Health Industry Washington Watch : Washington DC Healthcare Industry Law Firm : Reed Smith : Health Industry Washington Watch : Regulations, Medicare/Medicaid, Governmental Organizations

This post was written by Scot T. Hasselman, Paul W. Pitts, Susan A. Edwards and Nancy E. Bonifant.

The Centers for Medicare & Medicaid Services’ (“CMS”) Medicare Shared Savings Program final rule offers potential opportunities as well as risks to health care providers and suppliers interested in forming accountable care organizations (“ACOs”). While the core principle of the Medicare Shared Savings Program is simple—reward improvements in quality and cost containment through a share of the resulting savings—the regulatory and operational requirements associated with the program are much more complex.

Reed Smith attorneys have prepared a comprehensive Client Alert summarizing and analyzing the final rule, focusing on provisions we believe are of greatest interest to health care providers and medical device and pharmaceutical manufacturers. We also summarize companion guidance documents published by various federal agencies, including the Office of Inspector General, the Department of Justice, the Federal Trade Commission, and the Internal Revenue Service. Our Alert details changes from the proposed rule, discusses CMS’s response to public comments, identifies the practical impact of the final rule, and flags questions and concerns associated with the program. 

In addition, Reed Smith will be hosting a teleseminar on this topic Wednesday, December 7, 2011. For more information or to register for this program, please click here.

Click here to read the full Alert (PDF).

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This post was written by Ruth Holzman and Joe Metro.

The IRS has issued updated guidance to drug manufacturers on the Affordable Care Act’s annual fee imposed on covered entities engaged in the business of manufacturing or importing branded prescription drugs. The guidance addresses submission of required information, IRS notification of covered entities of their preliminary fee calculation; submission of error reports for the dispute resolution process, and notification of final fee calculations. Among other things, the guidance provides that:

• Each covered entity that elects to submit a completed Form 8947, “Report of Branded Prescription Drug Information,” for the fee year 2012 (reporting sales for the sales year 2010) must do so by December 15, 2011.
• IRS will mail each covered entity a paper notice of its 2012 preliminary fee calculation by April 2, 2012. This mailing will include an NDC attachment that lists the covered entity's NDCs and the sales data reported to the IRS by each governmental program.
• A covered entity may request a CD-ROM with the NDC attachment in an Excel spreadsheet. The request must be made by March 1, 2012 by telephone or by e-mail.
• If a covered entity wishes to submit an error report regarding its preliminary fee calculation it must do so by May 16, 2012. To file an error report, the covered entity must use the template on a CD-ROM that was mailed to it with its preliminary fee calculation.
• IRS will notify each covered entity of its final fee calculation for 2012 by August 31, 2012.
• The covered entity must pay this fee by September 30, 2012.

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This post was written by Paul W. Pitts, Susan A. Edwards, and Debra A. McCurdy.

Today the Centers for Medicare & Medicaid Services (CMS) released its long-awaited final rule to implement the Medicare Shared Savings Program as authorized by Section 3022 of the Affordable Care Act (ACA).  The Shared Savings Program is intended to encourage physicians, hospitals, and certain other types of providers and suppliers to form accountable care organizations (ACOs) to provide cost-effective, coordinated care to Medicare beneficiaries.  Under the final rule, an ACO that meets established quality and performance standards and surpasses a minimum savings target will be able to share a percentage of savings (in addition to traditional fee-for-service payments under Medicare Parts A and B).  While the ACA requires CMS to "establish" the Shared Savings Program no later than January 1, 2012, CMS has indicated that it will begin accepting applications for the Shared Savings Program January 1, 2012, but the start date will be later in 2012. In the final rule, CMS made a number of notable changes to the proposed rule, as highlighted after the jump.

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This post was written by Scot T. Hasselman, Carol C. Loepere, Daniel A. Cody, Paul Pitts, Debra A. McCurdy and Susan A. Edwards.

The Patient Protection and Affordable Care Act (“PPACA”), enacted in March 2010, requires that the Secretary (“Secretary”) of the Department of Health & Human Services (“HHS”) establish a Medicare “Shared Savings Program” by January 1, 2012.  The Shared Savings Program is intended to encourage physicians, hospitals, and certain other types of providers and suppliers to form accountable care organizations (“ACOs”) to provide cost-effective, coordinated care to Medicare beneficiaries. Physicians, hospitals, physician groups, other providers, policymakers, and many other stakeholders in the health care industry have eagerly anticipated the issuance of the ACO proposed rule. On March 31, 2011, under the authority of the Secretary, the Centers for Medicare & Medicaid Services (“CMS”) issued the proposed rule.

Reed Smith attorneys and analysts have prepared a comprehensive Client Alert which first provides a brief overview of the ACO model, then summarizes the proposed rule, listing areas of comment solicited by CMS and identifying the practical impact of the proposed rule, as well as questions and concerns that may emerge. Finally, this Client Alert summarizes the jointly issued CMS and OIG notice with comment period discussing the waiver of the physician self-referral law, the anti-kickback statute, and certain provisions of the civil monetary penalty law in connection with the Medicare Shared Savings Program. The Alert provides a summary and analysis of those provisions of the proposed rule and the proposed waiver that we believe are of greatest interest to health care providers, and medical device and pharmaceutical manufacturers. Click here to read the full Alert (PDF).

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On March 23, 2011, the Centers for Medicare & Medicaid Services (CMS) published a notice announcing that the 2011 Medicare application fee for institutional providers (excluding physicians and nonphysician practitioners) is $505. Note that CMS has adopted a broad definition of institutional entities subject to the application fee; it applies to “any provider or supplier that submits a paper Medicare enrollment application using the CMS-855A, CMS-855B (not including physician and nonphysician practitioner organizations), CMS-855S or associated Internet-based PECOS enrollment application.” As authorized under CMS’s February 2, 2011 final Medicare/Medicaid/CHIP provider screening rule, institutional providers must pay the application fee when enrolling in Medicare, revalidating their Medicare enrollment, or adding a new Medicare practice location, effective March 25, 2011. Likewise, effective March 25, 2011 prospective or re-enrolling Medicaid or CHIP providers must submit the applicable application fee unless: (1) the provider is an individual physician or nonphysician practitioner; or (2) the provider is enrolled in Medicare or another state’s Medicaid or CHIP program and has already paid an application fee. The application fee will be used to fund new provider screening tools, such as unannounced site visits, background checks, and fingerprinting, and other program integrity efforts. The provider screening rule established a hardship exception process and allows Medicaid to waive the fees in certain circumstances. CMS also has released information on the mechanics of making application fee payments. For more information about the rule, see Reed Smith’s alert.

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On February 2, 2011, the Centers for Medicare & Medicaid Services (CMS) published a final rule with comment period (Final Rule) implementing provisions of the Affordable Care Act (ACA) that strengthen provider and supplier screening provisions under Medicare, Medicaid, and the Children's Health Insurance Program (CHIP). The rule is effective March 25, 2011, as mandated by the ACA (although CMS is delaying the effective date of a provision requiring fingerprint-based criminal history record checks for certain providers until after additional subregulatory guidance is issued).

Among many other things, the Final Rule applies various screening tools, including unannounced site visits, background checks, and fingerprinting, based on the level of risk associated with different provider and supplier types. The Final Rule also: imposes application fees on institutional providers and suppliers; authorizes CMS and states to impose moratoria on new provider enrollment to protect against a high risk of fraud; authorizes the suspension of payments pending an investigation of a credible allegation of fraud; provides guidance to states regarding termination of providers from Medicaid and CHIP if terminated by Medicare or another state program; and addresses termination of providers and suppliers from Medicare if terminated by a Medicaid state agency. The rule also discusses comments regarding an ACA requirement that providers or suppliers in certain industry sectors establish compliance programs; these comments will be considered in a future rulemaking.

CMS notes it has identified specific provisions surrounding implementation of fingerprinting for certain providers and suppliers that may be subject to change based on public comments; comments on the fingerprinting requirements only will be accepted until April 4, 2011.

Our full alert provides an analysis of the major provisions of the extensive Final Rule.

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The Institute of Medicine (IOM) has begun work on advising the HHS Secretary on how to define EHBs for purposes of the ACA insurance package provisions. The IOM Board on Health Care Services held a workshop on this topic in January 2011, and the next meeting is scheduled for March 2-3 in Costa Mesa, CA.  

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The House of Representatives has voted to repeal the ACA, by a largely party-line vote of 245 to 189. The House subsequently passed H. Res. 9, to instruct four House committees (Education and the Workforce, Energy and Commerce, Judiciary, and Ways and Means) to report legislation to replace the law with provisions that achieve a number of objectives, including: removing excessive regulations and wasteful spending, decreasing health insurance premiums through increased competition and choice, medical liability system reform, increasing the number of insured Americans, increasing state flexibility to administer Medicaid, and encouraging personal responsibility for health care coverage and costs, among others. As previously reported, the President has said he would not sign the repeal bill if it ever reached his desk (which is unlikely in light of Democratic control of the Senate). In his State of the Union address on January 25, 2011, President Obama offered to work with lawmakers to “improve this law by making care better or more affordable.” 

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On January 6, 2011, CMS published a notice formally announcing the establishment of a new Center for Consumer Information and Insurance Oversight within CMS to implement the provisions of the ACA that address private health insurance. The new Center replaces the Office of Consumer Information and Insurance Oversight within the Office of the Secretary.  

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The Government Accountability Office (GAO) has announced the appointment of 15 members to the Methodology Committee of the Patient-Centered Outcomes Research Institute (PCORI).  The Committee is charged with helping PCORI develop methodological standards and guidance for comparative clinical effectiveness research.  

