Source: https://www.crowell.com/Practices/Health-Care/Health-Care-Reform-Law-Regulatory-Resources/Regulatory-Actions-2012
Timestamp: 2018-02-23 00:10:06
Document Index: 376309619

Matched Legal Cases: ['§ 1322', '§ 1322', '§ 132', '§ 1322', '§ 156', '§ 1602']

Regulatory Actions 2012 | Crowell & Moring LLP
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Regulatory Actions 2012
Consumer Operated and Oriented Plan (CO-OP) Funding Slashed by Fiscal Cliff Legislation
Section 644 of the American Taxpayer Relief Act of 2012 ("ATRA," more commonly referred to as the recently enacted "fiscal cliff" legislation), makes changes to section 1322 of the Affordable Care Act (ACA § 1322). ACA § 1322 directed the Secretary of Health and Human Services to establish a Consumer Operated and Oriented Plan (CO-OP) in each state as an alternative to for-profit insurance carriers in individual and small group markets. CO-OPs must reinvest any profits or government funding to reduce premiums, expand enrollment, or increase benefits. Additionally, CO-OP members select their board of directors from among their enrolled membership.
ATRA Section 644, which was enacted "to provide assistance and oversight to qualified nonprofit health insurance issuers that have been awarded loans or grants under section 1332," directs the Secretary of Health and Human Services to establish a fund for the CO-OPs. Section 644 then upholds the funds already allocated under ACA § 132, but otherwise rescinds 90% of ACA § 1322's unobligated funds. Originally, Congress had appropriated $6 billion for the CO-OP program, but later reduced that amount to $3.8 billion. CMS has awarded more than $2 billion in loans to CO-OPs in twenty-four (24) states. But some estimate that many CO-OPs will default on planning or solvency loans. Now, as a result of ATRA, more than $1.4 billion in additional funding has been cut.
CMS Releases HHS Risk Adjustment Model Algorithm Instructions
The Centers for Medicare and Medicaid Services (CMS) released the HHS Risk Adjustment Model Algorithm Instructions, which is intended as a supplement to the draft HHS notice of benefit and payment parameters published on December 7, 2012. Section 1342 of the Affordable Care Act provides for permanent risk adjustment programs to transfer funds from plans with relatively lower-risk enrollees to plans with relatively higher-risk enrollees. This new draft provides HHS risk adjustment model instructions for benefit year 2014. The plan would: calculate a plan average risk score for each covered plan based upon the relative risk of the plan's enrollees, and apply a payment transfer formula in order to determine risk adjustment payments and charges between plans within a risk pool within a market within a state. The proposed risk adjustment addresses (1) the newly insured population, (2) plan metal level differences and permissible rating variation, and (3) the need for risk adjustment transfers that net to zero. The draft provides the algorithm used to develop and calculate risk scores. Click here for the draft.
Summary of Treasury, IRS Proposed Regulations Regarding Employer Shared Responsibility Requirement
On December 28, 2012, the Department of the Treasury and the Internal Revenue Service (collectively, the "Service") issued a proposed rule ("Proposed Rule") regarding the employer shared responsibility provisions – the so-called "pay or play" provisions – set forth in section 4980H of the Internal Revenue Code of 1986, as amended ("Code"). Read more.
OPM Releases Proposed Rule on Establishment of Multi-State Plan Program for Affordable Insurance Exchanges
The Office of Personnel Management (OPM) published in the December 5, 2012 Federal Register a proposed rule that would implement the Multi-State Plan Program (MSPP). Section 1334 of the Affordable Care Act (ACA) creates the MSPP to foster competition among plans competing in the individual and small group health insurance markets on the Affordable Insurance Exchanges on the basis of price, quality, and benefit delivery. The ACA directs OPM to contract with private health insurance issuers to offer at least two multi-state plans on each of the Exchanges in the 50 states and the District of Columbia. Comments with respect to the proposed rule are due on or before January 4, 2013. The first open enrollment period for MSPP plans begins on October 1, 2013 for coverage starting in January 2014. Click here to read our summary of the rule.
