May 2012 Health Care Compliance Update
The Health Law Web Site & Blog
Be sure to check out the Health Law web site and blog: Updated daily, the content in the blog focuses attention on topics related to health care compliance, reimbursement, and food and drugs.
Health Care Compliance & Reimbursement Daily Smart Chart
The Health Care Compliance and Reimbursement Daily Smart Chart provides access to the full text of Federal Register issuances, case law, CMS Letters and Memorandums, and administrative decisions at approximately 5:00 p.m. CST of the day they were published and includes a brief summary of the document, the citation, and issuing agency or court. Additionally, recap news stories from CCH Editorial summarizing the most important documents of the week and month are included. The Daily Smart Chart is available via the IntelliConnect mobile app (IC Mobile). For further information, go to
Health Care Compliance Letter
Volume 15-5, May 15,2012, Read the Letter
Antitrust
Experts weigh in on antitrust guidance for health care provider collaboration
Is the Department of Justice (DOJ) and Federal Trade Commission (FTC) antitrust guidance adequate for health care provider collaboration? In its report, Federal Antitrust Policy: Stakeholders’ Perspectives Differed on the Adequacy of Guidance for Collaboration Among Health Care Providers, the Government Accountability Office (GAO) found that the health care industry groups and experts in antitrust law (stakeholders) have different perspectives on the adequacy of three key aspects of antitrust guidance for health care provider collaboration: (1) clinical integration, (2) greater use of exclusive collaborative arrangements, and (3) which collaborative arrangements are exempt from antitrust.
The FTC and the Antitrust Division of the DOJ issued specific guidance for health care providers on the application of antitrust laws, including the analysis undertaken to determine whether to challenge a particular collaborative arrangement among competing health care providers is unlawful. FTC and DOJ also issued guidance in October 2011 describing their approach to antitrust policy for Accountable Care Organizations (ACOs) that are eligible to participate in the Medicare Shared Savings Program (SSP). The SSP is intended to promote provider collaboration to reduce costs and improve quality of care for Medicare beneficiaries by allowing ACOs to receive a portion of the net savings realized as a result of their efforts.
The stakeholders’ differing perspectives of the key aspects of the antitrust guidance for health care provider collaboration are as follows:
Clinical integration, which involves integrating clinical activities across providers in a collaborative arrangement, is one way for a collaborative arrangement to satisfy the requirement that the arrangement demonstrate the potential to yield significant benefits, such as reduced costs or improved quality, in order to be able to jointly negotiate prices. Five of the six experts and one of the four industry groups said that the guidance was sufficient, while one expert and two industry groups found the clinical integration guidance was inadequate.
Exclusive collaborative arrangements restrict the ability of providers within a collaborative arrangement to contract with other arrangements or health plans. The use of exclusive arrangements has the potential to improve or reduce competition, depending on the circumstances, GAO said. Four of the experts found that the guidance on exclusive arrangements was reasonable, while three industry groups stated that FTC and DOJ should permit greater use of exclusive arrangements.
Collaborative arrangements that areexempt from antitrust analysis are presumed to be lawful and considered to be within a safety zone. One of the four industry groups and one of the six experts said the size and scope of the safety zones outlined in the FTC and DOJ Statements of Antitrust Enforcement Policy in Health Care issued in 1996 were appropriate, while three industry groups and three experts contended that the safety zones should be expanded to include a wider range of arrangements. GAO Report, GAO-12-291R, March 16, 2012
Anti-kickback
GAO recommends changes to electronic health records incentive program
The Government Accountability Office (GAO) has made four recommendations to CMS to improve the administration of the electronic health records (EHR) incentive program. The program will provide up to $30 billion from 2011 through 2019.The GAO examined (1) efforts by CMS and four states to verify whether providers qualify to receive EHR incentive payments, and (2) information reported to CMS by providers to demonstrate meaningful use in the first year of the Medicare EHR programThe GAO recommended that the CMS Administrator:(1) establish time frames for expeditiously implementing an evaluation of the effectiveness of the agency’s audit strategy for the Medicare EHR program; (2) evaluate the extent to which the agency should conduct more verifications on a prepayment basis when determining whether providers meet Medicare EHR program’s reporting requirements; (3) collect the additional information from Medicare providers during attestation that CMS suggested states collect from Medicaid providers during attestation; and (4) offer states the option of having CMS collect meaningful use attestations from Medicaid providers on their behalf.GAO Report, "First Year of CMS's Incentive Programs Shows Opportunities to Improve Processes to Verify Providers Met Requirements," GAO-12-481, April 30, 2012, Health Care Compliance Reporter, ¶550,092
Identity Theft
Provider vulnerability to medical identity theft addressed
Medical identity theft has become one the fastest growing forms of identity theft. Although individuals have used physician identifiers of deceased and nonpracticing providers to fraudulently bill Medicare for years, much of the focus on medical identity theft has been on theft of patient’s personal information and health insurance information.For providers, medical identity theft happens when the identify thief uses a providers’ unique medical identifiers such as National Provider Identifiers (NPIs), Tax Identification Numbers (TINs) or medical licensure information to bill insurance fraudulently for items or services that the provider never provided or prescribed. For example, medical identity thieves may steal the personal information of providers through hacking databases or posting sham hiring ads, CMS Deputy Administrator for Program Integrity, Peter Budetti, MD, JD explained in a recently posted article on the CMS website titled “7 Ways to Protect Yourself from Medical Identity Fraud”.
