[32 Pa.B. 6429]
[Continued from previous Web Page] 35. Section 2600.144. Use of tobacco and tobacco-related products.--Protection of public health, safety and welfare; Reasonableness; Clarity.
Subsection (b)(2)
This subsection requires a PCH to ensure that proper safeguards are taken at all times to protect the rights of nonsmoking residents. Commentators indicated that the language was vague. The final-form regulation should indicate what specific steps a PCH should implement to protect nonsmoking residents. If it means that a designated area for smoking must be in a separate room that is ventilated to prevent smoke from entering the rest of the PCH, this requirement should be set forth in the final-form regulation.
Subsection (d) and (e)
Subsection (d) prohibits smoking during transportation of residents by the PCH. Subsection (e) prohibits smoking in resident bedrooms. One commentator suggested that rather than creating mandated prohibitions, the regulation should require PCHs to disclose its policies concerning the use of tobacco to prospective residents. The Department should explain the justification for these prohibitions or delete them from the final-form regulation. In addition, the final-form regulation should require that PCHs disclose their policies on smoking and methods to protect nonsmokers to prospective residents regardless of whether the prohibitions are retained.
Subsection (f)
This provision requires that the designated smoking area be included in the written fire safety procedures. However, this subsection provides no guidance on how the designated smoking area is to be addressed in the fire safety procedures. Does it mean that fire safety procedures for the smoking area should be developed and discussed? The final-form regulation should clarify this requirement.
Subsection (g)
Subsection (g) appears to be a subpart of subsection (f) and may be unnecessary. It should be deleted or its one sentence should be incorporated into subsection (f) in the final-form regulation.
36. Section 2600.145. Supervised care.--Reasonableness; Clarity.
This section states that a resident in need of services beyond what is available at the PCH shall be referred to the appropriate assessment agency. Commentators indicated that this section should include a reference to the resident's physician as well as identify the types of assessment agencies to which a resident is to be referred. PANPHA noted that the AAA is the appropriate assessment agency for publicly funded elderly persons. Whether it is the county AAA, county mental health agency or another agency, the final-form regulation should indicate the types of assessment agencies that are appropriate for different types of PCH residents.
37. Section 2600.161. Nutritional adequacy.--Consistency with other regulations; Reasonableness; Clarity.
Subsection (b)
The first sentence states: ''At least three nutritionally well-balanced meals shall be provided daily to the resident'' (emphasis added). In contrast, subsection (a) reads: ''Meals shall be offered which meet the nutritional needs of the residents . . . '' (emphasis added). Since many PCH residents may leave their PCHs at will and may go out for meals with relatives or friends, the word ''offered'' is more appropriate and should be used in both subsections (a) and (b).
Subsection (d)
Explain why subsection (d) is needed, since subsection (a) contains the requirements for nutritional needs and subsection (b) requires ''three nutritionally well-balanced meals.''
Subsection (e)
This subsection mandates: ''Dietary alternatives shall be available for a resident who has special health needs, religious beliefs regarding dietary restrictions or vegetarian preferences.'' There are two concerns.
First, this subsection is in conflict with subsection (d) that requires each meal contain items from all four food groups. For example, many vegetarians do not consume dairy products.
Second, commentators indicated that many PCHs do not have the resources available to offer alternative diets. Rather than mandating this service, the final-form regulation should require that a PCH discuss food preferences or dietary requirements with a prospective resident. The PCH can inform a prospective resident as to whether it can accommodate the resident's dietary needs, and the prospective resident can either choose that PCH or look for another PCH or a different type of facility.
Subsection (f)
This subsection requires PCHs to provide ''therapeutic diets as prescribed by a physician or certified nurse practitioner.'' Commentators stated that not every PCH offers this service. Most do not have a dietitian on staff. In addition, PCH residents have the right to come and go from the PCH at will and the PCH cannot be sure that the resident remains on the therapeutic diet. In PCHs where most of the residents are supplemental security income (SSI) recipients, it may be cost prohibitive to provide this service. This subsection should be deleted or amended in the final-form regulation to apply only to PCHs that offer this type of service. If a PCH cannot provide this type of service, the final-form regulation should require that the PCH disclose this to prospective residents or to agencies or parties seeking to place others at the PCH.
Subsection (g)
The second sentence of this subsection reads: ''Other beverages shall be available and offered to the resident at least every 2 hours.'' Many commentators criticized this requirement as expensive, impractical and unnecessary. Many PCH residents are capable of getting their own beverages. The Department should either delete this sentence from the final-form regulation or should provide a rationale for it.
38. Section 2600.162. Meal preparation.--Protection of public health, safety and welfare; Consistency with other regulations; Reasonableness; Clarity.
Subsection (a)
This provision requires PCHs to prepare foods in a consistency that meets the needs of the residents. Paxton Ministries indicated that this type of requirement would be cost prohibitive for a nonmedical facility serving SSI recipients. Instead of making it mandatory, this type of service or the lack of it should be disclosed to prospective residents before they move into the PCH and be set forth in the ''resident-home contract'' under § 2600.26.
Subsection (c)
The first clause of this subsection reads: ''There may not be more than 14-16 hours between the evening meal and the first meal of the next day, unless a resident's physician has prescribed otherwise . . . . '' Commentators observed that this rule would allow a PCH to serve the evening meal at 8 p.m. and wait until noon the next day to serve breakfast. They indicated that this was not healthy or safe. The final-form regulation should reduce this period to 14 hours or require that a snack be offered during the period between the evening meal and breakfast.
