Additional Federal Grants for Health Insurance Exchanges

HHS announced that ten states have qualified for a total of $229 million in federal grants to help establish their state-based health insurance exchanges.  In addition, HHS issued a final rule which allows states to request PPACA “innovation waivers” beginning in 2017.  To qualify, such a state must demonstrate that their plan would cover at least as many eligible persons under PPACA benefit mandates as required under the federal law.  If states do not set up their own exchanges, the federal government would have to step in to form an exchange.  The President’s budget has requested about $864 million in FY 2013 to establish the federal exchange, setting up another avenue for Republicans to impede the implementation of the PPACA this year.

Supreme Court Provides More Time for PPACA Arguments

Acceding to DOJ and other pleas for more time to argue whether the AIA prevents the consideration of a challenge to the PPACA individual mandate until the penalties for non-compliance begin in 2014, the U.S. Supreme Court added another 30 minutes for each party to make their case.  The court will hear six hours of argument over the individual mandate, Medicaid expansion, severability and AIA from March 26 to March 28.  In related news, seven state attorneys general said they have filed suit against the federal government to challenge the PPACA rule requiring employers with religious affiliations to offer no-cost contraceptive coverage under their health care plans.

CO-OP Loans Approved

The CMS CCIIO also announced that $638.7 million in federal loans have been granted to seven private, nonprofit Consumer Operated and Oriented Plans (CO-Ops).  Additional applications will be considered throughout 2012.  The PPACA authorized CO-OPs to help increase competition among health insurers.  Any profits of such CO-OPs are required to be used to improve quality, benefits and premium affordability for covered participants.

Proposed "Meaningful Use" and EHR Standards

The Office of the National Coordinator for Health Information Technology issued a proposed rule which lays out the standards and certification criteria needed to meet “meaningful use” of electronic health records beginning in 2014.  The ONC said the electronic health record certification criteria would provide for increased clarity and transparency.  Also, CMS released a proposed rule for Stage 2 of the Medicare and Medicaid EHR program which provides incentive payments to eligible health care providers when they adopt certified EHR technology.  The rule, “Medicare and Medicaid Programs; Electronic Health Record Incentive Program—Stage 2 (CMS-0044-P)”, defining Stage 2 “meaningful use” criteria would increase the requirements for the electronic capture of health information in a structured format and for the exchange of clinically relevant information between providers at care transitions, among other elements.  Comments are due within 60 days from March 7.

DEMO Project Criteria

CMS issued a final rule defining the public input and transparency requirements that states must meet in order to have CMS approve Section 1115 new coverage and delivery demonstration projects under Medicaid and SCHIP.

Alzheimer's Research Plan

The President’s Alzheimer’s advisory council released a draft framework for expanding and coordinating disease research through public-private partnerships, such as establishing registries to enroll Alzheimer’s patients in clinical trials and developing new models of care (e.g. medical homes and accountable care organizations).

FDA Issues

Drug Shortage Addressed - The FDA announced steps to increase the supply of certain cancer drugs which have been in short supply.  The FDA has allowed a temporary importation of a replacement drug for the shortage of doxorubicin hydrochloride liposome injection and approved a preservative-free methotrexate generic drug for the treatment of children with acute lymphocytic leukemia and for the high-dose therapy of osteosarcoma.  The FDA also issued draft guidance for manufacturers on the requirements for both mandatory and voluntary notifications to the FDA of issues that could result in a drug shortage or supply disruption.

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