Obama to Sign Executive Order Addressing Shortages of Medicines

[This article posted on October 31, 2011. It is posted within the following categories: Corporate, Pharma & Devices, via Michael Douglas, MD, MBA.]

The president will issue an executive order today requiring the FDA to act on potential drug shortages in the phrama marketplace. Previously, drug companies were only required to notify the agency if a preparation was to be discontinued. Any other notification would be completely voluntary on the part of the manufacturer. The executive branch action is only the latest maneuver[1] by this administration to “get tough” in the way of roadblocks initiated by the GOP in the legislature to nix his jobs bill en toto.

Most preparations affected are used in the aucte setting: electrolyte mixtures, chemotherapeutics, and anesthetics. The FDA reported over 170 instances of shortages in 2010, with an increase projected for this year. President Obama also expressed his support for legislation that would require streamlining the notification process; pharma companies would have to notify the FDA of shortages six months in advance. All of this is good news for patients, who stand to benefit the most from timely intervention in acute medical treatments. | LINK

  1. In the past week, Obama has issued orders creating relief for “underwater” homeowners and current college students with high tuition debt. []
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PSA Screening Guidelines Offer Discussion and Learning Opportunities

[This article posted on October 27, 2011. It is posted within the following categories: Diversions, Healthcare Policy & The Media, Knowledge & Medicine, Science & Research, via Michael Douglas, MD, MBA.]

One axiom is certain in medicine: there is always room for controversy. And that’s good, because it spurs further scholarly thought and research — both qualities can only help patients and providers in the long run. With the current discussion in the media regarding the utilization of the PSA in determining the course of action in prostate cancer screening, so many fundamental issues surrounding patient informed consent, unnecessary treatments, and the potential harms from treatments — can serve as valuable teaching points for patients and current and future physicians alike. The discussion — highlighted in the current NEJM — really brings this point home.

Watchful waiting and active surveillance may help prevent the conversion of overdiagnosis to overtreatment, mitigating the harms of screening that are so accurately portrayed by the task force. … we primary care clinicians must ensure there is no more routine, indiscriminate PSA screening — and no washing our hands of responsibility once the patient is referred to a specialist for prostate-cancer treatment. We owe it to our patients to provide them with the kind of guidance about this screening test that they need and deserve…

LINK | USPSTF guidelines on PSA screening here

New CMS ACO Rules Are Designed to Promote Adoption within Reform

[This article posted on October 24, 2011. It is posted within the following categories: CMS, Healthcare Policy & The Media, Knowledge & Medicine, Pharma & Devices, Politics & The Law, via Michael Douglas, MD, MBA.]

New rules for accountability care organizations out today from CMS may please providers amid reports of inefficient care delivery models and quality. When the feds released initial ACO rules earlier this year, the process was met with major rounds of criticism with physicians barking the loudest. As a group, its top concern was the financial risk involved (lowered reimbursements amid higher penalties) in agreeing to participate.

Quality benchmarks in EHR adoption and clinical outcomes in certain key chronic medical diagnoses as part of the ACA-mandated rules have all but been retooled with the release of new ACO parameters.

The regulations reduced the number of quality measures by about half and increased the financial incentives for providers. The changes won preliminary praise from major trade groups and professional associations, which moved quickly to digest hundreds of pages of rules from multiple federal agencies, including the CMS, the Federal Trade Commission and the Justice Department.

Enhanced opportunities in order to improve quality amid a decrease in the perceived risks of doing so. With this new credo in place, many initial hostilities toward the inclusion of ACOs within the scope of reform may be tempered just a bit. | LINK

Survey Data on Antidepressant Drug Use Released

[This article posted on October 21, 2011. It is posted within the following categories: Healthcare Policy & The Media, Knowledge & Medicine, Pharma & Devices, Science & Research, via Michael Douglas, MD, MBA.]

With the continued destigmatization of some forms of mental illness in the community (namely, the diagnoses of depression and anxiety), it comes as no surprise that we are more willing than ever to discuss treatment and prevention more openly. Oh, and it also doesn’t hurt that — within the general population at any given time — 10 percent of Americans are taking an antidepressant.

According to the Centers for Disease Control, the rate of antidepressant use has skyrocketed by a factor of 4X over the past 25 years. Females lead the pack in all age demos save for the youngest — ages 12-17. Interestingly, income status was not a predictor of use, the agency cites; although, slightly more than 1 in 12 persons taking the drugs is Caucasian. Most disturbingly, though, is the apparent lack of care access or followup once these drugs are prescribed: just under a third of patients have seen a mental health professional (or primary care physician — assuming the drugs are possibly given for off-label uses) within the previous 12 months. Excellent survey data here.

