Latest Drugwonks' Blog
This quote from an unnamed administrtation source in the New York Times says it all: “There is no general mandate under Medicaid to reimburse providers for all or substantially all of their costs,” the administration said. Substantially. As in ten cents on the dollar. Maybe. Anyone out there willing to increase their business by charging 75-90 percent less?
States Can Cut Back on Medicaid Payments, Administration Says
By ROBERT PEAR
Published: February 25, 2013
WASHINGTON — The Obama administration said Monday that states could cut Medicaid payments to many doctors and other health care providers to hold down costs in the program, which insures 60 million low-income people and will soon cover many more under the new health care law.
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Manuel Balce Ceneta/Associated Press
Gov. Jerry Brown of California, center, on Monday during a National Governors Association meeting in Washington.
The administration’s position, set forth in a federal appeals court in California, has broad national implications as it comes as the White House is trying to persuade states to expand Medicaid as part of the new law.
The statement of federal policy infuriated health care providers and advocates for low-income people. But it may encourage wavering Republican governors to go along with the expansion because it gives them a tool to help control costs.
Byron J. Gross, a lawyer at the National Health Law Program, an advocacy group for low-income people, said: “The federal government is trying to bend over backward to show flexibility and accommodate states as much as it can. California is an example of that.”
In a brief filed with the United States Court of Appeals for the Ninth Circuit, in San Francisco, federal officials defended a decision by California to cut Medicaid payments to many providers by 10 percent.
Kathleen Sebelius, the secretary of health and human services, approved the cuts in October 2011 after finding that beneficiaries would still have “adequate access” to the wide range of services covered by Medicaid.
The Obama administration urged judges to uphold those cuts, which are being challenged by patients, doctors, dentists, hospitals, pharmacists and other health care providers in California.
AARP, the lobby for older Americans, joined the health law advocacy group and more than a dozen consumer groups in opposing the cuts, which they said would reduce access to care for millions of current and future beneficiaries.
In an interview, Gov. Jerry Brown of California, a Democrat, said the Medicaid cuts were essential to his efforts to dig the state out of a budget hole.
“California has a great record of providing more benefits, expanding to more people, doing more of everything,” said Mr. Brown, who was here for the winter meeting of the National Governors Association. “But I believe in balancing our budget, living within our means.”
“We like the president’s commitment to extend health care to as many Americans as possible, and we can be powerful partners,” Mr. Brown said. “But we need more authority than we now have. I want to emphasize that — more authority than we have now to manage the Affordable Care Act and the expansion of Medicaid.”
Medicaid is one of the fastest-growing items in state budgets. Cutting payment rates saves money for states and for the federal government, which will pay most of the costs for people who become eligible for Medicaid under the new law.
Health care providers said California’s payment rates were inadequate even before the cuts. They pointed to a federal study that said, “California stands out because of its very low Medicaid payment levels.”
In an interview, Dr. Paul R. Phinney, president of the California Medical Association, a plaintiff in one of the court cases, said: “Two-thirds of doctors in California cannot afford to participate in Medicaid because the rates are so low. The problem will only get worse if rates are cut as we move more and more people into Medicaid.”
The cuts were supposed to take effect in 2011 but have been held up, pending the outcome of litigation.
Health care providers said California was cutting Medicaid payment rates for “purely budgetary reasons.”
In court papers, the Obama administration said, “It is entirely appropriate for a state to review its Medicaid plan to determine whether it can continue to satisfy its statutory obligations at lower payment rates.” Indeed, the administration said, states should conduct such reviews “to avoid the perpetuation of payment rates that are unnecessarily high.”
Federal law says Medicaid rates must be “sufficient to enlist enough providers” so that Medicaid beneficiaries have access to care at least to the same extent as the general population in the same geographic area.
The Obama administration said California officials had agreed to monitor beneficiaries’ access to care and to “take prompt action if any problems are indicated.”
Moreover, the administration said, Congress gave states “wide discretion” to set Medicaid rates, and courts should not second-guess decisions by Secretary Sebelius on the adequacy of rates.
“There is no general mandate under Medicaid to reimburse providers for all or substantially all of their costs,” the administration said.
Is the concept of “limited use” approvals falling victim to concerns that the could become a tool for the agency to narrow approved indications and to bar off-label prescribing.”
Janet Woodcock calls it like she sees it, “Given that there is skepticism and controversy, to pick an area where there is a compelling need might be a reasonable thing to do.”
It seems likely that limited use will be limited (at least initially) to anti-infective drugs.
As BioCentury points out, “Restricting the pathway to anti-infectives would allow FDA to address a public health crisis and test drive the concept, but would disappoint patient advocacy organizations and emerging biotech companies that hope the regulatory tool could speed development and approval of new drugs for a variety of conditions.”
And the pathway would be voluntary. Woodcock, “The pathway would be voluntary,” said Woodcock, and would be used to help companies tailor highly streamlined development programs to meet urgent public health needs.
