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Tuesday, February 07, 2012
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Lyceum Newsletter Perspectives
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States Need to Protect Constituents, Take Control of Health Reform
07/09/2010
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Federal health reform will reduce coverage options for individuals and employers and result in greater concentration in insurance markets.
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The broad effects of health reform legislation, if implemented as enacted, will be to impose significant new Medicaid costs on state taxpayers, disrupt state health insurance markets and the current coverage of tens of millions of Americans, and usurp state authority.
The new federal insurance regulations, particularly the provisions setting new, uniform federal benefit requirements, will reduce coverage options for individuals and employers and will likely drive up health insurance premiums. They are also likely to result in greater concentration in health insurance markets, leaving only a few large insurers operating as public utilities with a regulated low rate of return selling undifferentiated products to customers with no other options.
State lawmakers now face the task of finding ways to protect their constituents—including state taxpayers, health insurance policyholders, and individuals who depend on public health care programs—from the adverse effects of health reform. Governors and state legislators need to start planning their responses now and begin drafting any applicable legislation for consideration in their next legislative session.
The wisest approach is to move reform measures that better position their states under either of two possible scenarios: a new Congress that repeals health reform, or a protracted, multi-year political and legal battle conducted against the backdrop of an Administration attempting to implement the legislation as enacted.
Specifically, state lawmakers should immediately and aggressively pursue the following strategies.
Shift non-elderly Medicaid and CHIP enrollees into premium support.
The most effective tool for states to control their Medicaid and CHIP spending is to shift their programs from directly paying providers to subsidizing private coverage for enrollees. Not only will this “premium support” approach help states control spending; in many states it will also increase beneficiary access to physicians.[1]
States should immediately begin designing and implementing Medicaid and CHIP premium support initiatives for non-institutionalized beneficiaries. In doing so they should take advantage of the flexibility remaining in federal law by adopting all “benchmark plan” designs, providing for maximum allowable enrollee cost-sharing, and replacing the individual cost-effectiveness test with an average cost-effectiveness test.
States should also pursue contracting with one or more private insurers to create supplemental policies that cover required “wrap-around” benefits for Medicaid beneficiaries enrolled thorough premium support in less comprehensive private plans. Then the state can simply pay the premiums for those supplemental policies as well.
The advantages of premium support for enrollees are that they will likely get better access to physicians and more appropriate medical care. In addition, subsidized private coverage is free of the “welfare stigma” associated with traditional Medicaid, or even Medicaid managed-care plans, since providers will only see the private coverage—not the subsidies behind it.
Premium support will also help expand and strengthen a state’s private insurance market—particularly its small-employer coverage market—by adding a large number of mainly healthy and younger individuals to the market
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From a state budget perspective, cost savings from premium support are likely to come in four forms:
- savings from increased enrollee cost-sharing
- efficiency savings from covering under a single policy all members of a family currently covered separately by different combinations of public or private plans,
- administrative savings achieved by significantly reducing the need for the state’s Medicaid and CHIP programs to operate systems that directly reimburse providers and verify claims, and
- likely the biggest source of savings will come from more appropriate use of medical care.
While private plans pay doctors higher rates, if Medicare and CHIP beneficiaries with premium support get earlier and more coordinated physician care, their historic practice of over-using expensive hospital emergency room services should decline—thus, offsetting the increased spending on physician care while also addressing the problem of emergency room over-crowding.
Finally, states should craft their “premium support” initiatives as state-plan amendments to their programs, rather than submitting waiver requests to HHS. Unlike the waiver process, over which the Secretary of Health and Human Services is granted broad discretionary authority, Medicaid and CHIP state plan amendments can only be disallowed if the Secretary finds that they would violate statutory federal requirements for how states operate their programs.
Refuse to administer the new federal high-risk pools.
To date, 18 governors have wisely refused to let their state governments administer the new federal high-risk pool.[2] There are sound reasons for their decisions, as the new high-risk pools are poorly designed.
Any U.S. citizen or lawful resident with a pre-existing medical condition who has been uninsured for at least six months will be eligible for coverage. Congress gave the Secretary of Health and Human Services complete discretion in determining which pre-existing medical conditions will qualify—no matter how minor. Thus, unless the Secretary decides to limit eligibility only to those individuals with expensive conditions, it is certain that demand will quickly outstrip the available funding.
