Regulatory Actions 2011

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  • CMS issues proposed "sunshine" rule

    On December 19, 2011, the proposed "sunshine" rule, pursuant to provisions of the Affordable Care Act, was published in the Federal Register. Issued by the Centers for Medicare & Medicaid Services, this proposed rule imposes transparency and reporting requirements on certain drug and medical supply manufacturers covered by Medicare, Medicaid, or CHIP, requiring them to report annually on payments or transfers made to physicians or teaching hospitals. In addition, it requires such manufacturers and group purchasing organizations to report on certain ownership and investment interests. Comments on this proposed rule are due by February 17, 2012. Click here for the proposed rule [PDF].
  • Essential Health Benefits Bulletin released by Department of Health and Human Services

    On December 16, 2011, the Department of Health and Human Services issued its Essential Health Benefits Bulletin (EHHB), which, pursuant to the Affordable Care Act, outlines proposed policies related to the package of essential health benefits to be offered by individual and small group markets. The EHHB is designed to provide states with flexibility in carrying out requirements under the Affordable Care Act. Click here for the EHHB in its entirety [PDF]. In addition, click here for a CCIIO summary of key aspects of the bulletin.
  • Consumer Oriented and Operated Plan Program rule released

    On December 13, 2011, the Department of Health and Human Services published in the Federal Register a final rule related to the establishment of the Consumer Operated and Oriented Plan (CO-OP) Program. This program, established under the Affordable Care Act, makes available loans in every state for the creation of "consumer-governed, private, nonprofit health insurance issuers to offer qualified health plans in the Affordable Insurance Exchanges." The final rule will go into effect on February 13, 2012. The first round of grant awards is anticipated for January 2012, with subsequent quarterly application deadlines to follow through the end of 2012. Click here for the final rule in its entirety [PDF].

  • CMS issues ERRP reimbursement announcement

    On December 13, 2011, the Centers for Medicare & Medicaid Services announced that, based on projected funding estimates for the Early Retiree Reinsurance Program (ERRP), it would be exercising its authority under 45 C.F.R. § 149.45(a) to deny ERRP reimbursement requests for claims incurred after Dec. 31, 2011. Click here for notice of this announcement [PDF].
  • DOL releases MEWA guidance

    On December 5, 2011, the Employee Benefits Security Administration (EBSA) released several rulemakings designed to implement provisions of the Affordable Care Act related to multiple employer welfare arrangements (MEWAs). Section 521 of ERISA, enacted under Section 6605 of the Affordable Care Act, authorizes the Secretary of the Department of Labor (DOL) to issue a cease and desist order if it appears that a MEWA is fraudulent, creates an immediate danger to public safety or welfare, or can be reasonably expected to cause significant, imminent, and irreparable injury. It also authorizes the Secretary to issue a summary seizure order if it appears that a MEWA is in a financially hazardous condition.

    Accordingly, EBSA has released two proposed rulemakings and two notices to implement the DOL's MEWA authority. First, EBSA has released a proposed rule (1) establishing the procedures for issuance of an ex parte cease and desist or summary seizure order, and (2) establishing procedures for use by ALJs and the Secretary when a MEWA or other person challenges a temporary cease and desist order. Click here for the proposed rule.

    Second, EBSA released a proposed rule implementing the registration and reporting requirements for MEWAs under the Affordable Care Act. The proposed rules apply to MEWAs and certain other entities that offer or provide health benefits for employees of two or more employers. Click here for this rulemaking. Both rulemakings will be published in the December 6, 2011 issue of the Federal Register, and comments are due March 5, 2012 (90 days after publication).

    Consistent with the two above rulemakings, EBSA has also released two notices of proposed revisions to Form M-1 (Report for MEWAs and Certain Entities Claiming Exception) and Form 5500 (Annual Return/Report filed by administrators of employee benefit plans). These form revisions will update filing requirements for MEWAs pursuant to the Affordable Care Act provisions and proposed rules. Click here for the notice of proposed revisions of the Form M-1. In addition, the proposed revised Form M-1 itself can be found by clicking here. Click here for the notice of proposed revisions to the Form 5500. For further information, you may also wish to view the concurrently issued fact sheet and news release.
  • OMB receives hospice services final rule for regulatory review

    On December 5, 2011, the OMB received for regulatory review a final rule of the Centers for Medicare & Medicaid Services (CMS) on requirements for long term care facilities with respect to hospice services. According to the relevant announcement, long-term care facilities will be required to have an agreement with hospice agencies when hospice care will be provided. In addition, the final rule will include quality of care requirements. Click here for the announcement of OMB review.
  • Centers for Medicare & Medicaid Services releases final MLR rules

    On December 4, 2011, the anticipated rules related to Medical Loss Ratio (MLR) requirements under the Affordable Care Act were released by the Centers or Medicare & Medicaid Services (CMS). Under the final rule, health insurance companies are generally required to spend at least 80 percent of premiums on provision of care. Insurance companies that fail to do so will be required to provide rebates to beneficiaries. The final rule provides, among other things, that rebates received will be tax-free and also includes a number of provisions geared at transparency about the MLR requirements. The final rule also phases down the special circumstances adjustment to mini-med plan MLRs but retains the ex-patriate plan multiplier adjustment. This final rule provides for a comment period, with comments due by January 6, 2012. The modifications to the MLR rules included in the final rule will go into effect on January 1, 2012. Click here for the final rule.

