Sep
7
PUBLIC POLICY & REGULATORY AFFAIRS
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TARGET HEALTH excels in Regulatory Affairs and Public Policy issues. Each week we highlight new information in these challenging areas.
Biosimilars, Interchangeables & Innovation – The Innovative Industry and the Affordable Care Act
It appears that the pharmaceutical industry is placing ever larger bets on biologically derived products, large complex biologically synthesized molecules, as opposed to the smaller, chemically synthesized molecules which have been its historical strength. The reason is that despite the high cost of manufacture and the requisite high cost to patients, the return on investment has become higher for biologically derived medicines. Due to the promise of personalized medicine with its potential to more accurately target these expensive agents, increasing efficacy and safety margins, their value for patients and profitability for innovators are poised to grow.
The Affordable Care Act (Health Reform) incorporates provisions seeking to promote the discovery and development of biologics by threading the needle between innovation, access and cost. Reciprocating the pathway designed to expedite generic competition for small molecules, the Act defines a pathway for “interchangeable biosimilars’’, biological products with minor differences from the reference compound (differences virtually inevitable among competitors given the inherent variation in biologic syntheses) yet demonstrated to have “safety, purity, and potency” similar to the reference molecule. If switching between the reference and biosimilar compound can be shown to be safe and preserve efficacy, a product can be additionally designated as “interchangeable” and substituted for the reference product without the intervention of the prescribing physician.
In return for this expedited pathway for biosimilars, the innovative industry receives 12 years of exclusivity; no biosimilar application can be approved for twelve years after the first licensing (note: not the date of patent issue) of the reference product.
As with much of the Affordable Care Act, enabling regulations must be written, so the practical impact remains uncertain. However, the fact that key players, especially the trade association BIO, seem pleased is instructive. The Act seems to recognize and support the clinical and economic value of innovation while seeking to balance this support with the critical need for cost-containment. While the practical outcome remains unknowable, the intent seems “on-target” and our innovative colleagues should be reassured that policymakers seem supportive of their efforts. (Mark L. Horn, MD, MPH; CMO of Target Health)
FDA Launches New Organizational Performance Management System
The FDA has launched an innovative performance management system designed to advance the President’s commitment to transparency, public participation, and collaboration in the work of government. The system, called FDA-TRACK, will monitor more than 100 FDA program offices through data from key performance measures established each year. That data will be gathered monthly, analyzed and presented each quarter to FDA senior leadership. Importantly, the public will be able to track this data and the agency’s progress through the FDA-TRACK website.
FDA-TRACK is designed to be informative, encourage accountability among the people who work at the FDA, and make that work more transparent. It gives managers and employees a new way to measure their effectiveness in meeting goals to protect the public health and provides a way for the public to monitor agency activities.
Adapted from several successful state and local performance management models, FDA-TRACK hopes to set the standard for open government at the federal level. The system monitors performance indicators in four categories:
Common Measures – Agency-wide measures applicable to each of more than 100 program offices and may focus on the agency’s most recent priorities. Example: Increase the total number of employees who are trained in the Incident Command System, which helps the agency respond to emergencies.
Key Center Director Measures – Center-specific measures that are applicable to each Center and are central to the Center’s priorities and strategic goals. Example: Increase the FDA’s technical guidance by increasing the number of technical publications drafted, which enables the Center to better prepare industry and consumers.
Program Measures – Program office-specific measures that are applicable to the office and reflect work important to the public and to the FDA’s mission. Example: Monitor the percentage of 510(k) decisions meeting the 90-day Medical Device User Fee Act goal during a specific time period.
Key Projects – Program office-specific projects that are applicable to the office and important to the mission and objectives of the office. Performance for Key Projects is measured through achievement of the stated milestones within the project’s plan. Example: The development of a new risk-based approach for evaluating safety, effectiveness, and quality of new animal drugs.
For more information about our expertise in Medical Affairs, contact Dr. Mark Horn. For Regulatory Affairs, please contact Dr. Jules T. Mitchel or Dr. Glen Park.
Aug
23
PUBLIC POLICY & REGULATORY AFFAIRS
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TARGET HEALTH excels in Regulatory Affairs and Public Policy issues. Each week we highlight new information in these challenging areas.
Developing Products for Rare Diseases and Conditions
The FDA has charged the Office of Orphan Products Development (OOPD) to dedicate its mission to promoting the development of products that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions. In fulfilling that task, OOPD interacts with the medical and research communities, professional organizations, academia, governmental agencies, and the pharmaceutical industry, as well as rare disease groups.