The basic concept is for FDA to allow extremely streamlined development programs for drugs for well-defined subpopulations for which benefits clearly outweigh risks, and to couple expedited approvals with measures intended to discourage inappropriate off-label prescribing.
What measures? And through what authority? BioCentury opines that, “The lack of specifics and distrust of the agency’s intentions have led some critics to assume FDA is seeking a broad expansion of its power over the practice of medicine, and others to accuse the agency of plotting to allow dangerous under-tested drugs on the market.”
There is little controversy about approving drugs based on relatively small studies that demonstrate high levels of efficacy in tightly targeted populations. But FDA’s suggestion that it could work with physicians and payers to limit use of a marketed drug in the absence of documented safety concerns is controversial.
Since the FDA is being attacked from almost every side -- it’s likely they are doing something right.
And anti-infectives are a good place to start.
The Washington Post reports that David G. Miller, executive vice president of the International Academy of Compounding Pharmacists, "said he will support legislation requiring pharmacies that operate like drug manufacturers to register with the Food and Drug Administration and be subject to stricter standards enforced by the agency." The Post notes, "Miller and his 2,700-member group have traditionally argued that all pharmacies should fall under the purview of state pharmacy boards, not the FDA, and fought efforts in 2007 to shift primary oversight from the states to the federal government. On Thursday, Miller said he now wants to see FDA registration for what he describes as compounding manufacturers and supports giving the agency the power to enforce safety standards for these firms."
HHS issued a final rule on Wednesday that includes language that will increase the number of drugs eligible for reimbursement by insurers under the Affordable Care Act's essential health benefits requirements. Under the final rule, insurers must cover at least one drug per therapeutic area or the same number of drugs in each category and class as specified in the state benchmark plan, whichever is greater. The rule also states that a health plan "must have procedures in place that allow an enrollee to request and gain access to clinically appropriate drugs not covered by the health plan." The language on coverage requirements for drugs is virtually identical to that included in the proposed rule in November.
In response to comments expressing concerns about the cost of the requirement, HHS said it believes the policy "reflects drug coverage in a typical employer plan and will have a negligible effect on premiums." The agency added that the policy will be a "transition" for the first two plan or policy years starting in 2014 -- when ACA is slated to come into effect -- and that it "will study and take into considerations the effects this policy, if any, have on changing typical drug coverage in the market."
If we want to change our national healthcare paradigm we must also change the way people learn, discuss and address healthcare issues. And that means social media.
Attention Pharmaceutical Industry: If you’re not at the table, you’re on the menu.
If you can't measure it, then it doesn't count.
The FDA plans to draft guidances on how companies should create goals for a REMS and on the other metrics needed to determine if those goals are successfully met and a guidance on methodologies for assessing REMS. (FDA agreed in the PDUFA V commitment letter to issue a draft assessment guidance by the end of September 2014.)
An OIG review of 49 REMS, and the FDA’s reviews of those assessments states the obvious, “If FDA does not have comprehensive data to monitor the performance of REMS, it cannot ensure that the public is provided maximum protection from a drug’s known or potential risks.”
But sometimes the obvious is important to state.
According to the Pink Sheet, “FDA currently possesses no way to force sponsors to provide the needed assessment data, so OIG recommends the agency seek enforcement authority from Congress. FDA agreed that this recommendation should be pursued if an opportunity arises. That opportunity could be the reauthorization of the Animal Drug User Fee Act, which is eyed as a means to gain approval of a track and trace system.”
We’ll see if that dog hunts.
When it comes to social media, the FDA wants companies to do what’s in the best interest of the physician and the patient (really!). But there’s an unfortunate disconnect – the regulatory go-forward proposition of many companies is to avoid any regulatory ambiguity. The result is a vast regulated healthcare speech wasteland. Alas, when it comes to social media, “in compliance” and “in the best interest of the public health” are often viewed as mutually exclusive.
Personal epigenetic 'signatures' found consistent in prostate cancer patients' metastases
Discovery may help distinguish indolent from lethal cancers
In a genome-wide analysis of 13 metastatic prostate cancers, scientists at the Johns Hopkins Kimmel Cancer Center found consistent epigenetic "signatures" across all metastatic tumors in each patient. The discovery of the stable, epigenetic "marks" that sit on the nuclear DNA of cancer cells and alter gene expression, defies a prevailing belief that the marks vary so much within each individual's widespread cancers that they have little or no value as targets for therapy or as biomarkers for treatment response and predicting disease severity.
A report of the discovery, published in the Jan. 23 issue of Science Translational Medicine, describes a genomic analysis of 13 men who died of metastatic prostate cancer and whose tissue samples were collected after a rapid autopsy.
Samples from three to six metastatic sites in each of the patients and one to three samples of their normal tissue were analyzed to determine the amount of molecular marks made up of methyl groups that attach to sites along the genome in a process known as DNA methylation. The process is part of an expanding target of scientific study called epigenetics, known to help drive cell processes by regulating when and how genes are activated. Mistakes in epigenetic processes also are known to trigger or fuel cancers.
