A top House Republican this week urged federal investigators to look into the conduct of Food and Drug Administration (FDA) officials surrounding the 2009 recall of Motrin. 

Rep. Darrell Issa (Calif.), senior Republican on the House Oversight Committee, asked HHS Inspector General Daniel Levinson Tuesday to investigate whether the FDA "purposely and improperly sought to impede and mislead a Congressional oversight investigation." 

Issa is accusing FDA officials of (1) issuing media statements "that are inconsistent with key facts;" (2) trying "to mislead Congress by omitting key facts about FDA's knowledge" of an under-the-radar Motrin recall in 2009; and (3) refusing to allow committee investigators to interview an agency employee "with clear first-hand knowledge of an FDA failure."

The "phantom recall" of Motrin began in 2009, when McNeil — a subsidiary of Johnson & Johnson that makes Motrin — hired private contractors to buy up defective Motrin from retailer shelves, rather than launching a national recall, which would have been public.

"Run in, find the product, make your purchase and run out," the contractors were instructed. "There must be no mention of this being a recall of the product."

Issa and Rep. Edolphus Towns (D-N.Y.) have both been critical of McNeil surrounding the episode. More recently, though, the lawmakers have also scrutinized the FDA over what the agency knew about the phantom recall — and when. 

The oversight panel is holding a hearing on the saga Thursday, with leaders from FDA, Johnson & Johnson and McNeil all invited to testify. 

U.S. adults' opinion of Democrats' signature healthcare reform law ticked upward over the last month, as the law's benefits begin to kick in.

Forty-nine percent of adult Americans say they have a favorable opinion of the healthcare bill President Obama signed into law in March, while 40 percent have an unfavorable impression.

That's the most favorable opinion potential voters have had since July, and a rebound in the monthly Kaiser Health Tracking Poll from last month, when health reform suffered a net negative, 43-45 percent, approval rating.

The improved opinion about healthcare comes after the six month anniversary of the law's implementation celebrated by Democrats last year. That anniversary kicked in some of the first, basic benefits accrued by Americans under the law.

Both Democrats and Republicans are counting on the controversial healthcare bill to carry votes for them in this fall's heavily contested elections. Republicans have pledged to repeal the legislation and replace it with their own reforms, while Democrats have sought to highlight the benefits that would be threatened by the GOP's repeal effort.

The Kaiser poll, which has been one of the most regular surveys to track the implementation of healthcare, found that roughly a quarter of the public back repealing the bill.

Twenty-six percent of said it should be repealed -- the GOP position -- while a proportion of those who are opposed to the law still believe it should be given a chance to work before lawmakers look to repeal.

The poll, conducted Sept. 14-19, has a three percent margin of error.

A pair of top House Republicans went after the White House Tuesday over new rules that will lead to next year's extinction of some Medicare prescription drug plans.

Reps. Dave Camp (Mich.), senior Republican on the Ways and Means Committee, and Wally Herger (R-Calif.), the ranking member of the Ways and Means health subpanel, said the "paternalistic" new guidelines will confuse millions of seniors forced to change Part D plans in 2011.

"This 'government knows best' approach to healthcare is a frightening consequence of the decision to break the President's pledge that 'if you like the plan you have you can keep it,'" the lawmakers wrote Tuesday in a letter to Health and Human Services Secretary Kathleen Sebelius.

The critique is a direct response to a recent report, conducted by Washington-based Avalere Health, indicating that new administration rules will force a number of Part D plans to fold next year — including the 2nd and 9th most popular plans by enrollment. 

Those "meaningful differences" rules — created as a part of the new health reform law — are designed to limit the number of similar plans a single Part D sponsor can offer in one region, so as not to confuse seniors with an overwhelming number of choices. 

Insurers, under the rules, are allowed to offer only one standard plan and up to two enhanced plans in any one region, with the Centers for Medicare and Medicaid Services (CMS) specifying "meaningful" cost differences between the two categories. For sponsors offering two enhanced plans, the agency has also established a minimum of coverage differences to distinguish the products.

Avalere estimates that more than 3 million of the roughly 17 million seniors enrolled in Part D will be forced to switch plans as a result of the changes. Those affected will be moved automatically to different plans offered by the same sponsor.

Still, the automatic switch has done nothing to appease Camp and Herger. The lawmakers are asking CMS for "all documents and correspondence related to CMS' decision to eliminate prescription drug plans over the last two years." 

