Health Law Advisor

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

On September 3, 2010, the Centers for Medicare & Medicaid Services ("CMS") issued a proposed rule withdrawing regulations governing the determination of "Average Manufacturer Price" ("AMP"), the definition of "Multiple Source Drug," and the application of federal upper reimbursement limits ("FULs") for Multiple Source Drugs (the "Proposed Rule"). This withdrawal would impact the applicable regulations finalized by CMS in 2007 and 2008 but would leave intact other sections of the 2007 ...

by Shawn Gilman and Frank C. Morris, Jr.

A little-noticed provision of the Patient Protection and Affordable Care Act (PPACA) will significantly impact both health care manufacturers and providers.  The provision amends the Rehabilitation Act of 1973 to require regulations by March 23, 2012, mandating that all medical diagnostic equipment and health care provider locations be able to accommodate the needs of individuals with disabilities.  This requirement would mean a redesign of both diagnostic equipment and locations for patient interactions to assure that individuals ...

Now that we have sweeping new health care legislation, the Patient Protection and Affordable Care Act ("the Act"), let's look at the rollout of the accountable care provisions--i.e., those changes to the payment and delivery system that hold the most long-term promise of improving quality and cost-efficiency. They are discussed in my most recent article: "The Timeline for Accountable Care: The Rollout of the Payment and Delivery Reform Provisions in the Patient Protection and Affordable Care Act and the Implications for Accountable Care Organizations," published last week in ...

In my most recent article in the series I have been writing for the BNA's Health Law Reporter on payment and delivery system reform, accountable care organizations and bundled payments, I comment on where things are now that federal reform has stalled. The article, titled "Payment and Delivery System Reform: It's Only a Matter of Time," argues that changes in payment and delivery are on the horizon regardless of the pace of federal reform and that providers (and payers as well) should continue their efforts toward accountable care to meet the cost and quality challenges that ...

With the rejection in the Senate Finance Committee of two separate proposals to create a substantial public health insurance option and, instead, the approval of the relatively weak co-op proposal (which the CBO estimates to be unlikely to establish a meaningful presence and will result in only half the budget amount of $6 billion will be spent) it seemed as though the public option had breathed its last breath.  However, new developments indicate that the public option, in various forms, is still alive. 

Senator Schumer (D-NY), having failed to pass his “level playing ...

Perhaps in recognition of its benefits to areas affected by shortfalls in specialists and primary care physicians or the need for remote monitoring, telemedicine received significant funding in the ARRA. For instance, the Rural Utilities Service was allocated $2.5 billion to fund “shovel-ready” distance learning, telemedicine, and broadband program; the Indian Health Services received $85 million to fund telemedicine; and a portion of the $2 billion allocated to the Office of the National Coordinator is to be used to support the “infrastructure and tools for the ...

As the “Three Tenors” (Chairmen Waxman, Miller and Rangel) struggle to finance the access enhancements that are central to the President’s health reform aspirations, the need for meaningful payment reform continues to challenge. This week House Speaker Nancy Pelosi urged the Chairmen to sharpen their pencils in this regard. Moreover, in a letter to the Speaker and Majority Leader Steny Hoyer, the fiscally-conservative “Blue Dog” coalition of House Democrats has now said that the current drafts fail to include sufficient structural reforms likely to succeed in ...

For the last week or so, the health reform public policy debate has been keyed to the Senate HELP Committee’s draft and thus dominated by whether or not the “Exchange” to be employed in access reform should include a “public plan” and, if so, whether such a plan should have the power to access provider payment rates tied to Medicare and whether Medicare participating providers would be required to contract with it. With this week’s release of the Senate Finance Committee’s draft, it will be interesting to see whether payment reform can similarly capture the ...

Although there are some big issues that remain unresolved, such as the "public plan" component, it appears that we will see reform legislation pass in 2009. Drafts of the legislation are being prepared now by various members of Congress and their staffs.

The focus on medical homes, physician hospital organizations and accountable care organizations is very real, as is the focus on payment reform, including bundled payments and other forms of capitation-like reimbursement. A key element of the debate relates to "how integrated" a provider organization will need to be to qualify for ...