether it has a rational basis, or whether it is arbitrary, based upon the rulemaking record. Minnesota case law has equated an unreasonable rule with an arbitrary rule. 30 Arbitrary or unreasonable agency action is action without consideration and in disregard of the facts and circumstances of the case. 31 A rule is generally found to be reasonable if it is rationally related to the end sought by the governing statute The Minnesota Supreme Court has further defined an agency s burden in adopting rules by requiring it to explain on what evidence it is relying and how the evidence connects rationally with the agency s choice of action to be taken. 33 An agency is entitled to make choices between possible approaches as long as the choice made is rational. It is not the proper role of the Administrative Law Judge to determine which policy alternative presents the best approach since this would invade the policymaking discretion of the agency. The question is rather whether the choice made by the agency is one that a rational person could have made Mammenga v. Department of Human Services, 442 N.W.2d 786 (Minn. 1989); Manufactured Housing Institute v. Pettersen, 347 N.W.2d 238, 244 (Minn. 1984). 30 In re Hanson, 275 N.W.2d 790 (Minn. 1978); Hurley v. Chaffee, 231 Minn. 362, 367, 43 N.W.2d 281, 284 (1950). 31 Greenhill v. Bailey, 519 F.2d 5, 19 (8 th Cir. 1975). 32 Mammenga, 442 N.W.2d at ; Broen Memorial Home v. Department of Human Services, 364 N.W.2d 436, 444 (Minn. Ct. App. 1985). 33 Manufactured Housing Institute, 347 N.W.2d at Federal Security Administrator v. Quaker Oats Co., 318 U.S. 218, 233, 63 S. Ct. 589, 598 (1943). 7

8 17. In addition to need and reasonableness, the Administrative Law Judge must also assess whether the rule adoption procedure was complied with, whether the rule grants undue discretion, whether the Department has statutory authority to adopt the rule, whether the rule is unconstitutional or illegal, whether the rule constitutes an undue delegation of authority to another entity, or whether the proposed language is not a rule In this matter, the Department did propose some changes to the rule language after publication in the State Register. Most of these were set forth in the memorandum distributed at the hearing 36, but additional changes were made a the end of the initial comment period. Therefore, the Administrative Law Judge must also determine if the final language is substantially different from that which was originally proposed The standards to determine if new language is substantially different are found in Minn. Stat , subd. 2. The statute specifies that a modification does not make a proposed rule substantially different if the differences are within the scope of the matter announced in the notice of hearing and are in character with the issues raised in that notice, the differences are a logical outgrowth of the contents of the notice of hearing and the comments submitted in response to the notice, and the notice of hearing provided fair warning that the outcome of that rulemaking proceeding could be the rule in question. 20. In determining whether modifications make the rules substantially different, the Administrative Law Judge is to consider whether persons who will be affected by the rule should have understood that the rulemaking proceeding could affect their interests, whether the subject matter of the rule or issues determined by the rule are different from the subject matter or issues contained in the notice of hearing, and whether the effects of the rule differ from the effects of the proposed rule contained in the notice of hearing Any substantive language that differs from the rule as published in the State Register has been assessed to determine whether the language is substantially different. Because most of the changes are not controversial, not all of the altered language has been discussed. Any change not discussed is found to be not substantially different from the rule as published in the State Register. Analysis of the Proposed Rules 22. This report is limited to discussion of the portions of the proposed rules that received significant comment or otherwise need to be examined. All of the public comments were fully considered. A detailed discussion of the proposed rules is unnecessary when the proposed rules are adequately supported by the SONAR or the 35 Minn. R Ex Minn. Stat , subd Minn. Stat , subd. 2. 8