Subsection (d)
PCHs must procure food ''from sources approved or considered satisfactory by Federal, State or local authorities.'' There are two concerns. First, what is meant by ''considered satisfactory''? Second, what agencies are included in the phrase ''Federal, State or local authorities''?
Subsection (e)
If a resident misses a meal, this subsection requires the PCH make available and offer food to the resident that is adequate to meet nutritional requirements. Commentators indicated that this was an unreasonable and impractical requirement for many PCHs. Rather than mandating that all PCHs provide food 24 hours per day, the final-form regulation should require that PCHs inform residents of their policies concerning missed meals.
Subsection (f)
Meals at PCHs are required to include a variety of hot and cold food under this subsection. PHCA-CALM noted that depending on the season or weather, the PCH with resident input may decide not to offer both hot and cold food at some meals. The subsection should be amended in the final-form regulation to allow a PCH to adjust its menu based on the preferences of its residents.
Subsection (h)
This subsection requires that adaptive eating equipment or utensils be made available and meet the needs of the residents. This is unnecessary since this requirement is already set forth in § 2600.104(d). The words ''and utensils'' should be moved to § 2600.104(d) and § 2600.162(h) should be deleted.
39. Section 2600.164. Withholding or forcing food prohibited.--Protection of public health, safety and welfare; Reasonableness; Clarity.
There are three concerns.
First, subsection (a) reads: ''A home may not withhold meals, beverages, snacks or desserts as punishment.'' Paxton Ministries suggested adding language stating that food and drink may be withheld when necessary due to scheduled medical or dental procedures. This clarification should be added to the final-form regulation.
Second, there is a need for clarification of subsection (b), which provides: ''A resident may not be forced to eat food.'' The Elder Law Project and Pennsylvania Protection and Advocacy, Inc. recommended that the regulation be amended to require the PCH staff to use ''all appropriate cueing to encourage and remind residents to eat and drink.'' However, if the PCH staff cannot do this, the regulation should require referrals to medical care personnel and transfer to an appropriate facility.
Third, subsection (c) requires PCH staff to observe whether a resident refuses to eat consecutively during a 24-hour period. If the resident is not eating, the resident's physician or family should be contacted. Paxton Ministries notes that it will be very difficult to verify that all residents are eating in a large independent living facility where residents are free to come and go, and may go out for meals. Generally, this behavior would be noted in addition to other symptoms of physical or psychiatric deterioration. The Department should review this subsection and determine whether it needs to include observations of other symptoms to include situations when the PCH staff is unable to observe a resident at each meal.
40. Section 2600.171. Transportation.--Protection of public health, safety and welfare; Reasonableness; Consistency with other regulations; Clarity.
This section sets forth requirements for transportation of residents provided by the PCH via staff or volunteers. There are five concerns.
First, it is not clear how the various requirements in § 2600.56, which are based on hours and needs of the residents, would translate into staffing level during the transport of one or more residents under subsection (a)(1). This subsection states that the staff-to-resident ratios specified in § 2600.56 will apply during transportation. Section 2600.56 contains 13 subsections. The intent of subsection (a)(1) needs to be explained in the final-form regulation.
Second, what is the purpose of the requirement in subsection (a)(5) that one of the staff members transporting residents has completed the initial new hire direct care staff training? The final-form regulation should be amended to recognize the value and experience of existing staff.
Third, unless there is a need for the inclusion of ''syrup of ipecac'' as one of the required items in the vehicle's first aid kit as set forth in subsection (a)(6), it should be deleted. One commentator noted that the American Red Cross did not recommend this item.
Fourth, this section should also instruct PCHs to utilize the Medical Assistance Transportation program for SSI recipients. This should be included in the final-form regulation. In addition, the Department should assist PCHs in linking SSI residents with this program.
41. Section 2600.181. Self-administration.--Protection of public health, safety and welfare; Reasonableness; Consistency with other regulations; Clarity.
Associations representing PCH owners and operators, organizations of advocates for PCH residents, the City of Philadelphia Behavioral Health System and many individual commentators were united in calling for a program to properly train PCH staff in medication administration. A program would resolve many of the concerns with medications administered to PCH residents.
Several commentators, including the City of Philadelphia, noted the existence of medication administration training programs for staff in other residential settings. These programs could readily be used as models for a program for PCH staff. The program would include training and a written examination to determine competency. We agree with commentators. Has the Department explored the development of a program for PCH staff? The final-form regulation should be amended to include certification of PCH staff who assist residents in medication administration.
In addition to the need for a training program, there are specific concerns with the proposed regulation.
First, subsection (c) should be amended in the final-form regulation to recognize that it is the resident's physician who determines whether the resident can self-administer medications.
Second, the ability of a person to self-administer medication is a determination that should be based on the clinical experience, observations and judgment of a health care professional such as a physician or certified nurse practitioner. PCH staff should be required to defer to the judgment of these licensed professionals rather than refer to a regulation to determine who can self-administer. This should be clarified in subsection (e).
42. Section 2600.182. Storage and disposal of medication and medical supplies.--Protection of public health, safety and welfare; Reasonableness; Consistency with other regulations; Clarity.
Many commentators generally found the requirements in this section to be unclear and unworkable. For example, subsection (d) requires that ''prescription, OTC [over the counter] and CAM [complimentary and alternative medications] shall be stored separately.'' One commentator asked from what are these medications to be stored separately. In addition, several PCHs indicated that it was safer and more efficient to store medications for same individual together.
