PPACA Impact and Opportunities

PPACA Impact and Opportunities http://www.ppacaimpactandopportunities.com/ en Copyright 2012 Fri, 18 May 2012 08:45:41 -0800 Fri, 18 May 2012 08:45:41 -0800 http://www.movabletype.org http://blogs.law.harvard.edu/tech/rss Subscribe with My Yahoo!Subscribe with NewsGatorSubscribe with My AOLSubscribe with BloglinesSubscribe with NetvibesSubscribe with GoogleSubscribe with PageflakesSubscribe with PlusmoSubscribe with The Free DictionarySubscribe with Bitty BrowserSubscribe with Live.comSubscribe with Excite MIXSubscribe with WebwagSubscribe with Podcast ReadySubscribe with WikioSubscribe with Daily RotationSubscribe with FlurrySubscribe with netomat HubSubscribe with NewsAlloySubscribe with Attensa for OutlookSubscribe with Yourminis.com Alternative Provider Reimbursement Models - How Are They Treated Under MLR Rules? <p><strong>by <a href="http://www.ebglaw.com/showbio.aspx?Show=13853">Joseph J. Kempf, Jr.,</a> and <a href="http://www.ebglaw.com/showbio.aspx?Show=7408">Jackie Selby</a></strong></p> <p>Evolving reimbursement models for health care providers (away from “fee for service” and toward “pay for performance” and risk sharing) raise interesting questions as to how such payments will be treated under the new medical loss ratio rules under the Patient Protection and Affordable Care Act. Some of the payments will not qualify as “medical expense” or “quality improvement activities” and will be treated as “administrative expense,” so providers and insurers and health plans may want to take these rules into account when structuring alternative reimbursement methodologies.</p> <p align="center"><a href="http://www.ebglaw.com/showclientalert.aspx?Show=16041"><strong>Read the full alert here</strong></a></p><img src="http://feeds.feedburner.com/~r/HealthReformMusings/~4/NuGfZDsuTc0" height="1" width="1"/> http://feeds.lexblog.com/~r/HealthReformMusings/~3/NuGfZDsuTc0/ http://www.ppacaimpactandopportunities.com/2012/05/articles/cost-of-health-care/alternative-provider-reimbursement-models-how-are-they-treated-under-mlr-rules/ Alternative Provider Reimbursement ModelsCost of Health CareMLRmedical expensemedical loss ratio Fri, 18 May 2012 08:37:13 -0800 Epstein Becker & Green, P.C. http://www.ppacaimpactandopportunities.com/2012/05/articles/cost-of-health-care/alternative-provider-reimbursement-models-how-are-they-treated-under-mlr-rules/ Epstein Becker Green Recognized as a HITRUST CSF Assessor to Provide Clients with Security and Privacy Risk Assessment for Protected Health Care Information <p>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.</p> <p>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.</p> <p align="center"><b><a target="blank" href="http://www.ebglaw.com/shownews.aspx?Show=16017">Read the Full Announcement from Epstein Becker Green</a></b></p><img src="http://feeds.feedburner.com/~r/HealthReformMusings/~4/A5ZfaF3b6Xg" height="1" width="1"/> http://feeds.lexblog.com/~r/HealthReformMusings/~3/A5ZfaF3b6Xg/ http://www.ppacaimpactandopportunities.com/2012/05/articles/health-information-technology/epstein-becker-green-recognized-as-a-hitrust-csf-assessor-to-provide-clients-with-security-and-privacy-risk-assessment-for-protected-health-care-information/ CSFCommon Security Framework AssessorEpstein Becker GreenHIPAAHITECHHITRUSTHealth Information TechnologyHealth Information Trust Alliance Tue, 08 May 2012 08:26:51 -0800 Epstein Becker & Green, P.C. http://www.ppacaimpactandopportunities.com/2012/05/articles/health-information-technology/epstein-becker-green-recognized-as-a-hitrust-csf-assessor-to-provide-clients-with-security-and-privacy-risk-assessment-for-protected-health-care-information/ New York Health Benefit Exchange Established by Executive Order <p><strong>by <a href="http://www.ebglaw.com/showbio.aspx?Show=13853">Joseph J. Kempf, Jr.,</a> and <a href="http://www.ebglaw.com/showbio.aspx?Show=12143">Jane L. Kuesel</a></strong></p> <p>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.