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MaineCare Benefits Manual - Adopted Rules

The MaineCare Benefits Manual (10-144, Department of Health and Human Services, Chapter 101) is available on the Secretary of State (SOS) website.

There is always a delay between the effective date the Office of MaineCare Services' adopts a rule and the date it is posted on the SOS website. Therefore, the Office of MaineCare Services posts recently adopted rules here until thay are posted on the SOS website.

Clarifications regarding adopted rules are also posted here.

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10-144 MaineCare Benefits Manual, Chapter II, Section 2, Adult Family Care Services

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CONCISE SUMMARY: The adopted rules permanently adopt emergency rules currently in place. This rule increases the limit of reimbursable beds in an Adult Family Care Home from six to eight beds. This rule also adds an additional type of licensure that Adult Family Care Homes may have in order to be reimbursed appropriately when the facility has more than six beds. Previously, Adult Family Care Homes must be licensed as an Assisted Living Program: Level III Residential Care Facility. Those facilities with more than six beds will require licensure as an Assisted Living Program: Level IV Residential Care Facility. This rule is not anticipated to have any negative economic impact on small businesses.

EFFECTIVE DATE: September 30, 2008

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Chapter II and III, Section 35, Hearing Aids and Services

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CONCISE SUMMARY: The adopted rules reflect the current practice of only allowing members under age 21 to receive this service. Prior Authorization has been eliminated for all but one code. Updated criteria for medical evaluation and testing were added. Audiologists were added as hearing aid dispensers to conform to a change in their scope of practice. Terminology, such as using MaineCare instead of Medicaid and member instead of recipient, is also updated. Chapter III establishes new billing codes based on HIPAA compliant coding.

EFFECTIVE DATE: December 1, 2008

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Chapter III, Section 12, Consumer Directed Attendant Services

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CONCISE SUMMARY: The Department permanently adopts these rules to comply with Federal HIPAA guidelines for coding for attendant care services. Until now, these services have been billed using local codes. After research and testing, the Department has determined that the HIPAA compliant codes can be implemented in the current system. The provider (s) billing under this section will only need to make minor billing changes as a result of this change. There are no adverse impacts on small business or municipalities as a result of this change.

EFFECTIVE DATE: February 1, 2009

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Chapter 101, MaineCare Benefits Manual, Chapter III, Section 67, Principles of Reimbursement for Nursing Facilities

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CONCISE SUMMARY:The Department has permanently adopted rule changes for Chapter III, Section 67, Principles of Reimbursement for Nursing Facilities, in order to comply with budget appropriations for nursing facility reimbursement and State statute for conversion of nursing facility beds and medical director costs. Specifically, the new rate methodology changes the base year from 1998 to 2005 to calculate direct care and routine care costs; the rule clarifies the impact of conversion of nursing facility beds to residential care beds; and the base year cost for medical director is increased from $1,200 to $10,000. The Department also adopts changes that establish a new prospective per diem rate by adding a direct care regional cost component, hold harmless provision, and direct care add-on to the rule. In addition, all providers will receive a one time payment for the time period between July 1, 2008 and December 15, 2008, which equitably distributes a portion of the money appropriated in the budget. Other changes made in this rulemaking include the ability for the Department to waive administrator costs that are included under the management ceiling for smaller nursing facilities of forty (40) or fewer beds. Other minor technical, format and grammatical changes were adopted.

EFFECTIVE DATE: March 15, 2009

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Chapters II & III, Section 29, Community Support Benefits for members with Mental Retardation and Autistic Disorder

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CONCISE SUMMARY:The final rule adopts emergency rules that were put in to place on 1/1/09. The final rule reduces reimbursement for Community Support, Employment Specialist Services and Work Support with Medical Add On. The final rule also eliminates Behavioral Add On. This rule is not anticipated to impose on small businesses any additional administrative cost required for compliance.

