WASHINGTON -- As the nation's leaders wrapped another week of haggling over the debt limit and spending cuts, President Obama indicated on Friday that he would support charging wealthier Medicare recipients more for using the program.
During a Friday morning news conference, Obama was asked whether he was open to considering "means testing," which would require wealthier seniors to pay more for Medicare. He said that was one of several ideas on the table to make the Medicare program more sustainable.
He said he could "envision a situation where for somebody in my position, having to pay a little bit more on premiums, or co-pays, or things like that would be appropriate. And, again, that could make a difference."
"Modest modifications can save you trillions of dollars," he said.
Obama added that he wanted to protect current Medicare beneficiaries as much as possible, and that he wouldn't support changes that would disrupt Medicare coverage for those who are currently 65 or older.
He also made it clear that he opposes the proposal of Rep. Paul Ryan (R-Wisc.) to provide seniors and the disabled with an annual stipend, based on income, that would be used to buy a private insurance plan of their choice.
AARP immediately fired off a press release criticising the president for endorsing means testing.
"Medicare is not a welfare program," said AARP Senior Vice President Joyce Rogers. "Seniors pay into Medicare their entire working lives based on the promise that they'll have secure health coverage when they retire. Applying a means test for their earned benefits would erode the popular support that has sustained these programs for years and made them so effective in helping older households."
IPAB Back-and-Forth
Medicare was a hot topic on the Hill this week, with Congress holding two hearings entirely devoted to discussing the program and the Independent Payment Advisory Board (IPAB) mandated by the Affordable Care Act (ACA) as a way to control Medicare spending.
Health and Human Services Secretary Kathleen Sebelius told the House Budget Committee Tuesday that Congress can make the controversial Medicare cost-cutting panel obsolete by passing laws that rein in spending themselves.
During the hearing, Republicans characterized IPAB as a bureaucratic rationing mechanism, while Democrats said it is necessary to curb out-of-control Medicare spending.
The IPAB, a board of 15 officials appointed by the president, would be tasked with finding ways to slow Medicare spending if it's projected to grow too quickly in the upcoming year.
The panel would submit its proposals to Congress starting in fiscal 2015. If Congress doesn't agree with the proposal, it must pass its own set of cuts of the same size by August of that year. If Congress doesn't act, the HHS secretary is required by law to implement the cuts.
Much of the hearing consisted of Ryan, chairman of the budget committee, defending his own Medicare plan while knocking the controversial IPAB. In turn, Sebelius defended the IPAB and criticized the controversial Ryan plan.
The following day, another panel took up the issue during a tense hearing in which Sebelius said Obama was in discussion with a number of potential nominees to serve on the IPAB.
HHS Relaxes Requirements for State Exchanges
The Department of Health and Human Services has released a proposal granting states some flexibility in how they will establish and run the new insurance exchanges that are a crucial piece of the ACA.
Under the ACA, each state has to set up a marketplace offering insurance plans that meet certain benchmarks by 2014.
Under the law, states must show by Jan. 1, 2013 that they are capable of running an insurance exchange in a year's time or opt out and have the federal government run their exchange. Under Monday's proposal, states would have a little more leeway.
If a state can't show it's capable of setting up its own exchange by the start of 2013, but appears to at least be on the right track, it can receive conditional approval from HHS to participate.
And, if a state isn't ready to start an exchange in 2014, they can hold off until 2015, as long as they give the federal government one year's notice, according to federal health officials who spoke to reporters Monday afternoon.
The proposed rule would also allow states to decide whether they want their exchanges run by local or regional governments, or by a nonprofit organization.
The Congressional Budget Office estimates 8.9 million people will use the exchanges in 2014 and 23.4 million in 2018.
FDA to Exempt Common Devices from Premarket Review
The FDA said it would exempt several dozen types of diagnostic tests and radiology products from 510(k) premarket notification requirements, bowing to pressure from industry and Congress.
The devices are designated to be in the two lowest-risk categories. Among the 75 different product classes to be exempted are platelet adhesions tests, alcohol breathalyzers, and more than 40 other clinical chemistry tests. Also included in the exemption were about 20 devices used in imaging studies such as x-ray collimators and film processors.
In a draft guidance document, the FDA said that "it believes the safety and effectiveness of these devices is sufficiently well established and they have sufficiently controlled risks that general controls are sufficient and a 510(k) review is not necessary to assure the safety and effectiveness of such devices."
The FDA has been criticized by device manufacturers and some members of Congress for what they say are excessively lengthy and unpredictable review decisions.
Panel Backs Lymphoma Drug
An FDA advisory panel voted unanimously Thursday to recommend accelerated approval for an investigational drug to treat Hodgkin lymphoma in patients who have already had a stem cell transplant, and for patients with relapsed or resistant systemic anaplastic large cell lymphoma.
Brentuximab vedotin, which Seattle Genetics will market as Adcetris, combines an antibody with a chemotherapy drug to treat the rare blood cancer in a novel way. The antibody binds to the CD30-positive Reed-Sternberg cells that are characteristic of the disease, while the drug -- monomethyl auristatin -- then attacks the internal structure of the cells.
The Oncologic Drugs Advisory Committee based its 10-0 vote on the Hodgkin lymphoma indication on the company's open-label trial in which three-quarters of the patients treated with brentuximab vedotin had at least some reduction in tumor burden and more than a third had a complete remission.
Later in the day, the advisory committee again voted 10-0 that the drug should also be approved for relapsed or refractory systemic anaplastic large cell lymphoma (ALCL).
There have been no new agents approved for the treatment of Hodgkin lymphoma since 1977 and there are no standard or approved therapies for patients who are refractory or relapsed after stem cell transplant.
The FDA is not required to follow the advice of its advisory committees, but it often does. The agency is expected to make its final decision by August 30.
Next Week
Congress will resume talks about raising the national debt ceiling and consider cuts in health programs, including Medicare and Medicaid, as potential cost-savers while committees continue to hold healthcare hearings.
On Wednesday, the Oversight and Investigations Subcommittee of the House Energy and Commerce Committee will hold a hearing on FDA medical device regulation, the fifth in a series of similar hearings. On Thursday, the Senate Special Aging Committee will hold a hearing on ways to reduce drug costs in Medicare.
On Monday, the National Alliance of State Health Cooperatives will hold a conference on cooperatives, a term that was, at one point, the hot topic in healthcare reform, and has since received scant attention. The same day, the Alliance for Health Reform will sponsor a briefing on the new CMS Innovation Center.
Over at the FDA, the agency's Endocrinologic and Metabolic Drugs Advisory Committee will meet Tuesday to vote whether the novel diabetes drug dapagliflozin appears effective at treating diabetes. In briefing documents released Friday, FDA reviewers said the drug appears effective, but may pose breast and bladder cancer risks as well as liver toxicity.
On Wednesday the FDA's Circulatory Systems Devices Panel will discuss and vote on the Edwards SAPIEN Transcatheter Heart Valve, manufactured by Edwards Lifesciences.
On Thursday, the same committee will discuss and vote whether the FDA should grant a humanitarian device exemption for the Berlin Heart Excor Pediatric Ventricular Assist Device, which is a pneumatically-driven extracorporeal ventricular assist device designed to provide bridge-to-transplant mechanical support to the heart.
Also on Thursday, the Gastrointestinal Drugs Advisory Committee will discuss the results from a clinical trial of Centocor Ortho Biotech's infliximab (Remicade) in pediatric patients with moderately to severely active ulcerative colitis.