IRS Releases Guidance on Branded Prescription Drug Fee for 2013 Fee Year
On November 29, 2012, the IRS released Notice 2012-74, which provides guidance with respect to the branded prescription drug fee for the 2013 fee year. The branded prescription drug fee, which is imposed by section 9008 of the Affordable Care Act, is an annual fee on covered entities engaged in the business of manufacturing or importing branded prescription drugs. The Notice focuses on (1) the submission of Form 8947, "Report of Branded Prescription Drug Information," (2) the time and manner for notifying covered entities of their preliminary fee calculation, (3) the time and manner for submitting error reports for the dispute resolution process, and (4) the time for notifying covered entities of their final fee calculation. Please click here for the text of the Notice.
CMS Issues Proposed Rules on Rate Review, Risk Pools, Guaranteed Availability and Renewability, and Fair Premiums Under Patient Protection and Affordable Care Act (Comments due by Dec. 26, 2012)
The Centers for Medicare and Medicaid Services (CMS) published in the Federal Register on Monday, November 26, 2012 a notice of proposed rulemaking (NPRM) seeking comments on, inter alia, the implementation of the Patient Protection and Affordable Care Act's (PPACA) policies related to guaranteed availability, guaranteed renewability, rate review, single risk pools, and fair health insurance premiums. Click here to read our summary of the rule.
CMS requests quality management information for Exchanges
The Centers for Medicare & Medicaid Services (CMS) on November 27, 2012 published a request for input on quality management for health plans operating under the new health insurance Exchanges. It is seeking information on existing quality measures and rating systems, strategies and requirements for quality improvement, purchasing strategies to promote care redesign and patient safety, and methodologies to measure health plan value. Responders are invited to make recommendations on the most effective ways to enhance and align the quality reporting and display requirements for Qualified Health Plans starting in 2016. Details can be found here.
On November 23, 2012, the United States Department of Health and Human Services (HHS) published a Federal Register notice announcing that the National Committee for Quality Assurance (NCQA) and URAC were recognized accrediting entities for purposes for fulfilling the accreditation requirement for certification of qualified health plans (QHPs).
Section 1311(c)(1)(D)(i) of the Patient Protection and Affordable Care Act (PPACA) requires health plans to be accredited by a recognized accrediting entity in order to be certified as QHPs and operate in the Affordable Insurance Exchanges, including the federally-facilitated and State Partnership Exchanges. The ACA requires all states to establish an Affordable Insurance Exchange on or before January 1, 2014. If a state does not establish an exchange or elects not to have an exchange approved by January 1, 2013, HHS will create and operate a federally-facilitated exchange within the state. An issuer must demonstrate that each plan offered on an Exchange is a QHP.
This notice follows HHS's final rule published July 20, 2012, titled "Patient Protection and Affordable Care Act; Data Collection to Support Standards Related to Essential Health Benefits; Recognition of Entities for the Accreditation of Qualified Health Plans." That rule finalized 45 C.F.R. § 156.275, "Patient Protection and Affordable Care Act; Establishment of Exchanges and Qualified Health Plans; Exchange Standards for Employers" (Exchange Rule), which set forth the requirements for recognition as an accrediting entity.
CMS Proposed Rule on Affordable Care Act Standards for Essential Health Benefits, Actuarial Value and Accreditation
The Patient Protection and Affordable Care Act (PPACA) requires all health plans offered through Health Insurance Exchanges (Exchanges) and small group and individual products offered outside of the Exchanges to offer a core package of items and services, known as essential health benefits, and to meet specified actuarial value levels. On November 20, 2012, the U.S. Department of Health and Human Services (HHS) issued a proposed rule for the purpose of clarifying and elaborating on the requirements for offering essential health benefits and for meeting actuarial value levels. The proposed rule also sets a timeline for qualified health plans (QHPs) to be accredited in the Exchanges and a process for recognition of additional accrediting entities for purposes of certifying QHPs. The comment period expires December 26, 2012. Click here to read our summary of the rule.
