PPACA Impact and Opportunities : Health Care Lawyer & Attorney : Epstein Becker Green Law Firm : Insurance & Costs : Health Reform Musings Blog

Our colleagues at Epstein Becker Green have issued a client alert: "OIG Issues Updated Guidelines for Evaluating State False Claims Acts: Is More State Litigation on the Horizon?," by George B. Breen, Wendy C. Goldstein, and Daniel C. Fundakowski.

Following is an excerpt:

On March 15, 2013, the U.S. Department of Health and Human Services’ Office of Inspector General (“OIG”) released the Updated OIG Guidelines for Evaluating State False Claims Acts (“2013 Guidelines), which replaces the original version released in 2006.

The 2013 Guidelines describe OIG’s methodology for determining whether a state’s Medicaid false claims law satisfies the four requirements in Section 1909(b) of the Social Security Act (“Act”) that are necessary to qualify for a 10-percentage-point increase in the state share of Medicaid-related false claims recoveries. While Section 1909 of the Act does not require a state to enact false claims act legislation, only states that have enacted a qualifying law will be eligible for the 10-percentage-point increase in its share of Medicaid false claims recoveries.

Unquestionably, these recent changes have expanded provider liability under the federal False Claim Act, making it easier for relators to bring cases against health care providers, who may now be facing a more rigid regulatory regime. This recognition, coupled with a financial incentive, may spur state efforts to re-tool false claims statutes to comply with Section 1909 of the Act. Attendant with increased interest in Medicaid false claims actions will inevitably come increased compliance scrutiny. Accordingly, assessing compliance programs to ensure conformity with state payor programs is advised.

Read the full alert here.

Our colleagues at Epstein Becker Green have issued a client alert: "Key Compliance Actions for the New HIPAA Privacy Regulations," by Patricia M. Wagner, Pamela D. Tyner, and Leah A. Roffman.

Following is an excerpt:

As noted in previous Epstein Becker Green health reform alerts, on January 25, 2013, the long-awaited final omnibus rule (“Omnibus Rule”) issued by the U.S. Department of Health and Human Services was published in the Federal Register. The Omnibus Rule makes sweeping changes to the privacy and security regulations under the Health Insurance Portability and Accountability Act (“HIPAA”).

In light of the Omnibus Rule’s new requirements, business associates and covered entities should strongly consider reviewing their existing HIPAA privacy and security practices, including compliance policies and business associate agreements. While the Omnibus Rule takes effect on March 26, 2013, affected parties have until September 23, 2013, to come into compliance with most of its provisions. This alert reviews several of the regulatory changes and suggests action items to facilitate compliance with the new requirements.

Read the full alert here

Our colleagues at Epstein Becker Green have issued a client alert: "CMS Issues Final Regulations on Federal 'Sunshine' Law for Manufacturers and GPOs," by Amy K. Dow, Wendy C. Goldstein, Kim Tyrrell-Knott, Sarah K. diFrancesca, David C. Gibbons, Daniel G. Gottlieb, and Natasha F. Thoren.

Following is an excerpt:

On February 1, 2013, the Centers for Medicare & Medicaid Services issued long-awaited final regulations with a lengthy preamble relevant to Section 6002 of the Patient Protection and Affordable Care Act, also known as the “Physician Payment Sunshine Act.” This health reform alert provides an overview of the final regulations relevant to applicable manufacturers and group purchasing organizations (“GPOs”) and includes “key considerations” for applicable manufacturers and GPOs to contemplate as they prepare to implement the regulations.

Read the full alert here

Our colleagues Mark E. Lutes, Robert J. Hudock, and Patricia M. Wagner have issued an alert on modifications to the HIPAA privacy, security, and enforcement rules. Following is an excerpt:

On January 17, 2013, the Department of Health and Human Services released the highly anticipated, 563 page, Health Insurance Portability and Accountability Act (“HIPAA”) regulations (the “Final Rule”) that have been delayed for over 3 years. The Final Rule will be published in the Federal Register on January 25, 2013. The Final Rule addresses many of the compliance issues and unanswered questions facing covered entities and business associates. The effective date of the Final Rule is March 26, 2013--with a compliance date (for most provisions) by September 23, 2013 (there is an additional grace period for certain provisions). Epstein Becker Green is preparing an in-depth analysis of the Final Rule which will be forthcoming. In the meantime, below is a high level summary of the significant changes included in the Final Rule.  Read the full alert here.

Note that Ms. Wagner and Mr. Hudock will host a free webinar on this topic, titled "The Final Omnibus HIPAA Rule," on January 24, at 12:00 p.m. EST.