EFFECTIVE DATE: March 29, 2009

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Chapter II, Section 21, Home and Community Benefits for members with Mental Retardation or Autistic Disorder

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CONCISE SUMMARY:The adopted rule eliminates Behavioral Add On. Additionally, the rule creates an added level of support for Home Support Shared Living and Home Support Family Centered Support. Lastly, Intensive Family Centered Support was eliminated as a type of Home Support. This rule is not anticipated to impose on small businesses any additional administrative cost required for compliance.

EFFECTIVE DATE: March 29, 2009

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Chapters II of Section 90- Physician Services, Section 55-Laboratory Services, Section 75-Vision Services, Section 95-Podiatry Services, Section 101-Medical Imaging and Ch III of Section 90 Physician's Services

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CONCISE SUMMARY: This letter gives notice of a final rule: MaineCare Benefits Manual 10-144, Chapters II of Section 90- Physician Services and Section 55-Laboratory Services, Section 75-Vision Services, Section 95-Podiatry Services, Section 101-Medical Imaging and Ch III of Section 90 Physician's Services. The Department adopts the increase to the MaineCare reimbursement rate for non-hospital based physician services from 53% to 56.94% as of July 1, 2008. Furthermore, the Department is proposing to remove some prior authorization requirements for services including but not limited to hyperbaric oxygen therapy, cochlear implants, circumcision, septoplasty, and skin tag removal.

Finally the Department is adopting changes to Chapter II Section 55-Laboratory Services, Section 75-Vision Services, Section 95-Podiatry Services, Section 101-Medical Imaging. The Department has amended the language under the "reimbursement" sections to these areas of policy to clarify that the increase mentioned above does not apply to these services. MaineCare will reimburse the lowest of 53% of 2005 Medicare rates, the provider's usual and customary or the allowed amount of the Medicare Part B carrier for these services. Providers can visit the Office of MaineCare's website for a list of MaineCare covered services and rates. This rule change clarifies what the current rate is; the rate is not being decreased.

EFFECTIVE DATE: March 29, 2009

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Chapter III, Section 19, Home and Community Benefits for the Elderly and Adults with Disabilities

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CONCISE SUMMARY: The adopted rules establish different reimbursement rates for comprehensive care management services and mileage reimbursement for health care attendants. Specifically, comprehensive care management rates are reduced from $139.00 to $126.50 as directed by the emergency and supplemental budgets. The comprehensive care management rate reduction produces $62,000 in savings to the General fund for SFY 09. The mileage rates for health care attendants (specifically HHAs, CNAs, PCAs) are increased from $.32 per mile to $.44 per mile. This mileage rate change has a minimal budgetary impact to the General fund.

EFFECTIVE DATE: March 30, 2009

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Final Rule: Ch. 101, MaineCare Benefits Manual, Chapters II & III, Section 5, Ambulance Services

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CONCISE SUMMARY: The adopted rules reflect changes to this section to increase Ambulance Services base rates that will include ancillary services. Ancillary Services, which include oxygen, oxygen administration supplies such as disposable oxygen masks, intravenous therapy, EKG, endotracheal intubation, pulse oximetry, telemetry and defibrillation, will no longer be billed separately. RN services will also no longer be billed separately as the base rate for Specialty Care Transport has been increased. A definition of Specialty Care Transport has been added. These changes are being made so only HIPAA compliant codes will be utilized. Other changes to this section were made to update policy language.

The proposed rule does not impose an economic burden on small business, municipalities or counties.

EFFECTIVE DATE: May 21, 2009

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Final Rule: Ch. 101 MaineCare Benefits Manual Chapter III Section 21 Home and Community Benefits for Members with Mental Retardation or Autistic Disorder

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CONCISE SUMMARY:T his rule permanently adopts major substantive rules approved by the Maine State Legislature and currently in effect by emergency rule.