</p> <p align="center"><a href="http://www.ebglaw.com/showclientalert.aspx?Show=15991"><strong>Read the full alert here</strong></a></p><img src="http://feeds.feedburner.com/~r/HealthReformMusings/~4/ernIsWHdjsE" height="1" width="1"/> http://feeds.lexblog.com/~r/HealthReformMusings/~3/ernIsWHdjsE/ http://www.ppacaimpactandopportunities.com/2012/05/articles/cost-of-health-care/new-york-health-benefit-exchange-established-by-executive-order/ Andrew CuomoCost of Health CareExecutive OrderHealth Benefit ExchangeNew York Tue, 01 May 2012 11:55:36 -0800 Epstein Becker & Green, P.C. http://www.ppacaimpactandopportunities.com/2012/05/articles/cost-of-health-care/new-york-health-benefit-exchange-established-by-executive-order/ Medicare ACOs: Financial and Clinical Integration <p>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 <a target="blank" href="http://www.cms.gov/apps/media/press/release.asp?Counter=4333&intNumPerPage=10&checkDate=&checkKey=&srchType=1&numDays=3500&srchOpt=0&srchData=&keywordType=All&chkNewsType=1%2C+2%2C+3%2C+4%2C+5&intPage=&showAll=&pYear=&year=&desc=&cboOrder=date">27 Medicare Shared Savings Program participants</a> 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).</p> <p align="center"><strong><a target="blank" href="http://healthaffairs.org/blog/2012/04/11/medicare-acos-the-integration-of-financial-and-clinical-integration/">Click Here to Read the Full Blog Post on the Health Affairs Blog</a></strong></p><img src="http://feeds.feedburner.com/~r/HealthReformMusings/~4/yKIAkX_5mhE" height="1" width="1"/> http://feeds.lexblog.com/~r/HealthReformMusings/~3/yKIAkX_5mhE/ http://www.ppacaimpactandopportunities.com/2012/04/articles/access-to-health-care/medicare-acos-financial-and-clinical-integration/ Access to Health CareCompetitionCostsHealthInnovations in Health Care DeliveryLawMedicarePaymentPhysiciansQualityQuality of Health CareReformcare Thu, 12 Apr 2012 10:11:09 -0800 Doug Hastings http://www.ppacaimpactandopportunities.com/2012/04/articles/access-to-health-care/medicare-acos-financial-and-clinical-integration/ ACA Decision Should Not Delay Employer Prep for 2014 <p><strong>by </strong><a href="http://www.ebglaw.com/showbio.aspx?Show=7525"><strong>Jay P. Krupin</strong></a><strong> and </strong><a href="http://www.ebglaw.com/showbio.aspx?Show=13434"><strong>Adam C. Solander</strong></a></p> <p>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.</p> <p align="center"><a target="blank" href="http://www.ebglaw.com/showarticle.aspx?Show=15920"><strong>Read the full article</strong></a></p><img src="http://feeds.feedburner.com/~r/HealthReformMusings/~4/tCHLlR5FC3U" height="1" width="1"/> http://feeds.lexblog.com/~r/HealthReformMusings/~3/tCHLlR5FC3U/ http://www.ppacaimpactandopportunities.com/2012/04/articles/cost-of-health-care/aca-decision-should-not-delay-employer-prep-for-2014/ Cost of Health Care Mon, 09 Apr 2012 10:09:42 -0800 Epstein Becker & Green, P.C. http://www.ppacaimpactandopportunities.com/2012/04/articles/cost-of-health-care/aca-decision-should-not-delay-employer-prep-for-2014/ The Supreme Court Mulls Obamacare; the Health Care Industry Mulls the Supreme Court <p><strong>by <a href="http://www.ebglaw.com/showbio.aspx?Show=2214">Stuart M. Gerson</a></strong></p> <p>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.