GOP leaders on the Senate Finance Committee are calling for the panel to take a closer look at what's causing the recent wave of insurance premium increases. 

Sens. Chuck Grassley (Iowa) and Pat Roberts (Kan.) say the hearing will shed light on how extensively the new health reform law is driving the premium hikes.

"[A] recent article in the Wall Street Journal reported that some health plans will be raising premiums between 1 and 9 percent in the next plan year as a direct result of changes in the health reform law," the Republicans wrote last Friday in a letter to Finance Chairman Max Baucus (D-Mont.). "Others, including Secretary Sebelius, have predicted much lower increases.

"A public hearing would provide an opportunity to sort through these different estimates and review the changes affecting premiums."

The GOP leaders have specifically requested testimony from Jay Angoff, director of the Office of Consumer Information and Insurance Oversight, and Richard Foster, chief actuary at the Centers for Medicare and Medicaid Services.  

"Mr. Angoff should be made available to provide information about trends in the current health insurance marketplace while Mr. Foster should discuss some of the underlying issues and cost drivers behind health care inflation," the Republicans wrote. 

Rep. Dennis Kucinich this month is urging the Food and Drug Administration (FDA) to delay a verdict on whether to allow genetically engineered (GE) salmon to hit the market.

The Ohio Democrat, who chairs the House Oversight Committee's domestic policy subpanel, says the current process simply doesn't allow enough time for the public to weigh in.

"Given the magnitude of interest and concern expressed by the public on issues of food safety, food labeling and the environmental impact of GE animals, it is clear that serious and irreversible damage will result if public comment is curtailed," Kucinich wrote earlier this month to FDA Deputy Commissioner Joshua Sharfstein.

The FDA is meeting Monday and Tuesday to decide whether a Massachusetts-based company should be permitted to sell its genetically modified Atlantic salmon, which grows about twice as fast as its wild cousin. If approved, it would be the first genetically modified animal allowed to be sold as food. 

The agency is also weighing whether to force the company to label its salmon as genetically engineered.

Kucinich is sponsor of legislation requiring consumer-friendly labeling when food has been genetically modified.

Federal regulators face a tough choice on contraception as they finalize the rules for coverage of preventive services under the healthcare reform law.

The law requires that, starting Thursday, new health plans cover preventative care benefits without deductible, co-pay or coinsurance. The administration unveiled regulations implementing the provision two months ago, and stakeholders had until midnight on Friday to comment.

Back in July, regulators deferred a decision on "preventive care and screening" services specifically for women until August of 2011, prompting Planned Parenthood to declare that it would press for coverage of "all forms of FDA-approved prescription contraception." Stakeholders revisited the issue in their latest filings.

The U.S. Conference of Catholic Bishops raises three main concerns in its objections to coverage of contraception: 

- Family planning is not disease prevention;

- While preventive services are often low-risk options aimed at avoiding risky consequences later, contraceptives can have the opposite profile; and

- Mandating contraception or sterilization coverage poses a threat to the rights of conscience of religious employers and others.

"To prevent pregnancy is not to prevent a disease — indeed, contraception and sterilization pose their own unique and serious health risks to the patient," the group writes. "In addition, contraceptives and sterilization are morally problematic for many stakeholders, including religiously-affiliated health care providers and insurers."

Montana's commissioner of securities and insurance, however, wrote to urge mandatory coverage of "the full range of women's preventive health care needs, including family planning."

"Pregnancy is an expensive proposition and prevention of unplanned pregnancy is highly cost effective," writes Commissioner Monica Lindeen. "For every public dollar invested in contraception, nearly $3.75 is saved in Medicaid expenditures that would have been needed for prenatal care, labor and delivery, postpartum care, and the infant's first year of medical care.

"In addition, the costs of complications can be very high. Women with unplanned pregnancies have more complicated pregnancies and deliveries on average due to increased likelihood of inadequate prenatal care, exposure of the fetus to harmful substances, and low birth weight."

On another note, the National Assembly on School-Based Health Care is urging regulators to ensure students' confidentiality. Plans are required to issue explanations of benefits to policyholders — often a parent or guardian — when paying a healthcare provider, and this can be a problem for sensitive services such as family planning, screening and counseling on sexually transmitted diseases, mental health and substance abuse services.

The American Heart Association also has a host of recommendations, mostly aimed at broadening the scope of services that must be covered without co-pays.

Leading Senate Democrats on Monday slammed the nation's biggest insurers for hiking premiums and blaming the increases on the new healthcare reform law.  

Sens. Max Baucus (D-Mont.), who heads the Finance Committee, and Jay Rockefeller (D-W.Va.), chairman of the Commerce panel, are calling on the companies to justify the premium hikes, some of which have crept into double digits following enactment of the law.  

Those increases, the lawmakers wrote to WellPoint, UnitedHealth Group, Aetna, Health Care Services Corp., and CIGNA, are "unnecessary" and "unjustified" in the face of reports that the companies are also churning large profits.

