Tuesday, August 19, 2014

Fwd: qotd: Smaller primary care practices have lower rates of preventable admissions

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Health Affairs
August 13, 2014 (online)
Small Primary Care Physician Practices Have Low Rates Of Preventable
Hospital Admissions
By Lawrence P. Casalino, Michael F. Pesko, Andrew M. Ryan, Jayme L.
Mendelsohn, Kennon R. Copeland, Patricia Pamela Ramsay, Xuming Sun,
Diane R. Rittenhouse and Stephen M. Shortell

The Affordable Care Act and initiatives by private health insurance
companies are driving major changes in the ownership of physician
practices, the incentives practices face to improve the care they
provide, and the processes practices use to improve care. Many practices
are consolidating into larger medical groups. Many others are shifting
from physician ownership to hospital ownership. Practices are
increasingly subjected to pay-for-performance and public reporting
programs and are being encouraged to implement processes used in
patient-centered medical homes.

Ambulatory care–sensitive admissions are defined by the Agency for
Healthcare Research and Quality (AHRQ) as admissions for conditions such
as congestive heart failure for which good primary care may prevent
admission.

In our large national study of small and medium-size primary care–based
practices, practices with 1–2 physicians had ambulatory care–sensitive
admission rates that were 33 percent lower than those of the largest
small practices (having 10–19 physicians). Practices with 3–9 physicians
also had rates that were lower than the rates for the largest small
practices, although slightly higher than the rates for practices with
1–2 physicians. These findings were unexpected, since small practices
presumably have fewer resources to hire staff to help them implement
systematic processes to improve the care they provide. Larger practices
did have higher patient-centered medical home scores than the practices
with 1–2 physicians (though not higher than those with 3–9 physicians)
and so appear to use more such processes, but these higher scores were
not associated with lower ambulatory care–sensitive admission rates in
multivariate analyses.

It is possible that small practices have characteristics that are not
easily measured but result in important outcomes, such as fewer
ambulatory care–sensitive admissions. For example, there is evidence
that patients in smaller practices are better able to get appointments
when they want them and better able to reach their physician via
telephone, compared to larger practices. It is also possible that
physicians, patients, and staff know each other better in small
practices, and that these closer connections result in fewer avoidable
admissions.

We cannot fully exclude the possibility that the largest practices,
which had a somewhat higher percentage of specialists, had patients who
were sicker and, therefore, more likely to have an ambulatory
care–sensitive admission. However, we controlled for the percentage of
specialists in practices and for patients' demographic characteristics
and comorbidities, and we found that the smallest practices cared for a
significantly higher percentage of dual-eligible patients and for
patients with more comorbidities.

Physician-owned practices had lower ambulatory care–sensitive admission
rates than hospital-owned practices in both bivariate and multivariate
analyses—approximately 13 percent lower in multivariate analysis.

Hospital ownership would be expected to result in a lower ambulatory
care–sensitive admission rate if hospitals provided additional resources
to practices to hire staff and implement systematic processes to improve
care. In fact, consistent with prior studies, we found that
hospital-owned practices used more patient-centered medical home
processes than physician-owned practices. But these practices
nevertheless had higher ambulatory care–sensitive admission rates.
Hospital acquisition of a practice might disrupt longstanding referral
relationships between the practice's physicians and specialists outside
the practice and might lead to other changes that result in worse
performance by the practice and higher ambulatory care–sensitive
admission rates.

We did not find an association between the ambulatory care–sensitive
admission rate and the use of patient-centered medical home processes or
between that rate and pay-for-performance or public reporting
incentives. Prior research has resulted in inconsistent findings
regarding the relationship between patient-centered medical homes and
physician practice performance and between incentives and physician
practice performance.

Physicians in small practices have no negotiating leverage with health
insurers, so insurers typically pay them much lower rates for their
services than they pay to physicians who practice in larger groups or
are employed by hospitals. This policy might be penny wise and pound
foolish if it drives small practices out of existence and if further
research confirms that small practices have lower ambulatory
care–sensitive admission rates, and possibly lower overall costs for
patients' care, than larger groups.