9 Department s oral or written comments, and there is no public opposition. The agency has demonstrated the need for and reasonableness of all rule provisions not specifically discussed in this report by an affirmative presentation of facts. All provisions not specifically discussed are authorized by statute and there are no other problems that would prevent the adoption of the rules. 23. The only disputed issue that had not been resolved by the time of the hearing involved staffing requirements for residential hospice facilities. The August 13, 2003 draft published in the State Register contained the following proposed rule: Residential Hospice Facility Staffing. Subp. 1. Requirements. A hospice provider that operates a residential hospice facility must ensure that: A. The residential hospice facility provides 24-hour, seven-day-a-week nursing services that are sufficient to meet total nursing needs according to each hospice patient s needs; B. Each shift at the residential hospice facility includes a licensed nurse who provides, supervises, or monitors direct care; C. The residential hospice facility has the number and type of personnel sufficient to meet the total needs of the hospice patients. Two staff persons, or one staff person and one volunteer, must be on the premises at all times; and D. A registered nurse must be on call whenever a registered nurse is not on duty. Subp. 2. Fines. A fine of $ shall be assessed for each violation of this part. 24. In the SONAR, the Department explained the steps it went through to arrive at that proposal. 39 There are only six licensed residential hospice facilities in the state, but, there are a number of existing facilities that will have to become licensed when these rules become effective, plus there are three potential additional facilities which are likely to be opened at some point in the future. The six existing facilities include one which is licensed for ten beds and maintains an average daily census of eight to ten. There are four which are licensed for eight beds and maintain an average daily census of six to eight. And, there is one provider, Hospice of Luverne Community Hospital, which is licensed for five beds and maintains an average daily census of three to five. Five of the six existing licensed residential hospice facilities are staffing each shift with at least two persons, one of whom is a licensed nurse, and each has a licensed registered nurse (RN) on call whenever one was not on duty. The only exception to this pattern is Hospice of Luverne Community Hospital, which staffs with 39 SONAR, at pp

10 one unlicensed trained medical aide (TMA) on each shift, and four shifts per week are covered by a licensed practical nurse (LPN). The Department noted that its proposed staffing requirements would be consistent with existing practices at all the license facilities except for the one at Luverne. The Department noted that the Luverne situation was unique, and that the rules do contemplate alternative methods to provide hospice services via waivers and variances. The Department gave no assurance, however, that it would grant a waiver or variance to the Luverne facility. 25. Following the Department s announcement of its proposed rules, numerous comments were received by both the Department and the Administrative Law Judge. A number of them concerned a small facility in Slayton, Minnesota, which is not currently licensed as a residential hospice facility, but which would have to become licensed if the proposed rules went into effect. The facility, known as Hospice/Our House of Murray County, is a three-bedroom house that serves a maximum of three patients at any time. It is staffed with a trained medical aide (TMA) or certified nurse s aide (CNA), along with volunteers and family members of patients. The facility did not believe that it could survive if it had to have an LPN plus one other staff person on duty at all times. In addition to the Slayton facility, there were a number of facilities either under construction or in the planning stages, to serve rural areas in western and southwestern Minnesota. They did not believe that they could offer their proposed small-sized, home-like facilities if they were forced to have a licensed nurse on duty at all times. They proposed, instead, that there be at least one unlicensed certified staff member (such as a TMA or CNA, or home health aide) for up to and including four hospice patients. Appropriate staffing for five patients or more would be two staff persons or one staff person and one volunteer On October 28, 2003, the Department sponsored a meeting in New Ulm involving numerous hospice providers and other interested persons. The purpose of the meeting was to problem solve around the staffing issue. At the meeting, a revised proposal was developed, which was announced in advance of the November 12 hearing and was distributed and explained at the hearing. The revised proposal would require a licensed nurse on duty during each shift and a registered nurse on call at all times. In addition, for facilities with five or more residential hospice patients, there must also be two staff persons, or one staff person and one volunteer present. If the facility had four or fewer patients, it could have one staff person present, and one staff person or one volunteer on call and able to be on the premises within 20 minutes of a request. Finally, the November 12 proposal gave all facilities six months after the effective date of the rule to comply with the requirement that a licensed nurse be present on each shift. 27. At the hearing, the Department explained that the proposed changes were an outgrowth of the meeting in New Ulm and the public comments it had received. The Department based the cut off point of four or fewer patients on the experience reported by some of the small residential hospice providers and prospective providers. The Department also explained that it picked the 20-minute time limit to get another person 40 from Nona Magnussen, Hospice of Murray County, to Bonnie Wendt, Department of Health, dated October 13,

