6. RESULTADOS
6.1. Módulo 1: Aprendiendo sobre primates
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Vol. 80, No. 104
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Monday, June 1, 2015
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Proposed Rules
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E. Exempt ICRs
1. Administrative Actions While the requirements under §§ 431.220(a)(5) and (6), 431.220(b), 438.710(b)(2), 438.730(b), and 457.1270(a), (b), and (c) are subject to the PRA, since the information collection requirements are associated with an administrative action (5 CFR 1320.4(a)(2) and (c)), they are exempt from the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
et seq.)
Section 431.220(a)(5) and (6) would add PAHP enrollees as eligible for a state fair hearing as permitted in subpart B of 42 CFR part 438. Section 431.220(b) prescribes procedures for an
opportunity for a hearing if the state agency or non-emergency transportation PAHP takes action to suspend,
terminate, or reduce services, or an MCO, PIHP or PAHP takes action under subpart.
Before imposing any of the sanctions specified in subpart I, § 438.710(a) would require that the state give the affected MCO, PIHP, PAHP or PCCM written notice that explains the basis and nature of the sanction. Section 438.710(b)(2) states that before terminating an MCO’s, PIHP’s, PAHP’s or PCCM’s contract, the state would be required to: (1) Give the MCO or PCCM written notice of its intent to terminate, the reason for termination, the time and place of the hearing; (2) give the entity written notice (after the hearing) of the decision affirming or reversing the proposed termination of the contract and, for an affirming decision, the effective date of termination; and (3) give enrollees of the MCO or PCCM notice (for an affirming decision) of the termination and information, consistent with § 438.10, on their options for receiving Medicaid services following the effective date of termination.
Section 438.730(b) would require that if CMS accepts a state agency’s
recommendation for a sanction, the state agency would be required to give the MCO written notice of the proposed sanction. Section 438.730(c) would require that if the MCO submits a timely response to the notice of sanction, the state agency must give the MCO a concise written decision setting forth the factual and legal basis for the decision. If CMS reverses the state’s decision, the state must send a copy to the MCO.
Section 457.1270 would apply subpart I (Sanctions) of part 438 to CHIP. Within subpart I, § 438.710(a) would require that the state provide the affected entity with timely written
notice of the basis of the sanction. Section 438.710(b) would require that the state provide an entity a pre- termination hearing. If we accept a state agency’s recommendation for a
sanction, § 438.730(b) would require that the agency provide the MCO, PIHP or PAHP written notice of the proposed sanction. If the MCO submits a timely response to the notice of sanction, § 438.730(c) would require that the state agency provide the MCO, PIHP or PAHP with a concise written decision setting forth the factual and legal basis for the decision. If we reverse the state’s decision, the state must send a copy to the affected MCO, PIHP or PAHP. 2. Fewer Than 10 Respondents
While the requirements under §§ 438.8(m), 438.70(a), 438.102(a)(2), 438.350(a)(1) and (2), 438.360(c), 438.724, and 438.818(d) are subject to the PRA, in each instance we estimate fewer than 10 respondents.
Consequently, the information collection requirements are exempt (5 CFR 1320.3(c)) from the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).
Section 438.8(m) would require the MCO, PIHP, or PAHP to recalculate its MLR for any year in which a retroactive capitation change is made. As such retroactive adjustments are not a common practice, we only estimate that no more than three plans per year may have to recalculate their MLR.
Section 438.70(a) would require that states have a process to solicit and address viewpoints from beneficiaries, providers, and other stakeholders as part of the design, implementation, and oversight of the managed LTSS program. We estimate no more than 3 states per year would elect to move to a managed LTSS program.
Section 438.102(a)(2) specifies that MCOs, PIHPs, and PAHPs are not required to cover, furnish, or pay for a particular counseling or referral service if the MCO, PIHP, or PAHP objects to the provision of that service on moral or religious grounds; and that written information on these policies is made available to: Prospective enrollees, before and during enrollment; and current enrollees, within 90 days after adopting the policy for an any particular service. We believe the burden
associated with this requirement affects no more than 3 MCOs or PIHPs annually since it applies only to the services they discontinue providing on moral or religious grounds during the contract period. PAHPs are excluded from this estimate because they generally do not provide services that would be affected by this provision.