Small practices have many obvious disadvantages. It would be a mistake
to romanticize them. But it might be an even greater mistake to ignore
them, and the lessons that might be learned from them, as larger and
larger provider organizations clash to gain advantageous positions in
the new world of payment and delivery system changes catalyzed by health
care reform.

http://content.healthaffairs.org/content/early/2014/08/08/hlthaff.2014.0434.abstract

****


Comment by Don McCanne

It is believed that consolidation of the health care delivery system
through the formation of larger groups of physicians and through
hospital ownership of physician practices is anti-competitive and drives
up health care spending, especially through non-competitive pricing.
Nevertheless this consolidation is being encouraged under the assumption
that closer integration of the health care delivery system will improve
processes and outcomes, one rapidly expanding model being accountable
care organizations. This important study casts doubt on this concept.

One important measure of the quality of care being provided is
ambulatory care-sensitive admissions - admissions that can be prevented
through good primary care. This study shows that small primary care
practices had lower preventable admission rates than did larger
practices. Further, although larger practices did have higher
patient-centered medical home scores, the scores were not associated
with lower ambulatory care–sensitive admission rates. Also,
hospital-owned practices used more patient-centered medical home
processes than physician-owned practices, yet these hospital-owned
practices had higher ambulatory care–sensitive admission rates. Neither
pay-for-performance nor public reporting incentives improved the rate of
ambulatory care-sensitive admissions.

The policy and political communities are pushing innovations such as
more closely integrated groups through consolidation and accountable
care organizations, pay-for-performance, and patient-centered medical
homes, when there is sparse evidence that these measures will improve
quality or reduce costs. On the other hand, studies such as this
demonstrate that traditional Marcus Welby, MD-type primary care
practices serve us very well (as long as they do see more than one
patient a week).

Patients have better access through a long standing relationship with a
health care professional they know and trust and who knows and respects
them, while receiving their care at a lower cost. Although this
traditional model is now being threatened, a single payer system would
revitalize it as long as it serves patients well.

Monday, August 18, 2014

Fwd: qotd: Insurers continue to discriminate against the sick

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Letter
July 28, 2014
To: Sylvia Burwell, Secretary of Health and Human Services
From: Over 300 patient advocacy groups

Based on reports of enrollee experiences during the first year of
Marketplace implementation, we have identified a number of concerns.
These include discriminatory benefit designs that limit access, such as
restrictive formularies and inadequate provider networks; high
cost-sharing; and a lack of plan transparency that may deprive consumers
of information that is essential to making informed enrollment choices.

Limited Benefits:

Due to the manner in which Essential Health Benefits (EHBs) are defined
for plan years 2014 and 2015, select plans do not include all the
medications that enrollees may be prescribed to address their health
care needs. Plans are further restricting access to care by imposing
utilization management policies, such as prior authorization, step
therapy and quantity limits. Tying plan formulary requirements to the
number of drugs in each class in the state benchmark has resulted in
some plans not covering critical medications, including combination
therapies. Additionally, there is no requirement for plans to cover new
medications and plans can remove medications during the plan year as
long as the plan continues to meet the state's benchmark requirements.
Narrow provider networks and a lack of access to specialists are also
negatively impacting access to quality care for enrollees.

These design elements appear to affect certain patient populations
disproportionately – many of the same populations that were subject to
pre-existing condition restrictions prior to ACA implementation.

High Cost-Sharing:

Despite enrollee out-of-pocket limits that are included in the ACA and
reduced cost-sharing for people with very low income levels, some plans
are placing extremely high co- insurance on lifesaving medications, and
putting all or most medications in a given class, including generics, on
the highest cost tier. This creates an undue burden on enrollees who
rely on these medications. Unlike employer-sponsored plans, where
enrollees usually experience reasonable co- pays, enrollees in the
Marketplace are being subject to plans that impose 30%, 40% and even 50%
co-insurance per prescription. Such high co-insurance is shocking
enrollees and will lead to reduced medication adherence and medical
complications as people are unable to afford to begin or stay on
medications. Some plans are also imposing high deductibles for
prescription medications and high cost-sharing for accessing specialists.

We believe these practices are highly discriminatory against patients
with chronic health conditions and may, in fact, violate the ACA
non-discrimination provisions.