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This post was written by Ruth N. Holzman, Angelo Ciavarella, Joseph W. Metro and Vicky G. Gormanly.

On January 14, 2011, the Internal Revenue Service ("IRS") issued Notice 2011-9 (the "Notice"), which extended the filing date for reporting on Form 8947 a covered entity's 2009 sales of branded prescription drugs under the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010 (collectively, the "Affordable Care Act" or the "ACA"). The filing date for Form 8947 with respect to 2009 sales of branded prescription drugs was extended from January 20, 2011 to February 11, 2011. In addition, in response to numerous comments received by the IRS, the Notice made certain changes to Notice 2010-71, 2010-50 IRB (the "Initial Notice"), primarily with respect to the information requested from covered entities. Please click here to view the full alert prepared by Reed Smith Tax and Life Sciences Health Industry attorneys.

On November 29, 2010, the IRS issued the Initial Notice, which provided guidance on the calculation of the annual fee imposed on certain manufacturers and importers of branded prescription drugs for calendar years beginning after December 31, 2010. Click here to view Reed Smith's previous alert which includes a detailed description of the Initial Notice, including the definitions of "branded prescription drugs," "covered entity," "Sales Year" and "Fee Year."

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The new Republican leadership of the House of Representatives are moving ahead on legislation (H.R. 2) to repeal the Patient Protection and Affordable Care Act and the health care-related provisions in the Health Care and Education Reconciliation Act of 2010 (collectively known as the ACA).  On January 7, the House approved a procedural motion to allow a vote on H.R. 2 and a companion measure, H.Res. 9, instructing relevant committees to report legislation replacing the “job-killing health care law” with provisions that achieve a number of objectives, including: removing excessive regulations and wasteful spending, decreasing health insurance premiums through increased competition and choice, medical liability system reform, increasing the number of insured Americans, increasing state flexibility to administer Medicaid, and encouraging personal responsibility for health care coverage and costs, among others. The Congressional Budget Office estimates that H.R. 2 would increase the deficit by approximately $230 billion over the 2012–2021 period, although supporters of the legislation dispute that figure.) While the “repeal and replace” measures are expected to pass the House, the President has said that he would not sign the repeal bill if it ever reached his desk, which is unlikely in light of Democratic control of the Senate.

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The Internal Revenue Service (IRS) has issued several ACA guidance documents, including notices on the use of health flexible spending arrangements for purchases of over-the counter medicines and the prohibition on health plans discriminating in favor of highly-compensated individuals. 

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CMS has announced it is establishing the “Federal Coordinated Health Care Office,” which is mandated by the ACA to ensure more effective integration of Medicare and Medicaid benefits for individuals eligible for both programs and improving coordination between the federal government and states in the delivery of benefits for such individuals.

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CMS has issued guidance to state Medicaid directors on Section 6505 of the ACA, under which a state may not make payments for items or services provided under the state Medicaid plan or under a waiver to any financial institution or entity located outside of the United States. The provision is effective January 1, 2011, unless the Secretary determines that implementation requires state legislation other than funding legislation) to comply with this provision. According to the CMS guidance, certain tasks that support the administration of the Medicaid state plan (e.g., outsourcing enrollment or claims adjudication call centers) that may require payments to financial institutions or entities located outside of the U.S. are not prohibited by the statute. However, CMS states that payments for items or services provided under the state plan to financial institutions or entities (e.g., provider bank accounts or business agents) located outside of the U.S., Puerto Rico, the Virgin Islands, Guam, the Northern Mariana Islands, and American Samoa are prohibited. CMS also asserts that the ACA provision prohibits payments to telemedicine providers and pharmacies located outside of the U.S. or its territories. The impact on US-based telemedicine suppliers who employ or contract with physicians who provide services from outside the US via electronic means is unclear. 

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The Senate Health, Education, Labor and Pensions (HELP) Committee is planning a series of hearings on the Affordable Care Act, with the first hearing on January 27 focusing on insurance market reforms. Other hearings will include such issues as quality of care and fraud and abuse provisions; dates for those hearings have not yet been announced.

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HHS published a proposed rule on December 23, 2010 regarding the disclosure and review of “unreasonable” health insurance premium increases under the ACA. The proposed rule would establish a rate review program to ensure that all rate increases that meet or exceed an established threshold are publicly disclosed and reviewed by a state or HHS to determine whether the rate increases are unreasonable. An unreasonable rate increase would be defined as one that is excessive (that is, it causes insurance premiums to be unreasonably high in relation to the benefits provided under the coverage), unjustified, or unfairly discriminatory. For rate increases filed in a state on or after July 1, 2011 (or effective on or after July 1, 2011 in a state that does not require a rate increase to be filed), the threshold for whether rates are subject to review would be whether the average weighted increase in the rate filing (alone or in combination with prior increases in the preceding 12 month period) is 10% or more. After 2011, state-specific thresholds for review would be established. Additional background information is posted here.  

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On December 28, 2010, the Obama Administration published a request for information regarding how group health plans and health insurance issuers can employ value-based insurance design in the coverage of recommended preventive services. The notice seeks information on, among other issues: specific plan design tools to incentivize patient behavior; how to identify high-value treatment settings, providers, and delivery mechanisms; and ways to ensure that patients with particular co-morbidities or other special circumstances receive the medically-appropriate level of care. Comments are due February 28, 2011.

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The Internal Revenue Service (IRS) has issued documents related to the annual fee for manufacturers and importers of brand name pharmaceuticals under section 9008 of the ACA, which is payable beginning in 2011. Specifically, IRS Notice 2010-71 describes a proposed methodology for calculating the fee (including a discussion of covered entities, sales taken into account; an adjustment methodology; information submission requirements; and the fee calculation methodology). It also describes how the IRS will provide each covered entity with a preliminary 2011 fee calculation that will serve as a basis for comments by the covered entity on the proposed methodology. Preliminary 2011 fee calculations will be based on information submitted by manufacturers on Form 8947, Report of Branded Prescription Drug Information, which should be submitted to the IRS by January 20, 2011. The preliminary fee will be calculated and sent to each covered entity by May 2, 2011. If the IRS subsequently promulgates regulations that modify the fee calculation methodology, the modified methodology will be used to determine final fee amounts for 2011 that will be sent to each covered entity by August 15, 2011. The IRS seeks comments on all aspects of its prescription drug fee procedures; comments are due June 2, 2011. A Reed Smith analysis of the guidance is available here.  Separately, the IRS has released a request for public comments on issues to be addressed in future guidance on the new ACA excise tax on medical devices, which applies to sales of taxable medical devices after December 31, 2012. Comments specifically are requested on the excise tax exemption for any medical device “determined by the Secretary to be of a type which is generally purchased by the general public at retail for individual use,” and on issues pertaining to the application of existing Chapter 32 rules (pertaining to Manufacturers Excise Taxes) to this provision. The comment deadline is March 3, 2011. The solicitation notice (Notice 2010-89) will be published in IRB 2010-52, dated December 27, 2010. 

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On December 8, 2010, the Food and Drug Administration (FDA) published a notice requesting that stakeholders - particularly patient and consumer advocacy groups, health care professionals, and scientific and academic experts - notify FDA if they intend to participate in consultation meetings on the development of a user fee program for biosimilar and interchangeable biological product applications. The meetings will comply with an ACA mandate regarding consultation with stakeholders on the goals for the biosimilar and interchangeable biological product application review process for fiscal years 2013 through 2017 in advance of submission of recommendations to Congress. FDA earlier had requested information on companies (and their trade associations) that would be affected by a biosimilar user fee program. Notifications of intention to participate are due by January 10, 2011.

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Under the ACA, all Medicare fee-for-service claims for services furnished on or after January 1, 2010 must be filed with the appropriate Medicare contractor no later than one calendar year from the date of service or the claim will be denied. CMS is reminding providers and suppliers that Medicare claims with service dates from October 1, 2009 through December 31, 2009 must be filed by December 31, 2010 in order to be eligible for payment. 

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HHS has issued new guidance for "mini-med" (limited benefit) insurance programs requiring plain-language disclosure to consumers regarding the limited nature of the plan coverage. The guidance also sets forth the circumstances under which insurers that obtained a waiver can continue to sell new mini-med plans.

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On December 1, 2010, the Department of Health and Human Services (HHS) is publishing an interim final rule with comment period implementing ACA medical loss ratio requirements. Under the rule, beginning in 2011, insurance companies in the individual and small group markets must spend at least 80% of the premium dollars they collect on medical care and quality improvement activities, and insurance companies in the large group market must spend at least 85% of premium dollars on medical care and quality improvement activities. Insurance companies that do not meet the medical loss ratio standard will be required to provide rebates to their consumers beginning in 2012. The rule also requires insurance companies to publicly report how they spend premium dollars, beginning in 2011. For background information, see the HHS website.  Comments on the rule will be accepted until January 31, 2011. 

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The Centers for Disease Control and Prevention (CDC) is inviting comments on the development of guidance regarding an ACA provision requiring a health risk assessment to be included in the annual Medicare wellness visit benefit. CDC is collaborating with CMS to develop guidance for this type of assessment (which the CDC notes also may be helpful for privately-insured populations). Comments are due by January 3, 2011.  

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On November 16, 2010, CMS formally established a new Center for Medicare and Medicaid Innovation (Innovation Center). Created by the ACA, the Innovation Center will examine new ways of delivering health care and paying health care providers that can save money for Medicare and Medicaid while improving the quality of care. Richard Gilfillan, MD, has been named Acting Director of the Innovation Center. CMS also announced the launch of new demonstration projects that will support efforts to better coordinate care and improve health outcomes for patients. 