Furthermore, the law stipulates that an enrollee in a new high-risk pool cannot be charged a premium higher than the applicable standard rate for the same coverage in the general market. In contrast, all of the 34 states with existing state high-risk pools follow the long-standing guidance of the National Association of Insurance Commissioners (“NAIC”) to charge high-risk pool enrollees premiums that are at least 125 percent of standard rates.[3]
Specifying that premiums charged to enrollees in the new pools not exceed standard rates means that, relative to existing state high-risk pools, the new pools will provide more generous subsidies (at a higher cost) and will likely attract many more applicants, particularly individuals with relatively minor pre-existing medical conditions.
Finally, another major concern with state governments administering the program is that when the federal funding runs out, state lawmakers will be faced with either terminating the coverage of enrollees or continuing to fund the program with state tax dollars. From the perspective of state officials, they are better off letting the Department of Health and Human Services administer the program, either directly or through private-sector contractors. That way, federal officials will be the ones who are unambiguously responsible for any adverse funding or enrollment decisions.
Decline federal “premium review” grants.
The provisions instructing the Department of Health and Human Services to conduct health insurance premium reviews also authorizes HHS to distribute up to $250 million in grants to states to assist HHS in implementing those provisions. In exchange, however, state insurance departments must provide HHS with insurer data and collaborate with HHS in administering rate regulations.
To preserve the integrity and independence of their own insurance departments and insurance laws, state officials would be well advised to decline this offer of federal funding. The rate review provisions are not only poorly drafted, but were politically motivated additions to the legislation.
Statements by Administration officials since the enactment indicate that implementation of the provisions by the Obama Administration is likely to also be driven more by political considerations than by sound policy or genuine consumer protection. For example, both the statute and subsequent comments by Administration officials refer to “unreasonable premium increases.”
What is missing is any recognition that another key aspect of proper insurance regulation is to prevent the problems that occur if insurers under-price their products. If an insurer fails to charge enough in premiums to cover its expected claims costs, then it is at risk of being unable to make good on the promises made to its customers.
As any state insurance regulator understands, ensuring that carriers have sufficient premium income to cover future claims costs is an important consumer protection.
Also missing from the new federal law is any recognition of the equity issues involved in setting rules for insurers that cross-subsidize different lines of coverage. For example, is it “fair” if regulators require an insurer to limit premium increases on its individual market policies, but as a result the carrier then has to further increase rates for group policies to make up the difference, or vice-versa? Of course, there is no single “correct” set of answers to these kinds of questions, but state lawmakers and state insurance regulators at least have the benefit of decades of experience addressing such issues, while the federal government has none whatsoever.
To be sure, insurance companies (including non-profit ones) are not altruistic enterprises, and state insurance regulation is no more immune to political considerations than is federal regulation. However, given the demonstrated propensity of congressional leaders and Obama Administration officials to blame insurers for the adverse consequences of their own legislation, the vast disparity between the state and federal governments in experience and expertise in insurance regulation, and the inherent conflicts that will arise between the new federal rate regulations and existing state insurer solvency regulations, it is important that state lawmakers preserve the independence of their own insurance laws and state insurance departments.
That means states should not accept federal funding with strings attached that compromise their independence or make their insurance departments mere branch offices of HHS.
Implement state health insurance market reforms and exchanges based on state, not federal, designs.
Health reform will drive up health insurance costs with new coverage mandates while simultaneously trying to hold down premiums with politicized rate regulation. The federal standardization of coverage will also limit the ability of insurers to differentiate themselves in the market or offer their customers lower-cost benefit designs, while the minimum loss ratio regulations will reduce incentives for insurers to be more efficient in managing or paying for care—as insurers will be able to retain little, if any, of the savings that might result.
Faced with this impending regulatory “squeeze play,” insurers are already evaluating their options and can be expected to act in some predictable ways: Insurers with other lines of business (such as property or life insurance) will likely discontinue or sell their health insurance book of business to a competitor and exit the market.
Carriers that offer only health coverage will look to mergers and acquisitions as the path to becoming “too big to fail.” Their logic will be that if the federal government is going to turn private health insurance into a regulated utility with a low rate of return, then the way to survive is to be one of the remaining few large insurers that the federal government needs to keep in business in order to administer the system.
Thus, absent initiatives by state governments to counter these effects by expanding choice and competition, state health insurance markets will begin to see fewer carriers and plan options—most likely starting next year.
The best response for state lawmakers is to immediately move in the opposite direction of the new federal legislation by first determining their state’s needs and priorities, and then enacting their own reforms that increase health insurance choice, competition, and coverage while also reducing costs.