Section § 438.350 would add PAHPs to the list of affected entities in § 438.350(a)(1) and (2). The addition of PAHPs to the EQR process would require the nine states with PAHPs and existing EQRO contracts to modify their existing EQRO contracts. The estimated 3 states with PAHPs that do not
currently have an EQRO contract would need to enter into a contract with an EQRO.
Section 438.360(c) would require states to document, in the
comprehensive quality strategy required at § 431.502, which mandatory EQR- related activities it will apply the non- duplication provisions to, and why it believes these activities would be duplicative. Given that this is already standard practice for the 37 states that currently contract with MCOs and/or PIHPs, only the 3 states that contract only with PAHPs would have to revise their policies and procedures to include this in their comprehensive quality strategy.
Section 438.724 would require that the state provide written notice to their CMS Regional Office whenever it imposes or lifts a sanction on a PCCM or PCCM entity. Given the limited scope of benefits provided by a PCCM or PCCM entity, we anticipate that no more than 3 states may impose or lift a sanction on a PCCM or PCCM entity in any year.
Section 438.818(d) would require states new to managed care and not previously submitting encounter data to MSIS to submit an Implementation plan. There are currently only 8 states that do not use MCOs thus these would be the only states that may have to submit an Implementation plan should they adopt managed care in the future. 3. Usual and Customary Business Practices
Section 433.138(e)(1) would make a technical correction addressing state Medicaid agencies’ review of claims with trauma codes, to identify instances where third party liability (TPL) may exist for expenditures for medical assistance covered under the state plan. The correction would remove references to the International Classification of Disease, 9th edition, Clinical
Modification Volume 1 (ICD–9–CM) by replacing the references with a general description of the types of medical diagnoses indicative of trauma. States would use the International
Classification of Disease that they are using at the time of claims processing. There is no additional cost to the state related to the proposed changes to § 433.138(e) because the proposed changes do not require any action by the
state, if the state wishes to retain their usual and customary editing for the same types of traumatic injuries currently identified with ICD–9–CM.
While the requirements under §§ 438.10(c)(7), 438.208(b)(2),
438.208(b)(2)(i) and (iv), 438.208(b)(5), 438.210(b), 438.214, 438.360(c), 438.406(b)(5), 438.408(b)(2) and (3), 438.408(f)(1) and (2), and 438.416(b) and (c) are subject to the PRA, we believe the associated burden is exempt from the PRA in accordance with 5 CFR 1320.3(b)(2). We believe that the time, effort, and financial resources necessary to comply with the aforementioned requirements would be incurred by persons during the normal course of their activities and, therefore, should be considered usual and customary business practices.
Section 438.10(c)(7) would add PAHPs and PCCMs to the managed care entities that must have mechanisms in place to help enrollees and potential enrollees understand the requirements and benefits of managed care.
Section 438.208(b)(2) would require that MCOs, PIHPs and PAHPs
coordinate an enrollee’s care between settings or with services received through a different MCO, PIHP, PAHP and FFS. Section 438.208(b)(2)(i) would require discharge planning which has been a long standing industry practice since managed care plans consistently require authorization for all inpatient and facility care.
Section 438.208(b)(5) would require providers to maintain a record
according to medical industry accepted professional standards.
Section 438.210(b) would require contracts with MCOs, PIHPs, or PAHPs and its subcontractors to have written policies and procedures for the processing of requests for initial and continuing authorizations of services. The burden associated with this requirement is the time required to develop the policies and procedures which is standard industry practice for managed care plans.
In § 438.214, each state must ensure, through its contracts, that each MCO, PIHP, or PAHP implements written policies and procedures for the selection and retention of providers. Since all managed care programs utilize provider networks, this is industry standard practice.
Section 438.360(c) would require states to document, in the
comprehensive quality strategy required at § 431.502, which mandatory EQR- related activities it will apply the non- duplication provisions to, and why it believes these activities would be duplicative. Given that this is already
standard practice for the 37 states that currently contract with MCOs and/or PIHPs, only the three states that contract only with PAHPs would have to revise their policies and procedures to include this in their comprehensive quality strategy.
