Regulatory Transactions

Publisher’s Note: The publisher of this website was instrumental in the initiation of centralized regulatory review in the White Office of Management and Budget– its origins having begun in the Johnson Administration and utilized by eight subsequent Presidential Administrations.

A plethora of press articles are coming on line in the last eight hours which cast the OMB review in a non-favorable light. I remind all our readers that the office in OMB, the Office of Information and Regulatory Affairs, consisting of less than four dozen employees out of a million plus federal employees is the only group between an unchecked regulatory bureaucracy and the taxpayers check book.

From: Ag/FDA Blog – The OFW Law Blog

By Richard L. Frank and Bruce Silverglade

The White House’s role with USDA’s regulations for school foods and the WIC feeding program has been widely reported.  Lesser known is the White House involvement in FDA food labeling policy.

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About a year ago, FDA requested permission from the White House Office of Management and Budget (OMB) to conduct a study to find out if an “Added Sugars” disclosure would be helpful or confusing to consumers.  However, to coincide with the anniversary of the Let’s Move! campaign, FDA, on March 3, published its proposed rule including “Added Sugars” labeling despite the absence of any consumer survey research. OMB approval of FDA’s research study was granted in an untimely fashion three weeks after the proposed regulation was published (and then only after trade press reports had drawn attention to the matter).

From: National Association for Home Care & Hospice

A recent Bloomberg BNA article announced that the Office of Management and Budget (OMB) has received a proposed rule from CMS that would set 2015 payment rates for home health agencies.

According to the article:

“The rule (CMS-1611-P; RIN: 0938-AS14), would update the 60-day national episode rate based on the applicable home health market basket update and case-mix adjustment, the OMB said.

The proposal also would update the national per-visit rates used to calculate low utilization payment adjustments and outlier payments under the Medicare prospective payment system for home health agencies, it added.

From: National Low Income Housing Coalition

On June 11, the Office of Information and Regulatory Affairs (OIRA) at the Office of Management and Budget (OMB) posted a notice that the final NHTF regulations are at OMB and that a final rule is expected to released sometime in July 2014. While a posting does not guarantee that a final rule will be published by the date specified, the OIRA listing is a good sign and a positive step toward implementation of the NHTF. The NHTF was authorized by the Housing and Economic Recovery Act of 2008 (HERA) and HUD issued a proposed rule on October 29, 2010.

From: Rock River Times

WASHINGTON, D.C. — Fulfilling President Barack Obama’s commitment to make 2014 a year of action to strengthen the economy and grow the middle class, U.S. Secretary of Labor Thomas E. Perez has announced a proposed rule raising the minimum wage for workers on federal service and construction contracts to $10.10 per hour. The proposed rule implements Executive Order 13658, which was announced by the president Feb. 12.

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From: Health Data Management

Greg Slabodkin

The American Hospital Association is pushing the Centers for Medicare and Medicaid Services to promptly create a centralized repository on public health agency readiness to receive data hospitals must submit under the meaningful use program.

From: Occupational Health & Safety

SAN ANTONIO — Whether OSHA ever will update its permissible exposure limits (PELs) is debatable. The agency has tried before without success, and it agrees that these 40-year-old exposure limits are outdated and inadequate – so much so that it recommends that employers voluntarily adhere to NIOSH and ACGIH recommended limits and to Cal/OSHA’s PELs list.

Editor’s Note: In testimony before the House Education and the Workforce Subcommittee on Workforce Protections, the US Chamber of Commerce highlighted the importance of one of the lesser known “good government” laws, OMB’s Final Bulletin for Agency Good Guidance Practices.  As the Center for Effective Government explains, “OMB issued the Final Bulletin for Agency Good Guidance Practices (with authority under the Data Quality Act) which required OIRA’s review of significant guidance documents as well as public notice-and-comment on guidance documents deemed “economically significant.”

From: US Chamber of Commerce Congressional Testimony

From: American Bakers Association

by kkotche

ABA led a coalition of food industry organizations in a meeting with OMB on May 30 to discuss the coalition’s support for FDA’s public health goals but expressed concerns with the suggested approach of a PHO Tentative GRAS Determination Notice (TD). The Coalition recommended withdrawal of the notice and proposed that OMB should direct FDA to instead go through formal rulemaking which would include the safeguards, assessments and data required for such a significant action.

From: Association of Corporate Counsel

ByLeslie J. Levinson and Michaela B. Tabela/Edwards Wildman Palmer LLP

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On May 22, 2014, the Office of Management and Budget (OMB) announced that it would begin reviewing a proposed rule revising the conditions of participation (CoPs) that home health agencies must meet to participate in the Medicare program. The home health CoPs have not been revised since 1989. The proposed rule was published in 1997, but was never finalized. 

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