EFFECTIVE DATE: June 28, 2009

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Final Rule: Ch. 101 MaineCare Benefits Manual Chapters II and III Section 45 Hospital Services

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CONCISE SUMMARY: This adopted rule adjusts hospital reimbursement methodology. Chapter III, Section 45 clarifies and revises reporting requirements and defines the MaineCare Supplemental Data Form, and clarifies that cross-over payments are made to the extent required by CMS. Chapter III also increases the supplemental pool to be distributed among non-critical access hospitals from approximately $36 to $45 million and counts 50% of the psychiatric discharges when distributing the pool; increases the pool for the critical access hospital from $2 to 3.5 million; increases the PIP cap to approximately 81%; creates a separate section for Hospitals Reclassified to a Wage Area Outside Maine by the Medicare Geographic Classification Review Board and limits reimbursement under that section to hospitals reclassified prior to the effective date of the rule; revises sections 45.03, 45.04, 45.05 and 45.06 to separate the calculation of the PIP from the calculation of the Department’s obligation at settlement; establishes base discharge rates for acute care non-critical access hospitals (Franklin Memorial hospital services rate was changed due to a revision made to the base year report); and removes outdated material. Several provisions have a retroactive effective date of 10/1/08. Pursuant to 22 M.R.S.A. §42(8), the Department is authorized to adopt rules with retroactive application when, as here, it is necessary to maximize available revenue sources, and there is no adverse financial impact on any MaineCare provider or member.

These rules permanently adopt emergency rules, effective February 21, 2009, that reduce hospital-based physician reimbursement to 46.21% of costs, which is the closest to 70% of the Medicare fee schedule that the Department could fund with the resources used for physician reimbursement, as adjusted by the Supplemental Budget, which reduced reimbursement by $1,947,490 of state dollars. A percentage of costs is being used to calculate 70% of the Medicare fee schedule absent claims—based data. Prospective Interim Payments (PIP) will be lowered in an amount corresponding to the anticipated hospital-based physician payment reimbursement, which are paid separately and not paid as part of PIP. Permanent adoption of this methodology change will be contingent upon approval by the U.S. Center for Medicare and Medicaid Services (CMS).

Two proposed changes were withdrawn as a result of comments and legislative action. The provision for hospitals to report professional services on a CMS 1500 form separate from facility fees was withdrawn due to a moratorium enacted by Congress. Also, the reimbursement of non-emergency room hospital-based physicians at 70% of the Medicare fee schedule was withdrawn due to contrary pending legislation in the 1 st session of the 124 th Legislature. Two links were updated in Chapter II, Section 45.11 and Section 45.12.

This rulemaking does not adversely impact counties or municipalities, and it does not adversely impact small businesses of twenty (20) or fewer employees because the service affected by the rate reduction is not provided by small businesses.

EFFECTIVE DATE: May 23, 2009

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Chapter III, Section 97, and Appendices B, D, E, and F, Private Non-Medical Institution Services

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CONCISE SUMMARY: These rules permanently adopt emergency rules already in place that have recently been approved by the Maine State Legislature in LR 1883(03). The rules eliminate bedhold day reimbursement for PNMI services. Specific changes in these rules include that bedhold day codes are eliminated from Chapter III, including BQL, BRL, MRPL, RHL RHL9, RML RML2, RTSL, and PL. Some language regarding occupancy rates was also eliminated from Appendices B, D, E, and F. The Department also replaced some local codes with HIPAA-compliant standard codes that will not be implemented until further notice when the new claims system is operating. Providers will be given prior notice of the change for these billing codes.

EFFECTIVE DATE: July 2, 2009

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Chapters II and III, Section 6, Assisted Living Services

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CONCISE SUMMARY: In this rulemaking, the Department eliminated services provided under MaineCare Benefits Manual, Chapters II and III, Section 6, Assisted Living Services. The Department has determined that it is necessary to repeal these rules because these services were never approved as MaineCare services by CMS. Section 6 Assisted Living Services will no longer be provided under MaineCare as of July 1, 2009.

The Members currently receiving Assisted Living services will receive required notification of the discontinuation of these services and will receive an eligibility determination to assess what benefits and services they remain eligible for. Most will be eligible for MaineCare services under Section 96, Private Duty Nursing and Personal Care Services.