Lawmakers in each state can select from the following broad strategies the elements that offer the best approach for addressing their state’s particular needs and circumstances:
- increase consumer choice by creating a "defined contribution" option for employer-sponsored health insurance coverage,
- reduce coverage costs and allow more variety in plan design by repealing unnecessary state-mandated health insurance benefit requirements,
- encourage insurer participation by lowering barriers to market entry through statewide risk adjustment mechanisms collectively designed and administered by the carriers selling health insurance in the state,
- expand coverage options by creating a “premium aggregation” mechanism that enables individuals to buy coverage using contributions from multiple employers (such as when a family has two earners or an individual has two part-time jobs), and, in the case of low-income families, Medicaid or CHIP premium support payments from the state, and
- provide consumers with greater price and quality transparency with respect to insurance coverage and physician and hospital services.[4]
The fact that the federal legislation perverts the intent of a health insurance exchange—replacing its original purpose as a state tool for increasing consumer choice and encouraging greater variety and competition in health insurance with the new purpose of administering federal coverage uniformity, and supplanting state insurance regulators—should not dissuade state lawmakers from pursuing their own designs for exchanges (consistent with the original intent of the concept) or other administrative mechanisms as tools for implementing their own reforms to promote consumer choice and enhanced health plan competition.
For example, Utah officials and stakeholders determined in their assessment process that their state’s small businesses coverage offer rate was well below the national average and that Utah has a significant number of workers with two or more part-time jobs who do not qualify for employer group coverage offered to full-time employees. Thus, they decided to make defined contribution and premium aggregation using a state health insurance exchange key elements of Utah’s reform strategy.
They also devised an implementation strategy that relies on existing private vendors to provide the necessary administrative services at a negligible cost to the state’s budget.[5] Other states can also use private vendors to quickly design and implement similar solutions customized to their own particular needs and circumstances.
By enacting their own insurance market reforms and creating their own exchanges, or similar administrative mechanisms, based on their own designs now, states can make it politically more difficult for federal officials to implement provisions of the new federal legislation (such as minimum federal benefit standards) that will drive up premiums and reduce coverage choices.
State-designed exchanges can also serve as the administrative platform for implementing Medicaid and CHIP premium support initiatives and, if the legislation is not repealed by then, for organizing alternative coverage arrangements for individuals and employers who refuse to comply with the new federal mandates that also take effect in 2014.
Insist that federal officials explain publicly how they will administer health reform.
State legislators should convene public hearings and summon the federal Secretary of Health and Human Services, members of their state’s congressional delegation, and other federal officials to explain how they intend to implement the numerous provisions of the legislation that will affect their state’s Medicaid and CHIP programs and the private health insurance plans of individuals and employers.
If federal officials refuse to testify before state legislatures, their refusals will themselves be public testimony.
Conduct and publicize “benchmark” analyses.
States should immediately conduct “benchmark” analyses to provide “baseline” projections for at least the next five years for key metrics, and then use the results to measure the effects of various provisions of health reform. The results can also serve as a baseline for estimating the effects of any alternative state reform proposals.
Key metrics include:
- Projected annual enrollment and per capita spending for Medicaid and CHIP, by elgibility category under current law;
- Projected growth in average premiums in the state’s individual, small, and large group health insurance markets under current law;
- Projected average premiums by age in the state’s individual and small group markets under current law; and
- Current and projected health insurance coverage status of the state’s residents by source of coverage under current law.
Developing a state-specific baseline is the essential precursor to constructing state-specific estimates of the effects of the new federal law. State officials will want to construct their own estimates because, if for no other reason, national level estimates will not be sufficiently precise for state planning purposes.
Variations among the states in the composition of their populations, economies, health systems, public programs and insurance rules mean that, in any given state, the actual effects of a particular provision of the new law may differ significantly from the projected national effects estimated by federal officials. Indeed, significant disparities in the effects among states are likely to arise with respect to even minor provisions of the new law.
With their own, state-specific benchmark analyses in place, states will be able to more precisely estimate the effects of the new federal law and state lawmakers will be able to demonstrate to their constituents what portion of a particular result—such as an increase in insurance premiums—is attributable to the federal health care legislation and what portion is attributable to other factors.
State officials should recognize one simple fact: States are not mere agents of federal authority.
They are not powerless.
They have a duty to represent their citizens.
[1] For a more detailed discussion of Medicaid premium support, see Dennis G. Smith, “State Health Reform: Converting Medicaid Dollars into Premium Assistance,” Heritage Foundation Backgrounder No. 2169, September 16, 2008, read here.
