PPACA Impact and Opportunities

Continuing the Spotlight on Medicare Providers and Suppliers: New OIG Report Details Program Integrity Problems with Newly Enrolled Medical Equipment Suppliers

Epstein Becker & Green, P.C. — Tue, 17 Jan 2012 12:29:58 -0800

by George B. Breen and Amy F. Lerman

According to a new report released in December 2011 by the Office of Inspector General (“OIG”), more than 25 percent of all durable medical equipment (“DME”) suppliers faced enforcement actions by the Centers for Medicare & Medicaid Services during their first year of participation in the Medicare program. In its report, the OIG reviewed a sample of 229 newly enrolled suppliers and examined multiple data sources in order to assess the extent, if any, that the suppliers in the sample had program integrity issues. According to the report, during the first year of participation in the Medicare program, 26 percent of those suppliers classified as medium or high risk by the National Supplier Clearinghouse (“NSC”) for committing fraud, and 2 percent of those deemed low-risk by the NSC, had their Medicare billing privileges revoked or were subjected to prepayment claims review. This Alert addresses why DME suppliers, being among those that are subject to the highest levels of screening and scrutiny, need to be aware of these finding and offers thoughts on what suppliers need to do now to prevent and detect potential fraud, avoid prepayment review, and/or revocation of Medicare billing privileges.

Read the full alert here

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

Epstein Becker & Green, P.C. — Fri, 06 Jan 2012 12:39:40 -0800

by Lynn Shapiro Snyder and Lesley R. Yeung

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 plans to propose to define essential health benefits ("EHB") under section 1302 of the Affordable Care Act. The "bulletin" provides information to stakeholders (i.e., consumers, states, employers, and health insurance issuers) about what benefits are likely to be required under the EHB package. CCIIO is proposing to give states a significant role in defining the EHB package by allowing them to select from one of four benchmark health plan types that will serve as the standard for the health plans offered through the new state exchanges starting in 2014. Public comments may be submitted to CMS by January 31, 2012. Comments should be sent to EssentialHealthBenefits@cms.hhs.gov. Stakeholders interested in the EHB package definition process should consider submitting comments and actively engaging in public dialogue with HHS on the process now.

Read the full alert here

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

Epstein Becker & Green, P.C. — Sat, 17 Dec 2011 12:12:09 -0800

by Sarah K. Giesting, Wendy C. Goldstein, Kathleen A. Peterson, and Natasha F. Thoren

On December 14, 2011, the Centers for Medicare & Medicaid Services issued long-awaited proposed rules (“Proposed Rules”) related to the federal Physician Payment Sunshine Act applicable to pharmaceutical, medical device, biological and medical supply manufacturers and group purchasing organizations (“GPOs”). The Proposed Rules outline CMS’s proposals regarding implementation of the Physician Payment Sunshine Act and seek comments regarding these proposals. This health reform alert provides an overview of the Proposed Rules and then discusses some key considerations for manufacturers and GPOs as they evaluate and prepare comments to the Proposed Rules.

Read the full alert here

HHS Announces First Insurance Premium Rate Review Determinations: Implications for Insurance Carriers and Future Rate Reviews

Epstein Becker & Green, P.C. — Tue, 06 Dec 2011 13:45:34 -0800

by Jesse M. Caplan and Serra J. Schlanger

On November 21, 2011, the Center for Consumer Information & Insurance Oversight, in the Centers for Medicare & Medicaid Services (“CMS”), announced its determination that a health insurance premium rate increase of 11.58 percent in the small group market in Pennsylvania represented an “unreasonable” rate increase, while an 11.10 percent increase in the individual market in Montana did not. These long-awaited determinations represent the first application of CMS’s rate review regulations under federal health reform.

This Implementing Health and Insurance Reform alert discusses these first federal rate review determinations, and their implications for insurance carriers and future insurance premium rate reviews. It also provides a link to Epstein Becker Green’s interactive National Health Insurance Rate Review Scorecard, which offers insurance carriers, lawyers, and other stakeholders an up-to-date resource on federal and state health insurance rate review programs, standards, and initiatives.