Section 438.406(b)(5) would modify the language for evidence standards for appeals to mirror the private market evidence standards. This aligns the text with commercial requirements but does not alter the meaning.
Section 438.408(b)(2) would change the timeframe an entity has to reach a determination from 45 days to 30 days to align with Medicare. Most insurers offer more than one line of business, and therefore we believe this timeframe will allow MCOs, PIHPs, and PAHPs to be consistent with their usual and customary business practices and reduce their burden. Section 438.408(b)(3) would change the timeframe an entity has to reach a determination in an expedited appeal from 3 days to 72 hr to align with Medicare and the private market. Most insurers offer more than one line of business, and therefore we believe this timeframe will make Medicaid consistent with usual and customary business practices and reduce their burden. Section 438.408(f)(1) and (2) would require that an enrollee exhaust the appeals process before proceeding to the state fair hearing process, and change the timeframe in which a beneficiary must request a state fair hearing to 120 days. MCOs, PIHPs, and PAHPs would no longer have to maintain an appeal and a fair hearing simultaneously which will decrease administrative burdens. The changing of the timeframe to request a state fair hearing from ‘‘not less than 20 or in excess of 90 days’’ to 120 days aligns with the private market. Many insurers offer more than one line of business, and therefore we believe aligning these timeframes will make Medicaid consistent with their usual and customary business practices and reduce their burden.
Section 438.416(b) and (c) would set forth a standard for the minimum types of information an entity must record during the appeals process and how that information must be stored. This standard aligns with the standards in the private market. Most insurers offer more than one line of business, and therefore, we believe aligning record keeping standards will make Medicaid consistent with usual and customary business practices.
F. Submission of PRA-Related Comments
We have submitted a copy of this proposed rule to OMB for its review of the rule’s information collection and recordkeeping requirements. These requirements are not effective until they have been approved by OMB.
To obtain copies of the supporting statement and any related forms for the proposed collections discussed above, please visit CMS’ Web site at
www.cms.hhs.gov/Paperwork@ cms.hhs.gov, or call the Reports
Clearance Office at 410–786–1326. We invite public comments on these potential information collection requirements. If you wish to comment, please submit your comments
electronically as specified in the
ADDRESSESsection of this proposed rule. Comments must be received on/by July 27, 2015.
V. Response to Comments
Because of the large number of public comments we normally receive on
Federal Register documents, we are not
able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the DATESsection of this preamble, and, when we proceed with a subsequent document, we will respond to the comments in the preamble to that document.
VI. Regulatory Impact Analysis
A. Statement of Need
This proposed rule modernizes the Medicaid managed care regulations recognizing changes in the usage of managed care delivery systems since the release of the final rule in 2002. As Medicaid managed care programs have developed and matured in the
intervening years, states have taken various approaches to implementing part 438. This has resulted in
inconsistencies and, in some cases, less than optimal results. To improve consistency and adopt policies and practices from states that have proven the most successful, we propose revisions in this rule to strengthen beneficiary protections, support alignment with rules governing managed care in other public and private sector programs, strengthen actuarial soundness and the accountability of rates paid in the Medicaid managed care program, and implement statutory provisions issued since 2002.
According to the 2013 Actuarial Report on the Financial Outlook for Medicaid, total Medicaid outlays in federal FY 2012 exceeded $431 billion;
19http://www.medicaid.gov/medicaid-chip-
program-information/by-topics/financing-and- reimbursement/downloads/medicaid-actuarial- report-2013.pdf.
20CMS, Financial Management Report—Base
Payments, 2013.