CMS issues guidance to states on new Medicaid benchmark benefit coverage options
In a November 20, 2012 letter to state Medicaid directors, CMS provides guidance on the use of Alternative Benefit Plans for the new eligibility group for low-income adults, the relationship between Alternative Benefits Plans and Essential Health Benefits, and the relationship of section 1937 of the Social Security Act, adopted in 2005, to other provisions of Medicaid law. Beginning in 2014, provisions of the Affordable Care Act will expand Medicaid eligibility for lower-income adults. The enactment of Section 1937 gave states greater flexibility in structuring Medicaid benefit packages, including the option to offer Alternative Benefit Plans, based on "benchmark", "benchmark-equivalent," or "Secretary-approved" plans. In addition, under the Affordable Care Act, Alternative Benefit Plans must include coverage of defined Essential Health Benefits in ten benefit categories consistent with HHS regulations. The new guidance outlines CMS's plans for implementing the new Essential Health Benefits requirements in the context of Medicaid Alternative Benefit Plans. The notice states that a new proposed regulation will be issued shortly. States may submit Medicaid Plan Amendments to the CMS beginning in 2013, and these amendments must address eligibility, services covered, and fee-for-service methodology for the proposed Alternative Benefit Plans. More information can be found here.
On November 20, 2012, the Department of the Treasury, the Department of Labor, and the Department of Health and Human Services (collectively, the "Departments") issued proposed regulations regarding nondiscriminatory wellness programs in group health coverage and reflecting changes made to wellness programs as part of the Patient Protection and Affordable Care Act (Affordable Care Act or ACA). Click here to read our summary of the rule.
OPM Releases Draft Multi-State Plan Program Application
On September 20, 2012, the Office of Personell Management (OPM) has released the draft Multi-State Plan Program Application for the purpose of soliciting comments from health issuers who wish to offer individual and small group coverage through Multi-State Plans (MSPs) made available on the Affordable Insurance Exchanges and from any other interested parties. Comments are due by October 22, 2012.
HHS Adopts Enforcement Safe Harbor for Certain Plan Determination Notices from Non-Federal Governmental Plans
On August 17, 2012, the Department of Health and Human Services (HHS) published a notice containing an enforcement safe harbor with respect to the content of the adverse benefit determinations and final internal adverse benefit determinations issued to participants and beneficiaries in group health plans that are non-federal governmental plans (and health insurance coverage offered in connection with such plans). Generally, ERISA plans, including non-federal governmental plans, must provide information in adverse benefit determinations and final internal adverse benefit determinations regarding, among other things, (i) the private right of action under ERISA section 502(a) and (ii) the services the EBSA provides to participants and beneficiaries. This requirement can lead to inaccurate disclosures for non-federal governmental plans because the ERISA private right of action is not available to participants or beneficiaries in these plans and the EBSA does not provide services to these participants or beneficiaries. For this reason, HHS has announced that it will not enforce the requirements that non-federal governmental plans provide notice of the ERISA private right of action or contact information for the EBSA or a State Department of Insurance. The HHS notice is available here.
HHS Publishes Interim Final Rule with Comment Period Regarding Operating Rules for Health Care Electronic Funds Transfers and Remittance Advice Transactions
On August 10, 2012, the Department of Health and Human Services (HHS) published an interim final rule with comment period implementing parts of section 1104 of the PPACA, which requires the adoption of operating rules for the health care electronic funds transfers (EFTs) and remittance advice transaction. The purpose of the interim rule is to cut down on the cost of billing and insurance related tasks by automating many of these tasks through the electronic transfer of information, including through electronic fund transfers. Secretary Sebelius has announced that this new rule will cut red tape for doctors, hospitals and health plans and, in combination with a previously issued regulation, save up to $9 billion over the next ten years. The interim final rule is available here.
DOL, HHS and Treasury Issue FAQ About Affordable Care Act Implementation Part X
On August 7, 2012, the Department of Labor (DOL) issued a new FAQ about Affordable Care Act implementation (FAQ Part X) jointly prepared by the Departments of Health and Human Services (HHS), labor and Treasury (together, the "Departments:) regarding implementation of the summary of benefits and coverage ("SBC") provisions of the PPACA. The FAQ clarifies that Medicare Advantage plans are Medicare benefits not subject to the SBC requirement and that the Departments will not take any enforcement action against a group health plan because it does not provide an SBC with respect to a Medicare Advantage benefit package. The FAQ is available here.
HHS Releases an Issue Brief on Access to Women's Preventive Services under the PPACA
On July 31, 2012, the Department of Health and Human Services (HHS) published an issue brief estimating that 47 million women will have guaranteed access to women's preventive services with zero cost-sharing under the PPACA. Generally, HHS guidelines requiring non-grandfathered health insurance plans to cover certain preventive services for women without cost sharing under the PPACA take effect for plan years beginning on or after August 1, 2012.