More and more Democrats are urging the White House to scale back a proposal aimed at preventing loan defaults among career college students.

Sens. Herb Kohl (D-Wis.), Roland Burris (D-Ill.) and Bill Nelson (D-Fla.) — as well as Rep. Michael McMahon (D-N.Y.) — have all sent letters to the Education Department in the last week warning that the rule will limit education opportunities for low-income and minority students, who tend to attend for-profit schools in disproportionate numbers.

Some new limits on for-profit educators are appropriate to rein in abusive recruitment and lending practices, the lawmakers argue, but the current proposal goes too far, they say.

The lawmakers join dozens of House Democrats who had weighed in against the proposal in formal comments earlier in the month.

Although the agency on Friday extended its timeline for finalizing the most controversial parts of that rule, the scheduled effective date remains unchanged: July 1, 2012. 

The pushback from Democrats — combined with a fierce lobbying effort by the for-profit education industry — has upped the pressure on the administration to scale back the proposed limits as officials draft the final rule, scheduled for release early next year.

The issue is significant in the healthcare world because a large number of medical professionals are trained at for-profit schools.

The Education Department's so-called "gainful employment" proposal is designed to ensure that career and professional college students will earn enough in their fields to pay back their federal loans. The rule would require for-profit programs to show that graduates' annual loan payments don't exceed 8 percent of their starting salaries. Programs failing to meet that debt-to-income ratio could lose access to federal financial aid — an enormous stick for an industry that benefited from roughly $24 billion in federal loans and grants last year.  

The rule is one of 14 White House proposals aimed at combating two troublesome trends in the for-profit education industry: The rising rate of student loan defaults; and the emergence of aggressive recruiting practices that, in many cases, have misled students about the nature of their training and employability.

Even so, the industry says, the metrics proposed in the gainful employment rule are too strict — a message being echoed by Kohl, Burris, Nelson, McMahan and scores more members.  

Some lawmakers, though, are fully behind the White House proposal. Earlier in the month, a group of liberal upper-chamber Democrats — including Sens. Tom Harkin (Iowa), chairman of the education panel, and Majority Whip Dick Durbin (Ill.) — urged the Education Department to adopt the new guidelines as quickly as possible. 

"High student loan debt coupled with low repayment rates signal a questionable investment for students and taxpayers," the Democrats wrote. "We encourage swift implementation of the gainful employment regulation and would be concerned with any efforts to weaken the proposal." 

The Senate Finance Committee put federal insurance law under a microscope Tuesday with a hearing on private long-term disability policies. 

The hearing focused on whether the federal Employee Retirement Income Security Act (ERISA) inadvertently helps insurers deny disability claims. ERISA largely escaped scrutiny during the health reform debate as Democrats vowed to preserve the employment-based health insurance system governed by the 1974 law.

"Abusive insurance company tactics start with having doctors with conflicts of interest review claims," Finance Chair Max Baucus (D-Mont.) said in opening remarks. "Many of these doctors are employed either by the insurance company or by companies that do a lot of business with the insurance company. These arrangements make it far too easy for the doctors to deny claims, terminate claims, or reject appeals."

U.S. District Court Judge William Acker of Alabama said one of the main problems was the law's discretionary clause, which he called a "disaster" that allows plan administrators to both interpret the plan and decide how to apply it to a particular disability claim.

Disability law attorney Mark DeBofsky testified that "the story told over the past 35 years has been one revealing an utter betrayal of those lofty goals [of ERISA] and an egregious absence of remedies, sanctions, and access to normal federal court procedures. Contrary to the clearly expressed legislative intent, the courts have transformed ERISA into a shield that protects insurance companies from having to face the consequences of unprincipled benefit denials and other breaches of fiduciary duty."

He said Congress should act to: 

- Abolish the right given insurers to grant themselves a deferential review and allow claimants the ability to present witnesses and evidence in open court;

- Provide for jury trials;

- Preclude courts from remanding benefit claim disputes to the insurers; and

- Permit awards of statutory or other damages in appropriate cases.

Other questioned how big a problem the claims denials really were.

Sen. Olympia Snowe (R-Maine) wondered what's stopping states from doing away with the discretionary clause, as Montana, Texas and Michigan have done.

And ranking member Charles Grassley (R-Iowa) said ERISA was really the jurisdiction of the Senate HELP Committee.