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On November 22, 2010, CMS is publishing a proposed rule that would update Medicare Advantage (MA) and Part D prescription drug benefit regulations to reflect ACA requirements and make other program changes for contract year 2012. Specifically, the proposed rule would implement ACA provisions that, among other things: limit beneficiary cost sharing for certain services under MA plans; clarify the Secretary’s authority to deny certain MA and Part D plan bids; permit MA and Part D plans to waive a de minimis monthly beneficiary premium for low income subsidy (LIS) eligible enrollees and make related changes to LIS reassignment rules; provide for an income-related increase in Part D monthly premiums; eliminate Part D cost-sharing for full-benefit dual eligible individuals who are receiving certain home and community-based services; codify statutory changes to close the Part D coverage gap (sometimes referred to as the “donut hole”); update the methodology for using quality ratings to determine MA bonus payments; and provide for more frequent dispensing of certain branded drugs for Part D beneficiaries residing in long term care facilities to reduce waste. In addition to these ACA provisions, the rule would clarify program requirements to: prevent certain Part D and MA executives whose plans are barred from participation from serving in similar capacities in other plans; establish new standards regarding MA plan employment of personnel to make certain medical policy determinations; strengthen various beneficiary protection provisions; establish training requirements for MA and Part D sponsor agents and brokers; and establish plan fiscal solvency standards.  CMS will accept comments for 60 days after publication. In a related development, CMS has posted the 2011 Medicare Plan Star Ratings and announced a 3-year demonstration to provide MA plans with financial incentives to provide high-quality care.

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On November 17, 2010, the Obama Administration is publishing an amendment to current interim final rules to permit certain changes in policies, certificates, or contracts of insurance without loss of grandfathered status under the ACA. The amendment is effective November 15, 2010, and comments will be accepted until 30 days after publication.

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The ACA authorizes CMS to test innovative payment and service delivery models. For instance, the Medicare Shared Savings Program promotes the formation of accountable care organizations (ACOs), under which groups or providers may work together to coordinate care for Medicare beneficiaries and receive payments for shared savings if certain standards are met. In preparation for rulemaking to establish this program, CMS is requesting comments on certain aspects of the policies that will apply to ACOs, such as: standards to ensure that groups of solo and small practice providers have the opportunity to participate in the program; issues associated with small practices’ limited access to capital; the process of attributing beneficiaries to an ACO for purposes of measuring savings and improving quality; how to assess beneficiary and caregiver experience of care and patient-centeredness, quality performance standard; and other types of payment models. The comment deadline is December 3, 2010. The official version of the notice will be published on November 17. 

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Under the Medicare Coverage Gap Discount Program, which takes effect January 1, 2011, Medicare beneficiaries in the Part D coverage gap will have access to manufacturer discounts equal to 50% of the negotiated price of applicable drugs (that is, prescription drugs approved or licensed under new drug applications or biologic license applications). In order to participate, manufacturers must sign an agreement with CMS to provide the discount on all of its applicable drugs. CMS has announced that for those manufacturers not participating in the coverage gap discount program in 2011, the deadline for returning the signed agreements and labeler code spreadsheet is January 30, 2011 for the 2012 benefit year.

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The Obama Administration is publishing a notice November 17, 2010 requesting information to gain market analysis information in advance of future requests for proposals related to health plan external review processes. Specifically, the notice requests comments on operational issues associated with implementation of a federal external review process for health coverage in states that do not have an applicable external review process that meets the minimum federal standards. Information will be accepted for 21 days after publication.

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The ACA requires drug manufacturers to report the total number of units that are used to calculate the monthly average manufacturer price (AMP) for each covered outpatient drug no later than 30 days after the last day of the month. CMS has updated the Medicaid Drug Data Reporting system to enable reporting of AMP units to CMS for the October 2010 reporting period; October 2010 reports are due by November 30, 2010.

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The Obama Administration has made a much-anticipated announcement of the recipients of the $1 billion in new ACA therapeutic discovery project tax credits, which are designed to support research with significant potential to produce new therapies, address unmet medical needs, reduce the long-term growth of health care costs, or advance the goal of curing cancer within the next 30 years. The credit covers up to 50% of the cost of qualifying biomedical research, and is limited to firms with fewer than 250 employees. Almost 3,000 small biotechnology companies were awarded funds for a total of 4,606 projects.

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The Department of Health and Human Services (HHS) has announced new plan choices for people enrolling in the Pre-Existing Condition Insurance Plan (PCIP) for 2011. The new options will be available in 23 states and District of Columbia, where the program is federally-administered through the Office of Personnel Management.

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Senators Chuck Grassley and Herb Kohl have asked HHS Secretary Sebelius to take a number of steps to prepare for implementation of the ACA’s Physician Payments Sunshine Act provisions, under which drug and medical device manufacturers must disclose to HHS certain payments to physicians. The Senators note that some drug and medical device makers are preparing to meet the new requirements, but in the absence of clear guidance from the federal government, they are preparing payment data in non-uniform ways that is making it difficult for consumers to use. The senators cited the need for federal guidance “to ensure the same information is disclosed in the same way, and is meaningful.” To that end, they requested that HHS promptly designate an agency to oversee the creation and operation of the database and to report to them on the Department’s implementation timeline.

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The Department of Labor continues to issue frequently-asked questions regarding implementation of the market reform provisions of the ACA, the latest of which address grandfathering rules.

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CMS has provided guidance to states regarding implementation of Section 2601 of the ACA, which provides for a 5-year approval or renewal period for Medicaid demonstration programs under section 1115 of the Social Security Act (the Act) and waivers under sections 1915(b) and 1915(c) of the Act, through which a state serves individuals who are dually-eligible for Medicare and Medicaid.

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On November 17 and 18, 2010, the Health Resources and Services Administration is hosting a meeting of the Negotiated Rulemaking Committee on Designation of Medically Underserved Populations and Health Professional Shortage Areas. The Committee, which was authorized by the ACA, will be focusing on the various components of a possible methodology for identifying areas of shortage and underservice, based on the recommendations of the Committee in the previous meeting. 

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On December 3, 2010, CMS is hosting a public forum on the upcoming Community-Based Care Transitions Program, which was authorized by the Affordable Care Act to reduce hospital readmissions, test sustainable funding streams for care transition services, maintain or improve quality of care, and document measureable savings to the Medicare program. The registration deadline for in-person meeting attendance is November 19, and the deadline for webinar registration is December 2, 2010 (or when space is full). 

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This post was written by Carol Colborn Loepere and Scot T. Hasselman.

As widely reported in the media, on October 14, 2010, a federal judge in Florida ruled that he will allow a lawsuit challenging the constitutionality of the Affordable Care Act to proceed. The lawsuit argues that the ACA's individual mandate that people buy health insurance or else pay a penalty exceeds Congress's authority under the Commerce Clause. Judge Roger Vinson agreed, holding that Congress is attempting to regulate not interstate commerce but economic inactivity by requiring individuals to purchase a private product "based solely on citizenship and on being alive." Judge Vinson ruled that the plaintiffs "have at least stated a plausible claim that the line has been crossed" concerning the outermost bounds of federal power under the Constitution. Litigation pending in Virginia has also been allowed to proceed, while a U.S. District Court judge in Michigan dismissed a separate challenge to the litigation, raising the likelihood that the constitutionality of the law will need to be resolved by the U.S. Supreme Court. 

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The Centers for Medicare & Medicaid Services (CMS) has issued a letter to State Medicaid Directors providing preliminary guidance on section 6411 of the ACA, which requires states to contract with RACs to audit payments to Medicaid providers. CMS expects states to fully implement their RAC programs by April 1, 2011. CMS notes that it will be issuing regulations in this area shortly that will provide additional guidance. 

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Under the Medicare Coverage Gap Discount Program, which takes effect January 1, 2011, Medicare beneficiaries in the Part D coverage gap (sometimes called the "donut hole") will have access to manufacturer discounts equal to 50% of the negotiated price of applicable drugs (that is, prescription drugs approved or licensed under new drug applications or biologic license applications). In order to participate, manufacturers must sign an agreement with CMS to provide the discount on all of its applicable drugs. CMS has posted a complete list of applicable drug labeler codes for the 2011 calendar year (as of October 1, 2010). Beginning January 1, 2011; applicable Part D drugs may be covered under Part D only if they are marketed under labeler codes specified on the CMS list. While CMS does not anticipate many changes to this list during 2011, CMS notes that a manufacturer could add new labeler codes that currently are not marketed or currently are marketed by another manufacturer; in such case, CMS will promptly notify Part D sponsors.

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The Government Accountability Office (GAO) has announced the appointment of 15 members to the new National Health Care Workforce Commission authorized by the ACA. The Commission is charged with making recommendations on how to: align federal health care workforce resources with current national needs; coordinate activities at the federal, state, and local levels; and encourage innovations that address population needs, changing technology, and other factors.

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The Department of Health and Human Services (HHS) has added price estimates for private health insurance policies on its consumer website in an effort to make health insurance market data more transparent.

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This post was written by Daniel A. Cody, Scot T. Hasselman, Carol C. Loepere and Debra A. McCurdy.

On September 23, 2010, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule that would implement provisions of the Affordable Care Act (ACA) designed to strengthen provider and supplier screening requirements under the Medicare, Medicaid, and Children’s Health Insurance Program (CHIP). According to CMS, the Proposed Rule is intended to ensure "that only legitimate providers and suppliers are enrolled in Medicare, Medicaid, and CHIP, and that only legitimate claims will be paid."