The issue brief breaks down the 47 million women who will have guaranteed access to services at no cost by state and racial group. The issue brief is available here.
HHS Issues Final Rule Establishing Data Collection Standards
On July 20, 2012, the Department of Health and Human Services (HHS) issued a final rule establishing data collection standards necessary to implement aspects of PPACA section 1302, which directs the HHS Secretary to define essential health benefits. The final rule outlines the data on applicable plans to be collected from certain issuers to support the definition of essential health benefits and establishes a process for the recognition of accrediting entities for purposes of certification of qualified health plans. The final rule can be found here.
CCIIO Technical Guidance (CCIIO 2012-0005); Questions and Answers Regarding the Medical Loss Ratio Reporting and Rebate Requirements
Treasury and IRS Publish Additional Non-Substantive Corrections to Final Regulations on the Health Insurance Premium Tax Credit
On July 13, 2012, the Department of the Treasury (Treasury) and the Internal Revenue Service (IRS) published additional minor, non-substantive corrections to the final regulations regarding the health insurance premium tax credit codified in section 36B of the Internal Revenue Code by the PPACA (as amended) that were originally published on May 23, 2012. These corrections are in addition to the non-substantive corrections made on July 12, 2012. The corrections are available here.
Treasury and IRS Publish Non-Substantive Corrections to Final Regulations on the Health Insurance Premium Tax Credit
On July 12, 2012, the Department of the Treasury (Treasury) and the Internal Revenue Service (IRS) published a few minor, non-substantive corrections to the final regulations regarding the health insurance premium tax credit codified in section 36B of the Internal Revenue Code by the PPACA (as amended) that were originally published on May 23, 2012. The corrections to the preamble to the final regulations are available here and the corrections to the final regulations themselves are available here.
CCIIO and CMS Issue Information to Facilitate States' Selection of Benchmark Plans to Establish Essential Health Benefits
On July 3, 2012, the Center for Consumer Information and Insurance Oversight (CCIIO) and the Centers for Medicare & Medicaid Services (CMS) issued a document that provides information to facilitate States' selection of the benchmark plans that would serve as the reference plans for the essential health benefits (EHB). It updates a prior publication released on January 25, 2012 and complements the bulletin on the EHB released on December 16, 2011. The document provides an updated list of the three largest small group insurance products ranked by enrollment for each State, as well as lists of the three largest nationally available Federal Employee Health Benefit Program plans, a benchmark option under the intended approach outlined in the bulletin. It also provides the single largest Federal Employees Dental and Vision Insurance Program dental and vision plans respectively, based on enrollment. The document is available here.
HHS Releases Bulletin on the Transitional Reinsurance Program
On May 31, 2012, the Department of Health and Human Services (HHS) released a bulletin titled "Bulletin on the Transitional Reinsurance Program: Proposed Payment Operations by the Department of Health and Human Services." Section 1341 of the PPACA provides that a transitional reinsurance program will be established in each State to help stabilize premiums for coverage in the individual market from 2014 through 2016. All health insurance issuers, and TPAs for self-insured group health plans, will be required to submit contributions to support reinsurance payments to issuers that cover high-cost individuals in non-grandfathered individual market plans.
The bulletin specifies the processes and timeframes HHS will employ to identify, calculate, and disburse reinsurance payments for the HHS-operated program. The bulletin is available here.
CCIIO Technical Guidance (CCIIO 2012-004); Questions and Answers Regarding the Medical Loss Ratio Reporting Requirements (May 30, 2012)
HHS Releases Non-Substantive Corrections to final Insurance Exchange Guidance
On May 29, 2012, the Department of Health and Human Services (HHS) published non-substantive technical and typographical corrections to the final insurance exchange guidance originally published on March 27, 2012. The corrections are effective as if included in the original final rule (i.e., they become effective on May 29, 2012). The corrections are available here.