The Physician Payment Sunshine Act, which was incorporated into Section 6002 of the Affordable Care Act, requires pharmaceutical, medical device, biological and medical supply manufacturers to file annual reports on payments to physicians and teaching hospitals. Despite the requirement in the law that manufacturers submit their first report in March 2013 disclosing payments made during 2012, two events have pushed back that obligation or taken the sting out of noncompliance.

First, although Centers for Medicare & Medicaid Services (CMS) was required to publish standards for reporting information and making that information available online to the public, it has yet to publish final regulations. As recently as May 2012, it posted a blog notice on its website announcing that manufacturers will not be required to start collecting data until January 1, 2013. The reason given for the delay was that it simply needed time to sort through the over 300 comments that were received.

The second event that should be good news to manufacturers comes from Vermont. Vermont, along with eight other states and the District of Columbia, already have laws requiring manufacturers to report payments to physicians as well as financial penalties for failing to submit reports. Even though the Sunshine Act supersedes those state laws, any part of a state law that contains different or broader reporting requirements than the federal law remains in effect. However, since CMS has not published its regulations, answering that question may be more difficult than it appears at first. The good news is that the Vermont Attorney General has offered a limited amnesty to manufacturers of medical devices and biologics (but not pharmaceuticals) who did not report during any period between July 1, 2009 and December 31, 2011. The reprieve waives the penalties, but not registration fees or penalties under other state laws. While a complete report is not required immediately, the offer is for a limited time only and is good through October 1, 2012. Any inquiries should be sent to the Vermont Attorney General’s office at prescribedproducts@atg.state.vt.us.

For more information, contact the author at rwanerman@ebglaw.com.

by George B. Breen and Amy F. Lerman

On March 9, 2012, the Centers for Medicare & Medicaid Services (“CMS”) released a final rule that modifies several of the durable medical equipment, prosthetics, orthotics, and supplies ("DMEPOS") supplier standards. Most notably, the final rule modifies restrictions on the "direct solicitation" of Medicare beneficiaries by DMEPOS suppliers. CMS stated in the final rule that its reason for making this modification is that the definition of "direct solicitation" was not feasible and has been criticized for being overly broad. DMEPOS suppliers and other providers need to be aware of this modification to the supplier standards set forth in the final rule, and, in particular, the revised guidelines regarding direct solicitation, because suppliers may need to modify their business practices with respect to interactions with Medicare beneficiaries for DMEPOS items and services.

Read the full alert here

by Jason B. Caron, O. Benton Curtis III, Anjali N.C. Downs, and Jennifer K. Goodwin

Almost two years after the passage of the Patient Protection and Affordable Care Act (“ACA”), the Centers for Medicare & Medicaid Services (“CMS”) released a proposed rule regarding overpayments to providers and suppliers, as provided for under Section 6402(a) of the ACA. To date, regulators, courts, clients, and members of the bar have interpreted the requirements of Section 6402(a) in various ways. The proposed rule provides CMS's view on this matter, and, given that CMS is proposing a number of potentially onerous requirements with regard to investigating, reporting, and returning overpayments, stakeholders should consider submitting comments. This health reform alert provides an overview of CMS's proposed rule and its potentially burdensome implications.

Read the full alert here

by Wendy C. Goldstein and Kathleen A. Peterson

On December 27, 2011, the U.S. Food & Drug Administration ("FDA"), Office of Prescription Drug Promotion ("OPDP") (formerly the Division of Drug Marketing, Advertising, and Communications) released a new draft guidance document titled "Guidance for Industry on Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices" (the "Draft Guidance"). The OPDP will accept comments on the Draft Guidance through March 29, 2011.

The FDA has a longstanding policy of permitting pharmaceutical manufacturers to respond to unsolicited requests for medical information about their products, even where such information pertains to unapproved products or uses. However, there has been considerable debate over what constitutes "unsolicited" in this regard. In July 2011, a group of seven manufacturers filed a "citizen petition" with the FDA, requesting FDA clarification of the following issues: (1) Manufacturer Responses to Unsolicited Requests; (2) "Scientific Exchange"; (3) Interactions with Formulary Committees, Payors, and Similar Entities; and (4) Dissemination of Third-Party Clinical Practice Guidelines.

The Draft Guidance relates only to the first of these requests. The Draft Guidance further states that it is not intended to address unsolicited requests for information about products that are not approved for any use.

Read the full alert here 

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

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 

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.

Read the full alert online