EFFECTIVE DATE: July 1, 2009

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MaineCare Benefits Manual, Chapter X, Section 2 (Non-Categorical Adults)

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CONCISE SUMMARY: The final rule repeals MaineCare Benefits Manual, Chapter X, Section 2, Benefits for Childless Adults, because most of the sub-sections duplicate rules in the MaineCare Eligibility Manual, Section 11000, and promulgates a new Chapter X, Section 2, now called Non-Categorical Adults, listing the covered services for this coverage group. In July 2008, the Department repealed sections 58, 100, and 111, and incorporated those services into Section 65 services. The covered services have not changed but the list of covered services has been revised to reflect the changes made in the consolidated MaineCare Benefits Manual, Chapter II, Section 65, Behavioral Health Services rules, adopted as final rules on October 29, 2008. This rule will not have any adverse impact on the administration of small businesses.

EFFECTIVE DATE: June 30, 2009

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Ch. 101, MaineCare Benefits Manual, Chapter II, Section 60, Medical Supplies and Durable Medical Equipment

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CONCISE SUMMARY: The adopted rules reflect changes to repeal and replace Section 60 in order to clarify the policy and to achieve legislatively mandated cost savings. Proposed changes include new language under Limitations, additional prior authorization requirements, and new language to clarify that items procured under a contract with the Department must be purchased, billed and reimbursed according to the terms of the contract. This Section has been totally replaced due to extensive formatting changes, including a thorough restructuring of the Appendix.

Changes made to the Section 60 proposed rule based on the State budget include: increasing the markup of the acquisition cost of DME to 40% from 30%, and DME providers must deduct any prompt payment discounts when determining the acquisition cost of DME. Several additional changes were made to clarify the Section 60 proposed rule due to comments received and legal review, such as; sleep studies for CPAP and Bi-Pap done within the last three (3) years will be accepted; limits for incontinent supplies for members under 21 were removed; and the time to obtain a written prescription for a Power Mobility Device was changed to 45 days.

The adopted rule does not impose an economic burden on municipalities or counties. The adopted rules are not expected to increase reporting, record keeping, or other administrative costs or skills necessary for reporting or recording for small businesses.

EFFECTIVE DATE: July 1, 2009

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Ch. 101, MaineCare Benefits Manual, Chapter II and III, Section 96, Private Duty Nursing and Personal Care Services

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CONCISE SUMMARY:These rules permanently adopt the emergency and proposed rules that establish a new Level IX eligibility level for Section 96 services. These criteria are based on eligible members’ medication administration needs and assistance with ADLs and IADLs. Furthermore, the Department adopts Chapter III, which provides three codes to providers that will be billing for Level IX services. Other minor technical and grammatical changes are also adopted.

EFFECTIVE DATE: September 28, 2009

 

   
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Section 45, Hospital Services, Chapter II

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CONCISE SUMMARY:These adopted rules establish admission eligibility and continuing eligibility criteria for hospital psychiatric unit services. These changes will assure the efficient operation of the MaineCare program by ensuring that only individuals who are eligible receive the service. Further, the administrative burden of utilization review will be lessened if the admission and continuing eligibility criteria are clear from the beginning. These rules also require reporting of additional physician administered rebatable drugs.

EFFECTIVE DATE: September 28, 2009

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Section 45, Hospital Services, Chapter III

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CONCISE SUMMARY: The Department is permanently adopting emergency rules currently in place that reduce hospital reimbursement. As mandated by the Legislature, in P.L. 2009, ch. 213, Part CC, effective July 1, 2009 the Department reduced hospital reimbursement. For acute care non-critical access hospitals, inpatient discharge rates (except for those from psychiatric units) were reduced 6.7% and reimbursement for outpatient services was decreased to 83.8% of costs. For critical access hospitals and hospitals reclassified to a wage area outside Maine, reimbursement for inpatient and outpatient services was reduced to 109% of costs. For all acute care hospitals, including critical access, hospital based physician reimbursement was decreased from 100% to 93.3% of allowable costs for inpatient non-emergency physicians, to 93.4% of costs for inpatient emergency physicians and to 83.8% of costs for outpatient non-emergency physicians.