Among many other things, the Proposed Rule would: apply screening tools, including unannounced site visits, background checks, and fingerprinting, based on the level of risk associated with different provider and supplier types; impose a $500 application fee on certain providers and suppliers; authorize temporary moratoria on enrollment of certain types of new providers and suppliers; require Medicare and Medicaid payments to be suspended upon credible allegations of fraud; and update various Medicaid screening requirements. Comments on the proposed rule will be accepted until November 16, 2010.

Our full alert provides an analysis of the proposed rule.

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As mandated by Section 6409 the ACA, CMS has released its Medicare self-referral disclosure protocol (SRDP). The SRDP sets forth a process to enable providers and suppliers to self-disclose actual or potential violations of the physician self-referral statute (known as the “Stark Act”). Under the SRDP, providers or suppliers would submit all information necessary for CMS to analyze the actual or potential Stark Act violations. The Secretary is authorized to reduce the amount due for violations of the Act based on certain factors, including timely self-disclosure. 

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On September 28, 2010, CMS posted a letter to State Medicaid Directors on implementation of the ACA Medicaid drug rebate provisions. This guidance revises the previous policy concerning the federal offset of Medicaid prescription drug rebates, and further specifies the process CMS will use for the estimation and collection of these offsets. It also provides information on rebates for Medicaid managed care organization (MCO) drugs, MCO formularies, and the treatment of MCO physician-administered drugs. In addition, the guidance addresses manufacturer reporting requirements, the treatment of discounts under the Medicare Coverage Gap Discount Program for purposes of determining best price, and changes to Medicaid excluded drug provisions. 

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The Government Accountability Office (GAO) has announced appointments to the Board of Governors for the new Patient-Centered Outcomes Research Institute (PCORI), as authorized by the ACA. The GAO still is accepting nominees for the PCORI Methodology Committee; the deadline for those nominations is October 29, 2010.

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The Internal Revenue Service (IRS) is inviting public comments on the application of ACA rules prohibiting insured group health plans from discriminating in favor of highly-compensated individuals. Comments will be accepted until November 4, 2010. The IRS also has issued guidance on the ACA’s revised definition of medical expenses as it relates to over-the-counter drugs. The IRS invites comments on further guidance that may be needed in this area. Comments are due December 27, 2010.

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The Department of Labor (DOL) has issued Technical Release No. 2010-02, "Interim Procedures for Internal Claims and Appeals under the Patient Protection and Affordable Care Act," which sets forth an enforcement grace period until July 1, 2011 for compliance with certain new ACA provisions regarding internal claims and appeals. In addition, the DOL has posted a series of questions and answers regarding ACA implementation, focusing on Compliance; Grandfathered Plans; Claims, Internal Appeals, and External Review; Dependent Coverage of Children; Out-Of-Network Emergency Services, and Highly Compensated Employees. 

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Richard Gilfillan, MD, has been named Acting Director of a new Center for Medicare and Medicaid Innovation (CMI) within CMS. The Affordable Care Act established the CMI to research, develop, test, and expand innovative delivery arrangements to reduce program expenditures under federal health care programs while enhancing the quality of care furnished to beneficiaries.

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The Negotiated Rulemaking Committee on Designation of Medically Underserved Populations and Health Professional Shortage Areas is scheduled to meet October 13 - 15, 2010. The panel is charged with developing a comprehensive methodology and criteria for Designation of Medically Underserved Populations and Primary Care Health Professional Shortage Areas, as mandated by the ACA. 

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On October 5, 2010, the FTC, CMS, and the OIG are holding a workshop on accountable care organizations (ACOs). These organizations, authorized by the ACA, are designed to deliver high-quality and efficient health care services to consumers. The workshop is intended to assess how the variety of possible ACO structures in different health care markets could affect the prices and the quality of health care delivered to privately insured consumers, as well as to Medicare and Medicaid beneficiaries. The workshop also will address antitrust, physician self-referral, anti-kickback, and civil monetary penalty considerations associated with the various ACO models, and whether safe harbors, exceptions, exemptions, or waivers from these laws may be warranted. Physicians, physician associations, hospitals, health systems, payers, consumers, and other interested parties are invited to participate in the workshop. The deadline for registration and submission of comments to be considered for discussion at the workshop is September 27, 2010.  The workshop is scheduled to be webcast.

* * Transcripts from the ACO workshop are now available.

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The Department of Health and Human Services (HHS) is seeking public input regarding its development of a National Health Care Quality Strategy and Plan, as authorized by the ACA. To that end, HHS has released an 8-page document that outlines its initial thinking regarding the plan, highlighting specific areas where feedback would be particularly valuable to HHS. The broad areas addressed by the document include: Principles Guiding the National Quality Strategy; the Framework for the National Quality Strategy (better care, more affordable care, and healthy people/healthy communities); Priorities of the National Quality Strategy; Goals of the National Quality Strategy (such as reduction of preventable adverse events, increased coordination of care, and improved management of chronic illnesses); Measures of Progress to Priorities and Goals; and Stakeholder Engagement. The public comment deadline October 15, 2010. The initial Health Care Quality Strategy and Plan is due to Congress by January 1, 2011.

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CMS has issued guidance to states on implementation of Section 2302 of the ACA, which allows children who are enrolled in either Medicaid or CHIP to receive hospice services without foregoing curative treatment related to a terminal illness. Likewise, CMS has provided states with guidance on Section 6507 of the ACA, which mandates that states use certain National Correct Coding Initiative (NCCI) methodologies to promote correct coding and control improper coding leading to inappropriate payment of Medicaid claims. 

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In response to questions on previous memoranda, CMS has issued additional guidance on "Closing the Coverage Gap in 2011.” The new guidance addresses: enhanced alternative benefits designs without an initial coverage limit; non-calendar year employer group waiver plans; covered Part D drugs that are not applicable drugs under the Medicare coverage gap discount program; Part D vaccine administration fees; discounts on direct member reimbursements for prescriptions filled at out-of-network pharmacies; Part D compounds; and brand-only deductibles. 

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The HHS Office of Consumer Information and Insurance Oversight (OCIIO) has released subregulatory guidance on the process for health plans to apply for a waiver of restricted annual limits on the dollar value of essential health benefits if such a waiver is necessary to prevent a significant decrease in access to benefits or a significant increase in premiums. 

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On August 26, 2010, the Internal Revenue Service, Employee Benefits Security Administration (EBSA), and the HHS Office of Consumer Information and Insurance Oversight published a notice announcing the availability of guidance detailing interim procedures for the federal external review process and model notices both for internal claims and appeals and for external review processes under the Patient Protection and Affordable Care (Affordable Care Act or ACA). Among other things, the guidance (EBSA Technical Release No. 2010-01) provides an interim enforcement safe harbor for non-grandfathered self-insured group health plans not subject to a state external review process, and therefore subject to the federal external review process. 

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CMS has released information on ACA provisions that require a new minimum Medicaid rebate of 17.1% of the average manufacturer price (AMP), effective January 1, 2010, for drugs approved by the FDA exclusively for pediatric indications and for blood clotting factors. CMS also has released listings of the specific drugs impacted by these provisions. CMS also has issued Medicaid Drug Rebate Program Release No. 81, which, among other things, provides updated information on the new Medicaid rebate calculation for Single Source/Innovator Multiple Source line extension drugs in an oral solid dosage form. 

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On August 3, 2010, the Office of Consumer Information and Insurance Oversight (OCIIO) published a notice soliciting comments regarding ACA state insurance exchange provisions to inform future rulemaking and grant solicitations. OCIIO requests comments on number of specific questions in the following areas: state exchange planning and establishment grants; implementation timeframes and considerations; exchange operations; qualified health plans; quality; an exchange for non-electing states; enrollment and eligibility; outreach; rating areas; consumer experience; employer participation; risk adjustment, reinsurance, and risk corridors; and economic analysis, Paperwork Reduction Act, and Regulatory Flexibility Act considerations. Comments will be accepted until October 4, 2010.

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The OCIIO has published an interim final rule with comment period implementing the ACA's temporary high risk health insurance pool program. This program, which is intended to provide affordable health insurance coverage to uninsured individuals with pre-existing conditions, will continue until January 1, 2014, when health insurance exchanges are operational. Key issues addressed in the rule include administration of the program, eligibility and enrollment, benefits, premiums, funding, and appeals and oversight rules. The rule is effective July 30, 2010, and comments will be accepted until September 28, 2010. 

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CMS has finalized the model Manufacturer Agreement and model Third Party Administrator Agreement for the ACA Medicare Coverage Gap Discount Program. Under the Discount Program, which takes effect January 1, 2011, Medicare beneficiaries in the Part D coverage gap (sometimes called the "donut hole") will have access to manufacturer discounts equal to 50% of the negotiated price of applicable drugs (that is, prescription drugs approved or licensed under new drug applications or biologic license applications). In order to participate, manufacturers must sign an agreement with CMS to provide the discount on all of its applicable drugs. Notably, in response to comments received on the Draft Model Manufacturer Agreement released in May, the final Manufacturer Agreement requires manufacturers to pay quarterly invoices within 38 days of receipt, rather than 14 days. CMS also will provide certain claims-level utilization data to manufacturers with the invoices, and, upon audit, CMS will provide certain prescription drug event cost elements for a statistically significant sample size to allow manufacturers to validate discount calculations (CMS will not provide beneficiary-identifiable information, even upon audit). The deadline for manufacturers to return signed agreements and an associated labeler code spreadsheet is September 1, 2010.