    Relatedly, CMS concurrently issued an interim final rule with request for comments on MLR rebate requirements for non-federal governmental plans in group markets. Under the interim final rule, issuers of such plans are to distribute entire MLR rebates to the group policyholder, and the group policyholder is required to use the portion of rebates attributable to the premium paid by subscribers of such plans for the benefit of subscribers. This interim final rule likewise will go into effect on January 1, 2012. Comments are due 60 days after publication in the Federal Register, which is slated for December 7, 2011. Click here for this rulemaking.

    Finally, in light of the MLR rule updates, the Department of Labor (DOL) issued Technical Release No. 2011-04 regarding MLR rebates issued to policyholders who are group health plans under ERISA. According to the guidance, if a group health plan is entitled to a rebate, such rebates may constitute plan assets, requiring the policyholder to comply with ERISA fiduciary provisions for handling the rebates. If the plan sponsor is the policyholder, then the plan's portion of the rebate, if any, may depend on provisions of the plan or the manner of cost-sharing under the policy. The guidance, however, does not expressly address when an MLR rebate becomes an ERISA plan asset or whether an issuer delivering a rebate could be an ERISA fiduciary. Click here for the Technical Release.
  • ACO guidance published in Federal Register

    On November 2, 2011, the ACO and Shared Savings Program guidance, originally released on October 20, was published in the Federal Register. The interim final rule with comment period addressing Shared Savings Program waivers can now be found by clicking here. These regulations go into effect on November 2, 2011, with comments due by January 3, 2012. The final rule on the Shared Savings Program and ACOs, which enters into effect on January 3, 2012, can now be found by clicking here. Finally, the notice announcing testing of the Advance Payment Model for ACOs is now available by clicking here.

    Finally, in addition to the CMS guidance on ACOs, the Federal Trade Commission and the Department of Justice released the final version of their joint policy statement addressing enforcement of antitrust law in the ACO and Shared Savings program context. The final policy statement was published in the Federal Register on October 28, 2011, and can be found by clicking here.
  • CMS releases set of Medicare payment systems guidance

    On November 2, 2011, the Centers for Medicare & Medicaid Services (CMS) released several rulemakings on the public inspection desk related to Medicare payment systems and related revisions to existing regulations. First, CMS released a final rule with comment period revising the Medicare hospital outpatient and ambulatory surgical center payment systems. In addition, this rule contains revisions to the Hospital Value-Based Purchasing Program, provisions on exceptions to the physician self-referral prohibition, and patient notification requirements in provider agreements. The new regulations will be effective January 1, 2012, with comments on the final rule due by March 2, 2012. This rulemaking can currently be found here.

    Second, CMS released a final rule containing updates to the End-Stage Renal Disease (ERSD) prospective payment system for 2012. This rule also finalizes prior guidance in the form of an interim final rule. In addition to the ERSD-related updates, this rule revises the ambulance fee schedule regulations and durable medical equipment regulations. This rule likewise goes into effect on January 1, 2012. It can currently be found by clicking here.

    Finally, CMS released an additional final rule with comment period revising the Part B physician fee schedule and payment policies so as to conform with changes in medical practice and the relative value of services. These regulations also go into effect on January 1, 2012, and comments are due 60 days after the date of issuance for public inspection (i.e. 60 days from November 2, 2011). This final rule can be found by clicking here.
  • HHS announces extension of Temporary Certification Program

    On November 2, 2011, the Department of Health and Human Services (HHS) released a notice announcing the extension of the Temporary Certification Program. This program helps make Certified Electronic Health Record (EHR) Technology available for adoption and use for participants in the Medicare and Medicaid EHR Incentive Programs. Originally set to expire on December 20, 2011, the Temporary Certification Program will be extended to align with the effective date of forthcoming rules adopting new standards and rules regarding meaningful use of EHR technology. The notice announcing the extension can presently be found by clicking here.

  • CMS announces new Medicare premiums and deductibles for 2012

    On November 1, 2011, the Centers for Medicare & Medicaid Services (CMS) published in the Federal Register several notices setting forth new Medicare premium and deductible rates for the upcoming year. First, CMS announced new inpatient hospital deductibles and hospital and extended care services coinsurance amounts for Medicare Part A. Click here for this announcement. Second, CMS announced Medicare Part B monthly actuarial rates, premium rates, and annual deductibles. Click here for this notice. Finally, CMS announced Medicare Part A premiums for uninsured aged and certain disabled individuals who have exhausted other entitlement. Click here for this notice. The new rates will enter into effect as of January 1, 2012.
  • Centers for Medicare & Medicaid Services releases final ACO rule and additional guidance

    On October 20, 2011, the Centers for Medicare & Medicaid Services released the final rule on the Medicare Shared Savings Program, in addition to further related guidance, for Accountable Care Organizations (ACOs). The Shared Savings Program is an initiative geared toward more coordinated care among providers. The program enables ACO providers and suppliers to receive traditional fee-for-service payments under Medicare Parts A and B, and to become eligible for additional payments if they meet program quality standards and savings requirements. According to the Department of Health and Human Services (HHS), the final rule includes broader incentives and a streamlining of the program in comparison to the earlier proposed rule. The regulations will go into effect 60 days after publication in the Federal Register, which is slated for November 2, 2011. Click here for the final rule.