In addition, these rules eliminate the COLA adjustment for SFY’s 2010 and 2011 for non critical access acute care hospitals for inpatient discharge rate and for psychiatric unit discharge rates. Th e Department capped the PIP payment so that the total payment to all hospitals is not less than 80%. All of the above mentioned changes are contingent upon approval from CMS.

EFFECTIVE DATE: September 28, 2009

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Chapters III, Section 22, Home and Community Benefits for the Physically Disabled

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CONCISE SUMMARY: The Department adopts Chapter III, Section 22, Home and Community Benefits for the Physically Disabled for purposes of increasing the attendant care services rate. This rate increase results from funds that were formerly reimbursed with all State dollars and will now receive Federal match. This rate change is retroactive to July 1, 2009.

EFFECTIVE DATE: November 1, 2009

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Section 109, Speech and Hearing Services, Chapter III

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CONCISE SUMMARY: These adopted rules permanently adopt emergency rules currently in place which increase reimbursement rates for speech and hearing agencies as directed in the FY 2010 budget.

EFFECTIVE DATE: September 28, 2009

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Chapters II & III, Section 7, Free-Standing Dialysis Services

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CONCISE SUMMARY: The adopted rule is a new Section of MaineCare Benefits Manual. Currently, providers of dialysis services are billing MaineCare under Section 90, Physician Services. The Physician Services rule does not contain any policy pertaining to dialysis services. This new rule is a stand-alone policy for dialysis providers with its own definitions; covered services, including renal dialysis, prescribed drugs, and training for home dialysis; eligibility requirements; reimbursement; limitations; and billing instructions.

EFFECTIVE DATE: October 1, 2009

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Chapters II & III, Section 17, Community Support Services

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CONCISE SUMMARY: The final rules permanently adopt emergency rules were in effect 7/1/09. A new service was established called Community Rehabilitation Services that took the place of Section 97, Private Non Medical Institution rules, scattered site PNMIs for persons with severe and persistent mental illness. This service is billed on a per diem basis using a HIPAA compliant code to comply with certification requirements for the new payment system, Maine Integrated Health Management System (MIMHS).

Additionally, the final rule removed the Global Assessment of Functioning Score (GAF) and replaced it with Level of Care Utilization System (LOCUS) used to determine eligibility for Section 17 services. This was part of a budget initiative estimated to save $ 1,683,730.00 SFY 10 and $ 1,910,941.00 SFY11 in the general fund. The enhanced FMAP may alter the actual final savings.

The final rule also defined requirements for Assertive Community Treatment (ACT), including a HIPAA compliant per diem code (H0040) that will be effective when the new MaineCare claims payments system, Maine Integrated Health Management System (MIMHS) begins processing claims. Providers will be notified thirty (30) days in advance of the change.

The code for Intensive Case Management (ICM) was changed to a HIPAA compliant code (H0023) that is currently being used in Section 65, Behavioral Health Services ( but being phased out) that will be effective when the new MaineCare claims payments system, Maine Integrated Health Management System (MIMHS) begins processing claims. Providers will be notified thirty (30) days in advance of the change.

Other routine technical changes in response to comments were also made in the final rule. Other than providers of these specific services, this rule is not expected to fiscally impact or create new recording burdens for other small businesses and is not expected to yield new costs for municipal or county governments.

EFFECTIVE DATE: October 1, 2009

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MaineCare Benefits Manual, Chapter II, Section 80, Pharmacy Services

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CONCISE SUMMARY: The Department of Health and Human Services is adopting MaineCare Benefits Manual, Ch II, Section 80, Pharmacy Services. The adopted rules edit the definition of the Maine Maximum Allowable Cost as a result of savings initiatives. This rule also removes language in 80.05-3 (b), which allowed reimbursement for B-12 for documented pernicious anemia or megaloblastic anemia drugs for the conditions described and when the prescriber has written the diagnosis on the prescription. Finally, the Department is adding section 80.04-3, Academic Detailing Committee, to comply with 22 M.R.S.A § 2685. The Committee will provide evidence based education and outreach, improve quality measures and encourage better communication between the Department and health care professionals to reduce health complications and unnecessary cost associated with inappropriate drug prescribing. The Department also made other structural, administrative, grammatical and clarifying changes within this rulemaking.