</p> <p align="center"><a href="http://www.ebglaw.com/showclientalert.aspx?Show=15893"><strong>Read the full alert here</strong></a></p><img src="http://feeds.feedburner.com/~r/HealthReformMusings/~4/csb39D40cgo" height="1" width="1"/> http://feeds.lexblog.com/~r/HealthReformMusings/~3/csb39D40cgo/ http://www.ppacaimpactandopportunities.com/2012/04/articles/access-to-health-care/the-supreme-court-mulls-obamacare-the-health-care-industry-mulls-the-supreme-court/ ACAAccess to Health CareAffordable Care ActCost of Health CareIndividual MandateObamaObama AdministrationObamacareSupreme Courthealth care industry Mon, 02 Apr 2012 14:54:43 -0800 Epstein Becker & Green, P.C. http://www.ppacaimpactandopportunities.com/2012/04/articles/access-to-health-care/the-supreme-court-mulls-obamacare-the-health-care-industry-mulls-the-supreme-court/ CMS Issues Final Rule Modifying Restrictions on "Direct Solicitation" of Beneficiaries by DMEPOS Suppliers; Changes to Other DMEPOS Supplier Safeguards <p><strong>by <a href="http://www.ebglaw.com/showbio.aspx?Show=2009">George B. Breen</a> and <a href="http://www.ebglaw.com/showbio.aspx?Show=7658">Amy F. Lerman</a></strong></p> <p>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.</p> <p align="center"><a href="http://www.ebglaw.com/showclientalert.aspx?Show=15868"><strong>Read the full alert here</strong></a></p><img src="http://feeds.feedburner.com/~r/HealthReformMusings/~4/VODaKrf9PBw" height="1" width="1"/> http://feeds.lexblog.com/~r/HealthReformMusings/~3/VODaKrf9PBw/ http://www.ppacaimpactandopportunities.com/2012/03/articles/agency-information/cms-issues-final-rule-modifying-restrictions-on-direct-solicitation-of-beneficiaries-by-dmepos-suppliers-changes-to-other-dmepos-supplier-safeguards/ Agency InformationCMSDMEPOSDirect SolicitationFinal Ruledurable medical equipmentsuppliers Tue, 27 Mar 2012 07:03:24 -0800 Epstein Becker & Green, P.C. http://www.ppacaimpactandopportunities.com/2012/03/articles/agency-information/cms-issues-final-rule-modifying-restrictions-on-direct-solicitation-of-beneficiaries-by-dmepos-suppliers-changes-to-other-dmepos-supplier-safeguards/ Status Report on the Federal Health Insurance Rate Review Program <p><strong>by <a href="http://www.ebglaw.com/showbio.aspx?Show=8256">Jesse M. Caplan</a> and <a href="http://www.ebglaw.com/showbio.aspx?Show=14833">Serra J. Schlanger</a></strong></p> <p>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.”</p> <p>This <em>Implementing Health and Insurance Reform</em> 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.</p> <p align="center"><a target="blank" href="http://www.ebglaw.com/showclientalert.aspx?Show=15858"><strong>Read the full alert here</strong></a></p><img src="http://feeds.feedburner.com/~r/HealthReformMusings/~4/uR9g9igV6ok" height="1" width="1"/> http://feeds.lexblog.com/~r/HealthReformMusings/~3/uR9g9igV6ok/ http://www.ppacaimpactandopportunities.com/2012/03/articles/cost-of-health-care/status-report-on-the-federal-health-insurance-rate-review-program/ ACACCIIOCMSCost of Health CareFederal Health Insurance Rate Review ProgramPPACAscorecard Tue, 20 Mar 2012 13:43:54 -0800 