    In addition to the final Shared Savings Program rule, CMS has released (1) a notice announcing testing of the Advance Payment Model for ACOs, and (2) an interim final rule with comment period on waivers of application of the physician self-referral law, anti-kickback statute, and certain civil monetary penalty provision to ACOs. The first notice provides information for interested physician-owned and rural providers participating in the Shared Savings Program, with background about the model and the application process. Click here for the notice. Click here for the interim final rule on waiver provisions, issued jointly with the HHS Office of Inspector General. Comments on the interim final rule are due 60 days after publication in the Federal Register, also slated for November 2, 2011.

  • CMS issues regulatory reduction guidance

    On October 18, 2011, CMS issued three new rulemakings, all with a purpose of regulatory reduction and the elimination of burdensome and unnecessary regulations. The rulemakings include:

All three rulemakings are slated for publication in the Federal Register on October 24, 2011.
  • IOM Issues Report, Essential Health Benefits: Balancing Coverage and Costs

    The Patient Protection and Affordable Care Act (ACA) requires that healthcare benefits offered to individuals and small groups include a package of "essential health benefits" (EHB). The ACA provides some parameters and guidance for what EHB should include, but stops well short of defining EHB. On October 7, 2011, the Institute of Medicine (IOM) issued a 314-page report that undertakes to answer the question, "How, exactly, should one go about deciding what to include as essential in a health insurance plan?" That is, the IOM report describes how the federal government should go about defining EHB. The chief concern relating to EHB's definition, as the report's preface notes, is that "[i]f the package of benefits is too narrow, health insurance might be meaningless; if it is too broad, insurance might become too expensive."

    The IOM panel made two key decisions that framed the rest of the defining process. First, it decided that a "typical employer" should be a small rather than a large employer, and made a small employer's business profile basic to the cost criteria for definitions of EHB. And second, the panel opted for a definition of "essential" that establishes a set of basic requirements and that does not encompass every service included in the 10 statutorily mandated service categories or every service included in a typical employer plan.

    These antecedent definitions make up much of the platform on which the panel rests Chapter 5, "Defining the EHB," which spells out steps for arriving at a definition in Recommendation 1:

    By May 1, 2012, the Secretary should establish an initial essential health benefits (EHB) package guided by a national average premium target.

    1. The starting point in establishing the initial EHB package should be the scope of benefits and design provided under a typical small employer plan in today's market. To specify the initial EHB package, this scope of benefits should then be modified to reflect
      • The 10 general categories specified in Section 1302(b)(1) of the Affordable Care Act (ACA); and
      • The criteria specified in this report for the content of specific elements and aggregate EHB package (see Summary Figure S-2).
    2. Once a preliminary EHB list is developed as described in (A), the package should be adjusted so that the expected national average premium for a silver plan with the EHB package is actuarially equivalent to the average premium that would have been paid by small employers in 2014 for a comparable population with a typical benefit design.
    3. The Secretary should sponsor a public deliberative process to assist in determining how the adjustments to the EHB package should be made.
    4. Initial guidance by the Secretary on the contents of the EHB package should list standard benefit inclusions and exclusions at a level of specificity at least comparable to current best practice in the private and public insurance market.

    Other salient points in the IOM report include a discussion of how to define "medical necessity" (Chapter 5), a recommendation that HHS establish a research framework for collecting and analyzing data in order to evaluate EHB implementation (Chapter 7), and support for potential waivers from the federally defined EHB to states whose alternative EHB definitions are consistent with the ACA and with the criteria specified in IOM's report (Chapter 8).

  • The Institute of Medicine has released a report at the request of the Department of Health and Human Services regarding criteria and methods to develop an essential benefits package

    An October 6 news release issued concurrently with the report states that essential benefits should be based on what small businesses typically offer. Click here for news release; click here for the "Report in Brief."

  • OMB to review rule on Medicare Shared Savings Program: Accountable Care Organizations

    On October 6, 2011, OMB received for review a CMS final rule designed to implement provisions of PPACA related to Medicare payments to providers and suppliers participating in Accountable Care Organizations (ACOs). The new rules will enable such providers and suppliers to receive traditional Medicare fee-for-service payments under Parts A and B, and to become eligible for other payments based on applicable quality and savings standards. OMB's announcement of its review of this rule can be found here.