CCIIO Technical Guidance (CCIIO 2012-003); Questions and Answers Regarding the Medical Loss Ratio Reporting Form
Treasury and IRS Issue Final Regulations on the Health Insurance Premium Tax Credit
On May 23, 2012, the Department of the Treasury (Treasury) and the Internal Revenue Service (IRS) issued final regulations on the health insurance premium tax credit enacted by the PPACA (as amended). The health insurance premium tax credit is codified in section 36B of the Internal Revenue Code, which provides a tax credit for certain individuals who purchase health insurance coverage through an Affordable Insurance Exchange (Exchange).
The final regulations provide guidance to individuals who enroll in qualified health plans through Exchanges and claim the premium tax credit, and to Exchanges that make qualified health plans available to individuals and employers. The final regulations are effective on May 23, 2012. They are available here.
Memo to Insurance Companies: Guidance for Medical Loss Ratio Notices of Rebates (May 15, 2012)
Memo to Insurance Companies: Guidance for Medical Loss Ratio Annual Reporting Form (May 15, 2012)
CCIIO Technical Guidance (CCIIO 2012-002); Questions and Answers Regarding the Medical Loss Ratio Interim Final Rule
Treasury and IRS Issue Proposed Regulations and Notice of Public Hearing Regarding the Disclosure of Return Information
On April 27, 2012, the Department of the Treasury (Treasury) and the Internal Revenue Service (IRS) issued proposed regulations and a notice of public hearing regarding the disclosure of return information under section 6103(l)(21) of the Internal Revenue Code, as enacted by PPACA (as amended). Section 6103(l)(21) permits the disclosure of return information to assist Exchanges in performing those functions set forth in PPACA section 1311 for which income verification is required (including determinations of eligibility for the insurance affordability programs described in PPACA), as well as to assist State agencies administering a State Medicaid program under title XIX of the Social Security Act, CHIP, or a basic health program under PPACA section 1331 (if applicable).
The proposed regulations define certain terms and describe certain additional items of return information that will be provided, upon written request, in addition to those items specifically prescribed by statute under Code section 6103(l)(21). Comments on the proposed regulations are due by July 30, 2012. A public hearing has been scheduled for August 31, 2012. The proposed rules and notice of public hearing are available here.
CCIIO issues additional MLR guidance
On April 20, 2012, the Center for Consumer Information & Insurance Oversight (CCIIO) issued a new set of questions and answers (Q&As) on medical loss ratio (MLR) requirements under PPACA. Among other things, the Q&A clarifies that exchange user fees paid to a State or Federal Exchange are to be included in licensing and regulatory fees subtracted from the premium for the purpose of MLR calculations. In addition, the Q&A provides guidance related to specific plan types, small employer groups, the method for counting employees, "premium holidays," reinsurance and reporting requirements, the effect of state MLR requirements, mini-med policies, and rebates. For further information, you may access the new guidance here.
CCIIO Technical Guidance (CCIIO 2012-002); Questions and Answers Regarding the Medical Loss Ratio Regulation
IRS Issues Proposed Regulations Relating to the PPACA PCORI Fee
On April 17, 2012, the Internal Revenue Service (IRS) issued proposed regulations relating to what is commonly referred to as the PCORI fee. Section 6301(a) of the PPACA amended section 1181(b) of the Social Security Act to authorize the establishment of the Patient-Centered Outcomes Research Institute (PCORI), an institute designed to advance research and evidence synthesis to increase the quality and relevance of evidence concerning the manner in which diseases, disorders and other health conditions can effectively and appropriately be prevented, diagnosed, treated, monitored and managed. PCORI is funded in part by fees assessed on the issuers of certain health insurance policies and plan sponsors of certain self-insured health plans.
The proposed regulations implement and provide guidance on the PCORI fee. Comments on the proposed regulations should be submitted by July 16, 2012. The IRS will hold a public hearing on the proposed regulations on August 8, 2012. The proposed regulations are available here.
HHS Issues Proposed Rule to Streamline Health Care Administrative Transactions
On April 17, 2012, the U.S. Department of Health and Human Services (HHS) issued a proposed rule establishing new requirements for administrative transactions that would improve the utility of the existing HIPAA standards for electronic health care transactions and reduce administrative burden and costs. The proposed rule is the third in a series of regulations under PPACA section 1104, which requires HHS to issue a series of regulations over five years that are designed to streamline health care administrative transactions, encourage greater use of standards by health care providers, and make existing standards work more efficiently.
