Pharma Company Strives to Keep Star Performing Drug Close

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

Twenty-eleven and 2012 are going to be remembered in the near term as very profitable periods of the generic manufacture of many formerly branded mega-sellers. Of course, the agent getting the most media ink this week is atorvastatin (Lipitor), the ubiquitous cholesterol lowering pill whose miraculous ways even prompted a short-lived lobby to go OTC.

The pharma company Pfizer, it could be reasoned, would still have some skin in the game in spite of generic availability. Specifically, partnerships with pharma benefit managers and insurers would still give the company a stake in orgs that would inhibit generic availability by offering rebates and discounts of branded Lipitor. It is the potential for actions like this which gets the attention of legislators (specifically Democrats) who want fair competition — as opposed to stymied innovations in generic marketing from pocketed profits by PBMs and insurance companies.

Detailed in an NYT piece last month, the prospect for limited availability of generics — specifically for Medicare Part D beneficiaries is a sobering one. Pfizer claims cost equivalencies (with respect to lower co-pays on branded Lipitor) for beneficiaries if the pharma company is able to offer those discounts to third parties. It is an interesting development in what is usually an uneventful and mundane process.

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Minnesota: Healthcare Economist Predicts Positive Access to Care Under Reform

[This article posted on November 19, 2011. It is posted within the following categories: Knowledge & Medicine, Politics & The Law, Science & Research, via Michael Douglas, MD, MBA.]

Political coalitions here in Minnesota have largely towed the Democratic line, having gone decidedly blue in the last presidential election in spite of reports that the state was a purple one “in play” in an ultimate result that was anything but close.  The building within the democratic base also stands to reap benefits with respect to the reform law by its inception in 2014.

This, according to an MIT healthcare economist.

[Jonathon Gruber] told members of a governor’s task force Thursday that the federal health care law will reduce the health insurance racial disparities in Minnesota. [...] Gruber projects that almost 300,000 additional Minnesota residents would gain insurance coverage by 2016, and that those who currently buy health insurance on the individual market could pay 20 percent less in premiums after taxes.

Gruber was speaking in terms of the savings generated by increased access to healthcare with the advent of exchanges under reform. Dem Governor Mark Dayton has recently formed a couple of healthcare task forces — one of which will exclusively work to develop an exchange to increase access to the state’s un- and under-insured. | LINK

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WH Launches Front-End Program to Expand Healthcare Delivery Ahead of Reform

[This article posted on November 14, 2011. It is posted within the following categories: CMS, Corporate, Healthcare Policy & The Media, Politics & The Law, via Michael Douglas, MD, MBA.]

Grants in the total amount of over $1B will be targeted to healthcare orgs that work with federal agencies in an effort to increase the size of the overall healthcare workforce. The Obama administration is expected to announce today the availability of the funds to get initiatives started in as little as 6 months. I must admit, I was sent information on taking part in this effort.

“This will open the inbox for many innovators and organizations that have an idea to bring to the table,” Don Berwick, administrator for the Centers for Medicare & Medicaid Services, said in an interview. “We’re seeking innovators, organizations and leaders that have an idea to bring into further testing.”

Participating orgs with ideas brought to the table will be  grouped in the specially named CMS Center for Medicare & Medicaid Innovation. The initiative, praised by CMS head Don Berwick, is betting on using federal monies as an incentive to get the government involved in vetting other possible ways to spend more frugally ahead of reform and a pending physician shortage by decade’s end — two scenarios that will have to be met forcefully to ensure the onslaught of much needed healthcare delivery that won’t come cheap. | LINK

It’s Back to Basics in Nursing Homes in Treating Disease

[This article posted on November 8, 2011. It is posted within the following categories: Diversions, Healthcare Policy & The Media, Knowledge & Medicine, Science & Research, via Michael Douglas, MD, MBA.]

Just under 13 percent of skilled long term care facilities here in Minnesota are part of a project that is aimed at reducing the “supply side” of potentially unnecessary hospitalizations in the care of their elderly patients. The three year initiative is based upon data already gleaned from smaller tests and it essentially involves going back to the fundamentals of physical diagnosis — from all members of the skilled provider team.

“The problem is the doctors,” [Dr. Robert Kane, a University of Minnesota aging expert who is helping lead the experiment, said.] “Physicians familiar with nursing homes learn quickly to trust the precise information from nurses using the Interact tools. But for the others, especially nights or weekends, the default is hospitalization.”

I like to think of this as a recognition about what physicians have always known about medicine. Nothing substitutes for a thorough physical exam, regardless of who the examiner is. Any effort to utilize the good ol’ noggin to diagnose and treat without the knee-jerk rush to the hospital ED to provide primary care is always preferred, and it saves the proverbial bean counters on the acute care side of things (hospitals) of having to deal with yet another inappropriate admission. | LINK

Indiana Seeks Exemption from Key ACA Provision

[This article posted on October 12, 2011. It is posted within the following categories: Corporate, via Michael Douglas, MD, MBA.]

