CMS Grants First Waiver of Stark Law Expansion Restrictions—Are More Ahead?

Are changes to the landscape of physician hospital ownership ahead?

The Affordable Care Act amended the federal Stark Law to eliminate the “whole hospital exception” that permitted self-referrals provided the referring physician was authorized to practice at the hospital and the ownership or investment interest was in the hospital itself (as opposed to a subdivision). An exception, albeit a limited one, was created for existing hospitals. Such physician-owned hospitals are restricted, absent waiver authority from CMS, from expanding capacity in terms of the number of operating rooms, procedure rooms, and beds for which the facility was licensed as of March 23, 2010. In order to obtain a waiver of this rule, a hospital must qualify as an “applicable hospital” or a “high Medicaid facility.”

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District Court Weighs in on Level of Integration Required to Shield Health Care Collaborations from Section 1 Scrutiny

In Medical Center at Elizabeth Place v. Premier Health Partners et. al, Case No. 12-cv-26 (S.D. Oh. Oct. 20, 2014), the Southern District of Ohio held that previously-competing health care systems who join together in a revenue-sharing arrangement are incapable of conspiring with each other under Section 1 of the Sherman Act.  This is the latest decision to weigh in on the level of integration required among legally separate entities to be deemed a single economic actor for antitrust purposes, and particularly significant given the rapidly increasing number of collaborations within the health care industry following passage of the Affordable Care Act.

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Mobile Health Apps are in a Boom Phase – Why is it so Hard for Pharmaceutical Companies to Find Users?

Mobile medical and health applications have been in a boom phase for the past few years, but despite this trend, one group of entities has had trouble breaking into the mobile medical app sphere, pharmaceutical (i.e., pharma) companies.  A recent report published by Research2Guidance,  indicates that most major pharmaceutical companies have had trouble generating downloads for their health-related apps and even when they do, have trouble getting users to continue using their products.[1]  For example, some of the most successful pharma companies have only a handful of apps and less than 1 million active users.[2]  By contrast, there are more than a hundred thousand health-related apps on Google’s Play store and Apple’s iTunes store based on recent calculations, and some experts estimate that there could be as many as 500 million users of medical applications by 2015.[3]  What is the cause of this inability to generate downloads or hang on to users?  There are a few possibilities.

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Six Considerations For Employers Faced With The Ebola Virus Or Other Infectious Diseases

As the Ebola virus has spread to a second city in the United States, and with the potential for additional cities to be affected, many businesses are faced with the difficult task of determining how to properly handle their workforce in the face of such an epidemic.  While there are many concerns employers may have with respect to Ebola and their workforce, this article will focus on six key considerations for employers when managing this, or any other, health epidemic.

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Exploring the Relationship Between Price and Competition Among Physician Practices

The latest from the Journal of the American Medical Association (JAMA) is a thematic issue organized around a prominent topic in healthcare: price, cost, and competition. Contributing to the debate is an article titled, “Physician Practice Competition and Prices Paid by Private Insurers for Office Visits.”[1] The study is of particular interest because, as the authors note, evidence on the relationship between price and competition in the context of physician services (as opposed to hospitals or insurance companies) is fairly limited.

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Pioneer ACOs: Slowed Health Spending, Improved Quality and More Drop Outs?

The Centers for Medicare and Medicaid Services (CMS) recently released second year results on its Pioneer Accountable Care Organization (ACO) program. [1] [2]  The Pioneer ACO program is CMS’ ambitious foray into the ACO space and a predecessor to the broader Medicare Shared Savings Program (MSSP) that has resulted in the formation of hundreds of new ACOs nationwide.  CMS originally selected 32 provider organizations with a proven ability to coordinate care for their patients with the goal of transitioning the providers in those organizations from a fee-for-service payment model, to a shared savings model and finally to a population based payment model.  The Pioneer ACO program kicked off in 2012 and was intended to (1) improve quality and health outcomes for patients served by each Pioneer ACO, (2) achieve cost savings for the Medicare program and (3) reward providers who were able to achieve the dual goals of cost savings and improved quality.  Furthermore, Pioneer ACOs are eligible for higher levels of shared savings and subject to greater downside risk than MSSP ACOs. So, how have the Pioneer ACOs performed during their first two years?

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Device Advice: New Guidance From the FDA on Medical Devices and Cybersecurity

Are medical devices, subject to pre- and post-market regulatory controls, under increasing cybersecurity scrutiny? The FDA recently published recommendations for consideration of cybersecurity management in a product’s design and development phases, and in preparation of pre-market submissions.[1] While the agency emphasizes that it has issued a guidance document containing only nonbinding recommendations, is there an underlying expectation that manufacturers address—and that agency staff assess— such planning as part of the approval process?

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From Competitors to Co-Adventurers, Seven Hospital Systems Join with Anthem Blue Cross to Shake Things Up in Southern California

Anthem Blue Cross and seven competing hospital systems in Southern California are joining forces to establish a new health plan offering, Vivity.[1]  Operating with a combined 14 hospitals and approximately 6,000 physicians, the venture has already announced its first major customer: the State of California’s pension fund manager, the California Public Employees’ Retirement System (CalPERS).

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Final Meaningful Use Rule: CMS Loosens its Grip

The Centers for Medicare & Medicaid Services (“CMS”) finalized a rule on August 29th which should give providers some breathing room in complying with meaningful use requirements for the Electronic Health Record (“EHR”) Incentive Program (the “Final Rule”).  The EHR Incentive Program was developed by CMS to motivate health care providers to use and implement EHR systems.  Under the EHR Incentive Program, hospitals and healthcare professionals can qualify for incentive payments from CMS for “meaningful use” of certified EHR technology (“CEHRT”).  However, both the definition of “meaningful use” and the technologies which qualify as CEHRT are moving targets under the EHR Incentive Program and vary by “Stage.”  The EHR Incentive Program consists of Stages 1, 2 and 3 which represent set time periods during which providers must implement CEHRT to receive payments.  Each Stage has progressively more robust meaningful use objectives and clinical quality measures.  As a result, providers must continually update their EHR technology and quality assurance programs to receive payments under each Stage.

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A (Second) Lawsuit Seeks to Compel Statutory Timeframe for Administrative Law Judge Review of Medicare Claims Appeals

On August 26th, the Center for Medicare Advocacy filed a nationwide class action lawsuit against the Secretary of Health and Human Services. The complaint alleges that, as implemented, the Medicare administrative review process is in violation of Medicare statutory obligations and the Fifth Amendment’s Due Process Clause.[1]

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