11 to the facility based upon the time limit set forth in other rules for ambulance response times. Twenty minutes is the average of the three different ambulance response times contained in Minn. Rule Part , Subp Response to the Department s November 12 proposed change was generally positive. Both at the hearing, and in written comments, many hospice providers indicated that they found the revised staffing proposal to be feasible or doable. However, adverse comments came from both those who wanted a stricter rule, and those who wanted a more relaxed rule. The Minnesota Nurses Association commented that having only an LPN on duty at all times was not enough, and that the rule ought to require an RN on duty at all times. Other commentators focused on the proposal that only one other staff person would have to be present, arguing that even if there were only three or four patients in residence, the nurse with one staff person was just not enough. 41 But on the other hand, there was substantial testimony from the Slayton site to the effect that there is a serious need in rural Minnesota for a facility for persons who can no longer be taken care of at home as they are dying, but which does not cost so much that they cannot afford to move there. They pointed out that there are always nursing homes for those who want or need full time nursing services, and that the hospices in rural areas are really substitutes for staying at home in situations where there is no caregiver available at home. To have to staff with an around-the-clock nurse, even an LPN, plus at least one other staff person, would be prohibitively expensive for some very small facilities. Where the cost could be spread among a number of patients, the cost is not so bad, but where there may be only one or two or three patients, even the November 12 proposal would force some small facilities to either close or turn away patients who could not afford a cost which was substantially higher than what they are charging now. Our House of Murray County, located in Slayton, cares for a maximum of three people at any one time. It is currently licensed as an adult foster care facility, but the new legislation will force it to become licensed as a residential hospice. For the past seven years, it has used a TMA, CNA, or home health aide. It does not believe it can continue operating (at least not at the same cost as it currently charges) if it had to comply with the November 12 rule. 29. In response to the comments at the hearing and those submitted just after it, the Department decided to further modify the staffing rule. By Memorandum dated December 1, 2003, to the Administrative Law Judge from Assistant Commissioner Wolverton, the Department proposed that facilities licensed for four or more beds must have a licensed nurse on duty at all times within six months after the effective date of the rule. But for facilities licensed for three or fewer beds, there would be a choice: They could either have a licensed nurse on the premises or, in the alternative, have a home health aide who had completed specific modification training requirements on the premises at all times so long as a licensed nurse was on call and able to be on the premises within 20 minutes. In addition, if a residential hospice has five or more residential patients, then it must have on the premises two staff persons, or one staff person and one volunteer. If the hospice had four or fewer residential patients, then it 41 See, for example, testimony of Lisa Abicht-Swensen, Executive Director for Hospice of the Twin Cities, as well as message to Kay Herzfeld from Bob Solheim, Director of M.C. Little Memorial Hospice. 11

12 must have either two staff persons (or one staff person and one volunteer) on the premises, or, in the alternative, it must have one staff person on the premises and one staff person or one volunteer on call and able to be on the premises within 20 minutes. 30. The Department explained that it was not proposing to change the requirement (which had remained constant throughout all the versions) that all residential hospice facilities, regardless of size, must ensure that they provide nursing services sufficient to meet each patient s needs. That requirement would remain unchanged. But based on the evidence provided by supporters of Our House in Slayton, and other similarly-sized facilities that might be built in the future, the Department concluded that TMA staffing had proven to be adequate to meet the needs of a small number of patients. However, as the licensed capacity went from three to four, it would be too much to expect a TMA to be able to know when one of the patients needed to have a licensed nurse brought to the facility. Therefore, the Department proposes to require a licensed nurse on the premises if the facility is licensed for four or more beds. The Department explained that it chose to base the requirement on the licensed capacity of the facility, rather than on the actual patient census (which had been the measure used in the November 12 proposal), because it was possible that a new patient could arrive at any time, and the Department wanted to limit the situations without a licensed nurse on the premises to those where it was not possible for there to be more than three patients. 31. The Department s December 1 proposal drew criticism from the Minnesota Nurse s Association, which argued that numbers of patients do not determine appropriate type of staff, and that TMAs or any other unlicensed aide, even with the medication training component required by the rule, simply did not have the appropriate preparation to make judgments about patients medical conditions. 42 A somewhat different comment was received from Denise Brewers, of the Prairie Home Hospice in Marshall. She hoped that the Department would move the cut off point from three or fewer to four or fewer, or that the requirement be based on a facility s actual census, rather than its licensure. 43 The Department responded by noting that Ms. Brewers comments were based on financial projections about a proposed facility, not an existing one, and that they understood her to be building a five-bed residential hospice, not a three or four-bed one. The Department also noted that Cindy Slack, of the Sioux Valley System, which has a variety of medical facilities in Minnesota and proposes to build several residential hospices, indicated that Sioux Valley could live with the November 12 proposal, which would require an LPN on duty at all times for a four-bed residential hospice. 32. Factual support for the Department s final position is found in three years worth of surveys concerning the operations of the Slayton facility, Our House of Murray County. This is the three-person facility discussed earlier in this Report. Within three months after a person leaves the facility, a questionnaire is sent to the family. The questionnaires ask for evaluations of the facility s performance in a number of areas. 42 Message dated December 9, 2003 to Administrative Law Judge Carol Diemert. 43 messages from Denise Brewers dated December 2 and December 4,