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The Obama Administration continues to issue guidance documents and summary information regarding the ACA, including the following: 

• The OCIIO has posted "Questions and Answers on Enrollment of Children Under 19 Under the New Policy That Prohibits Pre-Existing Condition Exclusions."
• CMS has issued a memo to state Medicaid directors providing guidance on provisions of the ACA designed to remove barriers to offering home and community-based services through Medicaid state plans.
• CMS released a report entitled “Affordable Care Act Update: Implementing Medicare Cost Savings." 
• CMS has issued an educational article on the ACA’s timely filing standards for Medicare fee-for-service claims, under which Medicare claims for dates of service on or after January 1, 2010 received later than one calendar year beyond the date of service will be denied.

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On July 23, 2010, the Obama Administration published an interim final rule with comment period implementing ACA requirements regarding internal claims and appeals and external review processes for group health plans and health insurance coverage in the group and individual markets. The rules generally apply to plan/policy years beginning on or after September 23, 2010. Comments will be accepted until September 21, 2010. In addition, on July 19, 2010, HHS, along with the Departments of Treasury and Labor, published an interim final rule implementing ACA requirements that group health plans and health insurance issuers provide preventive benefits coverage. The rule also prohibits the imposition of cost-sharing requirements for certain preventive health services. The rules generally apply to plan/policy years beginning on or after September 23, 2010. Comments will be accepted until September 17, 2010.

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The HHS Administration on Aging is soliciting nominations for the 27-member Advisory Board on Elder Abuse, Neglect, and Exploitation, as required by the ACA’s Elder Justice Act provisions. The Advisory Board is tasked with identifying best practices and making recommendations regarding improving and enhancing government elder justice programs, research, training, and coordination. Nominations are due August 15, 2010.

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The Health Resources and Services Administration (HRSA) has announced that it will start enrollment on August 2, 2010 for entities that are newly eligible for the 340B Drug Pricing Program under the ACA, including children’s hospitals, free-standing cancer centers, critical access hospitals, rural referral centers, and sole community hospitals.

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HRSA has announced plans to establish a Negotiated Rulemaking Committee on the Designation of Medically Underserved Populations and Health Professions Shortage Areas, as mandated by the ACA.

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On July 13, 2010, CMS issued a letter to state Medicaid directors on implementation of Section 6506 of the ACA, which gives states up to one year from the date of discovery of an overpayment for Medicaid services to recover, or to attempt to recover, the overpayment before making an adjustment to refund the federal share of the overpayment.

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On July 2, 2010, CMS released its proposed rule updating the Medicare hospital outpatient prospective payment system (HOPPS) and the ambulatory surgical center (ASC) payment system rates and policies for calendar year (CY) 2011. The official version of the rule is scheduled to be published in the Federal Register on August 3, 2010. Comments on the proposed rule will be accepted until August 31, 2010. CMS expects to issue a final rule by November 1, 2010, which will be effective for services furnished on or after January 1, 2011. Highlights of the rule are available after the jump.

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On July 13, 2010, CMS is publishing its proposed rule to update the Medicare physician fee schedule (MPFS) for 2011. The proposed rule addresses a wide variety of Medicare Part B policies, including many policy revisions mandated by the ACA. CMS will accept comments on the proposed rule until August 24, 2010. A summary of the rule is available after the jump:

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On July 12, 2010, CMS published a proposed rule that would implement provisions of the Affordable Care Act that revise Medicare and Medicaid regulations regarding the imposition and collection of civil money penalties (CMPs) by CMS when nursing homes are not in compliance with federal participation requirements. Specifically, the proposed rule would: allow for CMP reductions when facilities self-report and promptly correct their noncompliance; offer in cases where CMPs are imposed an independent informal dispute resolution process; provide for the establishment of an escrow account where CMPs may be placed until any applicable administrative appeal processes have been completed; and, improve the extent to which CMPs collected from Medicare facilities can benefit nursing home residents. Comments will be accepted until August 11, 2010. 

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On June 28, 2010, the Obama Administration published an interim final rule with comment period implementing Affordable Care Act insurance reforms it dubs “a new Patient’s Bill of Rights.”  Specifically, the regulation issued by the Departments of Health and Human Services (HHS), Labor, and Treasury implements ACA provisions regarding preexisting condition exclusions, lifetime and annual dollar limits on benefits, rescissions, and patient protections applicable to group health plans and health insurance coverage in the group and individual markets . The interim final rules are effective August 27, 2010; but generally apply to group health plans and group and individual health insurance issuers for plan/policy years beginning on or after September 23, 2010 (with certain exceptions). Comments on the regulation will be accepted until August 27, 2010. An HHS fact sheet is posted here.  A Reed Smith analysis of the rule is available here.

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On June 29, 2010, the HHS Office of Consumer Information and Insurance Oversight (OCIIO) announced that it is now accepting applications for the Early Retiree Reinsurance Program (EERP), a $5 billion program established by the Affordable Care Act. The EERP will reimburse participating employment-based plans for a portion of the cost of health benefits for retirees age 55 and older who are not eligible for Medicare and their spouses, surviving spouses, and dependents. The EERP will reimburse sponsors for certain Medicaid claim costs between $15,000 and $90,000 (indexed for plan years starting on or after October 1, 2011). This temporary program became effective June 1, 2010 and will end no later than January 1, 2014.

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On July 1, 2010, HHS announced the establishment of a new Pre-existing Condition Insurance Plan (PCIP) that will offer coverage to uninsured Americans who have been uninsured for at least six months, have been unable to get health coverage because of a health condition, and are a U.S. citizen or are residing in the U.S. legally. To date, 29 states have elected to run their own plans, while 21 states have requested that HHS administer the plan. There are federal standards for general eligibility for the PCIP program, but state programs can vary on cost, benefits, and determination of pre-existing condition. The PCIP is a transitional program that will operate until 2014, when insurers will be banned from discriminating against adults with pre-existing conditions and individuals and small businesses will be able to purchase insurance through new Exchanges.

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Suppliers and manufacturers of durable medical equipment (DME), prosthetics, orthotics, and supplies (DMEPOS) will be impacted, directly and indirectly, by numerous provisions of the recently-enacted health reform legislation, H.R. 3590, the Patient Protection and Affordable Care Act (PPACA), as amended by H.R. 4872, the Health Care and Education Reconciliation Act of 2010 (Reconciliation Act), collectively known as the “Affordable Care Act” or ACA.

Among other things, the Affordable Care Act:  expands the Medicare DMEPOS competitive bidding program; revises the Medicare DMEPOS fee schedule payments (including applying a “productivity adjustment” to the fee schedule update); exempts pharmacies from certain DMEPOS accreditation requirements; revises Medicare power wheelchair payment policy; mandates disclosure of certain payments between manufacturers and physicians; institutes a variety of new program integrity provisions; and imposes a new tax on medical devices.  These provisions are discussed in greater detail below. 

This memorandum supplements our extensive Affordable Care Act analysis released in April 2010, which explains how the law expands access to health insurance (including through subsidies, mandates, and market reforms); reduces health care spending (particularly in the Medicare program); expands federal fraud and abuse authorities; and institutes a variety of other health policy reforms.  We also have posted additional Reed Smith Health Care Reform Review articles focusing on specific aspects of the legislation on our health policy blog, Health Industry Washington Watch, where we also are reporting on implementation efforts associated with the ACA.

To read the full alert, click here.

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This post was written by Elizabeth Carder-Thompson, Joseph W. Metro, Robert J. Hill, Jennifer A. Goldstein, Kevin M. Madagan, Carol C. Loepere and Debra A. McCurdy.

In April 2010, Reed Smith provided an extensive analysis of the recently-enacted health reform legislation, H.R. 3590, the Patient Protection and Affordable Care Act (PPACA), as amended by H.R. 4872, the Health Care and Education Reconciliation Act of 2010 (Reconciliation Act). Together, these sweeping measures expand access to health insurance (including subsidies, mandates, and market reforms); reduce health care spending (particularly in the Medicare program); expand federal fraud and abuse authorities and transparency requirements; impose new taxes and fees on health industry sectors; and institute a variety of other health policy reforms.

In this analysis, we concentrate on those provisions in the new law that will affect life sciences entities: pharmaceutical, device, and biologics manufacturers. These include significant revisions to the Medicaid drug rebate program and the Medicare Part D prescription drug program; an expansion of the Public Health Service Section 340B drug discount program; the imposition of substantial new industry fees and excise taxes; creation of an abbreviated approval pathway for follow-on biologics; and sweeping new reporting and disclosure requirements affecting all manufacturers regarding their relationships with physicians and teaching hospitals, among other changes.

Many of the new provisions require the Secretary of the Department of Health and Human Services (HHS) to issue implementing regulations. We have referenced notices that have been published already, and we will be reporting on additional developments in the coming months.

To read the full alert, click here.

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Under the ACA, certain group health plans and health insurance coverage existing as of March 23, 2010 (the date of enactment of the ACA), are considered “grandfathered” and excused from complying with some of the ACA’s health care improvement and market reform provisions. On June 17, 2010, the Department of Health and Human Services (HHS) and the Departments of Labor and Treasury published interim final rules on the "Status as a Grandfathered Health Plan under the Patient Protection and Affordable Care Act." Among other things, the rule establishes the circumstances under which plan sponsors may adjust co-payments, deductibles and employer contributions to their employees' premiums without forfeiting their grandfather status. For instance, as described in greater detail in the regulation, grandfathered plans may adjust costs to keep pace with medical inflation, add new benefits, make modest adjustments to existing benefits, voluntarily adopt certain new consumer protections, or make changes to comply with state or other federal laws. Plans will lose their grandfathered status, however, if they make major changes, such as significantly cutting or reducing benefits; significantly raising coinsurance, copayments, or deductibles; significantly lowering employer contributions or caps on payments for covered services; or changing insurance companies (with certain exceptions). The interim final rule is effective June 14, 2010, with certain exceptions, and comments will be accepted until August 16, 2010. HHS has posted a fact sheet summarizing the grandfathered health plan rule. 