The application of this section is unclear when residents administer their own medications without assistance and store their medications in their rooms. If a resident is using nonprescription medications without assistance, why is it necessary for the PCH to be involved?
43. Section 2600.183. Labeling of medications.--Reasonableness; Clarity.
One commentator questioned the use of the term ''original container.'' It indicated that many residents receive medications in ''bubble packs'' provided by pharmacies. It was unclear whether this section matches this situation.
Commentators also questioned the requirement in subsection (d) concerning ''sample medications.'' The subsection requires sample medications to be identified by the ''resident's use and accompanied by a physician's order.'' Many PCH residents receive sample medications from physicians outside the PCH who do not always communicate to the PCH the reasons for these medications. Commentators are unclear how this regulation would apply to these situations. The final-form regulation should recognize that there are a variety of residents with different relationships to their PCHs. In many situations, the PCHs are not involved in arranging medical care for their residents.
44. Section 2600.185. Use of medications.--Protection of public health, safety and welfare; Reasonableness; Clarity.
Subsection (c) states: ''Verbal changes in medication may only be made by the prescriber . . . . '' One commentator asked that this subsection be deleted because there are situations when the original prescriber is unavailable, but an available practitioner needs to make changes in the medication order due to negative side effects. The final-form regulation should be amended to recognize the need for flexibility in emergency situations.
In addition, commentators suggested that this section include language stating that medications shall only be administered to the resident for whom they were prescribed. We agree.
45. Section 2600.186. Medication records.--Reasonableness; Consistency with other regulations; Clarity.
Subsection (a) states: ''If a resident stores medications for self-administration in the resident's room, a current list of prescribed medications taken by the resident as reported to the home shall be maintained in that resident's record.'' There are two concerns:
First, what types of medications does this subsection cover? Is it referring to prescription, CAM and OTC medications?
Second, how is this provision consistent with the storage requirements in § 2600.182? If a resident stores medications in her or his room, is the PCH responsible for the proper storage of these medications?
46. Section 2600.225. Initial assessment and the annual assessment.--Reasonableness; Clarity.
This section requires the completion of a written assessment on standardized forms provided by the Commonwealth within 72 hours of, or before, admission. Subsection (a) states that the PCH administrator, a designee, whether this person represents the PCH or resident is unclear, or a human service agency may complete the assessment. Subsection (b) requires that the initial and annual assessment include the following areas: background information, medical assessment, social assessment, ADL assessment, IADL assessment, mobility assessment, medication assessment and psychological assessment.
The section provides no guidance regarding the content of these assessment areas or the qualifications of the individuals who would complete the annual assessments. Furthermore, there is no indication about who is to pay for these assessments. Some PCHs recommend that this assessment should be the responsibility of the referring agency. The Department needs to explain how this requirement will be implemented.
In addition, the terms ''human service agency'' in subsection (a) and ''State agency'' in subsection (d)(3) should be defined.
47. Section 2600.228. Notification of termination.--Protection of public health, safety and welfare; Reasonableness; Clarity.
This section requires that if a PCH initiates a discharge or transfer of a resident, it must provide the resident with a 30-day advance written notice. Commentators expressed concerns with situations when a PCH would need to immediately remove a resident from the facility because the resident may be threatening the health and safety of other residents or staff. One example was a PCH where most of the residents have mental health issues.
Subsection (d) provides that the Department may determine that removal of the resident at an earlier time is necessary to protect the resident. But, this subsection only addresses removal or discharge when the PCH intends to close. The final-form regulation should be amended to address situations when a resident needs to be removed quickly to protect both the resident and others at the PCH or for other reasons that impact the other residents of the PCH. This section should be consistent with §§ 2600.42(u) and 2600.26(a)(1)(viii) and (ix).
48. Sections 2600.231--2600.241. Secured units--Protection of public health, safety and welfare; Consistency with other regulations; Reasonableness; Clarity.
Sections 2600.231--2600.241 concern secured units in PCHs. However, commentators indicated that the provisions were incomplete. For example, both Community Legal Services and the Office of the State Ombudsman in the Department of Aging stress the need for the development of criteria to determine who may be admitted to a secured unit, staffing requirements and provisions for oversight by the Department.
Commentators also noted confusing requirements that either conflict with, or appear to duplicate, other provisions in other sections of the regulation. Examples include the provisions for restraints in § 2600.231 which conflict with the ''specific rights'' listed in § 2600.42(p) and § 2600.231(10) concerning lighting, which is also covered by § 2600.87. The Department should address these issues in the final-form regulation.
49. Sections 2600.261--2600.264. Enforcement--Protection of public health, safety and welfare; Reasonableness; Clarity.
These sections contain provisions concerning the classification of violations, penalties, revocation or nonrenewal of licenses and implementation of policies and plans. PCHs, advocates and the City of Philadelphia urged the Department to adopt the recommendations of the Personal Care Home Advisory Committee (Advisory Committee). They believe that the enforcement tools and policies set forth in the recommendation of the Advisory Committee would address concerns with PCHs.
The recommendations of the Advisory Committee include unannounced annual licensure inspections, implementation of the current classification system of violations, ban on admissions for PCHs without full license, increased requirements for plans of correction, quicker decisions by the Department on appeals, better disclosure of public information that pertains to PCHs and the establishment of a complaint investigation team. The Department should incorporate these recommendations into the final-form regulation.
50. Section 2600.263. Revocation or nonrenewal of licenses.--Protection of public health, safety and welfare; Implementation procedure;
The Northern Area Personal Care Home Administrators Association made two recommendations to improve enforcement activities and provide information to prospective residents. First, it suggested that there should be a ban on admissions for PCHs with a provisional license due to violations.