$250 billion, or 58 percent represented federal spending, and $181 billion, or 42 percent represented state spending.19
States have continued to expand the use of managed care in the past decade, not only to new geographic areas but to more complex populations, including seniors, persons with disabilities, and those who need long-term services and supports. Today, the predominant form of managed care in Medicaid is
capitated risk-based arrangements— virtually identical in structure and payment to arrangements in the private insurance market in many ways. Coordination and alignment with the private insurance market will improve operational efficiencies for states and health plans and improve the experience of care for individuals moving between insurance coverage options. Total Medicaid managed care spending (federal and state) exceeded $132 billion in 2013,20with
expenditures rising annually as new beneficiaries and programs move into a managed care delivery system. It is CMS’ responsibility to make sure these dollars are spent wisely, ensuring that there is adequate funding to support the delivery of required services to
beneficiaries without wasting state and federal tax dollars. Additionally, the prevalence of MLTSS being delivered through a risk-based capitated system has increased significantly since the regulations were last published. Beneficiaries using MLTSS are among the most vulnerable, and often require enhanced protections to preserve health and welfare. This regulation would codify these necessary beneficiary protections in MLTSS. The changes we propose in this rule for rate setting, medical loss ratio, encounter data, and reporting, would support and reflect the increased efforts of states and health plans to provide more comprehensive, coordinated, and effective care while achieving better health outcomes.
Congress established CHIP in 1997 through the passage of the Balanced Budget Act (BBA) and reauthorized it in 2009 with the passage of the Children’s Health Insurance Program
Reauthorization Act (CHIPRA). Since CHIP was established, participation has grown steadily, and the rate of
uninsured children has been reduced by half. The most recent data indicate that more than 87 percent of eligible children are enrolled in CHIP or Medicaid. Managed care has always
been a large part of CHIP, because the program was established in an era of increased use of managed care in all health care sectors and the flexibility granted to states in administering the program. Many states enroll all or nearly all of their CHIP population in managed care plans. At the same time, CHIP has historically had few regulations related to the use of managed care.
When Congress reauthorized CHIP in 2009 in section 403 of CHIPRA, it applied a number of the Medicaid managed care provisions in section 1932 of the Act to CHIP. In response, we released two State Health Official (SHO) letters 09–008 and 09–013, issued on August 31, 2009 and October 21, 2009, respectively, which provided initial guidance on the implementation of section 403 of CHIPRA. (SHO #09–008 is available at http:// downloads.cms.gov/cmsgov/archived- downloads/SMDL/downloads/ SHO083109a.pdf. SHO #09–013 is available at http://www.medicaid.gov/ Federal-Policy-Guidance/downloads/ SHO102109.pdf.) This proposed rule
builds on that guidance. It would align CHIP managed care standards with those of the Marketplace and Medicaid, where practical, ensuring consistency across programs. Consistency has the benefit of creating efficiencies for both plans and beneficiaries, including operational efficiencies for plans from using similar rules and smoother transitions between programs for beneficiaries.
The BBA established quality standards for Medicaid managed care programs: A quality assessment and improvement strategy, and an external, independent review. While these standards initially applied only to MCOs, the application of several of them has spread to PIHPs (via the regulations at part 438, subparts D (Quality Assessment and Performance Improvement, effective on August 13, 2002 (67 FR 40989)) and E (External Quality Review, effective on March 25, 2003 (68 FR 3586)) and to CHIP managed care programs (per the CHIPRA). States that use a combination of managed care and other delivery systems are encouraged to use their quality strategies to develop a comprehensive quality plan across all delivery systems (as described in State Health Official letter entitled Quality Considerations in Medicaid and CHIP (SHO #13–007, available at http://
www.medicaid.gov/Federal-Policy- Guidance/downloads/SHO-13-007.pdf)).
Changes, in both MA and the private sector, related to performance measurement, quality rating systems, and private accreditation help to
improve the health of beneficiaries while also controlling health care costs. Statewide comprehensive quality strategies, along with improvements to Medicaid and CHIP managed care quality, will give states additional tools to evaluate and improve the care received by beneficiaries.
For all of these reasons, the current regulatory framework is no longer the most appropriate or efficient to achieve program goals. We believe that it is necessary to modernize the Medicaid and CHIP managed care and quality regulations to support health care delivery system reform, improve population health outcomes, and improve the beneficiary experience in a cost effective and consistent manner in all states.
B. Overall Impact
We have examined the impacts of this rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96– 354), section 1102(b) of the Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104–4), Executive Order 13132 on Federalism (August 4, 1999) and the Congressional Review Act (5 U.S.C. 804(2)).