EFFECTIVE DATE: October 1, 2009

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MaineCare Benefits Manual, Chapter III, Section 67, Principles of Reimbursement for Nursing Facility Services

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CONCISE SUMMARY: These rules adopt methodology for the case mix index, the direct care cost component, and the routine cost component in order for the nursing facilities to be properly reimbursed. As a result of public comment, two changes were made to the methodology used to calculate upper limits for the direct care and routine cost components. Specifically, the peer group upper limit for the direct care and routine cost components are now based on the median base year cost per day multiplied by 89.185% as opposed to the 87.122% in the proposed rule. This change will be made retroactive to July 1, 2009. In addition, the Department is adopting a new reimbursement methodology for remote island nursing facilities. These rules are necessary to ensure continued MaineCare funding for nursing facility services provided to the medically fragile residents of Maine.

EFFECTIVE DATE: September 28, 2009

Responses to Public Comments

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MaineCare Benefits Manual, Chapters II & III, Section 62, Genetic Testing and Clinical Genetic Services

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CONCISE SUMMARY: The Department gives notice of a final repeal of a rule: MaineCare Benefits Manual, Chapters II & III, Section 62, Genetic Testing and Clinical Genetic Services. The Department is repealing this section of the MaineCare Benefits Manual to simplify the billing for this service and to repeal outdated clinical provisions currently in Section 62, Genetic Testing and Clinical Genetic Services. Currently the majority of genetic services are being billed under Sections 90 and 55 of the MaineCare Benefits Manual. Providers who were currently billing under Section 62 will now bill under Sections 90, Physicians Services and 55, Laboratory Services, as appropriate. No services are being reduced as a result of this rulemaking.

EFFECTIVE DATE:October 1, 2009

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MaineCare Benefits Manual, Section 46, Psychiatric Hospital Services, Chapter II

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CONCISE SUMMARY: These final rules establish admission eligibility and continuing eligibility criteria for psychiatric hospitals within psychiatric hospitals. These changes assure the efficient operation of the MaineCare program by ensuring that only individuals who are eligible receive the service. Further, the administrative burden of utilization review is lessened when the admission and continuing eligibility criteria are clear from the beginning.

EFFECTIVE DATE: September 28, 2009

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MaineCare Benefits Manual, Chapter’s II and III, Section 103, Rural Health Services

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CONCISE SUMMARY: The Department intends to transition to a new information system, MIHMS in 2010, with 30 days notice to providers. Upon implementation of MIHMS, the Department will delete the current local billing codes in Chapter III, Table 1, and replace them with the codes in Chapter III, Table 2, to become compliant with Federal HIPAA regulations. Furthermore, the Department is requiring providers to bill services, including documenting the type of visit, diagnoses and procedures on the UB04 claim form, which will replace the CMS 1500 form.

EFFECTIVE DATE: September 21, 2009

 

   
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MaineCare Benefits Manual, Chapter III, Section 29, Community Support Benefits for Members with Mental Retardation and Autistic Disorder

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CONCISE SUMMARY:The adopted rules specify modifiers that providers will use when the new payment system, MIMHS is implemented. Providers will receive a notice thirty days in advance of the code implementation. Other than providers of these specific services, this rule is not expected to fiscally impact or create new recording burdens for other small businesses and is not expected to yield new costs for municipal or county governments.