The OOPD administers the major provisions of the Orphan Drug Act (ODA) which provide incentives for sponsors to develop products for rare diseases. The ODA has been very successful – more than 200 drugs and biological products for rare diseases have been brought to market since 1983. In contrast, the decade prior to 1983 saw fewer than ten such products come to market.
In addition, the OOPD administers the Orphan Products Grants Program which provides funding for clinical research in rare diseases. The Office Of Orphan Products Development will also administer a new grant program, the Pediatric Device Consortia (PDC) Grant Program. The PDC Grant Program solicits grant applications from institutions/organizations that propose to develop nonprofit consortia to facilitate pediatric medical device development. FDA will provide grants to consortia whose business model and approach to device development will either result in, or substantially contribute to, market approval of medical devices designed specifically for use in children. Although administered by the OOPD, this grant program is intended to encompass devices used in all pediatric diseases, not just rare diseases.
For more information about our expertise in Medical Affairs, contact Dr. Mark Horn. For Regulatory Affairs, please contact Dr. Jules T. Mitchel or Dr. Glen Park.
Aug
16
PUBLIC POLICY & REGULATORY AFFAIRS – FDA Approves EllaTM Tablets for Emergency Contraception
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TARGET HEALTH excels in Regulatory Affairs and Public Policy issues. Each week we highlight new information in these challenging areas.
FDA Approves EllaTM Tablets for Prescription Emergency Contraception
The FDA has approved ellaTM (ulipristal acetate) tablets for emergency contraception. The prescription-only product prevents pregnancy when taken orally within 120 hours (five days) after a contraceptive failure or unprotected intercourse. It is not intended for routine use as a contraceptive. ellaTM is a progesterone agonist/antagonist whose likely main effect is to inhibit or delay ovulation. Since May 2009, the prescription product has been available in Europe under the brand name ellaOne.
An FDA Advisory Committee for Reproductive Health Drugs discussed ellaTM in June, 2010. The committee unanimously voted that the application for ellaTM provided compelling data on efficacy and sufficient information on safety for the proposed indication of emergency contraception.
The safety and efficacy of ellaTM were demonstrated in two Phase III clinical trials. One study was a prospective, multi-center, open-label, single-arm trial conducted in the United States; the other was a randomized, multi-center, single-blind comparator-controlled trial conducted in the United States, United Kingdom and Ireland.
Side effects most frequently observed with ellaTM in the clinical trials include: headache, nausea, abdominal pain, pain/discomfort during menstruation (dysmenorrhea), fatigue, and dizziness. The profile of side effects for ellaTM is similar to that of FDA-approved levonorgestrel emergency contraceptives. According to the product’s labeling, women with known or suspected pregnancy and women who are breastfeeding should not use ellaTM. A patient package insert also will be provided to ensure that women are fully informed of the benefits and risks involved in the use of ellaTM.
ellaTM is manufactured by Paris-based Laboratoire HRA Pharma. ellaTM will be distributed by Watson Pharma Inc., of Morristown, N.J.
For more information about our expertise in Medical Affairs, contact Dr. Mark Horn. For Regulatory Affairs, please contact Dr. Jules T. Mitchel or Dr. Glen Park.
Aug
9
PUBLIC POLICY & REGULATORY AFFAIRS – “Meaningful Regulations”
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TARGET HEALTH excels in Regulatory Affairs and Public Policy issues. Each week we highlight new information in these challenging areas.
“Meaningful Regulations”
The Department of Health and Human Services has just promulgated the Electronic Health Record (EHR) “Meaningful Use” requirements for 2011 & 2012. These are the requirements that must be met by providers to qualify for incentive payments awarded those who adopt compliant EHR systems.
These incentives are significant. Up to $44,000 are available through Medicare and $63,750 through Medicaid. In the words of Blumenthal & Tavenner, writing in the New England Journal of Medicine (5 August 2010), these incentives offer the health care community a “transformational opportunity to break through the barriers to progress.”
Historically, adoption of electronic records has been slow, a fact perplexing to many medical and political leaders. Acceptance has been hampered by (among other problems) cumbersome systems (poor design), high expense, inadequate support, and concerns with both routine practice downtime for training and maintenance and unanticipated downtime for system “crashes.”