Epstein Becker & Green, P.C. http://www.ppacaimpactandopportunities.com/2012/03/articles/cost-of-health-care/status-report-on-the-federal-health-insurance-rate-review-program/ RAC Roundup: What's on the Horizon for Medicare Part C and D RACs? Medicaid RAC Implementation Is Underway <p align="justify"><strong>by <a target="blank" href="http://www.ebglaw.com/showbio.aspx?Show=15138">Pamela D. Tyner</a>, <a target="blank" href="http://www.ebglaw.com/showbio.aspx?Show=7658">Amy Lerman</a>, and <a target="blank" href="http://www.ebglaw.com/showbio.aspx?Show=13266">Lesley R. Yeung</a></strong></p> <p align="justify">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.</p> <p align="center"><a target="blank" href="http://www.ebglaw.com/showclientalert.aspx?Show=15841"><strong>Read the full alert here</strong></a></p><img src="http://feeds.feedburner.com/~r/HealthReformMusings/~4/-B-Kp6CL6qU" height="1" width="1"/> http://feeds.lexblog.com/~r/HealthReformMusings/~3/-B-Kp6CL6qU/ http://www.ppacaimpactandopportunities.com/2012/03/articles/cost-of-health-care/rac-roundup-whats-on-the-horizon-for-medicare-part-c-and-d-racs-medicaid-rac-implementation-is-underway/ Cost of Health CareMedicaidMedicareMedicare AdvantagePrescription Drug BenefitRACRecovery Audit Contractor Thu, 15 Mar 2012 12:59:08 -0800 Epstein Becker & Green, P.C. http://www.ppacaimpactandopportunities.com/2012/03/articles/cost-of-health-care/rac-roundup-whats-on-the-horizon-for-medicare-part-c-and-d-racs-medicaid-rac-implementation-is-underway/ Poorly Crafted Wellness Programs Could Make Employers Sick <p><a href="http://www.ebglaw.com/showbio.aspx?Show=7534">Kara Maciel</a>, Member of the Epstein Becker Green Labor and Employment, Litigation, and Health Care and Life Sciences Practices, was <a href="http://www.law360.com/articles/310340">recently interviewed by <em>Employment Law360 </em>concerning employer wellness programs</a>. </p> <p>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. </p> <p>“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. </p> <p><a target="blank" href="http://www.ebglaw.com/files/49291_Maciel-Employment-Law360-Poorly-Crafted-Wellness-Programs-3.7.12.PDF"><em>Click here to download the </em>Employment Law360<em> article in its entirety (PDF).</em></a></p><img src="http://feeds.feedburner.com/~r/HealthReformMusings/~4/kyXrnreU-YE" height="1" width="1"/> http://feeds.lexblog.com/~r/HealthReformMusings/~3/kyXrnreU-YE/ http://www.ppacaimpactandopportunities.com/2012/03/articles/access-to-health-care/poorly-crafted-wellness-programs-could-make-employers-sick/ Access to Health CareAmericans with Disabilities ActGINAGenetic Information Nondiscrimination ActHIPAAHealth Insurance Portability and Accountability ActPPACAhealth carewellness programs Thu, 08 Mar 2012 13:04:49 -0800 Epstein Becker & Green, P.C. http://www.ppacaimpactandopportunities.com/2012/03/articles/access-to-health-care/poorly-crafted-wellness-programs-could-make-employers-sick/ Paying Attention to the Fine Print: The Summary of Benefits and Coverage Final Rule and Its Impact on Consumers and the Health Insurance Market <p><strong>by <a href="http://www.ebglaw.com/showbio.aspx?Show=8974">Shawn M. Gilman</a> and <a href="http://www.ebglaw.com/showbio.aspx?Show=12291">Julia E. Loyd</a></strong></p> <p>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.