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The ACA provides a tax-free, one-time $250 check for beneficiaries who reach the Part D coverage gap during 2010 and are not eligible for low-income subsidies. A June 10, 2010 CMS memo to Part D plan sponsors provides additional information on implementation of coverage gap rebate. The memo notes that prompt submission of prescription drug event (PDE) records is necessary to ensure that eligible beneficiaries receive rebates in a timely manner. CMS also instructs sponsors on how to prepare to address situations such as: the enrollee has not received a rebate check because of an address change or unsubmitted PDE records; the enrollee does not understand how they reached the coverage gap; or the enrollee mistakenly believes they reached the coverage gap, but did not. HHS also has announced a media campaign and other outreach efforts to protect beneficiaries from potential scams associated with the rebate checks. In addition to rebate checks, the ACA provides for a Part D drug discount program under which Medicare beneficiaries in the Part D coverage gap will have access to manufacturer discounts equal to 50% of the negotiated price of the drug (except generic drugs), effective January 1, 2011. CMS continues to provide guidance on this program, including a June 2, 2010 memo to Part D plan sponsors addressing: determinations regarding the applicable discount if the sponsor offers Part D supplemental benefits with fixed copays in the coverage gap; Employer Group Waiver Plan requirements to submit attestations and to make benefit information available for audit; the application of the discount before Platino coverage is applied; and coordination of benefits with other non-Part D payers that incorrectly paid primary to Medicare.

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The Internal Revenue Service (IRS) has posted a document entitled "Request for Comments Regarding Additional Requirements for Tax-Exempt Hospitals."  The document discusses the ACA’s new requirements for 501(c)(3) hospitals related to community health needs assessments, financial assistance and emergency medical care policies, limitations on charges, and billing and collection. Comments will be accepted until July 22, 2010.

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The Government Accountability Office (GAO) is seeking nominations for the ACA’s Patient Centered Outcomes Research Institute Governing Board, which is charged with identifying national priorities for comparative effectiveness research.  Likewise, the GAO is seeking nominations for the National Health Care Workforce Commission, also established by the ACA.  Nominations for both panels are due June 30, 2010.

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The Centers for Medicare & Medicaid Services (CMS) has released a memo to Part D Plan Sponsors on "Additional Guidance on 2011 Coverage for Generic Drugs in the Coverage Gap." The memo responds to questions CMS has received about 2011 bid submissions and the new provision regarding coverage for generic drugs in the coverage gap included in the Affordable Care Act.

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CMS’s Office of Legislation has released preliminary questions and answers on the ACA’s provisions to encourage the development of Accountable Care Organizations (ACOs) to facilitate coordination and cooperation among providers to improve the quality of care for Medicare beneficiaries and reduce unnecessary costs. Participating ACOs that meet specified quality performance standards will be eligible to receive a share of Medicare savings if established criteria are met. CMS anticipates holding an “open door forum” listening session this summer to solicit stakeholder ideas. CMS expects to issue a proposed rule to implement the program this fall, and the program is slated to begin by January 1, 2012.

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The Department of Health and Human Services (HHS) has announced the availability of $60 million in Affordable Care Act grants for states and communities to help individuals and their caregivers better understand and navigate their health and long-term care options. Funding also can be used to support state Medicaid agencies as they transition individuals from nursing homes to community-based care, along with other activities to better integrate the medical and social services care models. The deadline for applications is July 30, 2010, and grants will be awarded in September 2010.

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On June 7, 2010, CMS announced the availability of $51 million in Affordable Care Act Health Insurance Premium Review Grants, the first round of grants under a new $250 million ACA grant program intended to strengthen insurance rate review processes. To be eligible for a $1 million first round grant, a state must submit a plan for how it will use grant funds to develop or enhance its process of reviewing and approving, disapproving, or modifying health insurance premium requests.

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This post was written by Scot T. Hasselman, Andrew C. Bernasconi and Nathan Fennessy.

In April 2010, Reed Smith provided an extensive analysis of the recently-enacted health reform legislation, H.R. 3590, the Patient Protection and Affordable Care Act (PPACA), as amended by H.R. 4872, the Health Care and Education Reconciliation Act of 2010 (Reconciliation Act). Together, these sweeping measures expand access to health insurance (including subsidies, mandates, and market reforms); reduce health care spending (particularly in the Medicare program); expand federal fraud and abuse authorities and transparency requirements; impose new taxes and fees on health industry sectors; and institute a variety of other health policy reforms. 

In this analysis, we concentrate on those provisions in the new law that will affect Fraud Abuse and Program Integrity Provisions. These include changes to the federal False Claims Act, the Anti-Kickback Statute, and the Civil Monetary Penalty laws. In addition, we discuss the statutory predicates for upcoming anticipated regulations, including new transparency provisions and mandatory compliance programs.

Many of the new provisions require the Secretary of the Department of Health and Human Services (HHS) to issue implementing regulations, and we will be reporting on these developments in the coming months.

To read the full alert, click here.
 

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Recent guidance and summary documents regarding Affordable Care Act implementation include the following:

• CMS has released a brochure for Medicare beneficiaries with details on the tax-free, one-time $250 check for beneficiaries who reach the Part D coverage gap during 2010 and are not eligible for low-income subsidies. The first checks will be mailed June 10 and additional payments will be made monthly thereafter to newly-eligible beneficiaries.
• On May 24, 2010, CMS sent an email announcement to providers regarding the impact of the Affordable Care Act on payments under the skilled nursing facility (SNF) PPS for FY 2011. The announcement highlights the interaction between provisions that delay the introduction of the Resource Utilization Groups, version 4 (RUG-IV) case mix classification system until FY 2012, require that version 3.0 of the Minimum Data Set (MDS 3.0) Resident Assessment Instrument be implemented as planned in FY 2011, and require the concurrent therapy and look-back revisions to be applied in FY 2011.
• HHS and the Department of Justice (DOJ) have issued a press release highlighting provisions in the new health reform law that will build on current anti-fraud initiatives.
• CMS is sending a mailing to Medicare beneficiaries on "immediate benefits they may see from the enactment of the Affordable Care Act," including changes to the Medicare Part D drug program, preventive benefits, Medicare Advantage program, and insurance reforms.

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CMS has issued two regulations implementing Affordable Care Act provisions impacting hospital inpatient prospective payment system (IPPS) and long-term care hospital (LTCH) prospective payment system (PPS) payments.

• First, CMS has issued a “supplement” to its May 4, 2010 fiscal year (FY) 2011 IPPS and LTCH PPS proposed rule to implement provisions of the Affordable Care Act relating to FY 2011 Medicare payments for these facilities. CMS estimates that the supplemental rule would decrease cumulative operating and capital payments for IPPS providers by $820 million, while increasing LTCH payments by $13 million for FY 2011 (which is less than the prior estimate of a $41 million increase LTCH payments in FY 2011). Among other things, the supplemental proposed rule implements Affordable Care Act provisions that: reduce the FY 2011 IPPS market basket update by 0.25 percentage points and reduce the FY 2011 LTCH PPS annual update by 0.5 percentage points; provide additional payments for hospitals in counties with low per-enrollee Medicare spending; revise the hospital wage index for hospitals in frontier states; expand eligibility for certain low-volume payment adjustments; revise geographic reclassification eligibility standards; establish a national (rather than statewide) budget neutrality adjustment to the calculation of the rural floor for hospital wage index; extend the Medicare Dependent Hospitals program; and adjust payments to critical access hospitals for certain outpatient facility and ambulance services. With regard to LTCHs, the supplemental proposed rule extends for an additional two years provisions of the Medicare, Medicaid, and SCHIP Extension Act of 2007 (MMSEA) affecting certain LTCHs and LTCH satellite facilities, including (1) relief from payment adjustments for LTCHs whose admissions from co-located or non co-located hospitals exceed a certain threshold (commonly referred to as the "25% Rule"), (2) the moratorium on establishing new LTCHs and LTCH satellite facilities or expanding bed capacity in existing facilities, (3) the application of an adjustment for short stay outlier discharges, and (4) a one-time adjustment of the standard federal rate. The supplemental rule will be published in the Federal Register on June 2, 2010.  Note that CMS had provided conflicting information about the comment deadline for the supplemental rule; a separate correction notice clarifies that the comment deadline is June 18, 2010. 
• Second, on June 2, 2010, CMS is publishing final wage indices, hospital reclassifications, payment rates, impacts, and other related tables effective for the FY 2010 IPPS and rate year 2010 LTCH PPS, reflecting changes mandated by the Affordable Care Act applicable to rates during the remainder of FY/RY 2010 (April 1, 2010–September 31, 2010). These provisions require the extension of the expiration date for certain geographic reclassifications and special exception wage indices through September 30, 2010; and certain market basket updates for the IPPS and LTCH PPS. The standard federal rate for discharges under LTCH PPS occurring on or after April 1, 2010 is revised to $39,794.95. This change reflects a decrease from $39,896.65 established in the original LTCH PPS rule for RY 2010. The revised standard federal rates described in the notice are effective for payment years beginning October 1, 2009, although hospitals are paid based on these rates for discharges on or after April 1, 2010.

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The Health Resources and Services Administration (HRSA) has published an interim final rule with request for comment regarding its definition of an “underserved rural community” for purposes of the Rural Physician Training Grant Program under the Affordable Care Act. The interim final rule is effective 30 days after publication, and HRSA will accept comments on the definition until July 26, 2010. 