[2] The National Association of Insurance Commissioners has compiled lists of: the 30 states (plus the District of Columbia) that have initially indicated that they intend to contract with HHS to administer the federal risk pools; the 18 states that have told HHS that they will not apply to be a risk-pool contractor; and the two states that have yet to reach a final decision, read here. (June 18, 2010).
[3] Three states cap high-risk pool premiums at 125 percent of standard rates. Most have caps set at 150 percent to 200 percent of standard rates and only one sets its cap at a higher level (Florida, at 250 percent). See Kaiser Family Foundation, “State High-Risk Pool Rating Rules, January 2010,” StateHealthFacts.org, read here (June 18, 2010).
[4] For a more detailed discussion of risk-adjustment design, see Edmund F. Haislmaier, “State Health Care Reform: A Brief Guide to Risk Adjustment in Consumer-Driven Health Insurance Markets,” Heritage Foundation Backgrounder No. 2166, August 1, 2008, read here.
[5] Edmund F. Haislmaier, “State Health Care Reform: An Update on Utah’s Reform,” Heritage Foundation Backgrounder No. 2399, April 9, 2010 (read here) and Haislmaier, “State Health Reform: The Significance of Utah Health Insurance Reforms,” Heritage Foundation WebMemo No. 2569, July 29, 2009, read here.
| This article is excerpted from “Obamacare: Impact on States”, published July 1, 2010 by the Heritage Foundation. Read here. |
☆ ☆ ☆
Ed Haislmaier is a Senior Research Fellow at the Heritage Foundation in Washington DC.
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Drug Pricing Methodologies
Average Wholesale Price (“AWP”): The most commonly used price index in pharmaceutical transactions, AWP operates as a suggested list price. Buyers, typically, negotiate lower prices through the inclusion of discounts, rebates or free goods. Medicare uses it to calculate the cost of drug products administered in a physician’s office. PBMs, insurance carriers, and other managed care organizations use AWP to calculate payments to retail pharmacies for providing drug products to patients. Pharmacies often use AWP as a cost basis for pricing prescriptions.
Average Sales Price (“ASP”): The Medicare Modernization Act of 2003 established ASP as a drug payment system. The methodology uses quarterly drug pricing data, which drug manufacturers submit to the CMS. In calculating the ASP, the manufacturer must deduct various discounts, including prompt payment discounts. Like AWP, it serves as a baseline to determine Medicare reimbursement rates.
Average Acquisition Cost (“AAC”): The retailer’s cost to buy drugs from wholesalers: the final cost of the drug to the pharmacy after all discounts are subtracted.
Average Manufacturer’s Price (“AMP”): The average price retail pharmacies or wholesalers pay manufacturers. It is based on sales to the retail sector, which generally pays higher prices than other purchasing sectors. The federal government currently uses AMP to calculate rebates in the Medicaid outpatient prescription drug rebate program.
Wholesale Acquisition Cost (“WAC”): A manufacturer’s list price established for sales to wholesalers, and a basis for calculating rebates.
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MANUFACTURER TO PHARMACY (VIA WHOLESALER)
1. MANUFACTURER
↓ Wholesale Acquisition Cost (WAC) or ↓ Average Manufacturer's Price (AMP)
2. WHOLESALER
↓ Actual Acquisition Price (AAP)
3. PHARMACY
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MANUFACTURER TO PHARMACY
1. MANUFACTURER
↓ Average Manufacturer's Price (AMP)
2. PHARMACY
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PAYER TO PHARMACY
1. PAYER
↓ Reimbursement: Average Wholesale Price + Discount
2. PHARMACY
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PHARMACY TO PATIENT
1. PHARMACY
↓ Retail or Usual & Customary Price (U & C)
2. PATIENT/END-USER
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Drug Coding Procedures
Vendors use both the Health Care Common Procedure Coding System (“HCPCS”), devised by CMS, and Current Procedural Terminology (“CPT”), an AMA creation, to bill for drugs/products that are utilized in the physician’s office, clinic or home setting. These include drugs that are injected subcutaneously, intramuscularly, or intravenously, and drugs administered via nebulizers or other DME equipment.
The National Drug Code (“NDC”) serves as a universal product identifier for drugs and biologics. Although similar to NDC, J Codes contain less information, such as the name of the drug manufacturer. J Codes are administered under the HCPCS.
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The newsletter Perspectives features commentary and opinion on economic transition and business innovation across health care, financial systems and consumer business. Many contributions come from our participants, and reflect front-line experience.