</p> <p align="center"><a target="blank" href="http://www.ebglaw.com/showclientalert.aspx?Show=15780"><strong>Read the full alert here</strong></a></p><img src="http://feeds.feedburner.com/~r/HealthReformMusings/~4/ScZ57vprjcs" height="1" width="1"/> http://feeds.lexblog.com/~r/HealthReformMusings/~3/ScZ57vprjcs/ http://www.ppacaimpactandopportunities.com/2012/02/articles/cost-of-health-care/paying-attention-to-the-fine-print-the-summary-of-benefits-and-coverage-final-rule-and-its-impact-on-consumers-and-the-health-insurance-market/ Cost of Health CareFinal RulePatient Protection and Affordable Care ActSBCSection 2715Summary of Benefits and Coverage Wed, 29 Feb 2012 12:25:30 -0800 Epstein Becker & Green, P.C. http://www.ppacaimpactandopportunities.com/2012/02/articles/cost-of-health-care/paying-attention-to-the-fine-print-the-summary-of-benefits-and-coverage-final-rule-and-its-impact-on-consumers-and-the-health-insurance-market/ The Clock Is Ticking: CMS Issues a Proposed Rule on Reporting and Returning Overpayments <p><strong>by <a href="http://www.ebglaw.com/showbio.aspx?Show=2045">Jason B. Caron</a>, <a href="http://www.ebglaw.com/showbio.aspx?Show=15517">O. Benton Curtis III</a>, <a href="http://www.ebglaw.com/showbio.aspx?Show=9203">Anjali N.C. Downs</a>, and <a href="http://www.ebglaw.com/showbio.aspx?Show=13545">Jennifer K. Goodwin</a></strong></p> <p>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.</p> <p align="center"><a target="blank" href="http://www.ebglaw.com/showclientalert.aspx?Show=15770"><strong>Read the full alert here</strong></a></p><img src="http://feeds.feedburner.com/~r/HealthReformMusings/~4/mcI00n0wn90" height="1" width="1"/> http://feeds.lexblog.com/~r/HealthReformMusings/~3/mcI00n0wn90/ http://www.ppacaimpactandopportunities.com/2012/02/articles/agency-information/the-clock-is-ticking-cms-issues-a-proposed-rule-on-reporting-and-returning-overpayments/ ACAAffordable Care ActAgency InformationCMSProposed RuleProvidersSection 6402(a)overpaymentssuppliers Wed, 22 Feb 2012 12:32:02 -0800 Epstein Becker & Green, P.C. http://www.ppacaimpactandopportunities.com/2012/02/articles/agency-information/the-clock-is-ticking-cms-issues-a-proposed-rule-on-reporting-and-returning-overpayments/ CMS Issues Proposed Rule Relating to Manufacturer Rebates and Reimbursement Amounts for Outpatient Prescription Drugs Dispensed to Medicaid Beneficiaries <p><strong>by <a href="http://www.ebglaw.com/showbio.aspx?Show=2546">Kathleen A. Peterson</a>, <a href="http://www.ebglaw.com/showbio.aspx?Show=7085">Benjamin S. Martin</a>, <a href="http://www.ebglaw.com/showbio.aspx?Show=2233">Wendy C. Goldstein</a>, and <a href="http://www.ebglaw.com/showbio.aspx?Show=2784">Constance A. Wilkinson</a></strong></p> <p>This issue of <em>Implementing Health & Insurance Reform</em> 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.</p> <p>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.</p> <p align="center"><a target="_blank" href="http://www.ebglaw.com/showclientalert.aspx?Show=15758"><strong>Read the full alert here</strong></a></p><img src="http://feeds.feedburner.com/~r/HealthReformMusings/~4/fSMWOhMRgFU" height="1" width="1"/> http://feeds.lexblog.com/~r/HealthReformMusings/~3/fSMWOhMRgFU/ http://www.ppacaimpactandopportunities.com/2012/02/articles/cost-of-health-care/cms-issues-proposed-rule-relating-to-manufacturer-rebates-and-reimbursement-amounts-for-outpatient-prescription-drugs-dispensed-to-medicaid-beneficiaries/ AMPCMSCost of Health CareMDRPMedicaidMedicaid Drug Rebate ProgramProposed Rulebeneficiariesmanufacturer rebatesoutpatient prescription drugsreimbursement