Tag Archives: health reform

HEALTH REFORM: RAC Roundup: What’s on the Horizon for Medicare Part C and D RACs? Medicaid RAC Implementation Is Underway

From its inception as a three-state pilot, the Recovery Audit Contractor (“RAC“) program has grown to a permanent national program accounting for the collection of $398 million in Medicare overpayments in the first quarter of fiscal year (“FY“) 2012 alone.[1] Over the next year, the RAC program will expand its reach beyond the current focus on fee-for-service (“FFS“) payments under Medicare Parts A and B to include Medicare Part C (Medicare Advantage) and Part D (Prescription Drug Benefit) as well as state Medicaid programs. As Medicaid RAC programs get underway in the states, and private insurers offering coverage under Medicare Part C and D prepare for new, yet still undefined, RAC efforts, it is more important than ever for providers to make sure that their processes for documentation, billing, and coding are accurate and comprehensive. 

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HEALTH REFORM: CMS Issues Proposed Rule Relating to Manufacturer Rebates and Reimbursement Amounts for Outpatient Prescription Drugs Dispensed to Medicaid Beneficiaries

This issue of Implementing Health & Insurance Reform summarizes and discusses some issues raised by the proposed rule (“Proposed Rule”) that the Centers for Medicare & Medicaid Services (“CMS”) published on February 2, 2012, to implement changes to the Medicaid Drug Rebate Program (“MDRP”) and to reimbursement limits for outpatient drugs covered by Medicaid.

In Part 1, we discuss proposals relating to the MDRP that would change the manner in which pharmaceutical manufacturers calculate Average Manufacturer Price (“AMP”) and Best Price for Medicaid-covered outpatient drugs and the manner in which rebates that manufacturers pay on prescriptions of those drugs dispensed to Medicaid beneficiaries are calculated. The topics covered include: the sales and price concessions manufacturers would include in their calculate AMP calculations, as well as those that would be excluded; the alternate methodology manufacturers would use to calculate AMP for so-called “5i” drugs not generally dispensed in retail community pharmacies; the calculation of Medicaid rebates for line extensions of other drugs; and new reporting obligations for manufacturers. CMS is accepting comments on the Proposed Rule until April 2, 2012.

See right or click here to download the full alert (PDF).

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HEALTH REFORM: CCIIO Issues Bulletin on Plans to Define the Essential Health Benefits Package: Providing States with a Significant Role While Still Leaving Room for Public Input

On December 16, 2011 the Center for Consumer Information and Insurance Oversight (“CCIIO”) within the Centers for Medicare & Medicaid Services (“CMS”) released a “bulletin” to “provide information and solicit comments on the regulatory approachthat the Department of Health and Human Services (“HHS”) plans to propose to define essential health benefits (“EHB”) under section 1302 of the Affordable Care Act.”[1]Public comments must be submitted to CMS by January 31, 2012. Comments should be sent to EssentialHealthBenefits@cms.hhs.gov.

As we described in more detail in earlier publications (see the BNA Health Insurance Report article entitled The Importance of Stakeholder Participation in the Process to Define the ‘Essential Health Benefits Package‘”; the Epstein Becker Green Implementing Health and Insurance Reform alert entitled “Meeting the Requirements for Defining the ‘Essential Health Benefits Package’: DOL Publishes Survey of Employer-Sponsored Coverage“; and the Law360 article entitled “Defining the Essential Health Benefits Package“), the scope of the EHB package is defined in the Patient Protection and Affordable Care Act (“ACA”) to include the following 10 categories of services:

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HEALTH REFORM: CCIIO Issues Bulletin on Plans to Define the Essential Health Benefits Package: Providing States with a Significant Role While Still Leaving Room for Public Input

On December 16, 2011 the Center for Consumer Information and Insurance Oversight (“CCIIO”) within the Centers for Medicare & Medicaid Services (“CMS”) released a “bulletin” to “provide information and solicit comments on the regulatory approach that the Department of Health and Human Services (“HHS”) plans to propose to define essential health benefits (“EHB”) under section 1302 of the Affordable Care Act.”[1] Public comments must be submitted to CMS by January 31, 2012.Comments should be sent to EssentialHealthBenefits@cms.hhs.gov.

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HEALTH REFORM: CMS Issues Proposed Rules on Federal "Sunshine" Law for Manufacturers and GPOs

On December 14, 2011, the Centers for Medicare & Medicaid Services (“CMS”) issued long-awaited proposed rules with a lengthy preamble (collectively referred to herein as “Proposed Rules”) relevant to Section 6002 of the Patient Protection and Affordable Care Act, also known as the Physician Payment Sunshine Act. The Proposed Rules, along with sample reporting templates, are available athttps://s3.amazonaws.com/public-inspection.federalregister.gov/2011-32244.pdf.

Generally, the Physician Payment Sunshine Act requires applicable pharmaceutical, medical device, biological and medical supply manufacturers to report annually certain information to CMS regarding “payments and transfers of value” provided to “covered recipients.” The Physician Payment Sunshine Act also requires manufacturers and group purchasing organizations (“GPOs”) to report annually certain information to CMS regarding “ownership or investment interests” held by physicians and their immediate family members. The first report is due March 31, 2013. For an overview of the Physician Payment Sunshine Act, see the Epstein Becker Green health reform alert entitled “Federal Transparency Is Now a Reality: Challenges and Opportunities for Pharma, Devices, and PBMs.”

