Policy and Medicine

HHS to Begin HIPAA Audits

Starting this month, healthcare organizations will be subject to audits by the Office of Civil Rights (OCR), evaluating their compliance with the HIPAA privacy and security rules and breach notification standards.

The American Recovery and Reinvestment Act of 2009, in Section 13411 of the HITECH Act, requires the Department of Health and Human Services (HHS) to provide for periodic audits to ensure covered entities and business associates are complying with the HIPAA Privacy and Security Rules and Breach Notification standards. 

To implement this mandate, OCR is piloting a program to perform up to 150 audits of covered entities to assess privacy and security compliance.   Audits conducted during the pilot phase will begin November 2011 and conclude by December 2012.  Auditors will conduct a site visit, interview key personnel, and record results in reports that will be shared with the organization and the OCR.

The audit program serves as a new part of OCR’s health information privacy and security compliance program.   OCR will use the audit program to assess HIPAA compliance efforts by a range of covered entities.  HHS asserted that, “audits present a new opportunity to examine mechanisms for compliance, identify best practices and discover risks and vulnerabilities that may not have come to light through OCR’s ongoing complaint investigations and compliance reviews.”  OCR will broadly share best practices gleaned through the audit process and guidance targeted to observed compliance challenges via this web site and other outreach portals.

The pilot audit program itself is a three-step process.  The first step entailed developing the audit protocols.  The second step is the initial audits beginning this month.  The results of the initial audits will inform how the rest of the audits will be conducted.  The last step will include conducting the full range of audits using revised protocol materials.  

Every covered entity and business associate is eligible for an audit.  Selections in the initial round will be designed to provide a broad assessment of a complex and diverse health care industry.  OCR is responsible for selection of the entities that will be audited.

OCR will audit as wide a range of types and sizes of covered entities as possible; covered individual and organizational providers of health services, health plans of all sizes and functions, and health care clearinghouses may all be considered for an audit.  OCR expects covered entities to provide the auditors their full cooperation and support and remind them of their cooperation obligations under the HIPAA Enforcement Rule.  Business Associates will be included in future audits.

The privacy and security performance audit process will include generally familiar audit mechanisms.  Entities selected for an audit will be informed by OCR of their selection and asked to provide documentation of their privacy and security compliance efforts. In this pilot phase, every audit will include a site visit and result in an audit report. During site visits, auditors will interview key personnel and observe processes and operations to help determine compliance.

Following the site visit, auditors will develop and share with the entity a draft report; audit reports generally describe how the audit was conducted, what the findings were and what actions the covered entity is taking in response to those findings. Prior to finalizing the report, the covered entity will have the opportunity to discuss concerns and describe corrective actions implemented to address concerns identified.

The final report submitted to OCR will incorporate the steps the entity has taken to resolve any compliance issues identified by the audit, as well as describe any best practices of the entity.

Audits are primarily a compliance improvement activity.  OCR will review the final reports, including the findings and actions taken by the audited entity to address findings.  The aggregated results of the audits will enable OCR to better understand compliance efforts with particular aspects of the HIPAA Rules.  Generally, OCR will use the audit reports to determine what types of technical assistance should be developed, and what types of corrective action are most effective.

Should an audit report indicate a serious compliance issue, OCR may initiate a compliance review to address the problem.  OCR will not post a listing of audited entities or the findings of an individual audit which clearly identifies the audited entity.

Merck CEO Government Boards and Price Controls Threaten Medical Progress

 
In a recent editorial in the Wall Street Journal, Kenneth C. Fraizer, President and CEO of Merck & Co. asserted that, “government boards and drug price controls threaten to throw sand in the gears of medical progress.”

Fraizer recognized how life-science companies today are among America's premier innovators, with six of the top 10 companies in global research and development expenditures being biopharmaceutical, according to a 2010 report by Booz & Co. This innovation is what drives millions of jobs and tax dollars in America. For example, Merck has over 40,000 people on its payroll in the U.S.  And these high-quality jobs in biopharmaceutical research are skilled and labor-intensive, with an average salary of more than $95,000.

Moreover, American drug companies reinvest more than 20% of their U.S. sales revenues in research. As recently as 2008, more than 67% of all U.S. biopharmaceutical patents were issued to U.S.-based life-science companies. In addition, almost two-thirds of research on new medicines approved in the last 10 years was performed in this country.

Today, the U.S. accounts for 82% of the biotechnology research and development in the world and has over 2,900 medicines in the pipeline. In addition, U.S. biopharmaceutical exports rose to $46 billion in 2009 from $29 billion in 2005.

He also pointed out how the biopharmaceutical industry's scientists have produced a global revolution in health care. Medicines and vaccines created and produced by Merck treat patients in more than 140 countries. Among these are Victrelis, approved by the Food and Drug Administration this year as the first new drug in a decade to treat Hepatitis C; and Isentress, which has helped change HIV from a certain killer to a manageable chronic disease.