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Herman Cain’s Quippy Approach to Healthcare Policy

[This article posted on October 17, 2011. It is posted within the following categories: Corporate, Healthcare Policy & The Media, via Michael Douglas, MD, MBA.]

With all of the hubbub surrounding Herman Cain’s 9-9-9 taxation plan, it got me to thinking about what this really means for the financing of healthcare now that reform is upon us. Answer? I should just keep on wondering. The Soundbite Candidate really offers nothing substantial at this point — though, that could change if his polling continues to rise among GOP and Tea Party faithful.

Cain, who should employ the KISS mnemonic to all of his policy decisions, doesn’t stray from this credo with respect to healthcare. In fact, he cites a late-1960s era promo campaign to healthcare delivery and its skyrocketing costs: creating an ad campaign in order to change peoples’ behaviors and attitudes toward healthcare in this country. Via MOJO:

Cain got a chance to lay out what he would have done if he’d been in charge of the country and needed to deal with health care. His alternative? Lady Bird Johnson’s “Keep America Beautiful” campaign. Cain writes in his [1997 book, "Leadership Is Common Sense"] that the main problem the United States has with health care is one of attitude, and the former first lady’s anti-littering campaign was a stellar example of how an advertising campaign to change national attitudes can have a significant impact on behavior.

Who needs robust policy on healthcare when a potential president says it all comes down to simply not getting sick in the first place? Certainly, not Mr. Cain, whose recent cancer scare would have been much moreso had he not had his wealth to rely on for timely access to appropriate care. | LINK

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Study: Many Medicare Beneficiaries Obtain Surgeries in Last Year of Life

[This article posted on October 9, 2011. It is posted within the following categories: CMS, Knowledge & Medicine, Science & Research, via Michael Douglas, MD, MBA.]

A new study out of Harvard finds that approximately a third of all Medicare beneficiaries in the last year of life chose to have a major surgical procedure. The operative (excuse the pun) issue here is whether such timed, elective surgeries are necessary — implying a possible increase in life expectancy. Problem is, no one knows when the beneficiary will die.

By analyzing Medicare claims data the study authors found that, in a group of almost 2 million elderly beneficiaries, all of whom died in 2008, almost one-third had inpatient surgery in the year before they died, almost one in five in the last month of their lives and almost one in 10 in the week before they took their last breath.

The study itself is a good lesson in who exactly “benefits” in these cases. As futile as these findings may sound, there is no question that any procedure done within FFS Medicare coverage remains a reimbursement cache for the provider and hospital, crudely suggesting a financial incentive. While this scenario is entirely possible, it really doesn’t seem to be the impetus for the study’s findings, in my humble opinion. Besides being reflective of a cynical and laconic way of approaching the study’s results, it really makes no sense in a healthcare delivery system increasingly focused on positive outcomes (read: anything but mortality or unacceptable morbidity). The study, however, does usher in the need to discuss the perennial issue of quality of life versus the “appropriateness” of acute surgical treatment among consenting patients with significant chronic illness.

Multi-Faceted Effort to Increase Alzheimer Disease Awareness Launches

[This article posted on September 13, 2011. It is posted within the following categories: Corporate, Healthcare Policy & The Media, Politics & The Law, Science & Research, via Michael Douglas, MD, MBA.]

Alzheimer dementia continues to be among the most heavily researched and funded chronic diseases in medical science today. The increased awareness, brought into the spotlight and “modernized” more than 20 years ago following the high profile revelations of celebrites and politicians afflicted with the disorder, has led to increased patient education, public policy initiatives, and, of course, greater research monies in the effort to not only treat symptoms, but also to find a cure.

An international advocacy group is now asking municipalities to take awareness a notch higher with the commitment to even greater awareness of the disorder — addressing what it calls a “treatment gap”, hampering any gains on detection of the disorder at its earlier stages. Here in the U.S., the Obama admin is apparently hard at work in developing the country’s first-ever national anti-Alzheimer strategy aimed at sharply cutting the enormous healthcare costs associated with ancillary treatment .

The National Alzheimer’s Project: From Act to Action is an effort to support a committed and effective implementation of the National Alzheimer’s Project Act (NAPA). Information collected from individuals living with the disease, caregivers, providers and other stakeholders will be shared with the U.S. Department of Health and Human Services, which is responsible for creating a national strategy to address the crisis and coordinate across government agencies. This project is facilitated and supported by the Alzheimer’s Association.