Fri, 17 Feb 2012 12:37:46 -0800 Epstein Becker & Green, P.C. http://www.ppacaimpactandopportunities.com/2012/02/articles/cost-of-health-care/cms-issues-proposed-rule-relating-to-manufacturer-rebates-and-reimbursement-amounts-for-outpatient-prescription-drugs-dispensed-to-medicaid-beneficiaries/ FDA Releases Draft Guidance for Industry on Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices <p><strong>by </strong><a href="http://www.ebglaw.com/showbio.aspx?Show=2233"><strong>Wendy C. Goldstein</strong></a><strong> and </strong><a href="http://www.ebglaw.com/showbio.aspx?Show=2546"><strong>Kathleen A. Peterson</strong></a></p> <p>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.</p> <p>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.</p> <p>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.</p> <p align="center"><a target="_blank" href="http://www.ebglaw.com/showclientalert.aspx?Show=15640"><strong>Read the full alert here</strong></a> </p><img src="http://feeds.feedburner.com/~r/HealthReformMusings/~4/hlHrU4qvSws" height="1" width="1"/> http://feeds.lexblog.com/~r/HealthReformMusings/~3/hlHrU4qvSws/ http://www.ppacaimpactandopportunities.com/2012/02/articles/agency-information/fda-releases-draft-guidance-for-industry-on-responding-to-unsolicited-requests-for-offlabel-information-about-prescription-drugs-and-medical-devices/ Agency InformationFDAMedical DevicesOPDPOff-Label InformationOffice of Prescription Drug PromotionPrescription Drugs Wed, 08 Feb 2012 10:05:27 -0800 Epstein Becker & Green, P.C. http://www.ppacaimpactandopportunities.com/2012/02/articles/agency-information/fda-releases-draft-guidance-for-industry-on-responding-to-unsolicited-requests-for-offlabel-information-about-prescription-drugs-and-medical-devices/ New Rules Issued on Medical Loss Ratio Requirements <p><strong>by <a href="http://www.ebglaw.com/showbio.aspx?Show=2283">Gretchen Harders</a>, <a href="http://www.ebglaw.com/showbio.aspx?Show=2738">Daly D.E. Temchine</a>, and <a href="http://www.ebglaw.com/showbio.aspx?Show=13853">Joseph J. Kempf, Jr.</a><br /> </strong></p> <p>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.</p> <p align="center"><a target="_blank" href="http://www.ebglaw.com/showclientalert.aspx?Show=15543"><strong>Read the full alert here</strong></a> </p><img src="http://feeds.feedburner.com/~r/HealthReformMusings/~4/HU3HNJO0acM" height="1" width="1"/> http://feeds.lexblog.com/~r/HealthReformMusings/~3/HU3HNJO0acM/ http://www.ppacaimpactandopportunities.com/2012/01/articles/cost-of-health-care/new-rules-issued-on-medical-loss-ratio-requirements/ CMSCost of Health CareHHSMLRPPACAPatient Protection and Affordable Care Actmedical loss ratio Wed, 18 Jan 2012 09:38:26 -0800 Epstein Becker & Green, P.C. http://www.ppacaimpactandopportunities.com/2012/01/articles/cost-of-health-care/new-rules-issued-on-medical-loss-ratio-requirements/ Continuing the Spotlight on Medicare Providers and Suppliers: New OIG Report Details Program Integrity Problems with Newly Enrolled Medical Equipment Suppliers <p><strong>by <a href="http://www.ebglaw.com/showbio.aspx?Show=2009">George B. Breen</a> and <a href="http://www.ebglaw.com/showbio.aspx?Show=7658">Amy F. Lerman</a></strong></p> <p>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.