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HEALTH REFORM: Revisiting the Medicare Shared Savings Program: An Interagency Effort to Promote Accountable Care

On October 20, 2011, the Centers for Medicare & Medicaid Services (“CMS”) released its final rule (“Final Rule”) implementing the voluntary Medicare Shared Savings Program (“Program”) for accountable care organizations (“ACOs”). The Program was established by Section 3022 of the Patient Protection and Affordable Care Act. The Final Rule was released in conjunction with revised antitrust guidance from the Federal Trade Commission (“FTC”) and the Department of Justice (“DOJ”), as well as with the establishment by CMS and the Department of Health and Human Services’ Office of Inspector General (“OIG”) of several waivers from various fraud and abuse laws. As part of this interagency effort to facilitate participation in the Program, the Internal Revenue Service (“IRS”) also issued a fact sheet regarding nonprofit organizations’ participation in ACOs.

Click here to download the entire alert in PDF format.

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HEALTH REFORM: CMS Innovation Center Announces Four Models in Bundled Payments for Care Improvement Initiative

On August 23, 2011, the Centers for Medicare & Medicaid Services (“CMS”) Innovation Center announced a new initiative to encourage health care providers to better coordinate patient care.[1] The Bundled Payments for Care Improvement Initiative (“Bundled Payments Initiative”) seeks to align the financial incentives among hospitals, physicians, and non-physician practitioners through the use of a single negotiated payment for all services provided during an episode of care. The use of a bundled payment is expected to encourage hospitals, doctors, and other specialists to coordinate in treating a patient’s specific condition during a single hospital stay and recovery.

This is one of several new initiatives from the CMS Innovation Center intended to change the existing Medicare payment structure from one that pays for the quantity of care to one that pays for the quality of care. Participation in the Bundled Payments Initiative may serve as a first step for forming partnerships to improve care coordination and encourage participants to move into initiatives aimed at improving population health.

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HEALTH REFORM: Updated – HHS Publishes Health Insurance Premium Rate Review Final Rule, Amends Rule to Include Policies Sold Through Associations, and Lists States with Effective Rate Review Programs

EBG Introduces Interactive National Rate Review Scorecard

This Client Alert updates and replaces the Implementing Health and Insurance Reform alert issued on August 19, 2011, titled “HHS Publishes Health Insurance Premium Rate Review Final Rule Effective September 1st and List of States with Effective Rate Review Programs.”

On May 23, 2011, the Center for Consumer Information & Insurance Oversight (CCIIO), in the Centers for Medicare & Medicaid Services (CMS) of the United States Department of Health and Human Services (HHS) published its Final Rule implementing Section 2794 of the Public Health Service Act (PHSA). This Section requires HHS to establish a process for the review of “unreasonable” health insurance premium rate increases in the individual and small group markets. The Final Rule[1] remains largely unchanged from the Proposed Rule, with important exceptions.[2] The Final Rule and the key changes are summarized in this Client Alert.

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HEALTH REFORM: HHS Publishes Health Insurance Premium Rate Review Final Rule Effective September 1st and List of States with Effective Rate Review Programs

On May 23, 2011, the Center for Consumer Information & Insurance Oversight (CCIIO), in the Centers for Medicare & Medicaid Services (CMS) of the United States Department of Health and Human Services (HHS) published its Final Rule implementing Section 2794 of the Public Health Service Act (PHSA). This Section requires HHS to establish a process for the review of “unreasonable” health insurance premium rate increases in the individual and small group markets. The Final Rule[1] remains largely unchanged from the Proposed Rule, with important exceptions.[2] The Final Rule, and the key changes, are summarized in this Client Alert.

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HEALTH REFORM: OPM RFI Regarding Multi-State/National Insurance Plans

On June 16, 2011, the Office of Personnel Management (“OPM”) released a Request for Information (“RFI”) regarding the requirements of Section 1334 of the Affordable Care Act (“ACA”)[1] for OPM to contract with health insurers to offer multi-state qualified health plans (“MSQHPs”) to the individual and small-group markets. The purpose of the RFI is to provide OPM with information that will allow it to better understand the “interests and capabilities” of health insurance issuers that are potential MSQHP contractors. The contours of OPM’s implementation of the MSQHP contracts will have a significant impact on health insurance issuers that will participate in the state-based “American Health Benefit Exchanges” (“Exchanges”) for the individual and small-group markets.

This alert will describe the areas of feedback requested by OPM regarding implementation of MSQHPs. Although this document is not a Request for Proposal, the questions posed by the RFI are designed to aid OPM in the development of procurement documents. The RFI informs respondents that those who provide a “thoughtful, detailed response” may be invited to a one-on-one meeting with OPM for a more in-depth discussion. Accordingly, those health insurance issuers with a serious interest in participating as a MSQHP, either individually or as a member of a joint venture or teaming arrangement, would be well advised to submit a thoughtful response to secure the maximum opportunity to shape the procurement process. Respondents may protect the proprietary information in their response by marking it with a restrictive legend, and any disclosure by OPM to third parties for evaluation purposes will be subject to confidentiality obligations.

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