Consider this effort an amalgam of citizen awareness and discussion (townhalls) and legislation (congressional passage of the National Alzheimer Project Act) garnering bipartisan[1] support to fight a scourge that can leave heavy financial tolls on caregivers, families, and the healthcare delivery system itself.[2] A daunting task, to be sure — but one that is sorely needed. Here’s looking forward to December — the date when the president makes his plans for these initiatives very public. | LINK

  1. Just how bipartisan? In 2007, Newt Gingrich co-authored an article in Alzheimer’s and Dementia: The Journal of the Alzheimer’s Association, making the case for the creation of a federal Alzheimer strategy. []
  2. Alzheimer’s Association advocates sent more than 15,000 email messages to the White House asking the President to sign the National Alzheimer’s Project Act into law; on 1/4/11, he did — making this action the most significant legislative action with respect to Alzheimer funding intiatives up to this point. []

Walter Reed Hospital Closes

[This article posted on August 29, 2011. It is posted within the following categories: Healthcare Policy & The Media, Knowledge & Medicine, via Michael Douglas, MD, MBA.]

After more than a century of service (102 years, to be exact), Walter Reed Hospital in DC is closing its doors. This seemed to be an inevitability, especially after the facility had a difficult time separating itself from its healthcare delivery scandals during the George W Bush administration.

The Walter Reed Army Medical Center in Washington, D.C., closed its doors for the final time Aug. 27 as the remaining 18 patients were moved to the National Naval Medical Center in Bethesda, Md., one day ahead of schedule, thanks to the approach of Hurricane Irene. Walter Reed had provided medical care to military service members for 102 years.

While the beacon of military medicine is shutting its doors, the Reed moniker will still be intact, as those final 18 patients are transferred to the Bethesda National Military Medical Center — which will now be known as the Walter Reed National Military Center. | LINK

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Some Companies to Consider Jettisoning Coverage under Exchanges by 2014

[This article posted on August 24, 2011. It is posted within the following categories: Corporate, Healthcare Policy & The Media, via Michael Douglas, MD, MBA.]

A lot of what happens in 2014 will depend on what happens in 2012. Take this item, for example:

A large majority of employers in both studies said they expect to continue offering benefits once the exchanges start. But former insurance executive Bob Laszewski said he was surprised that as many as 8 or 9 percent of companies already expect to drop coverage a couple of years before the exchanges start.

Apparently, according to this survey, some employers are considering dropping their employer-sponsored plans on the heels of reform-generated healthcare exchanges. The decision by these companies to consider foregoing the costs of their coverage if they assume that fines levied will be a “cheaper” option is somewhat problematic, perhaps in the short term. If recruitment of workers is affected by a move to shutter employer-sponsored plans, for instance, smaller companies may have to rethink this strategy — especially in the face of likely government subsidies starting in ’14, that will assist them in this endeavor of corporate coverage.

For larger companies that can resist the likely call by GOP rabble-rousers as contributing to government-run “dumping” of consumers into exchanges, the joke may be on the punditry — as the entire healthcare marketplace would likely benefit from the influx of potential consumerism and competition among private carriers within those government created exchanges. Sure, some companies may be thinking of making these “painful” decisions now, but we will have to get through ’12 first to see exactly what forms insurance purchasing in the expanded marketplace will take. This point may be a mute one by January 2013.

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Debt Ceiling Deal Rattles Healthcare Delivery Prospects, Social Security and Medicaid Spared

[This article posted on August 2, 2011. It is posted within the following categories: CMS, Healthcare Policy & The Media, Knowledge & Medicine, Politics & The Law, Science & Research, via Michael Douglas, MD, MBA.]

The initial spin on the recently squared away budget deal preventing a national default relates a necessary evil that not only carries the partisan rift seen in advance of the legislation, but also becomes a harbinger for a financial outlook that, in some ways, looks as bleak as the presumptive default did. Still retaining its triple-A rating, the credit outlook for the United States will be reflected in a “negative” forecast — likely resulting in a downgraded credit status within the next couple of years. Of course, all of this big-picture wrangling really doesn’t mean much to the millions of people whose salaries are paid — in part — by the federal government. A harsh reality at the forefront of this thinking, given the current jobless rate and achingly persistent unemployment levels is the specter of the loss of unemployment insurance for those currently receiving benefits. Minnesota is just one of many states bracing for such an apocalypse which appears to be sparing future cuts in another enormous federal subsidy — Medicaid.

Department of Human Services Commissioner Lucinda Jesson said she was relieved that Medicaid, known as Medical Assistance in Minnesota, is exempted from the initial cut. That doesn’t mean the new bipartisan commission charged with driving down the deficit won’t come after it once the panel breaks out the budget knife. “We are going to track it very closely,” Jesson said Tuesday. She said her department will also keep a close watch on child protection, food support and other assistance for seniors.