Second, it suggested that information regarding provisional licenses due to violations be made available on the Department website. The Department should consider these recommendations for enhancing enforcement and providing consumers with useful information about PCHs.
51. Forms prescribed by the Department.--Reasonableness; Implementation procedures; Clarity.
Several provisions of the regulation refer to standardized forms or form provided by the Department. Section 2600.141(a) requires that a health examination be documented on standardized forms provided by the Department. Section 2600.225(a) requires that an initial assessment of a resident be documented on a standardized form ''provided by the Commonwealth, within 72 hours of admission or within 72 hours prior to admission.'' The Department should include information in the final-form regulation on how residents and PCH staff can obtain copies of these required forms. For example, a toll-free telephone number could be used to make requests, or copies could be made available on the Department's website.
52. Referencing other laws and regulations and approval by other agencies.--Consistancy with other regulations; Clarity.
In certain sections of this regulation, the Department references other regulations, laws and statutes, and approvals or methods approved by other regulatory agencies. The provisions of this regulation require PCHs to follow these other regulations, policies and statutes. To avoid confusion, the Department should cite the specific regulations or statutes that set forth these requirements. Sections missing specific references include §§ 2600.13, 2600.14(e), 2600.18, 2600.43(a), 2600.52, 2600.53(g), 2600.57(e)(6), 2600.103(j), 2600.106(1), 2600.130(c), 2600.182(f) and (h), 2600.231(8) and 2600.240(xiii).
This proposed regulation includes Fire Safety Approval standards in § 2600.14 and applicable Fire Safety standards in §§ 2600.121--2600.133. To avoid confusion and conflict, the Department should consider deleting the applicable provisions in these proposed sections and incorporate by reference all applicable fire safety standards from Department of Labor and Industry regulations.
53. Editorial Changes.--Clarity.
Sections 2600.1 and 2600.19(g)
''Assure'' should be ''ensure.''
Section 2600.4.
Insert a comma between ''visit'' and ''inspect'' in the definition of ''agent.'' ''A premise'' should be replaced with ''any premises'' in the definition of ''personal care home.''
Section 2600.42.
In subsection (g), ''365 days'' should be ''365 days per year.''
Under subsection (x), the word ''to'' between ''home'' and ''resident's'' should be changed to the word ''of.''
Section 2600.171.
There are two typographical errors in subsection (a)(2). The letter ''a'' between the words ''appropriate'' and ''safety'' should be deleted, and the word ''restraint'' should be ''restraints.''
Section 2600.184.
In subsection (b)(3), the phrase ''limited access to medication storage areas'' is incomplete.
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Department of Health Regulation No. 10-170
Public Swimming and Bathing Places
December 5, 2002 We submit for consideration the following objection and recommendation regarding this regulation. The objection and recommendation includes a reference to the criteria in the Regulatory Review Act (71 P. S. § 745.5a(h) and (i)) which has not been met. The Department of Heath (Department) must respond to these Comments when it submits the final-form regulation. If the final-form regulation is not delivered within 2 years of the close of the public comment period, the regulation will be deemed withdrawn.
1. Section 18.30. Water Samples.--Clarity.
Subsection (d)(3) states that the Department may require additional water samples be taken. It is not clear how the permittee will be notified by the Department that additional water samples are required. Subsection (d)(3) should be amended to specify that the permittee will receive written notice from the Department when additional water samples are required.
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Department of Public Welfare Regulation No. 14-479
Pharmaceutical Services
December 5, 2002 We submit for consideration the following objections and recommendations regarding this regulation. Each objection or recommendation includes a reference to the criteria in the Regulatory Review Act (71 P. S. § 745.5a(h) and (i)) which have not been met. The Department of Public Welfare (Department) must respond to these Comments when it submits the final-form regulation. If the final-form regulation is not delivered within 2 years of the close of the public comment period, the regulation will be deemed withdrawn.
1. General.--Disapproval by a Standing Committee; Policy Decision Requiring Legislative Review; Protection of the Public Health, Safety and Welfare; Economic and Fiscal Impact; Feasibility; Reasonableness.
Disapproval by the House Health and Human Services Committee; Policy decision requiring legislative review
The House Health and Human Services Committee (House Committee) disapproved the proposed amendments. In their letter dated October 9, 2002, the House Committee stated that a unanimous vote had been taken to '' . . . express in the strongest possible terms our opposition to this regulation at the proposed stage.''
The Senate Public Health and Welfare Committee Minority Chairperson Vincent Hughes submitted a letter opposing this rulemaking. In his letter dated November 21, 2002, the Minority Chairperson stated that he was '' . . . not convinced that the Department has adequately explored alternatives to reducing reimbursement.''
We agree with both the House and Senate concerns and herein state our objections to the proposed amendments.
2. Determination of Dispensing Fee and Estimated Acquisition Cost (EAC) of Drugs--Economic Impact; Reasonableness.
The proposed regulation sets the dispensing fee for legend and nonlegend drugs at $4.25, a 25¢ increase over the current dispensing fee. The regulation establishes the EAC for drugs at the average wholesale price (AWP) of the drug minus 15%. This represents a reduction in drug cost reimbursement compared to the current level of AWP minus 10%. Commentators have questioned the reasonableness of the proposed dispensing fee and EAC.