  • CMS issues proposed rule to revise Medicare Parts C and D regulations

    On October 3, 2011, the Centers for Medicare & Medicaid Services (CMS) released on the Federal Register's Electronic Public Inspection Desk a new proposed rule designed to implement revisions to the Medicare Advantage (MA) program (Part C) and prescription drug benefit program (Part D) regulations. The revisions address a number of goals, namely: "to implement new statutory requirements; strengthen beneficiary protections; exclude plan participants that perform poorly; improve program efficiencies; and clarify program requirements." In addition, CMS is considering revisions to the long term care facility conditions of participation requirements for pharmacy services. Comments on the proposed rule will be due 60 days after publication in the Federal Register, which has been slated for Tuesday, Oct. 11. Among the revisions considered, highlights include:

    • Implementation of Affordable Care Act with regard to the consolidation of prior guidance on the Coverage Gap Discount Program and implementation of Pharmacy Benefit Manager reporting requirements under Part D;
    • Implementation of MIPPA provision related to benzodiazepines and barbiturates as Part D drugs;
    • Provisions for beneficiary reinstatement into cost plans when good cause for failure to pay premiums can be established;
    • Provision of uniform ID cards for MA plan enrollees and guidance related to the determination of creditable coverage for the retiree drug subsidy;
    • A process for Independent Review Entity (IRE) reconsideration of Part D coverage determinations;
    • Procedures and standards for the exclusion of poor performers in the Parts C and D programs;
    • Measures to reduce costs, including the elimination of the requirement to purchase print advertising announcing non-renewal of cost contractors, implementation of hospital-acquired conditions and present-on-admission indicator policy for MA plans, changes to rules regarding agent/broker compensation, and cost-sharing associated with trial fills of prescription drugs;
    • And further codification and clarification of prior guidance under Parts C and D.
      The proposed rule can currently be accessed here.

  • Comment period for Exchange guidance extended to Oct. 31, 2011

    HHS has announced the extension of the comment period for both the proposed rule implementing the Affordable Insurance Exchange program and also the proposed rule implementing standards for States and insurance issuers related to reinsurance, risk adjustment, and risk corridors. Further information can be found at
    http://www.gpo.gov/fdsys/pkg/FR-2011-09-30/pdf/2011-25202.pdf.
  • CMS issues information request related to PPACA state "Basic Health Program" option

    On September 9, 2011, CMS issued on the Public Inspection desk a notice seeking information related to a state's option to establish a Basic Health Program under PPACA § 1331, rather than provide health coverage through the Affordable Insurance Exchange program. In addition to detailing PPACA provisions related to this program, the information request solicits responses to specific questions targeted at informing CMS's process of developing standards for the establishment and operation of a state Basic Health Program. Comments responses to the information collection request are due by 5 p.m. 45 days after publication in the Federal Register, which is slated for Sept. 14, 2011. Click here to access the notice [PDF].
  • CMS issues final rule amending definitions of "individual market" and "small group market"

    On September 6, 2011, a CMS final rule on rate increase disclosure and review and definitions of "individual market" and "small group market" was published in the Federal Register. This final rule amends a May 23, 2011 final rule in light of comments received and amends the definitions of "individual market" and "small group market" for rate review purposes "to include coverage sold to individuals and small groups through associations even if the State does not include such coverage in its definitions of individual and small group market." In addition, the rule also includes updates to standards related to disclosure of unreasonable premium increases. This rule goes into effect on Nov. 1, 2011, click here to access [PDF].
  • CMS issues notice regarding Bundled Payments for Care Improvement Initiative applications

    On August 25, 2011, CMS posted in the Federal Register a notice requesting applications for the Bundled Payments for Care Improvement initiative. This initiative has been established to explore "episode-based payment for acute care and associated post-acute care, using both retrospective and prospective bundled payment methods." Letters of intent are due by Sept. 22 for Model 1, and by Nov. 4 for Models 2 through 4. Click here to access the notice [PDF].

  • Summary of Benefits and Coverage guidance issued by CMS

    On August 22, 2011, HHS, IRS, and EBSA jointly published in the Federal Register new guidance related to disclosure of summary of benefits and coverage information for group health plans and health insurance coverage in the group and individual markets pursuant to PPACA. Comments on this rulemaking are due by Oct. 21, 2011. The Federal Register version of this proposed rule can be accessed by clicking here [PDF]. In addition to the proposed rule, further related guidance has been released by EBSA. Such guidance includes a Summary of Benefits and Coverage (SBC) template, a sample completed SBC, instructions for SBC completion for both group health plans and individual health insurance coverage, a guide for coverage examples calculations, a glossary, and "Why this matters" guidance. These items may be found on the EBSA website.

  • IRS issues guidance on annual fee for branded prescription drug manufacturing and importing

    On August 15, 2011, the IRS issued new guidance related to provisions of PPACA enacting an annual fee for entities engaged in the manufacturing or importing of branded prescription drugs. The new guidance was issued in the form of both temporary regulations and a proposed rule. Both rulemakings are slated for publication in the Federal Register on August 18, 2011. Comments on the proposed rule and requests for public hearing are due within 90 days of publication in the Federal Register. For further information, please see the proposed rule and temporary regulations respectively here and here.