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Maureen Bailey "Silent Epidemic" (volume 5, issue 2), "Nudging Temptation Aside: Behavioral Economics and Diabetes" (volume 5, issue 5)
Ms. Bailey is the author of the forthcoming book "The Diabetic Diva", a cookbook for diabetics with a foreword by Ron Rosedale, MD. Dr. Rosedale developed a nutritional protocol that has helped thousands of people reverse type 2 diabetes. Her work has also appeared in Barron's and The Economist. Read more about Maureen.
Tom Cronin "A Better Model for Disease Management" (volume 5, issue 11)
Mr. Cronin is CEO of Neighborhood Diabetes, where he and his partners on the Management Team have grown the company tenfold in the last five years. Prior to involvement in the acquisition of Neighborhood, Tom took a sabbatical from business and was a math teacher at an urban high school and high school varsity soccer coach. Prior to teaching, Tom was CEO and owner of CranBarry, Inc., an established manufacturer and distributor of women's sporting goods. Earlier, Tom was a consultant at Bain & Company, the international strategy consulting firm headquartered in Boston. Read more about Tom.
Bruce Cutter, MD "A New Oncology Business Model" (volume 5, issue 1)
Dr. Cutter is a practicing medical oncologist/hematologist at Cancer Care Northwest, a large integrated oncology group in Spokane, WA. As president and CEO from 2000 to 2007, Bruce lead the development of a comprehensive quality initiative called Foundations of Quality ("FOQ"). FOQ was developed six years ago, in close collaboration with Premera Blue Cross. This program, which includes a pay-for-performance contractual relationship, was founded on the quality principles promulgated by the Institute of Medicine, is physician-driven and collaborative, and based on a commitment by the practice to measurable quality and accountability. Read more about Bruce.
Steve Hyde "Personal Choice and Breast Cancer Screening" (volume 5, issue 12)
Mr. Hyde is the author two books: most recently, “Cured! An Insider's Handbook for Health Care Reform” (June 2009, Hobnob Publishing; read review) and, previously, “Prescription Drugs for Half Price or Less,” (2006, Bantam-Dell Division of Random House). He has been a public company CEO and chairman or board member of numerous companies. The former federal chief HMO financial regulator and a certified actuary, he started and grew Peak Health Care, Inc., into a highly successful public managed care company, recognized by Business Week Magazine as one of America’s Best Small Companies. He has extensive experience in managed care operations and strategy, health insurance, managed care regulation, consumer-driven health care, pharmacy benefits, disease management, medical information technology, medical group management, medical network and PPO operations, health benefit design & pricing, health insurance underwriting, community rating, and health service product development and marketing. Steve is CEO of Hyde Rx Services Corp., a health care management consultancy. Read more about Steve.
Wolfgang Klietmann, MD "Understanding H1N1 as a Pandemic Threat and Public Health Service Challenge" (volume 5, issue 11)
Dr. Klietmann is a clinical pathologist and medical microbiologist and serves at Harvard Medical School faculty as an appointed Lecturer on Pathology. Prior to his immigration to the United States in 1992, Klietmann founded and was president and physician-in-chief of a major Institute of Laboratory Medicine in Germany which he built into a peerless institution in its scientific standing and innovative diagnostic reputation among private laboratories in Germany. A prolific author and guest lecturer with over 200 publications and presentations delivered to audiences across the globe, the cornerstone of Klietmann’s career has centered on infectious diseases and bringing together individuals and organizations to share information, technology and resources. His work in biodefense includes a collaboration with MIT in a project for the Department of Defense. He serves as president on the board of directors of the Harvard Business School Health Industry Alumni Association and organized as co-chairman several major conferences held on the campus of Harvard Business School. His memberships in several scientific societies include a fellow of the College of American Pathologists. Read more about Wolfgang.
Tom McNulty, Pharm.D "New Strategies for Specialty Pharmacy" (volume 5, issue 12)
Dr. McNulty is co-founder and chief clinical officer of NovoLogix, Inc, a performance-based health care technology company delivering electronic claims re-pricing processes, prior authorization controls, and integrated patient care and pharmaceutical programs. His expertise includes medication adherence and compliance. Tom is a frequent speaker at industry events and conferences. Read more about Tom.
