Final Regulations for CO-Ops

CMS released final rules implementing the PPACA Consumer Operated and Oriented Plan (CO-OP) program.  Under the rules recipients of loans to set up the nonprofit cooperative insurance plans: will have two years instead of one to make the transition to member-elected boards; clarifies that, in addition to pre-existing issuers and their agents, holding companies that control insurance issuers that existed before July 16, 2009, are ineligible for the $3.8 billion in loans to set up the nonprofit health plans; and allows a CO-OP sponsor or applicant to receive funding from state or local governments as long as the CO-OP is not controlled by a government entity and it does not receive more than 40% of its total funding from state or local governments.

Issues Related to Challenges to PPACA in the U.S. Supreme Court

The interest in the upcoming Supreme Court case challenging the constitutionality of the PPACA is heating up with the latest move being by Senators Dick Durbin and Charles Grassley who have introduced legislation, S. 1945, which would require that open proceedings of the U.S. Supreme Court be televised.  Also, the court set the schedule for briefs to be filed ahead of oral arguments next spring in the Florida lawsuit challenging the federal health reform law.

DOL Proposes New Rules for MEWAs

The Department of Labor Employee Benefits Security Administration released two proposed rules establishing procedures for DOL to issue ex parte cease-and-desist orders and summary seizure orders to alleged fraudulent or insolvent MEWAs (multiple employer welfare arrangements as defined under ERISA) and would amend existing Form 5500 and M-1 reporting obligations for MEWAs.

PPACA School-based Grants

HHS announced that it has awarded more than $14.5 million in PPACA grants to 45 school-based health centers, allowing them to expand services to some 53,000 children in 29 states.

Early Retiree Reinsurance Program to Shut Down

CMS announced that it will not accept claims for the PPACA’s ERRP program that are incurred after year-end because it has already disbursed $4.5 billion of the $5 billion appropriated for the program.

Final Regs on Use of Medicare Claims Data

CMS released a final rule that allows for the release and use of select extracts of Medicare claims data to measure the performance of providers and suppliers in ways that protect patient privacy.  Interested parties will have to pay for the cost.  The regulations take effect on January 6, 2012.

FDA Meetings

The FDA provided notice that the agency will hold a public meeting on December 19th to take testimony on proposed new user fees that would provide the FDA with additional funding for the generic drug program in the amount of $299 million per year, adjusted for inflation, for five years.  The FDA also gave notice of a public meeting on December 16 to discuss the proposed recommendations for a biosimilars user fee program for FY 2013-17.

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