In 2001, the average reimbursement to pharmacies was $51.24 per claim using AWP minus 10% and a $4 dispensing fee. Under the proposed regulation at AWP minus 15% and a $4.25 dispensing fee, the average reimbursement to pharmacies would be $48.91. This represents an average decrease in reimbursement per prescription of $2.33. In 2001, the Department approved approximately 14.4 million claims. Therefore, the estimated annual decrease in pharmacy drug acquisition cost reimbursement resulting from the proposed regulation is $33,552,000.
Act 53 of 1996 directed the Department and the Department of Aging (Aging) to conduct a study to determine the cost of filling a prescription and providing pharmacy services in this Commonwealth. To fulfill this mandate, the Department and Aging contracted with Pricewaterhouse Coopers (PwC) to conduct a study to estimate pharmacy drug acquisition costs and profitability for the Medical Assistance (MA) Fee-for-Service and the Pharmaceutical Assistance Contract for the Elderly programs.
To determine the EAC, the PwC report examined data from a 1996 study on the acquisition cost of brand name drugs conducted by the Office of Inspector General for the United States Department of Health and Human Services (OIG study). The OIG study examined pharmacy costs for ten randomly selected states and the District of Columbia. The Commonwealth was not included in the OIG study. The results of the OIG study estimated that the National average for pharmacies' acquisition cost for brand name prescription drugs was AWP minus 18.3%.
The PwC study estimated that the average dispensing costs in this Commonwealth in 1997 were $6.22, compared to the National average of $6.06. In determining the estimated dispensing costs in this Commonwealth, the PwC study relied on a 1998 study by the National Association of Chain Drug Stores (NACDS). The PwC study also determined that dispensing fees paid by state Medicaid programs fell within a range of $4.01 to $4.50.
Commentators, including the Pennsylvania Pharmacy Council, the Pennsylvania Association of Chain Drug Stores, the Pennsylvania Pharmacists Association and individual pharmacy operators, challenge the validity of the OIG study. They note that the OIG study was challenged, and as a result, the EAC for brand name drugs revised to AWP minus 17.2%. Commentators, however, still question the methodology used in the revised report. Commentators also object to the proposed dispensing fee, asserting that the actual dispensing costs are significantly higher. Some commentators suggest a dispensing fee of $7.35 would reflect the actual cost to dispense a prescription in this Commonwealth. Another commentator noted that a 2000 NACDS study found the cost of dispensing a Medicaid prescription at $7.14.
We have several concerns related to the EAC and dispensing fees in the proposed regulation.
First, Act 53 of 1996 directed the Department to conduct a study of the dispensing costs and drug acquisition costs in this Commonwealth. However, the OIG study, on which the PwC relied, did not include this Commonwealth. Furthermore, PwC did not conduct an independent survey of drug acquisition costs or dispensing fees within this Commonwealth. Therefore, we question whether the Department has met the mandate of Act 53 of 1996.
Second, the proposed $4.25 dispensing fee falls significantly short of the $6.22 average dispensing cost cited in the PwC study. The Department should explain why it accepts the EAC estimates in the PwC study, but rejects the dispensing cost estimate in the same study.
Finally, without Commonwealth-specific data, we cannot determine if the proposed EAC of AWP minus 15% is a reasonable representation of Commonwealth pharmacists' drug acquisition costs. We are also unable to determine if the proposed 25¢ increase in the dispensing fee is sufficient to adequately reimburse pharmacists for their actual dispensing costs. Consistent with the directive in Act 53 of 1996, the Department should conduct a Commonwealth-specific study of drug acquisition costs and dispensing costs to determine any necessary modification to the reimbursement levels in the existing regulations. The Department should also include an analysis of the economic impact of revisions to reimbursement levels on participating MA program pharmacies.
3. Additional Reimbursement for Long-Term Care (LTC) Pharmacies.--Economic Impact; Reasonableness.
In current and proposed regulations, LTC pharmacies receive the same dispensing fee reimbursement rate that other pharmacies receive. In their comments, the LTC Pharmacy Alliance (LTCPA) and other LTC pharmacies listed specific services that LTC pharmacies provide that traditional retail pharmacies commonly do not provide. Examples of these services include 24-hour service, providing and maintaining emergency drug kits and developing drug carts to be used on specific floors of specific LTC facilities. LTCPA estimates the cost for a LTC pharmacy to dispense a prescription is $11.37 based on a study by the accounting firm BDO Seidman. LTCPA further estimates that this regulation will reduce the reimbursement to LTC pharmacies by approximately $22 million.
The 2000 Pennsylvania Legislative Budget and Finance Committee report estimates that it costs a LTC pharmacy an additional $2.87 to dispense a prescription. Other states such as Maryland, New Jersey, Florida, Virginia and Michigan provide additional reimbursement to LTC pharmacies based on the cost to provide additional services.
Given the Pennsylvania Legislative Budget and Finance Committee 2000 report, the costs associated with additional services provided by LTC pharmacies and supplemental reimbursement given by other states, the Department should provide additional reimbursement to LTC pharmacies or explain why additional reimbursement is not justified.
4. Pharmacy Carve-Out.--Reasonableness; Economic Impact.
Senator Hughes submitted comments objecting to the proposed regulation due to concerns that the Department has not fully explored alternatives to reducing pharmacy reimbursement. Senator Hughes specifically addressed ''carving-out'' pharmaceutical services from managed care as an option to be explored as a cost cutting measure. He suggested that the Department complete a comprehensive analysis of pharmacy ''carve-out'' to determine if additional pharmacy rebates resulting from a ''carve-out'' would exceed the potential increase in administrative costs associated with operating pharmaceutical services on a fee-for-service basis.