Transparency and Uniformity:

Individuals must have access to easy-to-understand, detailed information
about plan benefits, formularies, provider networks, and the costs of
medications and services. Unfortunately, individuals cannot access this
information easily through an interactive web tool such as a plan finder
or benefit calculator that matches an individual's prescriptions and
provider needs with appropriate plans (such as the one utilized by the
Medicare Part D program). Most troubling is the practice of requiring
co-insurance without information for an individual to understand what
their actual cost-sharing will be. Transparent, easy-to-navigate
grievances and appeals processes are needed, along with special
enrollment procedures when patients lose access to a medication due to
formulary changes during a plan year.

http://www.theaidsinstitute.org/sites/default/files/attachments/IAmStillEssentialBurwellltr_0.pdf

****


Comment by Don McCanne

In spite of regulations defining the essential health benefits to be
covered, actuarial values of the health plans, and adequacy of plan
descriptions, the private insurers continue to use deceit in
implementing these regulations to avoid enrolling individuals with
greater health care needs. Even if some of the current deceptions are
patched, they will always use the marketplace tool of innovation in
order to advantage themselves over patients.

Though the government may try to revise regulations as problems arise,
no regulation can ever alter the innate amorality of the industry - no,
make that immorality. The private insurers need to be replaced with a
single payer national health program.

Friday, August 15, 2014

Fwd: qotd: FDA proposes allowing off-label claims of risk reduction

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JAMA Internal Medicine
August 15, 2014
Proposed US Food and Drug Administration Guidance for Industry on
Distributing Medical Publications About the Risks of Prescription Drugs
and Biological Products
A Misguided Approach
By Sidney M. Wolfe, MD

In June 2014, the US Food and Drug Administration (FDA) for the first
time issued draft guidance for the pharmaceutical industry on
distributing scientific and medical publications about the risks of
approved prescription drugs and biological products. In my view, the
draft guidance, which is open for public comment until August 25, 2014,
has the potential to undermine the FDA's drug safety laws and
regulations and should be substantially changed.

As written, the draft guidance would allow pharmaceutical companies who
believe that the FDA-approved drug-labeling information overstates the
risks of their drug to tell physicians that the risks are, in fact,
lower. Companies could inform physicians of the purportedly lower risks
by distributing peer-reviewed articles and instructing their sales
representatives to discuss the information they contain about the lower
risks. Laws and regulations requiring FDA approval of the drug label
would have little meaning if a company, without the agency either
reviewing the data or approving it, can detail this information. In
analogy to the off-label promotion of unapproved uses of drugs, this
activity might be referred to as "off-label risk reduction."

The draft guidance states that
"FDA does not intend to object to the distribution of new risk
information that rebuts, mitigates, or refines risk information in the
approved labeling, and is distributed by a firm in the form of a reprint
or digital copy of a published study, if the study or the analysis and
the manner of distribution meet the [specified] principles…."

The agency guidance was issued in response to petitions from 11
pharmaceutical companies seeking clarification and expansion of the
limits on industry for communications with physicians and others without
risking FDA enforcement action for off-label promotion of unapproved
indications. Since 1991, pharmaceutical companies have paid tens of
billions of dollars to the United States for criminal and civil legal
violations. Two of the common forms of illegal activity have been
off-label promotion of unapproved uses of drugs and understating the
risks of approved uses.

The draft guidance suggests that the agency has now tilted toward
protecting industry's commercial speech and away from protecting
patients from the risks of prescription drugs and biological products.

Unfortunately, the draft guidance strikes the balance more toward the
industry's view of its First Amendment right to commercial speech than
toward the agency's mandate for patient protection.

The longer a drug is marketed, the historical pattern is for information
to develop about an increase in the risk to patients, not a decrease in
risk. FDA-approved labeling changes about risk are rarely about
reductions in risk. More commonly, labeling changes incorporate
information about increased risk, including many new boxed warnings. For
example, a 2005 FDA guidance that is frequently referred to in the 2014
draft guidance discusses, almost in its entirety, the various kinds of
post-marketing surveillance that result in information about increased
risks. Between 1975 and 2009, the FDA approved 748 new drugs; 114
(15.2%) received 1 or more boxed warnings after approval, and 32 (4.3%)
were withdrawn from the market for safety reasons.