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The PPACA established a tax subsidy for eligible small biotech companies known as the "qualifying therapeutic discovery project" credit. The tax subsidy consists of $1 billion of tax credits or, at the taxpayer's election, cash grants for "qualified investments" made by small biotech companies for the development of new therapies to prevent, diagnose and treat acute and chronic diseases. On May 21, 2010, the Internal Revenue Service (IRS) issued a notice establishing the program and announcing the procedures for applying for credits or cash grants.  A Reed Smith tax alert regarding the IRS guidance is available here.

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On May 21 CMS issued a revised version of its program instructions for the Medicare Coverage Gap Discount Program, which was established by the Patient Protection and Affordable Care Act (PPACA) as amended by the Health Care and Education Reconciliation Act of 2010, including CMS's responses to public comments received on its April 30 draft document. By way of background, effective January 1, 2011, the Discount Program generally will make available to Medicare beneficiaries in the Part D coverage gap (sometimes called the "donut hole") manufacturer discounts equal to 50% of the negotiated price of the drug, except with respect to generic drugs. Among many other things, in the updated guidance, CMS: states that it expects all manufacturers of applicable drugs will sign discount agreements and that it does not intend to apply its "extenuating circumstances" authority for 2011 to allow Part D coverage for manufacturers which do not do so; indicates that it expects manufacturers will continue to negotiate with Part D sponsors and other entities to provide rebates on Part D drugs purchased throughout the Part D benefit, and specifically during the coverage gap; reminds Part D sponsors that they will have the opportunity to make formulary changes during the August update window if necessary to address contracting changes; requires retroactive adjustments to applicable discounts when necessary to reflect the retroactive changes to the claim or beneficiary eligibility; states that the invoices to be sent to manufacturers will include "certain claim-level detail"; and indicates that employer group waiver plans will be subject to the program if their benefit designs include a coverage gap, but that they would not receive prospective payments for the program.

Also on May 21, 2010, CMS released a draft model agreement to be used by the HHS Secretary and manufacturers under the Medicare Coverage Gap Discount Program. The draft model agreement released by CMS on May 21 lists 13 specific responsibilities for Part D drug manufacturers. In addition to agreeing to provide the 50% discount for covered Part D drugs, the manufacturer is expected to, among other things: pay each Part D sponsor via electronic funds transfer within 14 days of being invoiced by the CMS contractor for the total quarterly applicable discounts; collect and make available relevant data, including utilization and pricing information; and submit to periodic audits of this data; agree to comply with all requirements imposed by the Secretary for purposes of administering the program; comply with all applicable confidentiality requirements of HIPAA; and provides a dispute resolution mechanism for invoiced amounts disputed by manufacturers, with ultimate appeal to the CMS Administrator, whose decision is final and binding. Contrary to the statement in the revised program instructions, the draft agreement does not provide for any claims-level information to be provided to manufacturers, instead defining the information to be provided as only "summary-level." CMS will not revise the standard agreement based on negotiations with individual manufacturers. Comments on the draft model agreement, which was published in the Federal Register on May 26, will be accepted until June 21, 2010.

The CMS notice also announces a public meeting on June 1, 2010 in Baltimore, Maryland to discuss the draft agreement. At the meeting, CMS will review the Discount Program and draft model agreement, and the agency intends to hear panels of various stakeholders and allow time for questions and answers. 

Separately, on May 21, CMS posted a document entitled “Delayed, Incorrect, and Non-Reporting of Monthly & Quarterly AMP."  The document responds to instances in which drug manufacturers submit information to CMS on why they cannot submit Medicaid average manufacturer price (AMP) data by the required deadline, or why reported AMPs were not calculated according to CMS guidance. CMS is "notifying manufacturers that submitting documentation to CMS explaining the reasons for delayed, incorrect, or non-reporting of AMP data for any reporting period does not discharge the manufacturer from its reporting requirements under Section 1927 of the Act, nor does it shield the manufacturer from possible penalties authorized by section 1927(b)(3)." CMS points out, however, that, there are regulatory provisions addressing situations in which a manufacturer becomes aware that its pricing data may be incomplete or its assumptions may have been incorrect and the manufacturer will not be able to correct or update its pricing in time for monthly or quarterly data submission deadlines. In such cases, the manufacturer may make certain reasonable assumptions and calculate monthly AMPs based on the best data available at the time of submission and then update the pricing data as soon as possible, according to the terms of the statute and rebate agreement.

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On May 13, 2010, the Internal Revenue Service, Employee Benefits Security Administration, and HHS published an interim final rule with request for comment that implements the PPACA requirement that health plans and issuers that offer dependent coverage make the coverage available until a child reaches the age of 26.  The rule is effective July 12, 2010, and comments will be accepted until August 11, 2010. These interim final regulations generally apply to plan/policy years beginning on or after September 23, 2010. HHS has posted additional background information on its Office of Consumer Information and Insurance Oversight web site.

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This post was written by Paul W. Pitts.

CMS published an interim final rule with comment period on May 5, 2010 implementing several enrollment and documentation changes to the Medicare and Medicaid programs as mandated by the PPACA. The rule is effective on July 6, 2010 and comments will be accepted through the effective date. In the final rule, CMS requires providers and suppliers to include their NPI on all Medicare enrollment applications, as well as all claims submitted to the Medicare and Medicaid programs. In addition, Part B services must be ordered or referred by a physician or, when permitted, another eligible professional. The final rule also requires physicians and other eligible professionals who order or refer Part B services for Medicare beneficiaries to be enrolled in the Medicare program or maintain a valid opt-out record. With respect to home health services, the services must be ordered by a physician (not an “eligible professional”). All claims submitted for Part B items or services must contain the legal name and NPI of the physician or eligible professional who ordered or referred the item or service. In addition, the rule requires both the furnishing and ordering provider or supplier of DMEPOS, home health, laboratory, imaging, or specialist services to maintain documentation of the order or referral for 7 years, including the NPI of the ordering or referring physician or eligible professional. The documentation of the order or referral must be supplied to CMS or the Medicare contractor upon request. Failure to comply with the documentation requirements may result in a 1 year revocation of enrollment and billing privileges in the Medicare program. Although much of the final rule was mandated by various sections of the PPACA, CMS is using its discretion to expand ordering and referring requirements to all Part B items and services except prescribed drugs. In the preamble to the final rule, CMS indicates that it “reserves the right” to apply these enrollment and ordering requirements to Part B drugs within the next year. 

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On May 5, 2010, the Department of Health and Human Services (HHS) published an interim final rule with comment period on the PPACA’s Early Retiree Reinsurance Program, which will reimburse participating employment-based plans for a portion of the cost of health benefits for early retirees and their spouses, surviving spouses, and dependents. The Secretary will reimburse plans for certain claims between $15,000 and $90,000 (indexed for inflation). The PPACA requires the Secretary to establish this temporary program not later than 90 days after enactment (June 21, 2010) and terminate the program by January 1, 2014. Funding for the program is limited to $5 billion. The rule is effective June 1, 2010, although HHS will accept comments on the document until June 4, 2010. 

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HHS published an interim final rule with comment period May 5, 2010 implementing a PPACA provision requiring the establishment of an internet website or “web portal” through which individuals and small businesses can obtain information about insurance coverage options in their state. Specifically, the rule adopts the categories of information that will be collected and displayed, and specifies the data HHS will require from issuers and request from states, associations, and high-risk pools to create this content. The rule is effective May 10, 2010; comments will be accepted until June 4, 2010.

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The Health Resources and Services Administration (HRSA) has announced its intent to use a negotiated rulemaking process to establish a comprehensive methodology and criteria for designation of medically underserved populations and primary care health professions shortage areas, as required by the PPACA. As part of this process, HRSA intends to establish a Negotiated Rulemaking Committee. HRSA is seeking comments on its proposed process, as outlined in the notice, along with nominations to participate in the committee; the deadline for submissions is June 10, 2010. 

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CMS has released several manual updates and other transmittals regarding implementation of PPACA policies, including the following:

• Revised Payment Files for the 2010 Medicare Physician Fee Schedule Database and Retroactive Provisions under the PPACA;. 
• Multiple Procedure Payment Reduction on the Technical Component of Certain Diagnostic Imaging Procedures;
• Systems Changes Necessary to Implement the PPACA Section 6404 - Maximum Period for Submission of Medicare Claims Reduced to Not More Than 12 Months; and
• Revised Outpatient Prospective Payment System Addenda A and B for January and April 2010 to reflect the PPACA.

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CMS has released for comment draft program instructions to Part D plan sponsors regarding implementation of the Medicare Coverage Gap Discount Program, enacted by the PPACA as amended by the Health Care and Education Reconciliation Act of 2010 (Reconciliation Act). In short, effective January 1, 2011, the Discount Program generally will make available to Medicare beneficiaries in the Part D coverage gap (sometimes called the "donut hole") manufacturer discounts equal to 50% of the negotiated price of the drug, except with respect to generic drugs. The draft instructions state that, with the exception of 2011, a drug will only be covered under Part D if the manufacturer has a signed agreement with CMS to provide the discount on coverage gap claims for all of its applicable drugs. CMS notes that because of the timing of Part D plan formulary submissions, CMS must allow coverage in 2011 of Part D drugs irrespective of manufacturer discount agreements, which could mean that some brand-name drugs on plan formularies will not be discounted in the coverage gap next year. CMS will provide additional guidance if this situation occurs. As also discussed in the draft program instructions, Part D sponsors will be required to provide the applicable discounts at point-of-sale, using funds provided by CMS through monthly prospective payments to pay pharmacies. CMS proposes to use a contractor to collect discount payments from manufacturers quarterly, based on new information to be submitted by Part D plan sponsors to CMS as part of prescription drug event (PDE) data. The guidance also covers such issues as enrollee dispute resolution, program monitoring/oversight, and discounts for beneficiaries with supplemental drug coverage. CMS will accept comments on the draft program instructions until May 14, 2010, and the agency will issue final program instructions after considering all public comments.