Providers for the adoption of a standard for a national unique health plan identifier (HPID) that would be used to identify health plans in covered transactions;
Providers for the adoption of an "other entity" identifier (OEID) to be used for entities that are not health plans, health care providers, or "individuals," that need to be identified in standard transactions;
Specifies the circumstances under which an organization covered health care provider must require certain noncovered individual health care providers who are prescribers to obtain and disclose a National Provider Identifier (NPI); and
Proposes to change the compliance date for the International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) for diagnosis coding, including the Official ICD–10–CM Guidelines for Coding and Reporting, and the International Classification of Diseases, 10th Revision, Procedure Coding System (ICD–10–PCS) for inpatient hospital procedure coding, including the Official ICD–10–PCS Guidelines for Coding and Reporting, from October 1, 2013 to October 1, 2014.
The proposed rule is available here. Comments are due by May 17, 2012. An HHS fact sheet is available here.
CMS issues Medicare Advantage and Medicare Prescription Drug Benefits Program guidance
On April 12, 2012, the Centers for Medicare & Medicaid Services issued new regulations, appearing in the Federal Register, implementing changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs. The new regulations, issued as a final rule with comment period, specifically "implement new statutory requirements; strengthen beneficiary protections; exclude plan participants that perform poorly; improve program efficiencies; and clarify program requirements." The new provisions address a range of issues, including:
the Coverage gap discount program;
Transparency requirements for entities providing pharmacy benefits management services;
Filing of Part D appeals with the Independent Review Entity;
Plan performance ratings;
Additional benefits for fully-integrated dual eligible special needs plans;
Clarification of durable medical equipment coverage limits;
Use of daily cost-sharing rates in drug utilization management and fraud, abuse, and waste control programs; and
Use of National Provider Identifier and standardized technology for accessing covered Part D drugs.
The regulations also address concerns with pharmacy-related conditions of participation for long-term care facilities. The new regulations largely will enter into effect on June 1, 2012. Because CMS has invited comment on specified issues, comments on those issues will be accepted through June 11, 2012. Click here to access the new guidance [PDF].
On Monday, April 2, 2012, the U.S. Office of Personnel Management ("OMB") published in the Federal Register final regulations which amend existing Federal Employees Health Benefits (FEHB) and the Federal Employees Health Benefits Acquisition Regulation (FEHBAR) provisions related to premium rate-setting methods for community rated plans. With "minor changes" to a June 29, 2011 interim final rule, see 76 Fed. Reg. 38282, the new regulations replace the prior similarly sized subscriber group (SSSG) rate-setting method with a medical loss ratio (MLR) calculation.
The updated MLR requirements impose obligations on all community-rated plans, except those subject to "traditional" community rating requirements under state law. The revised MLR regulations, like those embodied in the Patient Protection and Affordable Care Act (PPACA), are designed to offer "a more modern and transparent calculation while still ensuring that the FEHB Program is receiving a fair rate." In addition, OPM anticipates that the MLR requirement "will result in a more streamlined process for plans and increased competition and plan choice for enrollees."
The new regulations specifically provide that OPM will issue a separate credibility adjustment, apart from that defined by the U.S. Department of Health & Human Services (HHS). See 48 C.F.R. § 1602.170-14(c).
OPM declined to permit plans making MLR rebates under the PPACA health reform law to include any rebate required under that law for the FEHBP to be included as a reduction in premium under the FEHBP-specific MLR calculation. It also declined to permit plans to determine FEHBP MLR results based on a composite of multiple years' experience. OPM will expect plans to follow CMS guidelines for determining how to treat expenditures under the FEHBP MLR rule.
Memo to Insurance Companies: Medical Loss Ratio Annual Reporting Procedures (March 20, 2012)
HHS releases set of PPACA guidance
On March 16, 2012, the Department of Health & Human Services (HHS) released several rulemakings finalizing regulations on several issues under PPACA. The rulemakings include:
Final rule on PPACA reinsurance, risk corridor, and risk adjustment standards: These regulations adopt final standards devised to mitigate adverse selection and to promote premium stabilization, as the new Insurance Exchange program begins implementation. Published in the Federal Register on March 23, 2012, the regulations are slated to go into effect on May 22, 2012.