Additionally, the Philadelphia Association of Retail Druggists (PARD) asserts that ''carving-out'' pharmacy services would generate substantial increases in drug manufacturer rebates. Specifically, PARD estimates that ''carving out Pharmacy from the Health Choices program would generate an increase of $136 million/year in manufacturers rebates and control drug costs.''
Has the Department evaluated the ''carve-out'' option? If so, what are the evaluation results, and why hasn't it been pursued as an option to reducing pharmacy reimbursement?
5. Effective Date of the Regulation.--Reasonableness; Economic Impact.
The Preamble to the proposed regulation sets the effective date as October 1, 2002. There is no statutory mandate for retroactive implementation of the proposed regulation. Absent a mandate, we find it unreasonable for the Department to retroactively lower reimbursement to pharmacists participating in the MA program. Furthermore, the administrative costs of recalculating prior pharmacy reimbursements could be substantial, and could significantly reduce anticipated savings associated with retroactive implementation. The effective date of the regulation should be set as the date of final publication in the Pennsylvania Bulletin.
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Department of Public Welfare Regulation No. 14-477
Income Provisions for Categorically Needy NMP-MA and MNO-MA
December 5, 2002 We submit for consideration the following objections and recommendations regarding this regulation. Each objection or recommendation includes a reference to the criteria in the Regulatory Review Act (71 P. S. § 745.5a(h) and (i)) which have not been met. The Department of Public Welfare (Department) must respond to these Comments when it submits the final-form regulation. If the final-form regulation is not delivered within 2 years of the close of the public comment period, the regulation will be deemed withdrawn.
1. General.--Disapproval by a Standing Committee; Policy Decision Requiring Legislative Review; Protection of the Public Health, Safety and Welfare; Economic and Fiscal Impact; Feasibility; Reasonableness.
Disapproval by the House Health and Human Services Committee; Policy decision requiring legislative review
The House Health and Human Services Committee (House Committee) disapproved the proposed amendments. In their letter dated October 21, 2002, the House Committee found ''that the proposed changes will jeopardize the health and well being of many Pennsylvanians. The Committee unanimously and adamantly opposes'' this regulation.
The Senate Public Health and Welfare Committee (Senate Committee) submitted a letter opposing this rulemaking. In their letter dated November 25, 2002, the Senate Committee believed this regulation ''is not in the public interest as it fails to protect the public health and ultimately will result in additional costs for the Commonwealth and municipal governments.''
We agree with both the House and Senate Committees' concerns and herein state our objections to the proposed amendments.
Protection of the public health, safety and welfare
There are three concerns related to our criterion of protection of the public health, safety and welfare.
First, the Department estimates 7,196 individuals will lose NMP benefits and 14,802 individuals will lose Medicaid eligibility as a result of these amendments. The House Committee described this population as ''Pennsylvania's most needy and vulnerable citizens.'' Commentators have described these individuals as generally elderly, disabled or experiencing mental health problems. The Department should include a comprehensive description of the affected population in the final-form regulation.
Second, these amendments will cause many individuals to lose their prescription drug coverage. Commentators stated that without prescription coverage, many individuals won't be able to afford necessary medication. Among the commentators' concerns is the loss of independence for the elderly and individuals with mental illness. The Department gave no estimate of how the loss of this assistance will impact health. The Department needs to explain how the health, safety and welfare of the individuals will be protected upon the implementation of this regulation. The Department also needs to explain in detail what other assistance the individuals may be eligible for and whether the level of assistance is sufficient for the individuals to maintain their health.
Finally, the House Committee ''is very concerned about the potentially harmful impact of the proposed changes on Pennsylvania's most needy and vulnerable citizens.'' The Department should explain in the Preamble to the final-form regulation the alternatives considered to accomplish cost savings and why this regulation is the most reasonable way to cut costs in relation to other alternatives available to the Department.
Economic and fiscal impact; Feasibility
The House Committee and most commentators questioned whether the amendments will save or cost the Commonwealth money in the long run. The amendments: may cause increased hospitalizations and/or nursing home care; may simply shift costs to other programs; or may increase the cost of uncompensated care. We object to the lack of comprehensive economic and fiscal data in the Preamble and the Regulatory Analysis Form (RAF). The information provided fails to include analysis of these costs and therefore does not reflect the full impact of the proposed amendments, and calls into question the feasibility of the savings the Department claims will be accomplished by the amendments. In the Preamble and RAF for the final-form regulation, the Department must fully explain and quantify the overall impact of the amendments and demonstrate that the benefits outweigh the adverse effects and negative fiscal impact. Specifically, the Department must quantify the cost increases in the following four areas.
First, in the Preamble, the Department acknowledges the following may experience increases in enrollment:
* The Department's Medical Assistance for Workers with Disabilities program.
* The Insurance Department's CHIP and Adult Basic Programs.
* The Department of Aging's PACE/PACENET Program.
The Department must quantify the number of individuals who could be shifted to other programs and the costs for the final-form regulation in order to demonstrate the full impact of the regulation on state government.
Second, compounding our first concern, is the effect on matching Federal funds. The Department acknowledges in the Preamble that there will be a loss of Federal matching funds, but this loss was not included in the RAF. The Department also needs to demonstrate whether the Department's savings and loss of Federal funds will be greater than the costs incurred by other programs, some of which are fully funded by the Commonwealth.
