Supreme Court Hears Argument on Scope of False Claims Act

New York Office of the Medicaid Inspector General Releases 2014-2015 Work Plan

Companies doing business with the government are facing an unprecedented increase in liability risk as federal authorities and individual whistleblowers (called “relators”) aggressively use the Federal False Claims Act (“FCA”), 31 U.S.C. §§ 3729-3733, to allege an array of frauds on a broad range of government programs. The FCA exposes companies to millions of dollars in potential penalties and treble damages, not to mention potential suspension or debarment from federal contracting—a death sentence for companies in certain industries, especially for health care companies doing business with the Centers for Medicare and Medicaid Services, TriCare, and Medicaid. Continue reading this entry

OCR Releases Updated HIPAA Audit Protocol and Business Associate Listing Template

Regulations

The Office of Civil Rights (OCR) recently updated the audit protocol that it will be using to assess Covered Entities’ and Business Associate’s compliance with the Health Insurance Portability and Accountability Act (HIPAA) privacy, security, and breach notification rules. OCR also released a template that Covered Entities and Business Associates may use to keep track of their business associate relationships. The release of the updated audit protocol and Business Associate tracking template is part of the implementation of the Phase 2 HIPAA Compliance Audits. Continue reading this entry

CMS Abandons Payment Cut Imposed By Two-Midnight Rule

3-HospitalComplex

In the Fiscal Year (FY) 2014 Inpatient Prospective Payment System (IPPS) final rule, the Centers for Medicare & Medicaid Services (CMS) revised its Medicare policy for determining whether hospital encounters will be considered appropriately inpatient or outpatient. The status distinction has important consequences for both the provider and the beneficiary, including differences in co-insurance and deductibles, and what items and services are billable and the level of reimbursement paid to providers. Continue reading this entry

CMS Announces Latest Alternative Payment Model - Comprehensive Primary Care Plus

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Continuing in its efforts to promote alternative payment models, on April 11, 2016, CMS announced the Comprehensive Primary Care Plus (CPC+) model. CMS hopes to implement CPC+ in up to 20 regions, accommodating up to 5,000 practices, which would potentially encompass more than 20,000 doctors and clinicians and the 25 million people they serve. The model requires the participation of multiple payers, whose participation will be solicited in addition to individual practices. According to CMS, the initiative is designed to provide doctors the freedom to care for their patients the way they think will deliver the best outcomes and to pay them for achieving results and improving care. The CPC+ model is a 5 year model, expected to begin January 1, 2017. The model builds on the Comprehensive Primary Care initiative launched by CMS in late 2012 that ends at the end of this year. Continue reading this entry

Federal Agencies Provide User-Friendly Guidance on Compliance with Data Privacy Laws

CyberSecurity

How federal privacy laws apply to mobile health applications has been an area of significant ambiguity. Recently, the Federal Trade Commission’s (FTC), the U.S. Department of Health and Human Services (HHS) Office of Civil Rights (OCR), the Food and Drug Administration (FDA), and the HHS Office of the National Coordinator for Health Information Technology (ONC) joined together to provide a user-friendly web-based interactive tool to guide developers who are entering the heavily regulated mobile health industry with high-level guidance on how to navigate this complex regulatory environment. As noted by the director of the FTC Bureau of Consumer Protection, “Mobile App developers need clear information about the laws that apply to their health-related products.” In addition, the FTC released Best Practices Guidance for Mobile Health Developers to provide practical guidance for industry participants. Continue reading this entry