Read the full alert here

Medicare Providers and Suppliers Continue in the Spotlight: Medicare Providers and Suppliers Continue in the Spotlight

Epstein Becker & Green, P.C. — Tue, 06 Dec 2011 09:33:55 -0800

Expansion of the DMEPOS Competitive Bidding Program; Legislative Inquiry Related to Fraud and Abuse Enforcement Actions; and Automated Pre-Enrollment Provider Screening

by George B. Breen, Amy F. Lerman, Emily E. Bajcsi, Deepa B. Selvam

In order to be prepared for upcoming changes and to respond to new initiatives, providers and suppliers participating in Medicare must be aware of recent Congressional activity that would hold the federal government accountable for its intended enforcement efforts designed to curb health care fraud, waste, and abuse, as well as an effort by the Centers for Medicare & Medicaid Services (“CMS”) to implement automated pre-enrollment provider and supplier screening in January 2012. One example of the pressures that providers and suppliers face in this enhanced regulatory and enforcement climate is the upcoming expansion of the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (“DMEPOS”) Competitive Bidding Program, which is targeted to launch in July 2013 and for which the Round 2 bidding timeline was announced on November 30, 2011.

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Health Care Innovation in the Medicare Program: Value-Based Initiatives Beyond Accountable Care Organizations

Epstein Becker & Green, P.C. — Fri, 04 Nov 2011 06:23:42 -0800

by René Y. Quashie and Lynn Shapiro Snyder

As the health care industry analyzes the recently released final rule and related guidance regarding the Medicare Shared Savings Program (“MSSP”) for accountable care organizations (“ACOs”), it is important for the industry to also pay attention to key deadlines related to initiatives being implemented by the Center for Medicare and Medicare Innovation (“CMMI” or “Innovation Center”) within the Centers for Medicare & Medicaid Services (“CMS”).

While the MSSP ACO initiative is a permanent Medicare program, CMMI is developing and promoting other initiatives—some related to the MSSP, others not—which should be part of any provider’s considerations related to the “Medicare Menu” of options now available to customize an entity’s Medicare payment methodologies. This alert will address a number of key Medicare initiatives currently under way at the Innovation Center and another to be implemented by the Center for Medicare within CMS.

To explore the MSSP and other value-based initiatives further, Epstein Becker Green will cohost the following webcast:

Healthcare Transformation Accelerates:
What Could the MSSP and Other Value-Based Purchasing
Initiatives Mean for Your Organization?
Webcast: Nov. 9, 2011, 1 pm ET

Epstein Becker Green, KPMG Healthcare, and the JHD Group invite you to join the fourth webcast in a series that will explore the new regulations and the broader implications of moving toward payment systems that reward enhancements to quality, cost, and access.

The 120-minute session, which will dedicate 30 minutes to Q&A, will focus on how organizations can begin to connect the dots from the final MSSP rule to accountable care organizations, the increasing movement across the industry to new quality and cost-based payment models, and the regulations' strategic and operational implications for care delivery systems.

Read the full alert here Register for the webinar here

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

Epstein Becker & Green, P.C. — Thu, 27 Oct 2011 11:03:15 -0800

by Ross K. Friedberg, Shawn M. Gilman, Mark E. Lutes, David E. Matyas, René Y. Quashie, Serra J. Schlanger, Carrie Valiant, Dale C. Van Demark, and Lesley R. Yeung

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.

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

Epstein Becker & Green, P.C. — Fri, 16 Sep 2011 13:28:10 -0800

by Lesley R. Yeung, Shawn M. Gilman, and Serra J. Schlanger

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. 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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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

Epstein Becker & Green, P.C. — Wed, 14 Sep 2011 12:16:02 -0800

EBG Introduces Interactive National Rate Review Scorecard

by Jesse M. Caplan and Lynn Shapiro Snyder

Shortly after the September 1st effective date for the Centers for Medicare & Medicaid Services (CMS) Rate Review Regulations, the U.S. Department of Health and Human Services published an Amendment to the Final Rule that revises the definitions of “Individual Market” and “Small Group Market” to include insurance policies sold to individuals and small groups through associations, whether or not the applicable state includes association coverage in its own definitions of the individual and small group markets. CMS also recently added two more states to the list of states with “effective rate review programs” covering both the individual and small group insurance markets.

This updated Client Alert provides further analysis of these key changes. Featured in today’s BNA Health Insurance Report, this Client Alert also refers to Epstein Becker Green's new interactive National Health Insurance Rate Review Scorecard. The Scorecard offers insurance carriers, lawyers, and other stakeholders an up-to-date resource on federal and state health insurance rate review programs, standards, and initiatives.