Kavita Nair, PhD "Value-Based Benefit Design: Getting It Right" (volume 5, issue 4)
Dr. Nair is an associate professor in the department of clinical pharmacy at the University of Colorado (Denver) School of Pharmacy. Her current area of research involves pharmacy benefit design in managed care and retail pharmacy including the structure, pricing and reimbursement of medications, factors affecting the reimbursement of medication in retail pharmacy, willingness to pay for retail pharmacists services and consumer attitudes regarding their pharmacy benefit plans and the impact of multi-tiered reimbursement mechanisms on medication utilization. She is currrently working with Anthem Blue Cross Blue Shield of Colorado to examine the impact of two and three tier co-pay pharmacy benefit plans on the drug utilization patterns of a commercially insured population and a Medicare managed care population. She is also working with various Pharmacy Benefit Managers to examine the impact of converting prescription Claritin to an over-the-counter status on medication utilization and reimbursement mechanisms. Read more about Kavita.
Susan Pantely "Benefit Design Strategies and Oral Anticancer Medications" (volume 6, issue 1)
Ms. Pantely is a principal and consulting actuary with Milliman. She works with a broad range of clients, including Blue Cross/Blue Shield plans, HMOs, commercial insurers, government agencies and healthcare providers. Her work includes rate development, provider contract review, reserve certification, capitation development, Medicare risk feasibility studies, HMO start-ups, HMO due diligence, and development of risk sharing and reimbursement arrangements for physician groups, PHOs, and other integrated delivery systems. In addition, Susan has extensive experience with the valuation, financial analysis, and projection of healthcare services for several state public health insurance (Medicaid) programs. Read more about Susan.
David Rose "Smart Packaging, Better Health Care" (volume 6, issue 1)
Mr. Rose is CEO of Vitality, inc. a company focused on connected-health devices and services. He teaches at the MIT Media Lab and speaks frequently on design and product innovation at conferences and corporate retreats. Previously, he was founder and CEO of Ambient Devices where he pioneered embedding Internet information in everyday objects like umbrellas, light bulbs, bathroom mirrors, and refrigerator doors, to make the physical environment an interface to digital information. Read more about David.
Robert Rowley, MD "Cloudburst: The New Frontier for Electronic Health Records" (volume 5, issue 11)
Dr. Rowley is a family practice physician and Practice Fusion’s Chief Medical Officer. Dr. Rowley has a first-hand perspective on the technology needs and challenges faced by healthcare practitioners from his 30 year career in the sector, including experience as a Medical Director with Hill Physicians Medical Group and as a developer of the early EMR system Medical ChartWizard. His family practice in Hayward , CA has functioned without paper charts since 2002. Read more about Robert.
David Willcutts "Are Expectations Too High for Health IT Vendors?" (volume 6, issue 2)
Mr. Willcutts is a long time health care services executive and entrepreneur focused on managed care, specialty pharmacy and home care services. He is currently the president and founder of Ready Consultant, LLC an early stage marketplace for healthcare consulting services created in response to the unprecedented level of health care initiatives underway in the US covering areas such as EHR, HIPAA, ICD10, and more. He previously founded Ancillary Care Management (now Novologix) in 1995 growing it to over $450 million in annual revenue before leaving in 2007. Read more about David.
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Selected Health Care Legislation
1965: Social Security Amendments authorized Medicare and Medicaid programs. The act created separate payment systems for in patient hospital care (Part A), and outpatient care, including home care and physician services (Part B). Read more here.
1983: Orphan Drug Act gave tax breaks, subsidies, and special exclusivity privileges to sponsors of drugs for rare diseases, defined as having fewer than two hundred thousand cases in the United States. The act implemented market exclusivity by granting protection for seven years against competition from any drug with a similar effect. Read more here.
1984: Hatch-Waxman “Generic Drug” Act required the FDA to accept bioequivalence as sufficient for approval and established the procedure for a generic drug approval called the Abbreviated New Drug Application (“ANDA”). The act extended patents for time lost during FDA review and for one-half the time lost during FDA-required clinical testing. The act capped the extension at a maximum of five years, and the total patent term at 14 years from the data of the FDA approval. Read more here.
1986: The Health Care Quality Improvement Act protected peer review bodies from private money damage liability, and prevented incompetent practitioners from moving state to state without disclosure or discovery of previous damaging or incompetent performance. Read more here.
1989: Omnibus Budget Reconciliation Act authorized resource-based, relative value scale reimbursement of physicians under Part B of Medicare. Read more here.
1990: Budget Reconciliation Act established Medi-Gap insurance regulation that limited exclusions for pre-existing conditions, requirements for uniformity in policies, civil penalties for duplicative services, mandatory rebates if policies failed to return specified percentages of each premium dollar, and rules for "simplification" and standardization of policies. The act also introduced a series of Medicare reforms that aimed to save $40 billion over five years. Read more here.