</p> <p align="center"><a target="_blank" href="http://www.ebglaw.com/showclientalert.aspx?Show=15524"><strong>Read the full alert here</strong></a></p><img src="http://feeds.feedburner.com/~r/HealthReformMusings/~4/rlexUV67z_A" height="1" width="1"/> http://feeds.lexblog.com/~r/HealthReformMusings/~3/rlexUV67z_A/ http://www.ppacaimpactandopportunities.com/2012/01/articles/cost-of-health-care/continuing-the-spotlight-on-medicare-providers-and-suppliers-new-oig-report-details-program-integrity-problems-with-newly-enrolled-medical-equipment-suppliers/ CMSCost of Health CareDMEMedicareOIGbilling privilegesdurable medical equipment suppliersenforcement Tue, 17 Jan 2012 12:29:58 -0800 Epstein Becker & Green, P.C. http://www.ppacaimpactandopportunities.com/2012/01/articles/cost-of-health-care/continuing-the-spotlight-on-medicare-providers-and-suppliers-new-oig-report-details-program-integrity-problems-with-newly-enrolled-medical-equipment-suppliers/ 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 <p><strong>by <a href="http://www.ebglaw.com/showbio.aspx?Show=2684">Lynn Shapiro Snyder</a> and <a href="http://www.ebglaw.com/showbio.aspx?Show=13266">Lesley R. Yeung</a></strong></p> <p>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 (<em>i.e.,</em> 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 <a href="mailto:EssentialHealthBenefits@cms.hhs.gov">EssentialHealthBenefits@cms.hhs.gov</a>. Stakeholders interested in the EHB package definition process should consider submitting comments and actively engaging in public dialogue with HHS on the process now.</p> <p align="center"><span><span><a target="_blank" href="http://www.ebglaw.com/showclientalert.aspx?Show=15503"><strong>Read the full alert here</strong></a></span></span></p><img src="http://feeds.feedburner.com/~r/HealthReformMusings/~4/V_0PoABON0k" height="1" width="1"/> http://feeds.lexblog.com/~r/HealthReformMusings/~3/V_0PoABON0k/ http://www.ppacaimpactandopportunities.com/2012/01/articles/access-to-health-care/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/ Access to Health CareCCIIOCMSCenter for Consumer Information and Insurance OversightEssential Health Benefits PackageSection 1302 Fri, 06 Jan 2012 12:39:40 -0800 Epstein Becker & Green, P.C. http://www.ppacaimpactandopportunities.com/2012/01/articles/access-to-health-care/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/ CMS Issues Proposed Rules on Federal "Sunshine" Law for Manufacturers and GPOs <p><strong>by <a href="http://www.ebglaw.com/showbio.aspx?Show=7368">Sarah K. Giesting</a>, <a href="http://www.ebglaw.com/showbio.aspx?Show=2233">Wendy C. Goldstein</a>, <a href="http://www.ebglaw.com/showbio.aspx?Show=2546">Kathleen A. Peterson</a>, and <a href="http://www.ebglaw.com/showbio.aspx?Show=14684">Natasha F. Thoren</a></strong></p> <p>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.</p> <p align="center"><a target="_blank" href="http://www.ebglaw.com/showclientalert.aspx?Show=15292"><strong>Read the full alert here</strong></a></p><img src="http://feeds.feedburner.com/~r/HealthReformMusings/~4/5HZLAaUH6yw" height="1" width="1"/> http://feeds.lexblog.com/~r/HealthReformMusings/~3/5HZLAaUH6yw/ http://www.ppacaimpactandopportunities.com/2011/12/articles/agency-information/cms-issues-proposed-rules-on-federal-sunshine-law-for-manufacturers-and-gpos/ Agency InformationCMSGPOsPhysician PaymentProposed RulesSunshine Actgroup purchasing organizations Sat, 17 Dec 2011 12:12:09 -0800 Epstein Becker & Green, P.C. http://www.ppacaimpactandopportunities.com/2011/12/articles/agency-information/cms-issues-proposed-rules-on-federal-sunshine-law-for-manufacturers-and-gpos/ HHS Announces First Insurance Premium Rate Review Determinations: Implications for Insurance Carriers and Future Rate Reviews <p><strong>by <a href="http://www.ebglaw.com/showbio.aspx?Show=8256">Jesse M. Caplan</a> and <a href="http://www.ebglaw.com/showbio.aspx?Show=14833">Serra J. Schlanger</a></strong></p> <p>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.