FDA Commissioner Margaret Hamburg on Friday (Sept. 6) asked her top managers to report back within three months on a plan to vertically realign the agency so that it can better tackle growing statutory mandates, globalization and a complex regulatory environment.

House Majority Leader Eric Cantor (R-VA) in a Sept. 6 memo to Republicans vows to follow Speaker John Boehner's (R-OH) previously revealed strategy to “dismantle, defund, and delay” Obamacare, and says the president has already signed seven bills repealing parts of the law or significantly reducing ACA-related spending.

CMS has changed course and approved a one-year extension for Oklahoma's 1115 demonstration “Insure Oklahoma,” which isn't a plan for Oklahoma to do the ACA Medicaid expansion but is an existing waiver that helps low-income adults afford health insurance and had been slated to expire at the end of the year, much to the state's chagrin.

FDA plans to publish a revised draft guidance on New Dietary Ingredient notifications this year and finalize the controversial document next year, the agency says in a newly unveiled food center priorities document for 2013-2014.

CMS program integrity chief Peter Budetti, who implemented many of CMS' steps toward predictive analytics, will step down next week from his position as the agency's first deputy administrator and director for program integrity, according to a CMS email obtained by Inside Health Policy.

House and Senate staff have been working on a bipartisan, bicameral basis throughout August recess to come to an agreement on drug compounding legislation, and stakeholders said they are encouraged by the continued focus on the issue.

The National Association of Medicaid Directors believes CMS should not publish its recalculated Federal Upper Limit pricing for Medicaid drugs before the agency is ready to release the final FUL rule required by the Affordable Care Act, which is scheduled for January, as the HHS Office of Inspector General pushes CMS to implement the new FULs due to pricing concerns.

Business stakeholders, while happy IRS finally issued draft regulations on the long-awaited Affordable Care Act reporting requirements, say the proposed policies -- particularly the agency's refusal to allow employers to combine both requirements into one report -- are still too burdensome and hope to work with the administration to further streamline the process.

Administration officials were developing a proposal to pitch to unions that would involve the creation of two separate health insurance trusts, one of which would allow those eligible for ACA exchange subsidies to receive them, sources say, in response to concerns voiced by many unions and other groups that workers enrolled in existing multi-employer plans are ineligible for such subsidies.

As lawmakers seek ways to pay for fixing the Medicare physician-pay formula, CMS actuaries estimate that a two-year-old legislative proposal by Sen. Tom Coburn (R-OK) and former Sen. Joe Lieberman (D-CT) would reduce Medicare spending by $536 billion over a decade.

The Generic Pharmaceutical Association is urging California Gov. Jerry Brown (D) to veto a biosimilar substitution bill that easily passed the state Senate this week.

A working group of drug companies and patient advocates, led by former HHS chief Tommy Thompson and a former FDA staffer, are urging lawmakers to impose stricter limits on office use drug compounding than those included in a Senate proposal and to require documentation of patients' need for modified FDA-approved drugs, according to compounding policy recommendations floated this week.

The Congressional Budget Office this week received industry-backed legislation to create patient-admission criteria for long-term care hospitals, which is viewed by some as the sector's last chance to avoid CMS' proposal to create much stricter admission criteria, which the American Hospital Association estimates would eliminate about 65 percent of LTCH patients.

Former President Bill Clinton on Wednesday (Sept. 4) said an apparent error in the health reform law that would prevent a full-time employee's family members from getting subsidized health insurance on the exchanges if the worker gets an affordable individual policy from their employer -- dubbed by some as the “families glitch” -- is “obviously not fair” and needs to be fixed by Congress.

CMS is considering changing the statement of work for Recovery Audit Contractors to include measures related to appeals overturned at the first level, and timeliness and accuracy, the agency said in response to a report from the HHS Office of Inspector General which found that CMS' performance evaluations of the RAC program -- which some hospitals say is overly aggressive -- did not look at how well the RACs were fulfilling their contracts.

Starting in November WellPoint will only cover compounded drugs that contain an FDA-approved product, making the insurer the third to tweak its policy since the practice of compounding has garnered nationwide attention, although the company attributes the stepped-up enforcement to Health Insurance Portability and Accountability Act changes.

The HHS Office of Inspector General in a new report criticizes CMS for not increasing the frequency of its hospice recertifications, noting the OIG recommended in 2007 that CMS recertify hospices more often as many hadn't been through the process in six years or more.

A key industry attorney and Health IT Now posed differing views about FDA's role in a tri-agency regulatory strategy for health information technology, with the attorney pushing for FDA to provide clear but flexible oversight while the broad-based stakeholder group said the agency's role should be limited to medical technologies.

The Biotechnology Industry Organization and rare disease patient advocates urge FDA to discuss rare diseases in the context of the agency's expedited approval programs, responding to FDA's recent guidance on the topic.

Pharmacists and some Medicare beneficiaries are pushing for more signatures on a bill that would let retail community pharmacies deliver diabetic testing supplies to Medicare beneficiaries.