What about cuts to the service side of the equation? Since Social Security and Medicaid are specifically exempted from the ravages of the debt ceiling bill, physicians could see an additional 2 percent pay cut on top of double-digit Medicare reductions already slated for 2012 under the debt ceiling deal. Perhaps more concerning is the strong likelihood for major Medicare cuts and overhauls in long term care payments as a by product of a commission[1] created as part of the deal agreed to on Sunday. Nursing homes would be hit extremely hard in this scenario — potentially affecting care delivery to the most medically complex beneficiaries in the LTC sector. Understandably, the deal reached by a less than jubilant Hill on Sunday has many folks extremely wary about the nation’s prospects on an already shaky economy. Its effects on federally subsidized healthcare delivery ups the ante for lobbyists, providers, and most importantly — patients. | LINK

  1. The deal to raise the debt ceiling would task a 12-member bipartisan committee to come up with $1.5 trillion in deficit reduction and would require a significant swath of cuts starting in 2013 if those efforts at reducing the deficit should fail. []

HHS: Insurance Required to Offer Birth Control, Contraceptive Planning

[This article posted on August 1, 2011. It is posted within the following categories: CMS, Corporate, Healthcare Policy & The Media, Knowledge & Medicine, Pharma & Devices, Politics & The Law, Science & Research, via Michael Douglas, MD, MBA.]

The requirement that new insurance provisions and services under reform and HHS rules provide the gamut of preventive womens’ healthcare services will also cover the infamous morning-after pill. Other required free services under the new rules include all birth control methods approved in the U.S., domestic violence screening, and support for breastfeeding.

The HHS noted that not every health insurance plan must comply with the new directive, however. “The administration also released an amendment to the prevention regulation that allows religious institutions that offer insurance to their employees the choice of whether or not to cover contraception services,” the agency said.

Perhaps most significantly, the rules prohibit charging a co-payment, co-insurance or deductible for this type of healthcare delivery — raising questions as to the feasibility for the feds to include such a provision in the short term. Medicare will also foot the bill for both dual-eligibles and dedicated beneficiaries. | LINK

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Big Box Retailer Forms Unlikely Alliance with Goal of Streamlining Medicaid Policy

[This article posted on July 1, 2011. It is posted within the following categories: CMS, Corporate, Healthcare Policy & The Media, Politics & The Law, via Michael Douglas, MD, MBA.]

For the first time, a major private coporation is partnering with a local hospital in assisting Medicaid beneficiaries in obtaining legal assistance in squabbles with the entitlement over public health care delivery, housing, medical equipment, and other basic needs guaranteed by Medicaid. It’s not just any partnership. The corporate entity is Wal-Mart, and it insists it will not be an adversarial force to the feds. The retailer’s involvement with a local Arkansas hospital is being piloted and could become a model for future national rollout. These medical-legal partnerships, as they are called, are designed to promote changes in the healthcare public-private policy sphere by becoming part of the beneficiaries’ heatlhcare team — alongside providers and hospitals.

Onsite, legal professionals become a part of the healthcare team.  Doctors will refer patients to lawyers for legal assistance when appropriate.  Just as a pediatrician refers a patient to a radiologist for a broken bone, a healthcare provider may refer a patient to an onsite attorney when an underlying social circumstance impairing a patient’s health is detected. 

Lest one believes that this is some conservative vs. progressive battle implemented by activists to inflame further the current drive toward reform in this administration — think again. These MLPs have the backing of the traditionally liberal-leaning American Bar Association. It is the hope of the parties involved that providing this type of legal assistance to Medicaid beneficiaries will usher in a new area of accountability by building broad public-private networks with a common goal enriching Medicaid care delivery as reform begins to take shape. | LINK

HHS Empowers Patients to ‘Share the Health’ as Part of Reform Messaging Effort

[This article posted on June 22, 2011. It is posted within the following categories: CMS, Healthcare Policy & The Media, Politics & The Law, Science & Research, via Michael Douglas, MD, MBA.]

Getting the word out about all the preventive services available to Medicare beneficiaries is about as easy as wiping out fraud within CMS completely. But that’s not stopping HHS from pulling out all the stops in an effort to curtail future spending on preventable medical problems.

On Monday, HHS Secretary Kathleen Sebelius announced that the agency was launching a publicity campaign, known as “Share the News, Share the Health” to alert Medicare patients, their doctors and their relatives that the services are available at no charge. “Our job is to make sure every single Medicare beneficiary in the country knows,” Sebelius said.

Chalk it up to a (political) campaign by the federal government to get patients knowledgeable and accepting of the benefits afforded them under the reform law. Overall, this effort is a good thing. At its most superficial, it is a way to catch disease earlier, implement higher quality care delivery for less ill patients sooner, and it represents a time saver for the primary care physician, freeing him from informing the beneficiary in order to make the most of the covered physician service/visit. More profound, however, is the stark effect this initiative could have on patient empowerment — as only slightly more than 10 percent of beneficiaries takes advantage of at least one of the covered preventive medical screenings and services.