1992: Prescription Drug User Fee Act established for a five-year period a mandatory fee to be submitted by a pharmaceutical company along with its application to finance the hiring of new employees and reduce average processing time. Read more here.
1996: Health Insurance Portability and Accountability Act (“HIPAA”) allowed for the protection of health insurance coverage for workers and their families when changing jobs, and established national standards for electronic health care transactions and national identifiers for providers, insurance plans, and employers to promote electronic data interchange. The act also authorized tax-deductible medical savings accounts. Read more here.
1997: Balanced Budget Act added Part C to Medicare, which expanded options for enrollment in managed care plans. Read more here.
1997: FDA Modernization Act reauthorized user fees for another five years, and introduced new inducements to conduct pediatric studies that included granting a sponsor an additional six months of exclusive marketing privileges beyond any patent or other nonpatent rights for which the drug may already be eligible. Read more here.
2003: Medicare Modernization Act provided a new outpatient prescription drug benefit under Medicare beginning in 2006 (Part D). In the interim, it created a temporary prescription drug discount card and transitional assistance program. It also included a provision for establishing health savings accounts. Read more here.
2005: Patient Safety and Quality Improvement Act established a system of patient safety organizations and a national patient safety database, to encourage reporting and broad discussion of adverse events, near misses and dangerous conditions. The Agency for Healthcare Research and Quality oversees many of its provisions. Read more here.
2009: The American Recovery and Reinvestment Act included the Health Information Technology for Economic and Clinical Health ("HITECH") Act, which provisions $19.2 billion in incentive money for the implemention and use of electronic health records. It also legislatively mandated the Office of the National Coordinator for Health Information Technology ("HIT"), and the creation of the HIT policy and standards committees. Read more here.
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Perspectives features commentary and opinion on economic transition and business innovation. Articles often reflect front-line experience.
We award badges to the five contributors ranking highest in total number of views.
Whether you've published one article or several, we're counting the sum of all reader 'clicks'.
Submit your commentary today. You, too, could become a Top Five contributor!
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Our one-page summaries describe in general terms roundtable proceedings. Because each Lyceum event is exclusive to its participants, we do not publish complete details.
- February 3, 2011 "Payers, Providers and Corporate Strategy", New York
- February 24, 2011 "Health Reform, Public Policy and Corporate Strategy", Washington
- March 29, 2011 "Health Care & Risk Management: Design, Implementation and Market Impact", Boston
- April 5, 2011 "Pharmacy Benefit Design, Biosimilars, and Supply Chain Issues", New York
- April 18, 2011 "Provider Business Models: New Opportunities, New Risks", San Francisco
- May 4, 2011 "Risk Management, Public Policy and Industry Realignment", Washington
- May 31, 2011 "Provider Business Models", New York
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Are you an independent consultant or sole proprietor? Do you operate your own franchise within a larger organization?
What if you could interact more closely with prospective clients and win valuable industry advocates at the same time?
Lyceum's highly regarded roundtables connect diverse stakeholders on topics of industry transition and business innovation. Our members share a common goal of making the best possible business decisions.
Lyceum Associates is pleased to offer unaffiliated individuals the opportunity to join corporate participants as members in our exclusive service.
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Disciplined Approach
Step 1 - Planning
We create in partnership with the client an effective roundtable series design that matches content to strategic objectives and emphasizes insight and urgency.
Step 2 - Execution
We advance the roundtable agenda, recruit high-value participants, and rapidly achieve goals.
Step 3 - Reporting
We present key takeaways and essential information in summary reports, and promote follow-up communication among participants.
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Essential Discussions
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Business Innovation
- Payer/Provider Business Models
- Benefit Design/Employer Strategies
- Information Technology
- Risk Management
Industry Transition
- Health Policy & Reform
- FDA
- Consumer Engagement
Case Studies
- ACOs/Integrated Care Delivery
- Insurance Exchanges
- Biosimilars (Follow On Biologics)
- Drug Distribution/ Alternative Pharmacy Networks
- Oncology Business Practices
- Physician Leadership
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High Return Events
“Market Knowledge”
A large pharmaceutical company weighs investment in different medication adherence programs, but questions how provider consolidation may or may not affect that investment. The Lyceum team designs a series of roundtables addressing adherence issues concerning the company’s specific medication(s). The roundtable series encompasses payers, different vendors, relevant patient groups, and a cross-section of providers. At the series’ conclusion, the Lyceum team delivers its assessment of the landscape and proposes a best course of action.