  • Agencies release second round of "Affordable Insurance Exchange" guidance

    On August 12, 2011, several rulemakings were released related to the insurance exchange program enacted under PPACA. The first of these is an HHS proposed rule on exchange functions in the individual market, eligibility rules, and standards for employer participation in the SHOP program for small businesses. CMS also released a proposed rule implementing PPACA provisions related to Medicaid eligibility, aiming to promote better coordination of Medicaid and CHIP with the insurance exchange program. Finally, an IRS proposed rule lays out requirements related to the premium tax credit available to individuals participating in the exchange program. Comments on all three rulemakings are due within 75 days of publication in the Federal Register, slated for August 17, 2011. These three rulemakings can be found respectively on the Public Inspection Desk here and here, and here. Concurrent with the new exchange guidance, HHS has also announced new recipients of its Exchange Establishment grants. Further information about this announcement is available here.

  • Preventive care guidance and rulemakings issued

    On August 1, 2011, new guidance and regulations related to preventive care, promulgated under PPACA, were issued by the responsible federal agencies. Specifically, the Internal Revenue Service (IRS), jointly with the Employee Benefits Security Administration (EBSA) and Health and Human Services Department (HHS), released an amendment to the interim final regulations implementing the rules for group health plans and health insurance issuers relating to coverage of preventive services under PPACA. This amendment was published in the Federal Register on August 3, 2011, with comments are due by September 30. This rulemaking can be accessed directly here. Along with this amendment, the IRS issued a separate notice of proposed rulemaking, adopting by cross reference the language of the above joint amendment. This notice of proposed rulemaking is likewise available here. Under the concurrent guidance issued by the Health Resources and Services Administration (HRSA), coverage for women's preventive services will be required of all new health plans, beginning August 1, 2012, at no additional cost to the patient. More information about the HRSA guidelines and PPACA's provisions on preventive care can be found here.

  • CCIIO announces grant opportunity

    The CMS Center for Consumer Information & Insurance Oversight (CCIIO) website has posted a link to the announcement of a grant opportunity available to participants in the Consumer Operated and Oriented Plan (CO-OP) program. The CO-OP program is designed to increase competition in the insurance market by encouraging the creation of private, non-profit consumer-based health insurance plans. Click here for further information about the grant and the application process. Voluntary letters of intent to apply for funding are requested as soon as possible, and first round applications are due October 17, 2011.

  • OMB receives interim rule on preventive services for review

    On July 28, 2011, OMB received for regulatory review a CMS interim final rule on preventive services under PPACA. Further information can be found here.
  • PPACA-related information collection requests issued by CMS

    Two information collection requests were published in the July 29, 2011 Federal Register, both concerning aspects of PPACA.
    • The first has a number of components. First, it would extend reporting requirements for programs established under PPACA to provide consumer assistance in resolving problems related to health coverage. Second, it seeks to create a database to store and track consumer inquiries to the agency on health coverage issues. Third, it would revise the existing information collection related to cooperative agreements to support state-operated insurance exchange programs. Comments are due 30 days after publication in the Federal Register. The notice may be found online here.
    • The second concerns a nationwide survey of health insurers to better understand the effect of PPACA insurance market reforms on premiums and coverage for certain benefits. Comments are due in 30 days. It may be found here.
  • Corrections issued for interim final rules on group health plan internal claims and appeals and external review processes

    On July 26, 2011, corrections to interim final rules jointly issued by the Internal Revenue Service, Employee Benefits Security Administration, and Department of Health and Human Services were published in the Federal Register. The corrections can be accessed here.
  • OMB receives proposed rules from CMS for regulatory review

    On July 26, OMB received for review two additional proposed rules being promulgated under PPACA. The first proposed rule, concerning "Uniform Explanation of Benefits, Coverage Facts, and Standardized Definitions," addresses standards applicable to group health plans and health insurance issuers in providing coverage and benefits information, as well as sets forth standard definitions of terms used in policies. Further information may be found here. The second proposed rule addresses aspects of the "Affordable Insurance Exchanges," including provisions on individual eligibility requirements and standards for verification of employer-sponsored health coverage, employer appeals, and employer SHOP participation. Additional information is available here.
  • CMS issues proposed rule on Consumer Operated and Oriented Plans (CO-OP) program

    On July 20, 2011, the proposed rule on the CO-OP program was published in the Federal Register. This program involves the creation of private, non-profit consumer-based health insurance plans, designed to elevate competition in the insurance market. Comments are due by September 16, 2011. The proposed rule can be found in its entirety here.
  • CMS issues proposed rule revising payment systems for hospital outpatient care and ambulatory surgical centers and proposing other Medicare changes

    This CMS proposed rule was published in the July 18, 2011 issue of the Federal Register. In addition to payment system revisions, the proposed rule seeks to revise Hospital Outpatient Quality Reporting Program requirements, ASC Quality Reporting System Requirements, Hospital Inpatient Value-Based Purchasing Program provisions, Medicare Electronic Health Record Incentive Program requirements, exceptions to physician self-referral rules, and patient notification requirements. Comments are due August 30, 2011. This proposed rule can be accessed here.