Historically, victimized health care providers had difficulty exonerating themselves from Medicare financial liabilities associated with identity theft because there was no established protocol for addressing provider identity theft issues. CMS, however, has taken steps to address provider vulnerability to medical identity theft by establishing the Provider Victim Validation/Remediation Initiative.Under the initiative, CMS, in coordination with Program Safeguard Contractors (PSCs) and Zone Program Integrity Contractors (ZPICs), has established Points of Contact throughout the country for providers to access if they have been the victims of identity theft and have suffered financial liability as a result. PSCs and ZPICs will conduct investigations and report their findings to CMS. CMS will make a final decision whether to relieve providers of liability based upon the evidence and other information. Providers who believe they are the victims of Medicare identity theft but who have not yet suffered any financial liability, should contact their jurisdictional MAC or contact the OIG hotline at 1-800-HHS-TIPS.CCH Chicago Bureau, April 19, 2012
On the Front Lines
Protecting Patient Privacy: Patients Value Electronic Health Records, But Worry about Data Breachesby Laura J. Merisalo and JoAnn Petsachnick
With a new federal initiative underway to examine health care provider organizations' compliance with patient privacy regulations, a new survey reveals patients at once trust that the confidentiality of their health records will be protected yet have significant concerns about data breaches.The survey was conducted to gauge patient perspectives on the security of their health information as those data move into electronic formats. Transitioning to electronic health records (EHRs) ramps up further as the Centers for Medicare & Medicaid Services (CMS) incentive program begins in earnest this year.EHRs are not new, nor are the concerns about protecting patient privacy. Although compliance with federal privacy regulations under the Health Insurance Portability and Accountability Act (HIPAA) began in 2003, a recently launched pilot audit program will run through the close of this year to test for HIPAA compliance and identify best practices (see “New Scrutiny of HIPAA Privacy Rule,” in this issue). Read the article.
This article was reprinted with permission from the Aspen’s Healthcare Registration, April 2012, Volume 21, No. 7.
Journal of Health Care Compliance
The March/April issue of the Journal of Health Care Compliance was mailedto subscribers on May 7, 2012, and is available to electronic subscribers.Read the Journal.
Columns
From the Editor—Roy Snell
Never Give Up Your Integrity
Best Practice—Julene Brown
If You Haven’t Already, It’s Time to Develop a Best Practice for the Important Message from Medicare
Health Information Management—Julie A. Dooling
It’s about the Patient: Engagement through Personal Health Records and Patient Portals
QIO—Harry M. Feder
CMS Outlines Current and FutureHospital Outpatient Reporting Elements
Life Sciences—Animesh Gandhi
Proposed Sunshine Act Creates Call to Action for Life Sciences Industry
Accountable Care—Sharita Jennings
ACOs: Importance of Compliance ProgramCertification
Bundled Payments—Ralph Levy, Jr.
“Beware the Bundle”: Medicare Announces Pilot Program for Bundled Payments to Providers
Health Information Technology—Tatiana Melnik
Class Actions, Federal Actions, and State Actions: The Data Breach Saga Continues
Overpayments—William Moran
Self-Reporting Medicare Overpayment
Physician Compliance—Robert H. Ossoff / Lauren Braswell / Michelle Raborn
The Value and Role Professional Coders Play in Health Care
Pharmaceutical—Lee H. Rosebush / Jonathan A. Havens
Pharmacy Billing: The Importance of Establishing IT Systems and Compliance Policies
Settlements—Kayla Tabela
CMS’ Proposed Overpayment Rule: Does the Bell Toll for Thee?
Lab—Christopher Young
Government Audits: Do it Right the First Time or Pay Later Even When YourLab Wins
Features
Gabriel L. Imperato / Fred Segal
A Referring Nightmare: The Recent Government Scrutiny of Hospital-Physician Compensation Agreements
Allan P. DeKaye / Gregory J. Naclerio
Suits and Scrubs Avoiding Orange Jumpsuits™ – Volume II: The Metamorphosis Crook
Lori J. Strauss
Patient Privacy- Then and Now
Scott A. Memmott / Jennifer L. Clarke
The Proposed Rule on Transparency Reports: Shedding Light on the Sunshine Act (Par II)
For the Record
Roy Snell
What Do Recent Changes at the OIG and DOJ Mean for Compliance?
Health Care Compliance Professional’s Manual
The Health Care Compliance Professional’s Manual quarterly update will be mailedto subscribers onJune 12, 2012.
Corporate Governance for Health Care and Compliance: A Practical Guide
The Corporate Governance for Health Care andCompliance: A Practical Guide annual update will be available to electronic subscribers on June 2, 2012. The update includes recognition of the new regulations for governance mandated by the Patient Protection and Affordable Care Act, the latest news from enforcement agencies including the Office of Inspector General, the Department of Justice, and CMS as well as the current and expanding activities of HEAT.
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