To protect patients and the public health, the FDA should substantially
revise its draft guidance for industry on distributing medical
publications about the risks of prescription drugs and biological
products. When new information supports a reduction in risk, the company
should inform the FDA and provide the evidence, as is required under
current regulations; if the agency is convinced, the label can be
changed. Off-label risk reduction is a misguided approach.

http://archinte.jamanetwork.com/article.aspx?articleid=1897291

****

Health Affairs
August 2014
Era Of Faster FDA Drug Approval Has Also Seen Increased Black-Box
Warnings And Market Withdrawals
By Cassie Frank, David U. Himmelstein, Steffie Woolhandler, David H.
Bor, Sidney M. Wolfe, Orlaith Heymann, Leah Zallman and Karen E. Lasser

After approval, many prescription medications that patients rely on
subsequently receive new black-box warnings or are withdrawn from the
market because of safety concerns. We examined whether the frequency of
these safety problems has increased since 1992, when the Prescription
Drug User Fee Act, legislation designed to accelerate the drug approval
process at the Food and Drug Administration, was passed. We found that
drugs approved after the act's passage were more likely to receive a new
black-box warning or be withdrawn than drugs approved before its passage
(26.7 per 100.0 drugs versus 21.2 per 100.0 drugs at up to sixteen years
of follow-up).

The Prescription Drug User Fee Act (PDUFA)—first enacted in 1992 and
renewed in 1997, 2002, 2007, and 2012—authorizes the FDA to collect fees
from drug companies to expedite the drug approval process. Congress
enacted the PDUFA in response to widespread concerns that the process
was taking too long.

New drugs have a one-in-three chance of acquiring a new black-box
warning or being withdrawn for safety reasons within twenty-five years
of approval. We believe that the ultimate solution is stronger US drug
approval standards.

http://content.healthaffairs.org/content/33/8/1453.full

****

JAMA Internal Medicine
August 15, 2014
Trends in Boxed Warnings and Withdrawals for Novel Therapeutic Drugs,
1996 Through 2012
By Christine M. Cheng, PharmD1; Jaekyu Shin, PharmD, MS; B. Joseph
Guglielmo, PharmD

Our study demonstrates that boxed warnings are common, affecting more
than one-third of recent drug approvals. While nearly three-quarters of
boxed warnings had been applied to novel therapeutics at the time of
approval, more than 40% acquired the warning after a median market
period of 4 years. Clinicians should be aware of the prevalence and
growing numbers of boxed warnings and the importance of continued
adverse event reporting for identifying new safety concerns.

http://archinte.jamanetwork.com/article.aspx?articleid=1897290

****


Comment by Don McCanne

The Food and Drug Administration (FDA) protects the public from
pharmaceutical firms that increase their drug sales by not being totally
forthcoming about both the effectiveness and safety of their drug
products. The required drug labeling is based on the best information
available. History has repeatedly confirmed that such oversight is
essential even now with the pharmaceuticals firms having paid tens of
billions of dollars in penalties for these continuing violations.

Yet the FDA seems to be allowing the pharmaceutical firms more leeway.
An example is that the FDA allows the firms to pay fees for the purpose
of expediting the consideration of new drug applications. Allowing them
to buy their way to the front of the queue is not only a compromise of
justice, much more importantly it has allowed new products to be
introduced to markets prematurely. This has resulted in an increased
need to add post-marketing black box warnings about more serious adverse
effects of the drugs. Of even greater concern has been the increased
need to withdraw drugs from the market, raising concern that the
accelerated approval process may have allowed the release of drugs that
never should have been on the market in the first place.

The current request pending before the FDA to allow pharmaceutical firms
to distribute studies that have not been cleared by the FDA that show
that their products are safer than the required labeling would indicate
should raise concerns since the first draft of this FDA guidance would
allow such activity. Although it proposes some guidance on how this
information would be distributed, based on previous behavior of the
pharmaceutical firms, there is absolutely no doubt that they would abuse
this process by supporting studies done by researchers who are friendly
to the industry, and by selecting only the favorable studies and burying
those that are less favorable.

Those who are concerned about this ill-advised FDA guidance, and we all
should be, can read the full draft of the guidance and then submit a
comment to the FDA. Public comments are open only until Aug. 25.

Draft Guidance;
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM400104.pdf

Submit a comment on the guidance:
http://www.regulations.gov/#!submitComment;D=FDA-2014-D-0758-0002