"Rather than look to throw consumers a life line, early reports indicate that some carriers are looking to raise rates even further in 2011, while blaming the patient protections in the Affordable Care Act for these cost increases," the lawmakers wrote. "This is irresponsible and unacceptable but is not, unfortunately, surprising."

The letter comes just a week after Health and Human Services Secretary Kathleen Sebelius delivered a similar message to America's Health Insurance Plans (AHIP), the industry's lobbying group, warning that the White House will have "zero tolerance" for "misinformation and unjustified rate increases." 

"I want AHIP's members to be put on notice: the Administration, in partnership with states, will not tolerate unjustified rate hikes in the name of consumer protections."

The insurance companies have defended their premium hikes, arguing that simple economics dictate that consumers will have to pay more to get more benefits. 

While Baucus and Rockefeller concede that some hikes might be necessary to comply with new consumer protections found in the law, those increases, they argue, should be in the neighborhood of 1 or 2 percent.

"If an insurer thinks it can blame the enactment of the Affordable Care Act for its rising premiums," they wrote, "it is surely mistaken." 

Healthcare providers would be subject to new screening measures based on their level of risk to federal health programs, under new proposed regulations released by the Centers for Medicare and Medicaid Services. The fraud, waste and abuse prevention measures were called for in the new healthcare reform law. 

The screening measures include database and licensure checks, unscheduled or unannounced site visits, even criminal background checks and fingerprinting for the highest-risk providers and suppliers to Medicare, Medicaid and the Children's Health Insurance Program. The proposed rule, which will be open for comment for 60 days, also establishes the criteria for six-month enrollment moratoriums to combat fraud and on payment suspensions during pending fraud investigations. 

"These are important new tools that are provided by the Affordable Care Act that will help move from the pay-and-chase approach, the reactive approach that we've been using, to one that makes it harder to commit fraud in the first place," CMS Administrator Donald Berwick said during a conference call Monday. "The new tools we're proposing are going to give us the ability to stop fraud on the front-end, by keeping out unscrupulous people who pose as providers and prey on our beneficiaries and on our programs." 

Improper payments cost federal health programs about $55 billion a year. The White House piggy-backed off the announcement to make the case that defunding healthcare reform, as some Republicans in Congress are advocating, would increase fraud. "Opponents are threatening to defund the Affordable Care Act," Assistant to the President for Special Projects Stephanie Cutter writes on the White House blog, "which would effectively handicap implementation and enforcement of these new rules that would help crack down on criminals and protect seniors."

Sen. Mike Enzi (Wyo.), senior Republican on the Senate education committee, is slamming a White House proposal designed to prevent students at for-profit career colleges from defaulting on their loans.

The proposal, Enzi said in comments submitted this month to the Department of Education (DOE), would not only disadvantage for-profit schools relative to their nonprofit competitors, but also limit access for many low-income and minority students, who tend to enroll in for-profits disproportionately.

"Admissions at for-profit institutions may become more selective, and otherwise academically qualified students may be denied admittance," Enzi wrote. "This outcome is contrary to nearly 50 years of Congressional efforts to make postsecondary education accessible to all Americans." 

The comments echo those of scores of other lawmakers — many of them Democrats — who are pushing the administration to delay the rule until the issue can be studied further. 

The issue is of great importance for the health sector because an enormous number of the nation's health professionals — from nurses to medical technicians — get their training at for-profits.

Under the proposed rule, for-profit programs would have to demonstrate that annual loan payments among recent graduates are less than 8 percent of their starting salaries. The idea is to ensure that graduates will be earning enough to pay off their debts after graduation.

The penalty for non-compliance is steep: Programs that fail to meet the standards could lose access to federal financial aid — of which 23 percent ($24 billion) went to for-profit schools last year.

Enzi said applying the new standards only to for-profit schools "will be sending the message that the Federal government is not concerned with the outcomes for over 75 percent of the Federal investment in student financial assistance."

Moreover, Enzi argued, it's not the government's role to ensure that students' educational choices "pay off." 

"Federal student financial assistance has historically been provided to increase access and help make postsecondary education more affordable," Enzi wrote. "It does not remove the responsibility of students and their families to make informed choices and to understand the financial consequences of those decisions." 

The comments put Enzi at sharp odds with Sen. Tom Harkin (D-Iowa), the chairman of the Senate education committee who's urging the White House to adopt the so-called "gainful employment" rule as quickly as possible.

“High student loan debt coupled with low repayment rates signal a questionable investment for students and taxpayers,” Harkin wrote to the DOE on Sept. 9. “[W]e encourage swift implementation of the gainful employment regulation and would be concerned with any efforts to weaken the proposal.”

Bolstering Harkin's argument, the Education Department this month issued new figures showing that the student-loan default rate at for-profits rose from 11 percent in 2007 to 11.6 percent in 2008 — much higher than default rates at nonprofit schools. 

"While for-profit schools have profited and prospered thanks to federal dollars, some of their students have not," DOE Secretary Arne Duncan said in a statement announcing the figures.