  • Department of Health and Human Services releases Affordable Insurance Exchange proposed regulations

    A set of two proposed rules governing a host of requirements for implementation of Affordable Insurance Exchanges was released by the Department of Health & Human Services on July 11, 2011. The exchange program is a key component of the health law reforms promulgated under PPACA. Together, the new proposed rules provide guidance for the operation of the anticipated exchange program, which aims to create a competitive marketplace for information about and purchase of affordable private health insurance by individuals and small businesses. The exchange program is currently set to go into effect on January 1, 2014. The proposed regulations separately address a number of issues regarding program requirements and implementation:

    • The first proposed rule sets forth core federal standards for creation and operation of exchanges on a state-by-state basis. In addition, the proposed rule addresses requirements for employer participation in the Small Business Health Options Program (SHOP) and establishes certification requirements for health plan participation in the exchange program. As a general matter, the proposed rule aims to promote flexibility for states in choosing how to design and implement exchange programs under the regulations. Comments are due 75 days after publication in the Federal Register, which is slated for July 15. Click here to view the proposed rule online.
    • The second proposed rule focuses on premium rate stabilization and sets forth standards for both states and health plans for achieving this goal. Specifically, the proposed state-based reinsurance program is designed to adjust for uncertain risks by making payments in the individual market where costs are particularly high. In addition, a temporary federal risk corridor program aims to limit both issuer losses and gains. Finally, a state-based risk adjustment program will make payment to health insurers with especially high-risk beneficiaries. Comments on this proposed rule are also due 75 days after publication in the Federal Register, set for July 15. Click here to view the proposed rule online.
  • CMS issues proposed rule revising policy on clinical diagnostic laboratory tests

    On June 29, 2011, the Centers for Medicare & Medicaid Services released a proposed rule retracting earlier policy under the Medicare 2011 Physician Fee Schedule final rule. Under the new proposed rule, a signature from a physician or qualified non-physician practitioner is no longer required for requisition for clinical diagnostic laboratory tests paid under the Clinical Laboratory Fee Schedule. Comments on the proposed rule are due 60 days from the date of issuance. Click here to access the proposed rule [PDF].

  • HHS issues notice of availability of proposed data collection standards for race, ethnicity, primary language, sex, and disability status

    On June 29, 2011, the Department of Health and Human Services (HHS) issued a notice pursuant to the Affordable Care Act proposing new draft standards for HHS data collections. According to a concurrently issued press release, the new standards will aid the Department in better understanding health disparities across various characteristics. Comments on the notice are due August 1, 2011. Click here to access the notice [PDF].

  • Amendment to 2010 interim final rule on internal claims and appeals and external review processes under Affordable Care Act issued

    On June 22, 2011, the Internal Revenue Service (IRS), Employee Benefits Security Administration (EBSA), and Department of Health and Human Services (HHS) jointly issued an amendment to a 2010 interim final rule on appeals procedures under the Affordable Care Act. The amendments to the 2010 regulations under the new interim rule address:
    • Expedited notification of benefit determinations involving urgent care;
    • Notice requirements for internal claims and appeals;
    • Deemed exhaustion of internal claims and appeals processes;
    • Form and manner of notice for internal claims and appeals;
    • The duration of the transition period for State external review processes;
    • Scope of the Federal External Review Process;
    • Clarification regarding requirement that external review decision be binding; and
    • Other technical guidance.
    In light of the amendment, additional technical guidance has been published by the involved agencies. The amendment was published in the June 24, 2011 issue of the Federal Register, click here to access [PDF]. Comments are due by July 25, 2011.
  • CMS issues proposed rule on Conditions of Participation for Community Mental Health Centers

    On June 16, 2011, the Centers for Medicare & Medicaid Services released a proposed rule setting forth conditions of participation (CoPs) for Community Mental Health Centers (CMHCs). The CoPs will consist of health and safety standards designed to better ensure quality of care for Medicare beneficiaries receiving health services at CMHCs. In the past, no such conditions of Medicare participation have been required by the agency for CMHCs. The proposed standards specifically address areas including "(1) personnel qualifications; (2) client rights; (3) admission, initial evaluation, comprehensive assessment, and discharge or transfer of the client; (4) treatment team, active treatment plan, and coordination of services; (5) quality assessment and performance improvement; and (6) organization, governance, administration of services, and partial hospitalization services." Comments on the proposed rule are due by Aug. 16, 2011. For more information, click to access the proposed rule [PDF].

  • CMS extends deadline on Pioneer Accountable Care Organization Model applications

    The Centers for Medicare & Medicaid Services has issued a notice extending the deadline for submission of Pioneer Accountable Care Organization (ACO) Model applications to August 19, 2011.& In addition, letters of intent are now due June 30, 2011. Click here for the notice [PDF].

  • New accountable care model information from CMS

    CMS has announced details on two new "accountable care organization" approaches under the Medicare program.

