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

Epstein Becker Green has been designated by the Health Information Trust Alliance (HITRUST) as a Common Security Framework (CSF) Assessor. This will allow the firm to provide health care organizations with privacy and security risk assessments to protect the entities from breaches of protected health information (PHI). The health care industry has accepted the HITRUST CSF as the most widely adopted security framework. Epstein Becker Green is the first law firm to become a CSF Assessor and the designation exemplifies the firm's distinct capability to identify and address risk for health care industry clients.

HITRUST provides resources, tools, education, and training to develop and maintain effective security programs for health care and life sciences companies that comply with security laws, regulations, and standards including HITECH, HIPAA, PCI, JCAHO, CMS, ISO, NIST, and various other federal, state, and business requirements.

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by Joseph J. Kempf, Jr., and Jane L. Kuesel

On April 12, 2012, Governor Andrew Cuomo issued an Executive Order requiring the State of New York to establish an American Health Benefit Exchange and Small Business Health Options Program in New York (together, the “Health Benefit Exchange”). The Governor’s action was taken in response to the mandate contained in Section 1311 of the Patient Protection and Affordable Care Act, and the New York Legislature’s failure to enact legislation to begin development of the Health Benefit Exchange. Although the Health Benefit Exchange is tied to compliance with federal health care reform, it will have an impact on all health care plans offered in the individual and small group markets in New York.

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Back in 1996, the Federal Trade Commission and Department of Justice, in providing antitrust guidance for multi-provider networks, considered financial integration and clinical integration as separate pathways for such networks to avoid per se violations of the antitrust laws and, instead, to be treated under the rule of reason, allowing for an assessment of their procompetitive vs. anticompetitive effects. With 65 organizations now participating in Medicare shared savings initiatives, including the 27 Medicare Shared Savings Program participants announced on April 10 (there are 32 Pioneer Accountable Care Organizations and 6 Physician Group Practice Transition Demonstration organizations), we can see, 16 years later, how clinical and financial integration in fact go hand in hand.  Under these various accountable care arrangements, multi-providers entities contracting with the Centers for Medicare and Medicaid Services as ACOs are required to demonstrate both quality (i.e., delivery reform featuring clinical integration) and cost efficiency (i.e., payment reform featuring financial integration).

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by Jay P. Krupin and Adam C. Solander

Since oral arguments ended at the U.S. Supreme Court, the media has been held captive by the predictions of attorneys and pundits as to the outcome. What most of these predictions have failed to capture, however, is that from an employer perspective, the Supreme Court's decision is unlikely to have any significant impact on the applicability of the Patient Protection and Affordable Care Act ("ACA"). As a result, the court's decision should not affect an employer's preparation moving forward.

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by Stuart M. Gerson

The three days of arguments about the constitutionality of the Patient Protection and Affordable Care Act are complete. The Justices of the Supreme Court of the United States have conducted their post-argument conference and are now turning their attention to the drafting and the discussions that will lead to a majority opinion and, likely, several dissents and concurrences. The Court's decision should be issued before the end of June. Health care companies and employers, like the rest of the population, await the ultimate decision. However, there are several matters that can be identified in the short run.

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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.

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by Jesse M. Caplan and Serra J. Schlanger

Since November 2011 the Center for Consumer Information & Insurance Oversight (“CCIIO”) in the Centers for Medicare & Medicaid Services has completed 22 reviews of health insurance premium rate increase filings in the individual and small group markets. Under the new federal rate review regulations, CCIIO has determined that six of the reviewed premium rate increases represented “unreasonable” increases while 16 of the rate increases were deemed “not unreasonable.”

This Implementing Health and Insurance Reform alert provides a summary and analysis of the completed federal rate review determinations to date. 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.

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by Pamela D. Tyner, Amy Lerman, and Lesley R. Yeung

The Recovery Audit Contractor (“RAC”) program is a national program aimed at identifying Medicare program overpayments and underpayments through a review of individual Medicare claims by contractors paid on a contingency fee basis. Over the next year, the RAC program will expand its reach beyond the current focus on fee-for-service 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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Kara Maciel, Member of the Epstein Becker Green Labor and Employment, Litigation, and Health Care and Life Sciences Practices, was recently interviewed by Employment Law360 concerning employer wellness programs. 

According to the article, businesses are turning to wellness programs to curb health care expenses, but programs that aren't carefully crafted can open employers up to costly privacy and discrimination litigation, attorneys say.  Wellness programs can lead to big savings for employers by targeting behaviors that can cause conditions that drive up their health care expenditures. But programs that give employers too much  information about their employees can leave employers vulnerable to claims that they have violated the  Health Insurance Portability and Accountability Act, the Americans with Disabilities Act, the Genetic Information Nondiscrimination Act, and state privacy and nondiscrimination laws, experts say. 

“Employers really can open themselves up to a litigation minefield if they do not properly craft their programs in a legally compliant way, with a particular focus on discrimination and privacy issues,” said Maciel. 

Click here to download the Employment Law360 article in its entirety (PDF).

by Shawn M. Gilman and Julia E. Loyd

On February 14, 2012, a final rule implementing Section 2715 of the Public Health Service Act, as added by the Patient Protection and Affordable Care Act, regarding the requirements for group health plans and health insurance issuers to provide a summary of benefits and coverage (“SBC”) to interested parties was published in the Federal Register. As set forth in the final rule, an SBC must be provided upon request or the occurrence of certain events and the content and format of the SBC must be in accordance with the extensive requirements contained in the final rule and associated guidance that was also issued on February 14, 2012. Although an extension from the statutory effective date of March 23, 2012 has been granted in the final rule, group health plans and health insurance issuers in the individual and group health markets will be required to take a number of steps in order to ensure compliance with the SBC requirements by September 23, 2012.

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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.

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by Kathleen A. Peterson, Benjamin S. Martin, Wendy C. Goldstein, and Constance A. Wilkinson

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.

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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.

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by Gretchen Harders, Daly D.E. Temchine, and Joseph J. Kempf, Jr.

On December 7, 2011, final rules on the medical loss ratio (“MLR”) requirements for insured health plans (and an interim final rule for non-federal governmental plans) were issued by the U.S. Department of Health and Human Services and the Centers for Medicare & Medicaid Services under the Patient Protection and Affordable Care Act. The MLR requirements are effective January 1, 2012, and any issuer who does not meet the MLR requirements for the 2011 MLR reporting year must pay rebates by August 1, 2012. This alert will address who should get a rebate and what we should expect to see under the MLR rules.

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