Read the full alert online

Brandon C. Ge, a Summer Associate (not admitted to the practice of law) in Epstein Becker Green's Washington, DC, office, contributed significantly to the preparation of this alert.

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

Epstein Becker & Green, P.C. — Mon, 22 Aug 2011 06:33:29 -0800

EBG Introduces Interactive National Rate Review Scorecard

by Jesse M. Caplan and Lynn Shapiro Snyder

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 remains largely unchanged from the Proposed Rule, with important exceptions. The Final Rule, and the key changes, are summarized in this Client Alert.

In addition, CCIIO released its list of states with effective rate review programs. Rate increases affecting states with effective rate review programs will be reviewed by those states, while those increases in states determined not to have effective rate review programs will be reviewed by CMS. Now that this list has been published, health insurance issuers can better determine which government agencies will be responsible for reviewing their rate increases, what standards will be applied when determining whether such increases are “unreasonable,” and whether the rate increases are subject to disapproval.

This Client Alert also introduces EBG’s new interactive National Health Insurance Rate Review Scorecard. The Scorecard offers insurance carriers, lawyers, and other stakeholders an up-to-date resource on federal and state health insurance rate review programs, standards, and initiatives.

Read the full alert online

Brandon C. Ge, a Summer Associate (not admitted to the practice of law) in Epstein Becker Green's Washington, DC, office, contributed significantly to the preparation of this alert.

OPM RFI Regarding Multi-State/National Insurance Plans

Epstein Becker & Green, P.C. — Wed, 29 Jun 2011 12:24:30 -0800

by Lynn Shapiro Snyder, Shawn M. Gilman, Adam C. Solander, and Constance A. Wilkinson

On June 16, 2011, the Office of Personnel Management (“OPM”) released the Request for Information (“RFI”) regarding Section 1334 of the Affordable Care Act, which requires OPM to contract with health insurers to offer multi-state qualified health plans (“MSQHPs”). 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 will offer MSQHPs through Health Insurance Exchanges. This alert summarizes the substantive information requested by OPM in the RFI. Additionally, this alert provides the statutory context in which OPM is operating pursuant to Section 1334 of the Affordable Care Act.

Read the full alert online

David C. Gibbons, a Summer Associate (not admitted to the practice of law) in EpsteinBeckerGreen's Washington, DC, office, contributed significantly to the preparation of this alert.

Overview of Methodology for Determining PSA Shares for Accountable Care Organizations Participating in the Medicare Shared Savings Program

Epstein Becker & Green, P.C. — Fri, 10 Jun 2011 10:34:21 -0800

by Patricia M. Wagner and Ross K. Friedberg

Among the criteria that the “Proposed Statement of Antitrust Enforcement Policy Regarding Accountable Care Organizations Participating in the Medicare Shared Savings Program” (“Proposed Statement”) uses to evaluate an accountable care organization’s (“ACO’s”) risk of an antitrust challenge is the ACO applicant’s “market share” within each of its service lines. The market share is a measure of the share of services an ACO participant provides in its Primary Service Area (“PSA”) relative to other providers. The share of services that each ACO participant provides in its PSA is the key factor that the agencies are proposing to use for determining whether an ACO will receive “Safety Zone” protection from the antitrust laws or be subject to mandatory expedited review from the agencies in order to participate in the Medicare Shared Savings Program. To assist with the PSA analysis, we have provided in this alert a step-by-step description of the proposed method for calculating PSA shares as well as an illustration of the steps involved in calculating PSA shares.

Read the full alert online

Overview of the FTC/DOJ Proposed Statement of Antitrust Enforcement Policy Regarding Accountable Care Organizations Participating in the Medicare Shared Savings Program

Epstein Becker & Green, P.C. — Tue, 07 Jun 2011 10:23:19 -0800

by Patricia M. Wagner and Ross K. Friedberg

On April 19, 2011, the “Proposed Statement of Antitrust Enforcement Policy Regarding Accountable Care Organizations Participating in the Medicare Shared Savings Program” (“Proposed Statement”) was published in the Federal Register. As noted in the Proposed Statement, the antitrust enforcement agencies (the Department of Justice Antitrust Division and the Federal Trade Commission issued the Proposed Statement in response to a perceived preference by potential accountable care organization (“ACO”) participants to operate in both the Medicare and commercial markets. In order to “maximize and foster opportunities for ACO innovation, the Agencies wish both to clarify the antitrust analysis of newly formed collaborations among independent providers that seek to become ACOs in the Shared Savings Program and to coordinate the antitrust analysis with CMS review of those ACO applications.” This alert provides an overview of the Proposed Statement.