From the Did You Know category today: the state of Indiana is challenging a key provision of the ACA having to do with the medical loss ratio for insurers. That’s the amount by which insurance premiums are set a certain degree of cost implementation for overhead. The ACA requires the insurer to spend 80 percent on healthcare delivery, or else pay a fine. Indiana is pursuing a federal waiver from this proviso. Healthcare consumer advocacy weighs in.

Indiana’s application is based on state politicians’ ideological opposition to health reform, not the realities of the state’s health care market … As the MLR regulations make clear, there must be a credible threat to the stability of the individual marketplace in order to grant a waiver. Indiana has demonstrated no such threat. We urge [HHS] to reject Indiana’s application.

Indiana is the only state in the country to request that consumer high deductible health plans be exempted from MLR provisions unconditionally. HHS will ultimately decide on the matter. | LINK

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Republicans Avoid Criticizing Own Costly Medicare Legislation

[This article posted on September 21, 2011. It is posted within the following categories: CMS, Corporate, Healthcare Policy & The Media, Knowledge & Medicine, Pharma & Devices, Politics & The Law, via Michael Douglas, MD, MBA.]

On the campaign trail recently, top GOP candidates have been rolling out the talking points with respect to the debate on healthcare policy and politics. That latter point is made quite clearly in the party’s stance on the “solvency”[1] of the prescription drug benefit under Medicare Part D. Asked whether this rather costly program — arguably one of the most significantly costly from the George W. Bush administration’s passage of MMA in 2003 — should be yanked (as they feel so-called Obamacare should be), you’ll get a resounding “no” on that policy point.

Although the House GOP have led the deficit hawk brigade in response to President Obama’s recent comments on balancing the budget, the party as a whole has been relatively quiet on the Medicare overhaul issue, especially as it pertains to Part D — a program the party structured and passed under Bush eight years ago. It’s no secret politics is in play, especially when monies to support the benefit have to come from the government’s general coffers — competing for earmarks for other priorities, like education funding.

Republicans like to point out that throwing drug coverage under Medicare, in part, to the pharma marketplace has offset initial costs for supporting the program via competition. But, currently, the wide variety (amid the spate of new branded preps) of traditionally cheaper generics probably has to do more with keeping costs low — with respect to beneficiary affordability and the marginal profits on such non-branded offerings by Pharma.

Fast forward to 2011 and the popular Medicare provision is being utilized by over 60 percent of retirees (with the balance coming from former employers’ plans), and it looks safe for now. The big unknown is when the inevitable resurgence in pharma spending increases will occur over the next ten to fifteen years — and how Part D will fare within the reform mix. | LINK

 

  1. There really is no dedicated tax toward funding the Medicare prescription drug benefit. []
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Report Examines Progress of States in Insurance Exchange Formation Ahead of Reform

[This article posted on September 12, 2011. It is posted within the following categories: CMS, Corporate, Healthcare Policy & The Media, Knowledge & Medicine, Politics & The Law, Science & Research, via Michael Douglas, MD, MBA.]

Ever wonder how the preparations for healthcare exchanges are proceeding? The Kaiser foundation has constructed a brief [PDF] which allows one to reasearch states’ plans in progress. To review, the establishment of healthcare exchanges by the feds under reform is meant to enable consumers to compare a selection of qualified health insurance options in order to find the plan that best meets their needs and budget — with a significant amount in taxpayer subsidies devoted to this purpose.

Among the highlights in the brief report: (1) discussion of governance of exchanges, with some states granting significant control over governance matters at the hands of the excutive branch; (2) plans by states to address conflict-of-interest issues regarding insurance plan representation within governing boards of exchanges; (3) the total amounts paid to states so far in the funding of exchange formations in their individual healthcare marketplaces; and (4) the effect of legal challenges brought forth in some states regarding the constitutionality of the insurance mandate provision of the ACA (most recently, the striking down of the state of Virginia’s challenge filed by its atty. gen.) on the formation of exchanges.

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Renowned Dallas Hospital Out of Medicare Compliance

[This article posted on September 3, 2011. It is posted within the following categories: CMS, Healthcare Policy & The Media, Knowledge & Medicine, Science & Research, via Michael Douglas, MD, MBA.]

The acute care hospital in Texas made famous for the emergent care given to JFK on 11/22/1963 is about to find out if Medicare will continue to reimburse for services rendered.

[C]MS says in a Thursday letter to Parkland that the date of a possible Medicare termination has been pushed back to allow state inspectors time to complete their reports on their follow-up inspection. CMS says if Parkland remains out of compliance, it will be terminated from the program on Sept. 30.

Generally, a hospital survey is an evaluation to determine the hospital’s compliance with state rules and federal regulations. The survey evaluates the hospital on such areas as nursing services, medical staff, dietary services, infection control, medical records, governing board, quality assessment and improvement, medical services, and physical environment.

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Veterans Admin Centers Rush to Fill Healthcare Needs of Female Vets

[This article posted on August 8, 2011. It is posted within the following categories: CMS, Corporate, Healthcare Policy & The Media, via Michael Douglas, MD, MBA.]