</p> <p>This <em>Implementing Health and Insurance Reform</em> 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 <a href="http://www.ebglaw.com/scorecard.aspx">National Health Insurance Rate Review Scorecard</a>, 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.</p> <p align="center"><a target="_blank" href="http://www.ebglaw.com/showclientalert.aspx?Show=15241"><strong>Read the full alert here</strong></a> </p><img src="http://feeds.feedburner.com/~r/HealthReformMusings/~4/K7qqJNNEI6k" height="1" width="1"/> http://feeds.lexblog.com/~r/HealthReformMusings/~3/K7qqJNNEI6k/ http://www.ppacaimpactandopportunities.com/2011/12/articles/cost-of-health-care/hhs-announces-first-insurance-premium-rate-review-determinations-implications-for-insurance-carriers-and-future-rate-reviews/ CIISCMSCost of Health CareNational Health Insurance Rate Review Scorecardinsurance carrierspremium rate review Tue, 06 Dec 2011 13:45:34 -0800 Epstein Becker & Green, P.C. http://www.ppacaimpactandopportunities.com/2011/12/articles/cost-of-health-care/hhs-announces-first-insurance-premium-rate-review-determinations-implications-for-insurance-carriers-and-future-rate-reviews/ Medicare Providers and Suppliers Continue in the Spotlight: Medicare Providers and Suppliers Continue in the Spotlight <p style="margin-left: 40px"><em><strong>Expansion of the DMEPOS Competitive Bidding Program; Legislative Inquiry Related to Fraud and Abuse Enforcement Actions; and Automated Pre-Enrollment Provider Screening </strong></em></p> <p><strong>by <a href="http://www.ebglaw.com/showbio.aspx?Show=2009">George B. Breen</a>, <a href="http://www.ebglaw.com/showbio.aspx?Show=7658">Amy F. Lerman</a>, <a href="http://www.ebglaw.com/showbio.aspx?Show=7386">Emily E. Bajcsi</a>, <a href="http://www.ebglaw.com/showbio.aspx?Show=12270">Deepa B. Selvam</a></strong></p> <p>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 (“<strong>CMS</strong>”) to implement automated pre-enrollment provider and supplier screening in <strong><u>January 2012</u></strong>. 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 (“<strong>DMEPOS</strong>”) Competitive Bidding Program, which is targeted to launch in <strong><u>July 2013</u></strong> and for which the Round 2 bidding timeline was announced on November 30, 2011.</p> <p align="center"><a target="_blank" href="http://www.ebglaw.com/showclientalert.aspx?Show=15239"><strong>Read the full alert here</strong></a></p><img src="http://feeds.feedburner.com/~r/HealthReformMusings/~4/mKp2R13Df_Y" height="1" width="1"/> http://feeds.lexblog.com/~r/HealthReformMusings/~3/mKp2R13Df_Y/ http://www.ppacaimpactandopportunities.com/2011/12/articles/access-to-health-care/medicare-providers-and-suppliers-continue-in-the-spotlight-medicare-providers-and-suppliers-continue-in-the-spotlight/ Access to Health CareCMSCompetitive Bidding ProgramDMEPOSMedicareProviderssuppliers Tue, 06 Dec 2011 09:33:55 -0800 Epstein Becker & Green, P.C. http://www.ppacaimpactandopportunities.com/2011/12/articles/access-to-health-care/medicare-providers-and-suppliers-continue-in-the-spotlight-medicare-providers-and-suppliers-continue-in-the-spotlight/