    -- First, the CMS Innovation Center is now accepting applications for the "Pioneer ACO Model," which will provide a faster path for mature ACOs that have already begun coordinating care for patients. Organizations interested in applying to the Pioneer ACO Model must submit a letter of intent on or before June 10, 2011. Applications must be received on or before July 18, 2011. The Pioneer ACO Request for Application, the Letter of Intent form and the Application form may be accessed at http://innovations.cms.gov/areas-of-focus/seamless-and-coordinated-care-models/pioneer-aco. The Innovation Center will hold an Open Door Forum to review the Pioneer ACO Model Request for Application on June 7, 2011.

    The Pioneer ACO Model is designed for health care organizations and providers that are already experienced in coordinating care for patients across care settings. It will allow these provider groups to move more rapidly from a shared savings payment model to a population-based payment model on a track consistent with, but separate from, the Medicare Shared Savings Program. The government says it is designed to work in coordination with private payers by aligning provider incentives, which will improve quality and health outcomes for patients across the ACO, and achieve cost savings for Medicare, employers and patients.

    The payment models being tested in the first two years of the Pioneer ACO Model are a shared savings payment policy with generally higher levels of shared savings and risk for Pioneer ACOs than levels currently proposed in the Medicare Shared Savings Program. In year three of the program, participating ACOs that have shown a specified level of savings over the first two years will be eligible to move a substantial portion of their payments to a population-based model.

    Pioneer ACOs will be expected to improve the health and experience of care for individuals, improve the health of populations, and reduce the rate of growth in health care spending. Participating ACOs will be held financially accountable for the care provided to their aligned beneficiaries. In addition, CMS will publicly report the performance of Pioneer ACOs on quality metrics, including patient experience ratings, on its website.

    -- Second, the CMS Innovation Center is seeking public comments on whether it should offer an Advance Payment Initiative that would allow certain ACOs participating in the Medicare Shared Savings Program access to a portion of their shared savings up front, helping providers make the infrastructure and staff investments crucial to successful ACOs. The advance payment would be made in the form of a monthly payment for each aligned Medicare beneficiary. Advance payments would be recouped through the ACOs' earned shared savings. ACOs would need to provide a plan for using these funds to build care coordination capabilities, and meet other organizational criteria.Public comments are sought by June 17th, 2011.

    More information about the Advance Payment ACO Model can be found at: http://innovations.cms.gov/areas-of-focus/seamless-and-coordinated-care-models/advance-payment/. The Innovation Center will accept comments on the Advance Payment ACO Model, if submitted prior to June 17, 2011. Comments should be submitted via email to: advpayACO@cms.hhs.gov.

    CMS will also be offering ACO Accelerated Development Learning Sessions to provide the executive leadership teams from existing or emerging ACO entities the opportunity to learn about essential ACO functions and ways to build capacity needed to achieve better care, better health and lower costs through integrated care models. Four sessions will be offered in 2011. Each will include a focused curriculum on core competencies for ACO development, such as improving care delivery to increase quality and reduce costs; effectively using health information technology and data resources; and building capacity to assume and manage financial risk. Additionally, the Accelerated Development Learning Sessions will not discuss elements of or specific requirements for participation in any CMS ACO program, including the Medicare Shared Savings Program.

    Individuals wishing to attend the June Accelerated Development Learning Session in person may register at https://acoregister.rti.org.

  • CMS Rules on Premium Increases (May 19, 2011) – HHS has issued a final rule requiring independent review at the state level for proposed premium rate increases of 10 percent or more for individual and small group health insurance plans. HHS will serve in a backup role in states that don't have the resources or authority to review rates. Starting September 2012, the 10-percent threshold will be replaced by state-specific thresholds that reflect the insurance and health care cost trends in each state. The final rule clarifies that HHS will work with states in developing these thresholds. The rule requires insurance companies to provide consumers with information about the reasons for certain rate increases and post the justification for those hikes on their website as well as on the HHS Affordable Care Act website. The regulation issued today finalizes proposed rules issued in December 2010. The final rule has several additions to the proposed rule, including a requirement that states provide an opportunity for public input in the evaluation of rate increases subject to review. HHS is also requesting comment from the public on applying the rule to individual and small group coverage sold through associations.

  • CCIIO Technical Guidance: Deadline for Submission of 2011 First Quarter MLR Data by Issuers of "Mini-med" and Expatriate Plans (May, 19, 2011)

  • CCIIO Technical Guidance: Submission of 2011 Quarterly Reports of MLR Data by Issuers of "Mini-med" and Expatriate Plans (April 26, 2011)

  • Accountable Care Organizations Regulations, Centers for Medicare & Medicaid Services, HHS (March 31, 2011) – CMS has issued the long-awaited proposed Accountable Care Organizations (ACO) regulations implementing section 3022 of the Affordable Care Act, which contains provisions relating to Medicare payments to providers of services and suppliers participating in ACOs. Under these provisions, providers of services and suppliers can continue to receive traditional Medicare fee-for-service payments under Parts A and B while being eligible for additional payments based on meeting specified quality care and financial savings requirements. Comments on the proposed regulations are due 60 days from the publication of the regulations in the Federal Register, which is currently slated for April 7, 2011.