Still, not all liberals are supporting the rule. Jesse Jackson, head of the Rainbow PUSH Coalition, is on Enzi's side, arguing that the change, while well intended, would hurt minority students.

"The amount of debt a student incurs and the student’s ability to repay that debt are not reflections of the quality of an institution," Jackson wrote in his own comments submitted to DOE. "To apply a standard that looks at debt and repayment as a measure of quality misses a greater opportunity to hold all institutions to a higher standard of student outcomes, namely, graduation rates and successful post-graduation careers."

The DOE is hoping to finalize its rule by Nov. 1.

A top House Democrat this week is blasting the Defense Department (DOD) over the tens of thousands of veteran discharges the agency has attributed to personality disorders in recent years. 

Rep. Bob Filner (D-Calif.), chairman of the House Veterans' Affairs Committee, said he's "deeply puzzled" how the agency could deem soldiers combat-ready, only to discover a pre-existing personality disorder after they've been injured — a diagnosis that can threaten a veteran's eligibility for government-sponsored health benefits. 

“DoD reports that the use of personality disorder discharges has decreased and that no soldiers have been wrongly discharged,” Filner said Monday in a statement. "I cannot help but suspect that our men and women are not getting the help that they need and are struggling with PTSD [post-traumatic stress disorder], TBI [traumatic brain injuries], and other stresses of war on their own because of wrongful personality disorder discharges."

Filner said he wants to take a closer look at the criteria used by DOD to guide personality disorder discharges, which numbered 22,600 between 2002 and 2007.  

Under current rules, service members diagnosed with personality disorders lose eligibility for disability benefits from the Department of Veterans Affairs (VA) because such a disorder isn't considered service-related. The distinction has sparked concerns among veterans advocates that misdiagnoses may have caused some soldiers to be unfairly denied their due benefits.

"A personality disorder discharge is a contradiction in terms," Joshua Kors, an investigative reporter who's covered the issue extensively, testified before Filner's committee last week. "Recruits who have a severe, pre-existing illness like a personality disorder do not pass the rigorous screening process and are not accepted into the Army."

A DOD official defended the agency's record, telling lawmakers the department is "confident" that those suffering service-related mental conditions "are being diagnosed and that those diagnoses are being considered prior to separation."

Filner isn't so sure. 

"I remain extremely concerned that our dedicated service members struggle to get the proper mental health care and support while fighting America's wars," said the California Democrat. "I hope that the military’s inattention to this particular issue is not the typical manner which the services address the needs of its troops, although I’m not optimistic that is the case."

The Food and Drug Administration will hold a two-day public hearing as it prepares to put into place regulations for the approval of generic versions of biological products, according to a draft document circulating among healthcare lobbyists.

The healthcare reform law allows for the approval of generic versions of biologics — also known as biosimilars — after 12 years of patent exclusivity. Biologics refers to medications and other medical products created through biological processes rather than chemistry.

The two-day hearing would take place on Nov. 2 and 3. Since it's a draft the document could change before publication in the Federal Register, but it provides insight into the issues on which the FDA is seeking comment from industry.

An FDA spokeswoman refused to comment on the draft.

"The purpose of this public hearing," the document states, "is to create a forum for interested stakeholders to provide input regarding the agency’s implementation of the statute concerning the following issues, among others: 

— Scientific and technical factors related to a determination of biosimilarity or interchangeability; 

— The type of information that may be used to support a determination of biosimilarity or interchangeability; 

— development of a framework for optimal pharmacovigilance for biosimilar and interchangeable biological products;

— scope of the revised definition of a  “biological product”; 

— priorities for guidance development;

— scientific and technical factors related to reference product exclusivity; 

— scientific and technical factors that may inform the agency’s interpretation of “product class” as it relates to available regulatory pathways for certain protein products during the 10-year transition period following enactment of the BPCI Act; and 

— the establishment of a user fee program for biosimilar and interchangeable biological products."

A broad coalition of business and consumer groups is requesting that the Senate schedule a vote on food-safety legislation "at the soonest possible date."

Twenty-two organizations representing the food industry, consumers and public health advocates wrote to Senate Majority Leader Harry Reid (D-Nev.) and Senate Minority Leader Mitch McConnell (R-Ky.) last week to urge action on the bill. On Monday five of the signing groups held a joint press conference at the Grocery Manufacturers Association to urge passage of "strong food-safety legislation [that] will reduce the risk of contamination and thereby better protect public health and safety." 

The stalled legislation would give the Food and Drug Administration power to recall tainted food, quarantine geographical areas and access food producers’ records. Similar legislation passed the House in July 2009.

The Senate Health Committee voted out the Senate version November, and unveiled a bipartisan manager's amendment at the beginning of the August recess. As a result, advocates were hoping for quick and easy passage of the legislation this month, but Sen. Tom Coburn (R-Okla.) is objecting on the grounds that the bill strengthens already inefficient government agencies and isn't paid for over the long term.