The American Council of Life Insurers and America's Health Insurance Plans testified that the system works well now. They both pointed out that insurers paid out more than $8.95 billion in long-term disability benefits in 2009 and that 82 percent of claimants said they were satisfied with their policies in an 2008 Harris Interactive poll.

"There's an assumption here that there's something broken right now," said Paul Graham, vice-president for insurance regulation and chief actuary at the American Council of Life Insurers. "And if you look at anecdotal evidence you will be able to find individual cases where you might have had some egregious behavior, and that's obviously quite unfortunate. But ... the idea that something's structurally wrong is not correct."

Democratic leaders on the Energy and Commerce health subcommittee will meet this week to examine draft legislation designed to ensure the safety of pharmaceuticals in an ever-globalizing world.

The draft bill, unveiled by E&C leaders last week, would enhance the safety and inspection requirements for American-sold drugs manufactured overseas — an effort to ensure that foreign consumer protections are at least as stringent as those in the U.S.

The bill is largely a response to an incident in 2008 when defective, Chinese-made heparin — a blood thinner — killed scores of Americans.

"We’ve learned more than a few troubling truths on the safety of some prescription medications, and we’ve learned it the hard way — with tragedies,” Rep. John Dingell (D-Mich.) said last week in a statement. 

"We know we need to address this, the only question now is how. We must ensure the Food and Drug Administration is adequately equipped to carry out the important mission of protecting American consumers."

The hearing is scheduled for Thursday. 

Witnesses will include Janet Woodcock, director of FDA's drug research center; William Vaughan, health policy analyst at Consumers Union; Kendra A. Martello, attorney for the Pharmaceutical Research and Manufacturers of America (PhRMA); Allan Coukell, head of medical safety at the Pew Health Group; William Hubbard, with the Alliance for a Stronger FDA; Andrew Emmett, managing director of the Biotechnology Industry Organization (BIO); and Gordon Johnston, vice president of regulatory sciences with the Generic Pharmaceutical Association (GPhA).

The House is expected to vote Wednesday on a bill guaranteeing medical care to 9/11 first responders.

More than 90 advocacy organizations sent a letter Monday to House Education and Labor Chair George Miller (D-Calif.) urging a vote on childhood nutrition legislation before the federal program expires Thursday.

"Some of the key provisions in the Healthy, Hunger-Free Kids Act for reducing obesity and supporting healthy eating by children include, updated nutrition standards for all foods sold in schools, increased lunch reimbursements, and training to help schools serve healthier meals," reads the letter. "The bill includes a number of provisions to expand access to child nutrition programs for hungry kids, including expansion of afterschool meals for at-risk children and improvements to direct certification to enroll more low-income children for free meals. The bill is bipartisan and fully paid for."

The signees include the American Diabetes Association, the American Heart Association and the American Public Health Association.

They want the House to pass the Senate's $4.5 billion bill, but liberal Democrats and some anti-poverty advocates are balking at a $2 billion future cut in food stamps to pay for the bill. The groups are increasingly defending the reauthorization as a key tool to fight childhood obesity — the goal espoused by first lady Michelle Obama in her Let's Move campaign.

The Senate bill, championed by Sen. Blanche Lincoln (D-Ark.), expands eligibility for school meal programs; establishes nutrition standards for all foods sold in schools; and provides a 6-cent increase for each school lunch to help cafeterias serve healthier meals. It passed by unanimous consent just before the August recess.

The Obama administration on Tuesday named the last of a long list of regional contractors charged with helping doctors and hospitals transition from paper-based medical records to electronic systems. 

CalOptima Foundation was awarded a two-year, $4.7 million contract to cover Orange County, Calif., while Massachusetts eHealth Collaborative will receive roughly $5.1 million to cover the state of New Hampshire, the Health and Human Services Department (HHS) announced.

The contractors are the final pieces of the national network of Regional Extension Centers (RECs) created to facilitate providers' adoption of health information technologies. That network was launched by last year's economic stimulus bill, with provided $677 million for RECs over two years. 

"The selection of these final awardees means that Regional Extension Centers are now in place in every region of our country to help health providers make the switch from paper-based medical practice to electronic health records," David Blumenthal, HHS' national coordinator for health information technology, said in a statement. 

"For primary care physicians and smaller hospitals in particular, the RECs will be an important resource to help meet the challenges of adopting [electronic health records] and using them to deliver better care."