"Knowing both the genetic and epigenetic changes that happen in lethal prostate cancers can eventually help us identify the most aggressive cancers earlier and develop new therapies that target those changes," says Srinivasan Yegnasubramanian, M.D., Ph.D., assistant professor of oncology at The Johns Hopkins University School of Medicine. "But there has been an open question of whether epigenetic changes are consistently maintained across all metastatic sites of an individual's cancer."
The research team found that while methylation patterns vary from one patient to another, many methylation patterns occur "very consistently" within different metastatic sites in an individual patient. They identified more than 1,000 regions of the genome where various types of DNA methylation were consistently maintained within their 13 subjects' genomes.
"As they evolve and grow, cancer cells acquire and maintain changes that enable them to continue thriving," says Yegnasubramanian. "We know that cancer cells maintain and pass along genetic changes in the nucleus of cells across metastatic sites, and our research now shows that epigenetic changes also are maintained to nearly the same degree."
The scientists say that the consistent methylation changes they found appear to represent so-called driver changes critical to the cancer's development and could be targets for treatment. By contrast, other methylation changes found only sporadically in the metastatic sites are more likely what are called passenger changes that occur by chance and are less promising as treatment targets or biomarkers than driver changes.
"Our study shows that for prostate cancer, at least, each person develops his own path to cancer and metastasis, and we can find a signature of that path in the epigenetic marks within their tumors," says Yegnasubramanian, who envisions that certain epigenetic changes can be grouped into clusters to be used as biomarkers signaling a lethal cancer.
Yegnasubramanian and his team also plan to study how each of the driver changes work and how they influence cancer metastasis.
http://www.economics21.org/commentary/incredible-lowering-medicare-drug-benefit-baseline
June 2003, "I happen to be a proponent of a single-payer universal health care program." -- Barack Obama
Calling for the revocation of the Kennedy/Daschle Non-Interference Clause is the Drug Importation canard of the Obama Administration. – a faux policy that pretends to offer an easy solution to a complex problem. Populism may "sell" but it doesn't solve – and it may be a stalking horse for something more ominous.
During Tuesday’s State of the Union the President said, “We’ll reduce taxpayer subsidies to prescription drug companies.”
And on Thursday (and right on cue), a “coalition of liberal groups” (according to an article in Politico), launched a campaign to allow Uncle Sam to negotiate Medicare drug prices, claiming it will “save billions of federal dollars every year.”
Senator Amy Klobuchar (D/MN) recently introduced a bill (S. 117) to empower the Health and Human Services Department to negotiate for lower drug prices. "This is a matter of fairness for our seniors, who deserve affordable prices for their prescription drugs, and it is a matter of fairness for America's taxpayers, who deserve less waste in our system," she said.
Senator Klobuchar should pay closer attention to the numbers.
The non-partisan Congressional Budget Office (CBO) has found that Part D plans “have secured rebates somewhat larger than the average rebates observed in commercial health plans.”
And the Medicare Trustees report that “many brand-name prescription drugs carry substantial rebates, often as much as 20-30 percent and that on average, across all program spending, rebate levels have increased in each year of the program.
Is the argument that Uncle Sam could do better?
According to the CBO (in 2004), revoking the Kennedy/Dascle Non-Interference Clause, “would have a negligible effect on federal spending because CBO estimates that substantial savings will be obtained by the private plans and that the Secretary would not be able to negotiate prices that further reduce federal spending to a significant degree. Because they will be at substantial financial risk, private plans will have strong incentives to negotiate price discounts, both to control their own costs in providing the drug benefit and to attract enrollees with low premiums and cost-sharing requirements.”
In 2007 after two years of experience with bids in the program, the CBO found that striking noninterference “would have a negligible effect on federal spending because … the Secretary would be unable to negotiate prices across the broad range of covered Part D drugs that are more favorable than those obtained by PDPs under current law.”
In 2009 after even further program experience, the CBO reiterated its previous views, stating that they, “still believe that granting the Secretary of HHS additional authority to negotiate for lower drug prices would have little, if any, effect on prices for the same reason that my predecessors have explained, which is that…private drug plans are already negotiating drug prices.”
Importantly, the CBO says that no further savings are possible unless the government restricts beneficiary access to medicines or establishes market-distorting price interventions.
In the words of USA Today (America’s vox populi) “Government price negotiation could leave people without drugs that manufacturers decide aren't sufficiently profitable under the plan … With that kind of clout, government might try to dictate prices, not just negotiate them. This could leave people without drugs that manufacturers decide aren't sufficiently profitable under the plan. The VA plan illustrates the point. It offers 1,300 drugs, compared with 4,300 available under Part D, prompting more than one-third of retired veterans to enroll in Medicare drug plans."
Is revoking the Kennedy/Daschle Non-Interference Clause the President’s next move towards what he has previously said is his preferred policy solution – a single payer system? It’s a question worth asking.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