EFFECTIVE DATE: November 1, 2009

Responses to Public Comments

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MaineCare Benefits Manual, Chapter VI, Primary Care Case Management

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CONCISE SUMMARY: The Department of Health and Human Services is adopting changes to Chapter VI, Primary Care Case Management (PCCM) to add a new level of services, Patient Center Medical Home. Patient Centered Medical Home services will assure effective, efficient and accessible health care services for eligible MaineCare members. Provider requirements are included in the adopted rule. Providers who are approved to deliver this service will receive $3.50 per member per month to deliver patient centered medical home services. This management fee is in addition to the $3.50 they receive for providing PCCM services for a total of $7.00 per member per month. Providers will be required to deliver additional integration of patient services, and participate in on-going educational and evaluation activities. The Department also added language to clarify what groups may not be required to participate in PCCM or PCMH services to be in compliance with federal guidelines and updated sections that have been revised or consolidated in the MaineCare Benefits Manual. The rulemaking will not yield any new administrative burdens or compliance-related costs that could fiscally impact municipal or county governments. The rulemaking has no adverse impact on small business.

EFFECTIVE DATE: November 1, 2009

Responses to Public Comments

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MaineCare Benefits Manual, Chapter II, Section 4, Ambulatory Surgical Centers

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CONCISE SUMMARY: These final rules update the definition of Ambulatory Surgical Center, per CMS Conditions for Care; update the conditions of care; clarify non-covered services; add documentation for assessments and informed consents; and make minor grammatical changes. This rulemaking has no adverse impact on small businesses employing fewer than twenty employees.

EFFECTIVE DATE: November 18, 2009

Responses to Public Comments

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MaineCare Benefits Manual, Chapter III, Section 15, Chiropractic Services

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CONCISE SUMMARY: These final rules allow for HIPAA compliant billing of chiropractic services under MaineCare’s new claims system, MIHMS. This rulemaking has no adverse impact on small businesses employing fewer than twenty employees.

EFFECTIVE DATE: November 23, 2009

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MaineCare Benefits Manual, Chapter II, Section 97, Private Non-Medical Institutions

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CONCISE SUMMARY: This rule will adopt an expiring emergency rule which added language detailing eligibility criteria, requiring prior authorization for children’s and adult’s behavioral health PNMI services, and defining models of children’s PNMI services for which standard rates are being set in separate major substantive rulemaking this month pursuant to Chapter III of Section 97. In addition, this rule will adopt additional definitions subsequently proposed which will facilitate eligibility and prior authorization determinations, including additional criteria for some services.

These changes are necessary to assure that PNMI services are medically necessary and that more cost effective community based services are used to the fullest extent possible. The Department expects to achieve significant cost savings as a result of these changes as directed by the Legislature, while still providing services deemed medically necessary. The rulemaking will not yield any new administrative burdens or compliance-related costs that could fiscally impact municipal or county governments. The rulemaking has no adverse impact on small business, as all providers impacted by these rules employ more than twenty employees.

EFFECTIVE DATE: October 30, 2009

Responses to Public Comments

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Chapter 275-Reporting Requirements for Pharmaceutical Manufacturers and Labelers; Office of the Attorney General, 26-239, Chapter 111, Reporting Requirements for Pharmaceutical Manufacturers and Labelers.

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CONCISE SUMMARY: This letter gives notice of a final rule: Department of Health and Human Services, 10-144, Chapter 275-Reporting Requirements for Pharmaceutical Manufacturers and labelers; Office of the Attorney General, 26-239, Chapter 111, Reporting Requirements for Pharmaceutical Manufacturers and Labelers. This final rulemaking clarifies Maine requirements for clinical trial registration and results reporting, compatible with current and anticipated Federal reporting requirements and with the capabilities of the publicly funded website, www.ClinicalTrials.gov. The rule modifies the scope of the trials required to be registered and reported. It includes requirements to report on observational studies and clarifies the requirements of reporting post hoc analysis of trial results. This rulemaking provides contact information and clarifies the application of penalty for violations. This rule change does not require reposting of previously posted trials. Other minor technical, grammatical and structural changes are included within this rulemaking. This rule change is not anticipated to have any adverse impact on small business.

EFFECTIVE DATE: November 2, 2009

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