Read the full alert online

Meeting the Requirements for Defining the "Essential Health Benefits Package": DOL Publishes Survey of Employer-Sponsored Coverage

Epstein Becker & Green, P.C. — Tue, 17 May 2011 10:38:54 -0800

by Lynn Shapiro Snyder, Clayton J. Nix, and Lesley R. Yeung

The U.S. Department of Labor (“DOL”) released a survey report on April 15, 2011, that is being used to satisfy a requirement in the Patient Protection and Affordable Care Act (“ACA”) that the Secretary of Labor “conduct a survey of employer-sponsored coverage” as a condition precedent to the development of the “essential health benefits package” by the Secretary of Health and Human Services (“HHS”). This DOL survey is the first step in the process laid out in ACA for establishing the minimum benefits package to be offered in the various health insurance exchanges for which subsidies and tax credits will be available. Under ACA, the Secretary of HHS ultimately has the discretion for determining the “essential health benefits package,” which goes to the heart of federal health reform. Companies that are interested in the scope of the “essential health benefits package” will want to review not only this published DOL survey in detail, but also other DOL survey information, and should consider weighing in with the Secretary of HHS before any preliminary positions are published by HHS in proposed or interim final regulations.

Read the full alert online

Health Care and Life Sciences Employers: Let's Meet on 6/7/11 in Washington, DC at Our HEAL (Health Employment And Labor) Summit

Epstein Becker & Green, P.C. — Mon, 09 May 2011 11:04:27 -0800

Please join the attorneys of EpsteinBeckerGreen on June 7, 2011, at the National Press Club, as we present eight panels covering labor and employment topics that have increasingly impacted employers in the health care industry.

Our first panel, entitled Significant Labor and Employment Issues that Affect Health Entities, will include representatives from the health care industry, such as a hospitals, skilled nursing facilities, and emergency medical services. These executive panelists will discuss the critical labor and employment issues they are currently experiencing and the greatest challenges they expect to manage.

EpsteinBeckerGreen attorneys representing the Labor and Employment, Health Care and Life Sciences, and Corporate Services practices will review the issues of concern and, over the course of the day, offer practical advice and solutions.

For more details and registration information, please visit the EpsteinBeckerGreen HEAL Summit page.

We hope to meet you and other readers of this blog.

CMS Announces State Demonstration Project Initiative for Dual Eligibles: Is Your State on the List?

Epstein Becker & Green, P.C. — Tue, 26 Apr 2011 13:28:23 -0800

by Lynn Shapiro Snyder and Amy F. Lerman

On April 14, 2011, the U.S. Department of Health and Human Services announced several initiatives that will offer states more flexibility to adopt innovative new practices in order to provide better and more coordinated care for Medicare and Medicaid enrollees who are dually eligible under both of these programs. Under one of these initiatives, 15 states have been awarded $1 million contracts to support the design of state demonstration projects that will aim to improve the coordination of care for dual eligibles. The Centers for Medicare & Medicaid Services (“CMS”), through its newly formed Federal Coordinated Health Care Office, will evaluate the projects proposed by the 15 states. CMS hopes to implement the top strategies as soon as 2012. Providers and payors in selected states who currently treat a significant number of dual eligibles may want to contact their agency representatives to help influence the way in which their state intends to pursue this demonstration project initiative.

Download the full alert (PDF) Read the full alert online

Diving into the Federal Issuances Implementing the Medicare Shared Savings Program: A Summary of Topic Areas On Which Government Agencies Specifically Requested Public Comments

Epstein Becker & Green, P.C. — Tue, 19 Apr 2011 13:11:04 -0800

by Ross K. Friedberg, Shawn M. Gilman, and Lesley R. Yeung

On March 31, 2011, the Centers for Medicare & Medicaid Services, the Department of Health and Human Services' Office of the Inspector General, the Federal Trade Commission, the Department of Justice, and the Internal Revenue Service released four separate issuances providing the public with the opportunity to comment on the creation of accountable care organizations eligible for participation in the voluntary Medicare Shared Savings Program ("MSSP"). This alert sets forth a listing of each of the places in which the government agencies specifically request comments from the public. Even those organizations that ultimately may decide not to participate in the MSSP should still take advantage of this unique opportunity to provide these agencies with comments and help shape the modifications being proposed to the Medicare program.

