PPACA Implementation

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On December 8, 2010, the Food and Drug Administration (FDA) published a notice requesting that stakeholders – particularly patient and consumer advocacy groups, health care professionals, and scientific and academic experts – notify FDA if they intend to participate in consultation meetings on the development of a user fee program for biosimilar and interchangeable biological product …

On December 1, 2010, the Department of Health and Human Services (HHS) is publishing an interim final rule with comment period implementing ACA medical loss ratio requirements. Under the rule, beginning in 2011, insurance companies in the individual and small group markets must spend at least 80% of the premium dollars they collect on…

The Centers for Disease Control and Prevention (CDC) is inviting comments on the development of guidance regarding an ACA provision requiring a health risk assessment to be included in the annual Medicare wellness visit benefit. CDC is collaborating with CMS to develop guidance for this type of assessment (which the CDC notes also may…

On November 16, 2010, CMS formally established a new Center for Medicare and Medicaid Innovation (Innovation Center). Created by the ACA, the Innovation Center will examine new ways of delivering health care and paying health care providers that can save money for Medicare and Medicaid while improving the quality of care. Richard Gilfillan, MD, has been …

On November 22, 2010, CMS is publishing a proposed rule that would update Medicare Advantage (MA) and Part D prescription drug benefit regulations to reflect ACA requirements and make other program changes for contract year 2012. Specifically, the proposed rule would implement ACA provisions that, among other things: limit beneficiary cost sharing for certain services…

On November 17, 2010, the Obama Administration is publishing an amendment to current interim final rules to permit certain changes in policies, certificates, or contracts of insurance without loss of grandfathered status under the ACA. The amendment is effective November 15, 2010, and comments will be accepted until 30 days after publication.

The ACA authorizes CMS to test innovative payment and service delivery models. For instance, the Medicare Shared Savings Program promotes the formation of accountable care organizations (ACOs), under which groups or providers may work together to coordinate care for Medicare beneficiaries and receive payments for shared savings if certain standards are met. In preparation…

The Obama Administration is publishing a notice November 17, 2010 requesting information to gain market analysis information in advance of future requests for proposals related to health plan external review processes. Specifically, the notice requests comments on operational issues associated with implementation of a federal external review process for health coverage in states that do…

The ACA requires drug manufacturers to report the total number of units that are used to calculate the monthly average manufacturer price (AMP) for each covered outpatient drug no later than 30 days after the last day of the month. CMS has updated the Medicaid Drug Data Reporting system to enable reporting of AMP units…

The Obama Administration has made a much-anticipated announcement of the recipients of the $1 billion in new ACA therapeutic discovery project tax credits, which are designed to support research with significant potential to produce new therapies, address unmet medical needs, reduce the long-term growth of health care costs, or advance the goal of curing cancer…

Senators Chuck Grassley and Herb Kohl have asked HHS Secretary Sebelius to take a number of steps to prepare for implementation of the ACA’s Physician Payments Sunshine Act provisions, under which drug and medical device manufacturers must disclose to HHS certain payments to physicians. The Senators note that some drug and medical device makers are…

On November 17 and 18, 2010, the Health Resources and Services Administration is hosting a meeting of the Negotiated Rulemaking Committee on Designation of Medically Underserved Populations and Health Professional Shortage Areas. The Committee, which was authorized by the ACA, will be focusing on the various components of a possible methodology for identifying areas of …

On December 3, 2010, CMS is hosting a public forum on the upcoming Community-Based Care Transitions Program, which was authorized by the Affordable Care Act to reduce hospital readmissions, test sustainable funding streams for care transition services, maintain or improve quality of care, and document measureable savings to the Medicare program. The registration deadline…

As widely reported in the media, on October 14, 2010, a federal judge in Florida ruled that he will allow a lawsuit challenging the constitutionality of the Affordable Care Act to proceed. The lawsuit argues that the ACA’s individual mandate that people buy health insurance or else pay a penalty exceeds Congress’s authority under the…