13 They also ask whether there are areas of concern that the family would like to raise. None of the questionnaires for three years raised any concerns about the quality or adequacy of staffing. Concerns were raised about too many visitors at one time, a need for softer chairs to sit on, and one respondent s desire for a more private bathroom. But the questionnaires demonstrate a very high degree of satisfaction with the staff, and no suggestion indicating that more staff were needed. Our House of Murray County has been using CNAs, home health aides or TMAs, with licensed nurses on call at all times. 33. After reviewing all of the comments and discussions about staffing requirements contained in the record, both oral and written, the Administrative Law Judge concludes that the Department has demonstrated a rational basis for its final proposal. There is no bright line dividing point where the record clearly shows an LPN be needed or not needed. It really depends on the needs of the patients who happen to be in the facility at that time. The Department s consistent position has been that a facility, regardless of size, must staff to meet the particular needs of the patients there. But if there are no particular needs, drawing a line becomes a matter of judgment and reasonable people could differ as to where to draw that line. The Administrative Law Judge finds the Department has justified its choice of a staffing level, and thus the Department may adopt the rule as it has finally proposed. 34. On a different topic, Jean McKeown, of Richfield, raised a concern about proposed Rule , subp The rule deals with confidentiality of health information. It prohibits a hospice provider from disclosing personal, financial, medical or other information about a patient, except as may be required or permitted by law. Ms. McKeown was concerned that this provision might be invoked by a hospice provider who wanted to cover up cases of potential abuse or neglect. She suggested that an additional sentence be added, which would make it clear that the rule was not intended to prevent disclosure needed to reveal, prevent, or remedy abuse or neglect of a patient. 35. The Department responded to this proposal by pointing out that the rule s exception that would allow disclosure of information as may be required or permitted by law was intended to address the problem raised by Ms. McKeown. The Department stated that there are numerous laws which require or permit disclosure, and which would prevent the kind of cover-up that Ms. McKeown was concerned about. The Department referred to the Vulnerable Adults Act, which requires certain reports and permits other reports regarding suspected maltreatment of vulnerable adults, as well as the Department s own authority to inspect all records of hospice providers, as well as federal regulation under HIPAA, which permits covered entities, such as a hospice, to disclose protected health information to the Minnesota Department of Health. The Department believed that these provisions would prevent a hospice from using the proposed rule to cover up abuse or neglect. 36. The Administrative Law Judge finds that the Department has justified its rule as initially proposed, and that it is not necessary to add the language proposed by 44 to Administrative Law Judge dated December 1, 2003, from Jean McKeown. 13

14 Ms. McKeown in order to make it needed or reasonable. Existing law and rule does grant the Department (and other governmental entities) access to all manner of records when there is any suspicion of abuse or neglect. Much of that authority is in statute, which takes priority over a rule in any case. While Ms. McKeown s concerns are understandable, the language she proposes would appear to excuse a facility from providing information not only to a government entity, but to any person who could claim it was needed to reveal, prevent, or remedy abuse or neglect. That language is too broad, and would require some limitation if the Department wanted to include it in the rule. The Department may adopt the rule without the language proposed by Ms. McKeown. Based on the foregoing Findings, the Administrative Law Judge makes the following: CONCLUSIONS 1. That the Department gave proper notice of the hearing in this matter. 2. That the Department has fulfilled the procedural requirements of Minn. Stat , and all other procedural requirements of law or rule. 3. That the Department has documented its statutory authority to adopt the proposed rules, and has fulfilled all other substantive requirements of law or rule within the meaning of Minn. Stat , subd. 1, 14.15, subd. 3 and (i) and (ii). 4. That the Department has demonstrated the need for and reasonableness of the proposed rules by an affirmative presentation of facts in the record within the meaning of Minn. Stat , subd. 4 and (iii). 5. That the additions and amendments to the proposed rules which were suggested by the Department after publication of the proposed rules in the State Register do not result in rules which are substantially different from the proposed rules as published in the State Register within the meaning of Minn. Stat , subd. 2 and 14.15, subd That any Findings which might properly be termed Conclusions and any Conclusions which might properly be termed Findings are hereby adopted as such. 7. That a finding or conclusion of need and reasonableness in regard to any particular rule subsection does not preclude and should not discourage the Department from further modification of the rules based upon an examination of the public comments, provided that the rule finally adopted is based upon facts appearing in this rule hearing record. Based upon the foregoing Conclusions, the Administrative Law Judge makes the following: 14

15 RECOMMENDATION IT IS HEREBY RECOMMENDED: that the proposed rules be adopted consistent with the Findings and Conclusions made above. Dated this 8 th day of January /s/ Allan W. Klein ALLAN W. KLEIN Administrative Law Judge 15