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Making Accountable Care a Reality: Multiple Federal Agencies Issue Proposed Guidance on the Medicare Shared Savings Program

Epstein Becker & Green, P.C. — Fri, 08 Apr 2011 13:22:22 -0800

by Shawn M. Gilman, Douglas A. Hastings, Mark E. Lutes, David E. Matyas, Lynn Shapiro Snyder, Carrie Valiant, Dale C. Van Demark, Patricia M. Wagner, and Lesley R. Yeung

On March 31, 2011, the Centers for Medicare & Medicaid Services ("CMS") released for public comment a much-anticipated Notice of Proposed Rulemaking implementing the voluntary Medicare Shared Savings Program ("Program") for accountable care organizations ("ACOs"). Also on March 31, the Office of Inspector General, along with CMS, released a Notice with Comment Period to solicit comments regarding proposed waivers from the federal health care program fraud and abuse laws for provider payments made in connection with the Program. On the same day, the Federal Trade Commission and the Department of Justice issued a Notice with Comment Period soliciting comments regarding a "Proposed Statement of Antitrust Enforcement Policy Regarding Accountable Care Organizations Participating in the Medicare Shared Savings Program," and the Internal Revenue Service issued a notice outlining its analysis of tax-exempt organization participation in Medicare ACOs.

Below, we link to the first alert in a series that will examine these regulatory issuances as well as future government pronouncements, including those currently being formulated by the Center for Medicare and Medicaid Innovation, which was established under the Patient Protection and Affordable Care Act to test innovative payment and service delivery models to reduce federal program expenditures.

Download the full alert (PDF) Read the full alert online

Early Retiree Reinsurance Program Benefits Are Limited to Medicare-Eligible Services: Watch Out for Compliance with Additional Government Issuances

Epstein Becker & Green, P.C. — Wed, 16 Mar 2011 13:45:17 -0800

by Lynn Shapiro Snyder and Lesley R. Yeung

The Early Retiree Reinsurance Program (“ERRP”) was created by the Patient Protection and Affordable Care Act to provide financial assistance to employers, unions, and state and local governments to help them maintain health insurance coverage for early retirees age 55 and older. A report published by the Department of Health and Human Services on March 2, 2011, states that almost 5,500 plan sponsors have been approved to participate in the ERRP and that $535 million in ERRP reimbursement payments have been made to date. It is important for plan sponsors and third-party administrators to understand that the health benefit claims that qualify for ERRP reimbursement are only those for medical services that would be covered by the Medicare program. Compliance is essential for those participating in the ERRP, especially when Medicare rules are relevant to this federal program.

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Awaiting the Medicare Shared Savings Program Regulations: Progress on the Road to Accountable Care?

Epstein Becker & Green, P.C. — Thu, 17 Feb 2011 09:01:17 -0800

by Douglas A. Hastings

According to the Administrator of the Centers for Medicare & Medicaid Services (“CMS”), Dr. Donald M. Berwick, the long-awaited proposed regulations implementing the Medicare Shared Savings Program should be out soon. Given the incredible proliferation of policy, business, and legal thinking about accountable care organizations (“ACOs”) that has taken place since the passage of the Affordable Care Act (“ACA”) less than a year ago, CMS’s initial effort to describe a program of payment and delivery reform built around the ACO “model” will contribute importantly to the national dialogue on accountable care and will give providers a first look at CMS’s detailed requirements for the Medicare Shared Savings Program.

What, then, are some of the key issues that the regulations are likely to address by which we can evaluate the Medicare Shared Savings Program’s potential progress on the road to accountable care? The way CMS further defines ACOs and structures the Medicare Shared Savings Program, including possible risk sharing features, will not only ultimately determine the success of the Medicare ACO program but will also no doubt affect the shape of burgeoning ACO efforts at the state level for Medicaid programs and in the commercial market.

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