Happily, there was ample opportunity for comment on the proposed requirements (initially released in January 2010). The Department listened, leading to flexibility in the final approach that had been missing in the original proposal. There are now a set of core requirements, all of which must be met, and an additional ten requirements from which providers must choose five. This flexibility, combined with the issuance (June 2010) of certification rules for EHR systems and the establishment of Regional Extension Centers to assist providers with adoption, provide reason for optimism that, with respect to EHRs, we may be approaching a long anticipated “tipping point” of broad adoption.
Target Health has long been convinced of the benefits of paperless operations in clinical trial management. We are pleased to see these benefits applied more broadly in clinical care and expect that the enhanced ability to securely manage, track, analyze and communicate clinical data will improve the quality and efficiency of care delivery. Increasingly, we see the potential to merge care delivery and clinical trial management to enhance safety and efficiency in drug development.
These are exciting times in health care. The benefits of information technology are about to be applied – potentially at least – in a systemically meaningful way, offering meaningful opportunities to improve care, enhance patient & provider satisfaction, increase efficiency, and save money…worthy objectives all. We are committed to doing our part to assure success. By Mark L. Horn MD, MPH, Chief Medical Officer Target Health Inc.
For more information about our expertise in Medical Affairs, contact Dr. Mark Horn. For Regulatory Affairs, please contact Dr. Jules T. Mitchel or Dr. Glen Park.
Jul
26
PUBLIC POLICY & REGULATORY AFFAIRS
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TARGET HEALTH excels in Regulatory Affairs and Public Policy issues. Each week we highlight new information in these challenging areas.
FDA Seeks Public Comment on New Federal Menu Labeling Requirements
The FDA has announced that it is inviting the public to submit comments and information to help the agency implement a new federal law that requires the posting of calorie content and other nutrition information on menu items at certain chain restaurants and similar retail food operations and vending machines. The new law, Section 4205 of the Affordable Care Act signed into law March 23, 2010, sets new federal requirements for foods sold at certain restaurants, coffee shops, delis, movie theaters, bakeries, ice cream shops, and in vending machines.
Prior to the new law, federal law required nutrition labeling on many packaged foods, which may be purchased in supermarkets and at other locations, and some states and local governments required nutritional labeling by restaurants in their jurisdictions. The new law requires restaurants and similar retail food establishments that are part of a chain with 20 or more locations that offer substantially the same menu items to list calorie content information on menus and menu boards, including drive-through menu boards.
Other nutrition information – total calories, total fat, saturated fat, cholesterol, sodium, total carbohydrates, complex carbohydrates, sugars, dietary fiber, and total protein – must be made available in writing on request. The act also requires vending machine operators who own or operate 20 or more vending machines to disclose the calorie content of their items.
The FDA is required by law to issue proposed regulations to carry out these provisions by March 23, 2011. The agency also expects to issue guidance concerning the requirements of Section 4205 of the Affordable Care Act. The FDA encourages members of the food industry, state and local governments, consumers, and other interested parties to offer comments and suggestions about menu labeling in docket number FDA-2010-N-0298. The docket was officially opened for comments on July 7, 2010 and will remain open for 60 days.
For more information about our expertise in Medical Affairs, contact Dr. Mark Horn. For Regulatory Affairs, please contact Dr. Jules T. Mitchel or Dr. Glen Park.
Jul
19
PUBLIC POLICY & REGULATORY AFFAIRS
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TARGET HEALTH excels in Regulatory Affairs and Public Policy issues. Each week we highlight new information in these challenging areas.
FDA Approves First Implantable Miniature Telescope to Improve Sight in Patient with Age-Related Macular Degeneration
Age-related macular degeneration (AMD) a condition that mainly affects older people, damages the center of the retina (macula) and results in a loss of vision in the center of the visual field. About 8 million people in the United States have AMD and nearly 2 million of them already have significant vision loss, according to the National Eye Institute. AMD can make it difficult or impossible to recognize faces or perform daily tasks such as reading or watching television.
The FDA has announced the approval of the Implantable Miniature Telescope (IMT) to improve vision in some patients with end-stage AMD. Surgically implanted in one eye, the IMT is a small telescope that replaces the natural lens and provides an image that has been magnified more than two times. The IMT is available in two models: one that provides 2.2 times magnification and another 2.7 times magnification. The IMT is designed to magnify and project images onto a healthy portion of the retina. The IMT is intended to be implanted in only one eye; the non-implanted eye is used for peripheral vision. The IMT is used in patients ages 75 years and older with stable severe to profound vision impairment (when vision impairment has not changed over time) caused by blind spots (bilateral central scotoma) associated with end-stage AMD. These patients also have evidence of a visually significant cataract.