Final rule and interim final rules on Medicaid eligibility changes: This rulemaking imposes new and revised policy and procedural requirements related to eligibility, enrollment, renewals, public availability of program information, and coordination in the Medicaid and CHIP programs, pursuant to PPACA. Also published in the Federal Register on March 23, 2012, the rule's provisions will go into effect on January 1, 2014. Because some of the rulemaking's provisions were issued as interim rules, comments are being accepted. The deadline for comment submission is May 7, 2012.
Final rules on student health insurance coverage under PPACA: This rulemaking contains final regulations pertaining to student health insurance coverage, based on provisions enacted as part of PPACA. These regulations were also published in the Federal Register on March 21, 2012, and it's provisions will go into effect on April 20, 2012.
Advance NPRM on PPACA preventive service regulations: This rulemaking, published in the Federal Register on March 21, 2012, provides an outline for the current Administration's approach to dealing with questions related to women's preventive service coverage in forthcoming amendments to existing regulations under PPACA on the same issue. Specifically, the Advance NPRM addresses the issue of coverage "sponsored or arranged by a religious organization that objects to the coverage of contraceptive services for religious reasons and that is not exempt" under regulations previously issued. The Advance NPRM includes a request for comments, with a comment deadline of June 19, 2012.
Notice on Early Retiree Reinsurance Program (ERRP): This notice, also published in the Federal Register on March 21, 2012, serves as an announcement of the timeline for use of reimbursement funds by plan sponsors participating in the ERRP. Specifically, the notice establishes a December 31, 2014 deadline for such reimbursement fund use.
HHS releases final Insurance Exchange guidance
On March 12, 2012, the Department of Health and Human Services released the anticipated final rule on insurance exchange establishment and standards for plan, individual, and employer participation. The new regulations will go into effect 60 days after publication in the Federal Register, slated for March 27, 2012. Because some of the provisions are being issued as interim final rules, comments will be accepted until 45 days after publication. Click here for the rulemaking [PDF]. In addition, click here for fact sheet describing the new rulemaking.
CMS issues Electronic Health Record (EHR) Incentive Program NPRM
On February 23, 2012, the Centers for Medicare & Medicaid Services (CMS) issued an NPRM containing Stage 2 criteria for participation in the EHR Incentive Program. Comments on this proposed rule will be due 60 days after publication in the Federal Register, slated for March 7, 2012.
EBSA releases proposed extension of information collection related to Internal Claims and Appeals and External Review Procedures
On February 22, 2012, the Employee Benefits Security Administration (EBSA) released a notice regarding information collection related to PPACA provisions on internal claims and appeals and external review procedures for non-grandfathered plans. The notice requests comments with respect to the proposed information collection's relationship to prior amendments (1) providing that plans are not required to include diagnosis and treatment codes on notices of adverse benefit determination and final internal adverse benefit notification, and (2) changing the method for determining who is eligible to receive a notice in a culturally and linguistically appropriate manner. Comments will be accepted through April 23. Click here to access the notice.
Agencies release new guidance on PPACA provisions
Two rulemakings released on February 22, 2012 aim at providing more transparency and assistance in carrying out various of the provisions under PPACA. First, the Centers for Medicare & Medicaid Services (CMS) has issued a final rule on the review and appeal process for Section 1115 Medicaid program demonstrations. The resulting regulations impose requirements designed to ensure transparency and public notice in the demonstration process. Second, the Treasury Department and Department of Health and Human Services have jointly issued regulations on the application, review, and reporting process for seeking waivers for state innovation. These regulations, which go into effect on April 27, 2012, can be accessed by clicking here [PDF]. Further information on both of these rulemakings, as well as a discussion on the new round of Affordable Insurance Exchange Establishment Grants, can be found in a CMS press release.
New guidance issued on Essential Health Benefits
On February 17, 2012, the Department of Health and Human Services released additional guidance on its website related to PPACA provisions on Essential Health Benefits (EHB). This guidance includes a new FAQ, which supplements prior guidance on the Centers for Medicare & Medicaid Services' likely approach to defining EHB in forthcoming regulatory actions. Click here for the new guidance [PDF].
Agencies issue final rules related to women's preventive services coverage
On February 15, 2012, the U.S. Department of Health & Human Services, the Internal Revenue Service, and the Employee Benefits Security Administration collectively published final rules on women's preventive services in the Federal Register. These rules finalized earlier issued interim regulations on the exemption for religious employers from contraceptive services coverage requirements and create a temporary enforcement safe harbor, during which the agencies will consider changes to the regulations. Click here to access this rulemaking [PDF].