It’s not every day that the typical Veterans Admin medical clinic sees a burgeoning number of female vets. Perhaps that’s why the VA has employed only around 60 percent of its female providers in all of its nationwide community-based clinics. Although there is a dedicated provider of womens health services at its more than 150 medical centers, the VA is acknowledging that there is a definite treatment deficit in this area of healthcare delivery.

The VA has been bringing doctors and nurse practitioners by the hundreds to mini-residency programs like this one outside Orlando, Fla., focused on women’s health. A key component of the training is performing pelvic exams on live models — typically volunteer nurses — who critique them.

These mini-residency type programs could grow in number in other (private, non-profit) settings as healthcare reform gets ramped up. In the case of the VA, the federal government is calling the shots to improve healthcare delivery to meet a patient-as-consumer need. In the general healthcare marketplace, Insurance could be making that call. | LINK

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Study: Medicaid Coverage ‘Substantially’ Improves Access to Care

[This article posted on July 7, 2011. It is posted within the following categories: CMS, Healthcare Policy & The Media, Knowledge & Medicine, Science & Research, via Michael Douglas, MD, MBA.]

How does obtaining health coverage (insurance) compare to not getting it at all? According to a trial published via the National Bureau of Economic Research (Harvard/MIT), beneficiaries’ quality of life was enhanced and made a “big difference” in those patients’ self-health perceptions and their daily outlook — according to the study’s lead author. A quick glance at the results confirms that all encompassing statement, especially since the study employed the diagnostic “gold standard” in trial research by utilizing a randomized, controlled design.

Taking a look at approximately the first year of coverage for Medicaid beneficiaries in the state of Orgeon, the study showed that healthcare expenditures for those who got coverage increased by almost $800/year. Those who received Medicaid were around 60 percent more likely to get mammograms. Medicaid recipients were over 50 percent more likely to have a regular primary-care doctor. They were also in better shape financially and less likely to have unpaid medical bills. Those who got Medicaid were also far more likely to report themselves in good or excellent health. ED admissions did not decrease; however, the increase in ED utilization by beneficiaries was not statistically significant.

It is clear from the results that coverage, in and of itself, has a positive effect on patients’ perceptions of health and wellness. What is not documented as much at this time is how this translates into outcomes with respect to various chronic problems such as obesity, diabetes, and risk factors (such as serum cholesterol, blood pressure, etc.) for heart disease. Also, it is unclear how these results translate into real numbers once reform increases Medicaid rolls substantially by 2014. Researchers plan on following the participants for at least another year. | LINK

Fed Gov’t Prepares to Unleash Covert Study to Determine Access to Primary Care Ahead of Reform

[This article posted on June 26, 2011. It is posted within the following categories: CMS, Corporate, Healthcare Policy & The Media, Knowledge & Medicine, Science & Research, via Michael Douglas, MD, MBA.]

The federal government is planning what has been termed as a “stealth survey” of predominantly primary care delivery systems in order to determine access-to-care data. The Obama administration is hoping that using actors posing as patients in achieving this goal will shed light on this issue in the wake of full scale reform within the next few years. Needless to say, many physicians are upset about it.

“I don’t like the idea of the government snooping,” said Dr. Raymond Scalettar, an internist in Washington. “It’s a pernicious practice — Big Brother tactics, which should be opposed.” … According to government documents obtained from Obama administration officials, the mystery shoppers will call medical practices and ask if doctors are accepting new patients and, if so, how long the wait would be.

Further, the government as Big Brother in this case, will try to gauge those wait time findings with follow-up questions on the type of coverage those “mystery shoppers” possess in order to discover any influences on access times therein. The cacophony among doctors in this case is wholly justified. Use of taxpayer monies for this type of research amounts to no more than survey data obtained in a very subjective and apparently non-standardized way to confirm what is already known about access-to-care. What is needed is a better use of these appropriated funds (the feds say the initial survey would cost $347,370) targeted toward increasing the absolute numbers of primary care physicians in the workforce. | LINK

HHS Amends Rules, Delays Action on Patient Appeals

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

HHS is scaling back its July 1 date it set to enforce new policies concerning insurance claims denials and reviews. According to the agency, states need more time to “adhere to requirements” — much to the frustration of patient advocacy groups and to the benefit of Insurance. Policyholders had 4 months in which to prepare appeals arguments previously under yet-to-be-instituted reform rules. Now it’s just 2 months.

Essentially, the Obama administration’s new rules give beneficiaries less time to prepare an appeal, less information about the reason for the denial and limitations on which denials can be appealed. Patients can still appeal if their coverage is canceled by an insurer, and decisions by external review panels are still in effect. External reviews will now start on January 1 of next year. The external review process is key to healthcare consumerism under the reform law, as patients have never before been required to complain to an independent review panel since individual states never entered into this regulatory aspect of reform until now.

Now that insurers have some breathing room until the initiation of this process and consumers have a narrower window of appeals action, the only question is who this move truly benefits in the long run. Expect to hear more concern from advocacy groups on matters of not only the delay of policy enaction, but also the apparent loss of protections as a result of a srinkwrapped appeals process. | PDF link to HHS document concerning new rules

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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.