Patients must undergo training with an external telescope with a low vision specialist prior to implantation to determine whether adequate improvement in vision with the external telescope can be obtained and to verify if the patient has adequate peripheral vision in the eye that would not be implanted. Patients must also agree to participate in a post-operative visual training program.
In a 219-patient, multi-center clinical study of the IMT, 90% of patients achieved at least a 2-line gain in either their distance or best-corrected visual acuity, and 75% of patients improved their level of vision from severe or profound impairment to moderate impairment. Because the IMT is a large device, implantation can lead to extensive loss of corneal endothelial cells (ECD), the layer of cells essential for maintaining the clarity of the cornea, and chronic endothelial cell loss. The chronic rate of endothelial cell loss is about 5% per year. Significant losses in ECD may lead to corneal edema, corneal decompensation, and the need for corneal transplant. In the study, 10 eyes had unresolved corneal edema, with five resulting in corneal transplants. The calculated five-year risk for unresolved corneal edema, corneal decompensation, and corneal transplant are 9.2%, 6.8% and 4.1%, respectively.
To ensure that the risks of IMT implantation are sufficiently and consistently communicated to patients, the FDA and the manufacturer created detailed labeling, including an Acceptance of Risk and Informed Decision Agreement, which patients must complete prior to IMT implantation. The agreement provides a guide for patients and their physicians to discuss the risks associated with IMT implantation. Patients should be given adequate time to review all of the information regarding the IMT. As a condition of FDA approval, the manufacturer, VisionCare Ophthalmic Technologies Inc. of Saratoga, Calif., must conduct two post-approval studies. In one study, VisionCare must continue follow-up on the subjects from its long-term follow-up cohort for an additional two years. Another study of 770 newly enrolled subjects will include an evaluation of the endothelial cell density and related adverse events for five years after implantation.
For more information about our expertise in Medical Affairs, contact Dr. Mark Horn. For Regulatory Affairs, please contact Dr. Jules T. Mitchel or Dr. Glen Park. TARGET HEALTH INC.
Jul
12
PUBLIC POLICY & REGULATORY AFFAIRS
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TARGET HEALTH excels in Regulatory Affairs and Public Policy issues. Each week we highlight new information in these challenging areas.
Berwick/CMS Update
Several months back we commented favorably on the appointment of Dr. Donald Berwick of the Institute for Healthcare Improvement to lead the Center for Medicare and Medicaid Services (CMS). Last week it emerged that the Administration has elected to “seat” Dr. Berwick through an interim appointment circumventing the Senate confirmation process ordinarily required for this post. Since the CMS is critical for the implementation of the Affordable Care Act. and has been without permanent leadership since 2006, the need to fill the vacancy with dispatch is clear. However, it is far from clear that it was either necessary or prudent to circumvent the approval process, thereby eliminating the opportunity to publicly vet sensitive and important issues related to the Act and address continuing public concerns about the new law. It is noteworthy that Senator Max Baucus, Democratic Chair of the Senate Finance Committee had the following comment…
“Senate confirmation of presidential appointees is an essential process prescribed by the Constitution that serves as a check on executive power and protects Montanans and all Americans by ensuring that crucial questions are asked of the nominee — and answered”
Since this controversial decision was announced, the Web has been saturated with videos showing Dr. Berwick praising Britain’s National Health Service and opining that humane health care is by definition redistributive of wealth. He will now have no public opportunity to offer additional perspective on these views. However one might feel about Dr. Berwick, the country would have benefited from an open and vigorous discussion of his views, his approach to implementing health care reform, and the issues he feels need to be most urgently addressed. Senate hearings may have been challenging, but they could have provided an effective forum to educate and mobilize the American people, helping us understand and confront some of the tough choices ahead in health care. It is true that this discussion would have caused discomfort, but all of us, including Dr. Berwick, would have been the better for having it. (by Mark Horn, MD, Chief Medical Officer, Target Health Inc.)
Another point of view by Joyce Hays, CEO, Target Health Inc:
Because the new law will expand Medicaid to cover 16 million more people with low incomes, this will be a challenge for the Center for Medicare and Medicaid Services, and a testing ground for new innovation. One could argue that there are those in Congress who have repeatedly stalled many of the administrations nominees for many months, whose clear intentions would have been to stall the appointment of Dr. Donald Berwick, and then to use this blocking tactic as (political) a way to revive arguments against the new healthcare law, which will be a political football in this fall’s elections. The agency that Dr. Berwick will be heading has been without a permanent administrator since October 2006. This other point of view is that although a long difficult struggle in the Senate confirmation process would have informed the public, definitely a positive, there are too many desperate citizens without healthcare, and too many doctors who could get staggering cuts in Medicare payments by those in the Congress holding up the confirmation process. The administration wanted to avert this damage.