“Corporate Action"
At the behest of its bankers and its own internal strategists, a health plan considers extending its corporate portfolio into the ownership of physician practices. Although financial models appear sensible, company management worries about hard-to-quantify cultural issues and marketplace uncertainty, from the response of patients to the emergence of alternative provider business models. Based on an interactive roundtable series including diverse provider organizations, employers and other market participants, the Lyceum team submits an independent analysis, allowing management to decide more confidently.
“New Product Development”
Anticipating increased demand for risk management tools addressing global payments, a health information services company plans to develop various proprietary solutions, but discovers that demand may not adequately materialize because of client uncertainty about how the marketplace is evolving. The Lyceum team coordinates a series of roundtables featuring the company, prospective users of its tools, and relevant market participants to provide immediate feedback on the marketplace and inspire greater confidence in the company’s offerings.
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Lyceum members occupy one seat at any event. Lyceum sponsors occupy multiple seats at one or more roundtable series. Members and sponsors qualify as GatherSmart® Executive participants. We expect other participants to pay a participation fee, and to become members or sponsors for continued involvement.
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Lyceum collaborates extensively with its participants on topic and event development.
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Lyceum pursues direct person-to-person contact, optimizing business development.
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Search hundreds of Lyceum roundtable and event participants. GatherSmart® Executive participants enjoy full access.
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The Lyceum Newsletter Perspectives dates back to June 2005, and encompasses more than three dozen discussion topics and over one thousand published pages.
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My GatherSmart is your starting point for dynamic group interaction. Connect to users across our community, search participants at past and future events, and more.
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ChatterSmart is a short-format news forum. Adding your thoughts is as easy as 1-2-3.
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View profile information on users across our entire community. GatherSmart® Executive participants enjoy full access.
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Read Sydney's Weblog Talking Transitions for related commentary and opinion.
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Lyceum Associates welcomes a variety of organizations as members in our service. Members represent diverse stakeholders, including for-profit and non-profit corporations, government agencies, academic institutions, consultancies, and financial service institutions.
User fees support our unique equal-participation, invitation-only format. These fees apply to individual business entities and cover multiple participants.
For enhanced client outreach and business development, we encourage series sponsorships.
Unaffiliated individuals may join Lyceum as contributors, and participate in roundtables and events.
View a checklist of our services.
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Gainful business development and investment require an ability to price future economic shifts within and across industries. Read "Talking Transitions" and learn more.
View the "Talking Transitions" Blog here.
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ACCESS TO THE LYCEUM NEWSLETTER "PERSPECTIVES" AND THE "PERSPECTIVES" ARCHIVES IS LIMITED ONLY TO AUTHORIZED SUBSCRIBERS WHO HAVE READ AND AGREED TO THE LYCEUM USER AGREEMENT, WHICH SOLELY GOVERNS THE CONDITIONS FOR USE OF ANY OF THESE SERVICES AND THE INFORMATION CONTAINED THEREIN. All contents Copyright © 2005-2012 Lyceum Associates, Inc. ALL RIGHTS RESERVED. These Services and the Content contained therein are protected under U.S. and foreign copyright and intellectual property laws, and may not be photocopied, reproduced or retransmitted in any form without the written consent of Lyceum Associates, which may be requested from info@lyceumassociates.com. The content and opinions expressed in "Perspectives" may change and do not constitute investment advice. Lyceum Associates is not responsible for the accuracy of information provided on third-party Web sites. GatherSmart@ is a registered trademark of Lyceum Associates, Inc.
ACCESS TO THE LYCEUM NEWSLETTER "PERSPECTIVES" AND THE "PERSPECTIVES" ARCHIVES IS LIMITED ONLY TO AUTHORIZED SUBSCRIBERS WHO HAVE READ AND AGREED TO THE LYCEUM USER AGREEMENT, WHICH SOLELY GOVERNS THE CONDITIONS FOR USE OF ANY OF THESE SERVICES AND THE INFORMATION CONTAINED THEREIN. All contents Copyright © 2005-2012 Lyceum Associates, Inc. ALL RIGHTS RESERVED. These Services and the Content contained therein are protected under U.S. and foreign copyright and intellectual property laws, and may not be photocopied, reproduced or retransmitted in any form without the written consent of Lyceum Associates, which may be requested from info@lyceumassociates.com. The content and opinions expressed in "Perspectives" may change and do not constitute investment advice. Lyceum Associates is not responsible for the accuracy of information provided on third-party Web sites. GatherSmart@ is a registered trademark of Lyceum Associates, Inc.
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