    Several other Federal agencies have also released content related to the ACO regulations:
    • CMS and HHS OIG jointly issued a notice with comment period outlining proposals for waivers of the Stark law, the anti-kickback statute, and certain provisions of the civil monetary penalty law in connection with the Medicare Shared Savings Program. The joint notice is available here.
    • The FTC and the DOJ jointly issued a "Proposed Statement of Enforcement Policy Regarding Accountable Care Organizations Participating in the Medicare Shared Savings Program." This statement is available here.
    • The IRS issued a notice requesting comments regarding the need for guidance on participation by tax-exempt organizations in the Medicare Shared Savings Program through ACOs. The IRS notice is available here.

    Lastly, CMS has provided several fact sheets related to ACOs that can be accessed here.

  • IRS Issues Guidance on Mandatory Form W-2 Informational Reporting of Employer-Sponsored Health Coverage
    On March 29, 2011, the IRS issued Notice 2011-28 , which provides interim guidance to employers regarding the new Form W-2 reporting requirement for employer-sponsored group health coverage. This requirement was added to the Internal Revenue Code by last year's health reform legislation, the Patient Protection and Affordable Care Act of 2010, Pub. L. No. 111-149. The IRS has requested comments, which are due by June 27, 2010, on this interim guidance. Click here for more.

  • Consumer Disclosure Notices of Proposed Health Insurance Rate Increases, Department of Health & Human Services (March 7, 2011) – HHS has published proposed consumer disclosure notices that insurers would be required to complete when proposing rate increases of more than 10 percent. The disclosure notices then would be published on the Health and Human Services Department website while insurers' proposed increases are reviewed. HHS published its notice of information collection request for the rate increase disclosures in the March 1, 2011 Federal Register.

  • Student Health Insurance Coverage, Centers for Medicare & Medicaid Services, HHS (Feb. 11, 2011) – This proposed rule seeks to extend key consumer protections under the Patient Protection and Affordable Care Act, as amended, to students enrolled in student health plans by clarifying that "student health insurance coverage" would be defined as "as a type of individual health insurance coverage," but, pursuant to section 1560(c) of the Affordable Care Act, certain Public Health Service Act and PPACA requirements would be inapplicable to this type of individual health insurance coverage. Section 1560(c) states:
    [N]othing in this title (or an amendment made by this title) shall be construed to prohibit an institution of higher education (as such term is defined for purposes of the Higher Education Act of 1965) from offering a student health insurance plan, to the extent that such requirement is otherwise permitted under applicable Federal, State, or local law.
    For example, the proposed rule would ultimately prohibit lifetime limits on coverage, but issuers of student health insurance coverage would be provided a slightly different transition period from the transition period provided in the interim regulations prohibiting annual and lifetime limits that were issued on June 28, 2010. HHS officials are seeking comments on what provisions of PPACA may be found inapplicable pursuant to section 1560(c), such as provisions governing the choice of medical providers and the application of the new medical loss ratio rules.

    Comments are due by April 12, 2011. This proposed rule would apply to policy years beginning on or after January 1, 2012.
  • Planning and Establishment of Consumer Operated and Oriented Plan Program; Request for Comments Regarding Provisions of Consumer Operated and Oriented Plan Program, Office of Consumer Information and Insurance Oversight (Feb 2, 2011) - HHS's OCCIO requests comments regarding regulatory implementation of section 1322 of PPACA prior to rulemaking. Section 1322 of PPACA requires the Secretary to establish the Consumer Operated and Oriented Plan (CO-OP) program to foster the creation of "qualified nonprofit health insurance issuers" that will offer qualified health plans in the individual and small group markets. Under the CO-OP program, the Secretary will make loans to assist in funding start-up costs for qualified nonprofit issuers and will award grants to assist such issuers in meeting State solvency requirements. Comments are due by March 4, 2011.

  • HHS publishes mini-med plan waivers. The Office of Consumer Information and Insurance Oversight has posted a summary and list of waivers it has granted through January 26, 2011 for mini-med health plans that do not provide the scope of coverage required under PPACA's three year phase out of mini-med plans. By 2014, health plans will be required to phase out annual dollar limits on benefits.

  • Delay of PPACA Nondiscrimination Provisions Applicable to Insured Group Health Plans, IRS (Jan. 10, 2011) – PPACA, as amended, establishes certain nondiscrimination rules that prohibit insured group health plans, in part, from discriminating in favor of highly compensated individuals. The IRS issued Notice 2011-1 (Notice) in order to delay the application of PPACA's nondiscrimination rules to insured group health plans until further guidance is issued at an unspecified later date. Specifically, the Notice states that the Treasury Department and the IRS, as well as the Departments of Labor and Health and Human Services, have determined that compliance with these requirements should not be required (and thus, any sanctions for failure to comply do not apply) until after regulations or other administrative guidance of general applicability have been issued.

    The Notice also solicits public comment on numerous issues, including what information should be included in future guidance on the topic. Comments are due no later than March 11, 2011.