The New York Times wrote: “One of Dr. Berwick’s first tasks will be to work with Congress to avert a 21 percent cut in Medicare payments to doctors, scheduled to occur late this year.
The American Medical Association has praised Dr. Berwick, saying he is “widely known and respected” for his efforts to improve the quality and safety of care. But cuts in Medicare payments could damage the quality of care and prompt doctors to turn away new Medicare patients, doctors say. Hospital executives who have worked with Dr. Berwick describe him as a visionary, inspiring leader
For two decades Dr. Berwick has championed the interests of patients and consumers. At the same time, he has spoken of the need to ration health care and cap spending, has supported efforts to “reduce the total supply of high-technology medical and surgical care” and has expressed great admiration for the British health care system. “
For more information about our expertise in Medical Affairs, contact Dr. Mark Horn. For Regulatory Affairs, please contact Dr. Jules T. Mitchel or Dr. Glen Park.
Jul
6
PUBLIC POLICY & REGULATORY AFFAIRS – CDER Drug Shortage Program (DSP)
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TARGET HEALTH excels in Regulatory Affairs and Public Policy issues. Each week we highlight new information in these challenging areas.
CDER Drug Shortage Program (DSP)
The Drug Shortage Program (DSP), within the Center for Drug Evaluation and Research (CDER), was established to address potential or actual shortages of prescription, over-the-counter, or generic drugs that have a significant impact on public health. Through communication, facilitation and negotiation, DSP works with pharmaceutical manufacturers, review divisions, compliance and other components of FDA to manage product shortages. The DSP focuses on shortages of medically necessary products since these shortages have the greatest impact on public health. The Drug Shortage page on the FDA website lists shortages primarily of medically necessary products. Shortages that are expected to be resolved quickly or which involve only a particular strength or package size, which has a substitute strength(s) and package size(s), are not usually the focuses of the DSP. Over the last ten years, the number of shortages has continued to increase. There are many reasons for this increase in shortages and some of the causes are as follows:
- Manufacturing issues – this may include problems with manufacturing, enforcement activities, raw material shortages, packaging shortages, and other reasons
- Business decisions may be made by firms to discontinue manufacturing of a drug – newer products continue to replace older products due to better safety profiles, better efficacy, more convenient dosing regimens, etc.
- Limited manufacturing capacity – often multiple products are produced on the same equipment which means that an increase in production of one product will usually result in a delay for another product produced on the same production line
- Market concentration – as firms discontinue manufacturing of various products, only one or two firms may remain as producers of a product.
Once a drug is determined to be in shortage the DSP consults with the CDER review division that has medical expertise on the drug in shortage to determine whether the drug is a medically necessary drug product. (A medically necessary drug is defined as a product used to prevent or treat a serious or life-threatening disease or medical condition for which there is no other available source of that product, alternative drug or therapy available.) On occasion expertise from outside the FDA is also obtained to make such a determination. The approved and unapproved (“off-label”) uses of a product are taken into consideration. There are many shortage situations over which FDA has no regulatory authority. FDA may, however, do the following:
- Expedite review of submissions from manufacturers – these submissions may be in support of a marketing application for a new product (NDA or ANDA), or may be in support of manufacturing changes which will allow a product to be available (for example, a chemistry supplement for a new manufacturing site) or may involve other issues (for example, toxicity data for an impurity identified in a product)
- Identify alternate manufacturers that can initiate or ramp-up production
- Find new/additional sources of raw material
- Advise/consult with sponsors on resolution of manufacturing issues
- Allow temporary import of a non-US product, in rare instances
For more information about our expertise in Medical Affairs, contact Dr. Mark Horn. For Regulatory Affairs, please contact Dr. Jules T. Mitchel or Dr. Glen Park.
Jun
28
PUBLIC POLICY & REGULATORY AFFAIRS
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TARGET HEALTH excels in Regulatory Affairs and Public Policy issues. Each week we highlight new information in these challenging areas.
FDA Approves First Diagnostic Assay to Detect Both HIV Antigen and Antibodies
Target Health is pleased to announce that Target e*CRF® was used for this program.