Third, the Department also states in the Preamble that there is potential for healthcare providers to have an increase in uncompensated care. These increases could affect both local governments and private providers. Some counties operate county-run nursing homes or clinics. Those affected persons who lose coverage could utilize these services when their coverage is eliminated, increasing uncompensated costs for these entities. Private providers could be affected in similar ways, through hospital stays, emergency room visits and other provided services. For the Commission to determine whether the amendments are in the public interest, the Department must provide these costs.
Finally, we question the economic impact on those individuals whose eligibility is eliminated by this regulation. Individuals who lose coverage will be faced with significant increases for health care. Given the limited income of this group, they could lose their homes, considerable amounts of their savings and other resources that could contribute to financial independence and security. Other individuals who can't afford to replace lost health coverage may experience medical problems that will inhibit their ability to maintain employment. If this assistance is lost, affected individuals could be forced into other assistance programs. How will this regulation affect individuals whose eligibility is eliminated by this regulation?
2. Section 181.12. Retroactive eligibility.--Clarity.
Section 181. 14. Eligibility under MNO-MA spend-down.--Clarity.
Sections 181.12(2) and 181.14(d)(1)(v) contain a time period of 3 months. How was this time frame determined?
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State Board of Certified Real Estate Appraisers Regulation No. 16A-7013
Biennial Renewal Fees and Examination Fees
December 5, 2002 We submit for consideration the following objections and recommendations regarding this regulation. Each objection or recommendation includes a reference to the criteria in the Regulatory Review Act (71 P. S. § 745.5a(h) and (i)) which have not been met. The State Board of Certified Real Estate Appraisers (Board) must respond to these Comments when it submits the final-form regulation. If the final-form regulation is not delivered within 2 years of the close of the public comment period, the regulation will be deemed withdrawn.
General.--Economic impact; Reasonableness.
This proposed regulation establishes and increases biennial renewal fees for certified real estate appraisers, certified brokers and appraisers and certified Pennsylvania evaluators. We understand that these fees are being established or increased due to the Board's potential for impending deficits.
The proposed fee for all three licensure categories is $225. The Preamble states, ''The biennial renewal fees defray general operating expenses and overhead - primarily in the areas of investigation, prosecution and enforcement. . . .'' To justify these proposed fees, the Board should explain whether these three areas are distributed equally among the three licensure categories.
The Board should also state why a one-time increase is a suitable solution to the potential for large deficits. Were any alternatives, such as a number of gradual increases, considered?
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Department of Public Welfare Regulation No. 14-478
Resource Provisions for Categorically NMP-MA and MNO-MA; Income Provisions for Categorically Needy NMP-MA and MNO-MA
December 5, 2002 We submit for consideration the following objections and recommendations regarding this regulation. Each objection or recommendation includes a reference to the criteria in the Regulatory Review Act (71 P. S. § 745.5a(h) and (i)) which have not been met. The Department of Public Welfare (Department) must respond to these Comments when it submits the final-form regulation. If the final-form regulation is not delivered within 2 years of the close of the public comment period, the regulation will be deemed withdrawn.
1. General.--Disapproval by a standing committee; Policy decision requiring legislative review; Protection of the public health and safety; Economic and fiscal impact; Feasibility.
Disapproval by the House Health and Human Services Committee; Policy decision requiring legislative review
The House Health and Human Services Committee (House Committee) disapproved the proposed amendments. The House Committee's concerns were explained in a letter dated October 10, 2002. The House Committee found the amendments detrimental to senior citizens and stated ''There is no doubt that, dependent on the limited resources and earnings available to them, impoverishment for the community spouse would be inevitable.''
The Senate Public Health and Welfare Committee (Senate Committee) submitted a letter opposing a portion of this rulemaking. In their letter dated November 25, 2002, the Senate Committee objected ''to the proposal to eliminate the home maintenance deduction.'' Further comments on this issue are contained in Comment 7.
We agree with both the House and Senate Committees' concerns and herein state our objections.
Protection of the Public Health and Safety; Potential hardship on the Community Spouse
Under the ''resource first'' model, a community spouse (CS) can retain and invest resources from the institutionalized spouse (IS) to bring his or her income to the Federal mandated minimum. When the IS dies, the CS will still be able to rely on those resources for income. Under the ''income first'' model, more of these resources will be spent by the IS to spend down to meet the Medical Assistance (MA) program's eligibility requirements. This could result in a dramatic reduction in the CS's income when the IS dies.
Many commentators do not believe the regulation will achieve the projected savings and will present a severe hardship on the CS. Comments submitted by elder law attorneys provide examples of the potential hardship for ISs and CSs. These examples point to situations where individuals would possibly lose their residences, as well as substantial amounts of their life savings, if the Commonwealth adopted the ''income first model.'' The Department should address the impact on individuals that would result from moving from the resource first model to the income first model.
Economic impact; Feasibility
The House Committee stated that ''rather than being a Medical Assistance cost containment measure, this regulation will force more seniors into poverty, resulting in their reliance on public assistance for survival.'' The incomplete fiscal data in the Preamble and the Regulatory Analysis Form (RAF) does nothing to refute this statement. The information provided simply does not reflect the full impact of the proposed amendments.
Specifically, we have four major concerns in the area of economic impact: the financial impact on the CS; the financial impact on a temporarily institutionalized individual due to the deletion of the deduction for maintenance of their home; the financial impact on the Commonwealth in terms of additional demand for services for an impoverished CS or temporarily institutionalized individual who loses their home; and the impact on the projected savings for the Commonwealth of the purchase of annuities by CSs and ISs to protect financial resources. These issues are discussed in more detail in Comments 5--7.