HHS issues proposed rules on the National Practitioner Data Bank
On February 15, 2012, new rules revising existing regulations were published in the Federal Register. Promulgated under section 6403 of PPACA, the new rules would consolidate regulations on the collection and disclosure of all relevant data banks in one CFR part. Comments on this NPRM are due on April 16, 2012. Click here to directly access the proposed rules [PDF].
Agencies issue Summary of Benefits and Coverage guidance
On February 14, 2012, long anticipated guidance on the Summary of Benefits and Coverage (SBC), required under PPACA, was published in the Federal Register. The guidance includes two rulemakings:
Final SBC rule
Additional guidance, including final templates, instructions, and related materials, as referenced in the Federal Register notice, is available at www.dol.gov/ebsa/healthreform. For a summary and more information on this guidance, you may also visit HHS.gov, which contains an HHS news release on the rulemaking.
CMS issues proposed rule on reporting and returning of Medicare overpayments
On February 14, 2012, the Centers for Medicare & Medicaid Services released a new notice of proposed rulemaking on the reporting and return of Medicare overpayments, issued under section 6402(d) of PPACA. The new rules would require such reporting and return by the later of 60 days after identification of the overpayment, or the due date of any corresponding cost report. Comments will be due by April 17, 2012. Click here to access the NPRM [PDF].
CCIIO Technical Guidance (CCIIO 2012-001); Questions and Answers Regarding the Medical Loss Ratio Interim Final Rule
IRS issues guidance on automatic enrollment, employer shared responsibility, and waiting periods
On February 9, 2012, the Internal Revenue Service (IRS) released new guidance on automatic enrollment, employer shared responsibility, and waiting periods under provisions of the PPACA health reform law. This guidance, issued in the form of an FAQ as Notice 2012-17, addresses these three issues, as well as the different approaches under consideration for future related regulatory actions. Click here to access the IRS notice [PDF]. You may also visit the Department of Labor website for substantially identical guidance.
IRS temporary regulations and NPRM to affect insurance issuers participating in CO-OP program
On February 7, 2012, the Internal Revenue Service (IRS) published temporary regulations authorizing the IRS to prescribe certain procedures were published in the Federal Register. Specifically, the temporary regulations allow the IRS to prescribe procedures for recognizing exemptions from Federal income tax with an effect on qualified nonprofit health insurance issuers participating in the Consumer Operated and Oriented Plan (CO-OP) program, created by PPACA. The temporary regulations can currently be found in the Federal Register [PDF]. In addition, an NPRM, with comments due April 9, 2012, which cross-references the temporary regulations, can be found at gpo.gov [PDF].
CMS issues final rule Medicare Advantage and Prescription Drug Benefits Program rule
On January 11, 2012, CMS released a new final rule implementing and finalizing rules addressing reporting requirements for gross covered retiree plan-related prescription drug costs and retained rebates by Retiree Drug Subsidy sponsors. The rule also addresses CMS's waiver authority. The rule will go into 60 days after publication in the Federal Register, slated for January 12, 2012.
DOL delegates authority added by PPACA to EBSA
On January 9, 2012 an order of the Department of Labor (DOL) was published in the Federal Register, delegating authority and assigning certain responsibilities to the Employment Benefits Security Administration (EBSA). The order specifically delegates DOL's authority under Sections 45R and 4980H of the Internal Revenue Code (both of which were added through the Affordable Care Act) to EBSA. This delegation includes the authority for defining the term "seasonal worker." Click here for the order [PDF].
HHS releases Electronic Funds Transfer rules
On January 5, 2012, the Department of Health & Human Services released new rules regarding Electronic Funds Transfers (EFT). The interim rule with comment period, promulgated pursuant to PPACA "administrative simplification" provisions, aims to create streamlined standards for submissions from health plans to banks when paying provider claims electronically, as well as standards for Remittance Advice notices. The new rules entered effect on January 10, 2012 and have a compliance date of January 1, 2014. Comments are due by March 12, 2012. Click here for rulemaking, accessed through the Federal Register [PDF].