HIV is the virus that can lead to acquired immune deficiency syndrome, or AIDS. HIV damages a person’s body by destroying specific blood cells, called CD4+ T cells, which are crucial to helping the body fight diseases. Two types of HIV have been identified: HIV-1 and HIV-2. HIV-1 is responsible for most HIV infections throughout the world. HIV-2 is found primarily in West Africa; however, cases of HIV-2 infection have been reported in North America and Europe. The Centers for Disease Control and Prevention report that approximately 18 million people in the United States are tested for HIV each year. Most recent CDC estimates are that there are about 56,000 new HIV infections in the United States each year. In addition, there are more than 1 million people living with HIV in the United States, according to CDC.
FDA has approved the first assay to detect both antigen and antibodies to Human Immunodeficiency Virus (HIV). This assay is approved for use as an aid in the diagnosis of HIV-1/HIV-2 infection in adults including pregnant women. It is also the first assay for use as an aid in the diagnosis of HIV-1/HIV-2 infection in children as young as two years old. The highly sensitive assay is intended to be used as an aid in the diagnosis of HIV-1/HIV-2 infection, including acute or primary HIV-1 infection. Since it actually detects the HIV-1 virus (specifically the p24 antigen) in addition to antibodies to HIV, the ARCHITECT HIV Ag/Ab Combo assay can be used to diagnose HIV infection prior to the emergence of antibodies. Most tests used today in the diagnostic setting detect HIV antibodies only. Although direct detection of the virus itself by nucleic acid testing is available, it is not widely used in diagnostic settings. The ARCHITECT HIV Ag/Ab Combo assay is not intended to be used for routine screening of blood donors. However, it is approved as a donor screening assay for HIV-1/HIV-2 infection in urgent situations where licensed blood donor screening tests are unavailable or their use is impractical. The ARCHITECT HIV Ag/Ab Combo assay will be used in clinical laboratories and in public health laboratories, and is the first assay approved in the United States to detect HIV antigen and antibodies simultaneously. The ARCHITECT HIV Ag/Ab Combo assay is manufactured by Abbott Laboratories, Abbott Park, Illinois.
For more information about our expertise in Medical Affairs, contact Dr. Mark Horn. For Regulatory Affairs, please contact Dr. Jules T. Mitchel or Dr. Glen Park.
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Jules T. Mitchel, President
Jun
21
PUBLIC POLICY & REGULATORY AFFAIRS
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TARGET HEALTH excels in Regulatory Affairs and Public Policy issues. Each week we highlight new information in these challenging areas
Health Reform Update/Nixing the “Doc Fix“ by a Target Health Doc
Lest any of our readers believe that the nation’s health care problems have been solved by passage of the Health Care Reform Bill (Patient Protection and Affordable Health Care Act), the ongoing legislative dance to secure relief from physician pay cuts mandated by the SGR (sustainable growth rate) legislation linking Medicare reimbursement to GDP growth offers a dose of reality. This linkage mandates cuts in Medicare reimbursement when spending exceeds defined GDP based limits; since passage, relief from these mandatory cuts has been granted through a series of temporary legislative “fixes“. The AMA campaigned vigorously for a permanent solution as a component of health care reform, but the cost was prohibitive and the dance of periodic “fixes“ continues. As On-Target goes to press, the latest legislative fix first failed to pass the Senate (confronting physicians with a 21% reduction in reimbursement) and then, after urgent negotiations, passed in revised form. This fix must now return to the House. Pending final passage (presumably) next week, claims will be processed at the reduced rate, potentially damaging medical practices with fixed costs yet undiminished responsibility, to provide critical services to Medicare patients.
On-Target predicts that the House will pass the new “fix“, kicking the proverbial “can down the road“ for another six months, but this is – euphemistically – no way to run a railroad (or any other critical enterprise for that matter). One takeaway, (among many) is that the voluminous health reform legislation recently passed is, to paraphrase Winston Churchill, not the end, not the beginning of the end, but perhaps the end of the beginning. There are thousands of pages of implementing rules to be written and, as is evidenced by this “doc-fix“ scenario, fundamental issues of quality, access, and cost remain unresolved. The key takeaway: we in healthcare will be managing through uncertainty for some time. By Mark L. Horn MD, MPH, Chief Medical Officer of Target Health Inc.
For more information about our expertise in Medical Affairs, contact Dr. Mark Horn. For Regulatory Affairs, please contact Dr. Jules T. Mitchel or Dr. Glen Park.