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This post was written by Elizabeth B. Carder-Thompson, Carol Loepere,  Joseph W. Metro, and Scot T. Hasselman.

We want to alert our manufacturer clients to the potential importance of a specific provision included in our analysis of the recent health care reform legislation. As we note at page 108 of our memorandum:

Medicaid Exclusion from Participation Relating to Certain Ownership, Control, and Management Affiliations (Sec. 6502)

[T]his provision requires Medicaid agencies to exclude individuals or entities from participating in Medicaid for a specified period of time if the entity or individual owns, controls, or manages an entity that: (1) has failed to repay overpayments during the period as determined by the Secretary; (2) is suspended, excluded, or terminated from participation in any Medicaid program; or (3) is affiliated with an individual or entity that has been suspended, excluded, or terminated from Medicaid participation.

In recent years, a number of pharmaceutical and device manufacturers that have been subject to investigation and enforcement activity by the Office of Inspector General, the Department of Justice, and/or state entities, have opted to have subsidiaries -- sometimes all but defunct ones -- plead guilty to a criminal kickback charge for which they are excluded from participation in Medicare and Medicaid under the mandatory exclusion provisions of 42 U.S.C. 1320a-7(a). The parent organization or another subsidiary then has continued to conduct business as usual, though typically subject to a Corporate Integrity Agreement.

The cited provision in the PPACA legislation could be interpreted to mean that, if a pharmaceutical manufacturer's subsidiary or affiliate takes a plea and is excluded, then state Medicaid programs must exclude the parent company from Medicaid participation. This in turn means that the parent's products will not be reimbursed by Medicaid programs -- in effect, that patients will not have access to that manufacturer's products. This is a draconian measure not previously contemplated as a mandatory matter. Further, such an action could be a predicate for Medicare exclusion as well. There remain some undefined terms in the legislation (for example, the period of exclusion), and it is unclear whether state Medicaid agencies might interpret the provision to allow them to adopt some type of "permissive exclusion" process, rather than having exclusions be automatic.

While at first blush this provision appears to be adverse to manufacturers in the sense that it authorizes additional sanctions, its practical implications in the context of global resolutions of dual track criminal-civil investigations are less clear. On the one hand, it could arguably provide even greater leverage to prosecutors than already exists. On the other hand, since the exclusion implications of a criminal kickback plea would likely be wholly unacceptable to a manufacturer, it could either act as a barrier to global resolutions or alternatively might force the parties to consider other sorts of pleas that are not subject to mandatory exclusion (e.g., pleas to FDA violations).

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CMS has issued guidance to State Medicaid Directors on the Medicaid prescription drug rebate provisions of the Patient Protection and Affordable Care Act (PPACA). Specifically, the letter addresses the increased rebate percentages for covered outpatient drugs dispensed to Medicaid patients, the extension of prescription drug rebates to covered outpatient drugs dispensed to enrollees of Medicaid managed care organizations, and the rebate offset associated with the increase in the rebate percentages (designed to ensure that savings resulting from the increases in the rebate percentages will flow to the federal government rather than the states). CMS also released an informational announcement on PPACA provisions impacting institutional providers. The announcement includes a brief overview of PPACA section 3401, which imposes a 0.25 percentage point reduction to the market basket updates for inpatient acute hospitals, long-term care hospitals (LTCHs), and inpatient rehabilitation facilities for fiscal year (FY) 2010, effective for discharges on or after April 1, 2010. The update also addresses PPACA sections 3137 and 10317, modifying certain hospital reclassification policies with October 1, 2009, and April 1, 2010 effective dates. While additional information will be forthcoming, CMS notes that providers will begin seeing payments under these provision in late April or early May. Finally, HHS has posted a fact sheet on the PPACA’s new temporary high risk pool program for individuals who are uninsured because of pre-existing conditions, including the estimated state allotments under this program.

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As focus shifts away from Congressional health reform activity, states are gearing up to act on the many PPACA provisions requiring their attention. Among other things, states will be looking to implement insurance market reforms; establish insurance exchanges; comply with new Medicaid eligibility, benefits, reimbursement and other policy revisions; and pursue funding opportunities under a variety of health policy grants and demonstration projects. A number of states already have created new state agencies or appointed working groups to meet these PPACA responsibilities. For instance, Colorado Governor Bill Ritter has named a Director of Health Reform Implementation and established an new Interagency Health Reform Implementing Board, and Maryland Governor Martin O’Malley has signed an executive order creating the Maryland Health Care Reform Coordinating Council. Michigan Governor Jennifer Granholm has established a Health Insurance Reform Coordinating Council and centralized health reform web site for state residents. Likewise, Wisconsin Governor Jim Doyle has established a state Office of Health Care Reform, along with a new website with information about reform implementation. State health reform implementation activities can be expected to accelerate in the coming weeks, particularly to address Medicaid and insurance market provisions with 2010 effective dates.

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On April 19, 2010, HHS published a notice announcing the creation of the "Office of Consumer Information and Insurance Oversight" within the HHS Office of the Secretary" to implement the provisions of the health reform bill that address private health insurance.  The Office consists of the following components:

• Office of the Director -- Provides executive direction, leadership, and support to the entire Office.
• Office of Oversight  -- Responsibilities include implementing and enforcing new rules governing the insurance market and medical loss ratios; performing rate reviews; and issuing rate review grants to states.
• Office of Insurance Programs -- Tasked with administering temporary high-risk pool programs and associated funding to states and the early retiree reinsurance program.
• Office of Consumer Support  -- Responsibilities include compiling comparative pricing data for the HHS web site; providing consumer assistance with the new health insurance system, and issuing consumer assistance grants to states.
• Office of Health Insurance Exchanges -- Responsible for developing and implementing policies for state-based exchanges; issuing planning grants to states; and overseeing the operations of exchanges. 

HHS also has established an OCIIO web page.

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Now that the Patient Protection and Affordable Care Act of 2010 (PPACA) and the companion Health Care and Education Reconciliation Act of 2010 (Reconciliation Act) have been enacted, attention shifts to analysis and implementation efforts. Reed Smith has prepared a number client alerts analyzing various aspects of the new health reform legislation, including a major alert concentrating on those PPACA provisions we believe are of most interest to health care providers and medical device and pharmaceutical manufacturers, along with summaries of major tax-related provisions of the PPACA, PPACA provisions impacting health plans, and the PPACA’s new tax incentives for small biotech companies. Future publications are planned, and will be available here.   

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On April 14, 2010, the Department of Health and Human Service (HHS), along with the Internal Revenue Service and the Employee Benefits Security Administration, published a notice soliciting comments on sections 1001 and 10101 of the PPACA. These provisions added section 2718 of the Public Health Service Act (PHS Act), which, among other things, requires health insurance issuers offering individual or group coverage to submit annual reports to the Secretary on the percentages of premiums spent on reimbursement for clinical services and activities that improve health care quality, and to provide rebates to enrollees if this spending does not meet minimum standards for a given year. Section 1562 of PPACA also added section 715 of the Employee Retirement Income Security Act of 1974 and section 9815 of the Internal Revenue Code of 1986, which effectively incorporate by reference section 2718 and other amendments to the PHS Act. The notice invites public comments in advance of future rulemaking, with particular emphasis on specific questions regarding: actual medical loss ratio (MLR) experience and minimum MLR standards; uniform definitions and calculation methodologies; level of aggregation; data submission and public reporting; rebates; federal income tax; enforcement; and economic analysis. Comments will be accepted until May 14, 2010.  

In addition, HHS published a second notice on April 14 requesting comments regarding Section 1003 of the PPACA, which requires the HHS Secretary to work with states to establish an annual review of unreasonable rate increases, monitor premium increases, and award grants to states for their rate review process. Specific areas in which HHS seeks comments include: rate filings and review of rate increases; defining unreasonable premium rate increases; public disclosure; exclusion from the health insurance exchange; and grant allocation. Comments will be accepted until May 14.   

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HHS Secretary Kathleen Sebelius has issued a letter to governors and independent insurance commissioners to gauge interest in the temporary high risk pool program established by the PPACA to provide coverage to people who are uninsured because of pre-existing conditions. CMS also has issued initial guidance to states on the new state option under the PPACA to provide Medicaid coverage for the lowest income adults without regard to disability, parental status, or most other categorical limitations. Likewise, CMS has issued a number of informal announcements about implementation of various PPACA provisions, including announcements addressing:

• The Extension of Ambulance Add-Ons for Ambulance Services
• Timely Filing Requirements for Medicare Fee-for-Service Claims
• Medicare Home Health Rural Add-On
• Extension of Moratorium that Allows Independent Laboratories to Bill for the Technical Component of Physician Pathology Services Furnished to Hospital Patients
• Extension of Therapy Cap Exceptions Process
• Continuation of Payments to Indian Health Service Providers, Suppliers, Physicians, and other Practitioners for Certain Part B Services
• Extension of the Outpatient Hold-Harmless Provision
• Extension of Reasonable Cost Payment for Clinical Lab Tests Performed by Hospitals with Fewer than 50 Beds in Qualified Rural Areas

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