2. Clarity of the amendments in relation to other regulations and statutes--Consistancy with existing regulations and statutes; Clarity.
Several commentators stated the amendments are similar to existing provisions in the United States Code, but vary in the use of terms and application of those terms. The Department should review the amendments in conjunction with Federal regulations and statutes. In addition, some commentators cited inconsistency with the Pennsylvania Code. The Department should make the final-form regulation consistent with the Federal and State requirements.
3. Effective date--Implementation procedures; Clarity.
This regulation is unclear regarding how parties will be affected once the final-form version is promulgated. Will the implementation of this rulemaking be tied to the initial date of application? The Department should add a section to this regulation outlining the timeline for implementation and compliance with this regulation.
4. Section 178.2. Definitions.--Clarity.
''MAMMNA,'' ''MIMMNA'' and ''shelter expense allowance''
These definitions contain substantive provisions. However, substantive provisions in definitions are not enforceable. Therefore, these substantive provisions should be moved to the body of the regulation.
5. Section 178.124. Resource eligibility for the institutionalized spouse.--Economic and fiscal impact; Reasonableness; Feasibility.
This section includes the formulas for calculating the monthly income for a CS. We have a number of concerns and questions.
Spousal refusal
First, this proposed rulemaking would require the CS to spend-down assets to qualify the IS for MA. In some cases, the CS may refuse to make these amounts available to an IS, due to the potential impoverishment of the CS. The rulemaking does not address this situation. The Department should include procedures dealing with CS refusal in the final-form regulation.
Interest income
Second, how will the amount of interest be determined? Subsection (b)(2)(i)(B) includes ''Interest and other income generated by the community spouse resource . . . are included as unearned income of the community spouse.'' The Department should develop a mechanism for determining the interest rate it will use to calculate the CS's unearned income toward the CS's MMNA in the final-form regulation. Rather than specifying a fixed rate in the regulation, the Department should tie the rate to a published index such as the interest rate on T-bills.
Treatment of Social Security Income (SSI)
Third, § 178.124(b)(2)(viii) states that the IS's income consists of the IS's total gross monthly income as defined in § 181.452(a). Section 181.452(a) incorporates § 181.101. This section includes SSI as total gross monthly income for the IS. Section 178.124(b)(2)(viii) requires the total gross monthly income of the IS be attributed to the CS for the purposes of calculating the CS's MMNA.
Section 407(a) of the Social Security Act (act) (42 U.S.C.A. § 407) states:
The right of any person to any future payment under this title [42 U.S.C.A. §§ 401 et seq.] shall not be transferable or assignable, at law or in equity, and none of the moneys paid or payable or rights existing under this title [42 U.S.C.A. §§ 401 et seq.] shall be subject to execution, levy, attachment, garnishment, or other legal process, or to the operation of any bankruptcy or insolvency law.The Second Circuit Court of Appeals in Robbins v. DeBuono, 218 F.3d 197 (2nd Cir. 2000) held that the assignment of the IS's SSI to a CS is in violation of section 407(a) of the act. Both Robbins and section 407(a) of the act appear to prohibit the transfer of SSI. The Department should explain its authority for allowing the transfer of the IS's SSI benefits or modify its regulations to exclude them.
Annuity purchase
Finally, commentators pointed out that the ability to purchase an actuarially sound immediate annuity to protect financial resources would deprive the Commonwealth of the savings it hopes to realize by implementing this regulation. The Department should add language specifying how it will treat these annuities and explain whether it considered these annuities when calculating the projected savings of this proposed regulation.
6. Section 178.174. Disposition of assets and fair consideration provisions for transfers on or after July 30, 1994.--Economic and fiscal impact; Reasonableness.
Subsection (d)
Section 178.174(d)(1) and (2) requires reporting of all assets transferred by an individual or an individual's spouse. We have three questions. First, do these paragraphs apply to post eligibility transfers? Second, it would appear that any transfer by a CS would impact the IS's eligibility for MA. Is this what the Department intended? The Department should explain.
Finally, is there a de minimis exception to subsection (d)? Commentators have pointed out examples where small transfers of assets could trigger reporting requirements, which would in turn trigger partial month ineligibility penalties. In the examples given, the penalties in some cases would amount to less than a day of eligibility. The Department should explain the need for these reporting requirements and how the benefits outweigh the costs. The Department also should consider adding a de minimis exception to this subsection in the final-form regulation.
7. Section 181.452. Posteligibility determination of income available from an MA eligible person toward the cost of care.--Economic and fiscal impact; Protection of the public health and safety; Reasonableness; Clarity.
This section sets forth deductions from an MA eligible person's total gross income. We have two questions.
Subparagraph (d)(5)(iii)
First, this subparagraph allows a total deduction limit of $10,000 for necessary medical or remedial care not covered under the MA Program. The Department should explain how the $10,000 amount was determined and the basis for including this required amount.
Additionally, the Department acknowledges in the Preamble that there will be potential costs to county and private long-term care facilities for residents who incur an outstanding unpaid medical expense. Has the Department quantified these costs?
Deletion of subsection (d)(6)
Second, this paragraph allowed a home maintenance deduction for short nursing home stays. The proposed rulemaking deletes this deduction. The elimination of this paragraph could leave individuals without enough financial resources to care for or keep their homes. The Department should explain why the deletion of this deduction is in the public interest.
JOHN R. MCGINLEY, Jr.,
Chairperson
[Pa.B. Doc. No. 02-2331. Filed for public inspection December 27, 2002, 9:00 a.m.]
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