America and Innovation

Consequently, the Merck CEO noted how many Americans “generally agree that our economic future depends on nurturing new ideas.” In fact, he pointed to President Obama’s 2011 State of the Union speech, in which the President said that, “the first step in winning the future … is encouraging American innovation.”

However, Fraizer pointed out that, “the life sciences are largely absent from most discussions about encouraging innovation, while the extensive research and development that stands behind each new vaccine or medicine is invisible to all but a few.” Most Americans have no clue about the extraordinary scientific innovation and huge R&D investment embodied in the small pill or capsule their doctors prescribe.

Moreover, “the actions of the administration and the proposals of some in Congress may significantly impede innovation in the biopharmaceuticals industry for the foreseeable future.” Fraizer noted that, “American leadership in pharmaceuticals and biotechnology is now threatened,” which also means the future health of Americans is threatened.

The loss of patent protection for older medicines, the imposition of artificial controls on prices and reimbursements in the U.S. and abroad, and the increased difficulty and cost of medical research breakthroughs has dimmed the prospects for companies large and small. Our complex discovery process comes with high costs and failure rates. In response, U.S. companies are consolidating and contracting, costing the U.S. an estimated 200,000 jobs since 2006 and more than 300,000 since 2000.

Threats to US Innovation

Consequently, Fraizer asserted that, “there are two big public-policy threats on the horizon for Merck and the biopharmaceutical industry.”

First, the Independent Payment Advisory Board, or IPAB, which originated in last year's health-reform law. This board has the power to reduce Medicare payments for innovative products simply because overall Medicare costs exceed certain budget targets in any one year. This effort is inherently designed to focus on reducing short-term costs at the expense of long-term investments.

The other harmful proposal on Washington's agenda would impose price controls for the first time on the Medicare Part D prescription-drug program. This successful program has allowed nearly 30 million seniors to have comprehensive drug coverage at a cost that is nearly 50% below initial projections. Frazier asserted that, “it makes no sense to overlay—as would bills proposed by Rep. Henry Waxman (D., Calif.) and Sen. Jay Rockefeller (D., W.Va.)—a price control onto a program that is already delivering high value at lower-than-projected costs.”

Consequently, the Merck CEO maintained that, the IPAB and the proposed Medicare price controls “will dampen incentives for innovation and job-creation, ultimately reducing access to life-saving and cost-saving treatments.” He pointed to a report from the Battelle Memorial Institute, which estimates that the kind of Medicare Part D policy now being considered in Congress could kill 130,000 or more U.S. jobs in and around the pharmaceutical industry.

Discussion

Accordingly, “rather than choke innovation,” Fraizer asserted that, “policy makers must find savings by readjusting existing incentives to use services and technologies that have little benefit and, in some cases, cause harm.” According to Medicare data published last month, for example, hospitals perform expensive double CT scans on 5.4% of patients, increasing costs and exposing patients to additional radiation.

Additionally, Fraizer recommended that, “policy makers focus, as does the new health-reform law, on creating positive incentives to prevent and treat diseases.” He noted how future medicines can reduce the costliness and pain of diseases such as Alzheimer's and cancer, for which there are many promising research leads. One study by the Alzheimer's Association found that the development of a new treatment that delays the onset of Alzheimer's could reduce Medicare and Medicaid spending on patients with Alzheimer's by more than $100 billion annually by 2030.

As with other companies in the industry, Fraizer acknowledged Merck's mission—to “discover, develop and provide innovative products and services that save and improve lives around the world—can play a critical role in meeting America's economic goals.”

He noted that, “the investment decisions Merck makes today will pay off in new cures a decade or more from now. Similarly, the fiscal decisions our nation makes today will profoundly influence the innovation investment that will help decide the economic and personal well-being of our children and grandchildren.”

Accountable Care Organizations: A Long Way to Go

 
One of the keystone provisions contained within the Affordable Care Act (ACA or health care reform) was the idea of Accountable Care Organizations (ACOs).  The provision states that ACOs will begin on January 1, 2012, with each capable of treating at least 5,000 Medicare patients.

Over the past several months, the issue of ACOs has been widely discussed and debated.  ACO’s are a “symbol of the Obama administration’s belief that driving providers to deliver better care will also eliminate large amounts of unnecessary spending.”

Consequently, a recent article from POLITICO noted that ACOs are “in danger of being crushed under its own weight.”

Background

The goal of ACOs is to facilitate coordination and cooperation among providers to improve the quality of care for Medicare beneficiaries and reduce unnecessary costs.  The program is intended to encourage providers of services and suppliers (e.g., physicians, hospitals and others involved in patient care) to create a new type of health care entity, an “Accountable Care Organization” that agrees to be held accountable for improving the health and experience of care for individuals and improving the health of populations while reducing the rate of growth in health care spending.  To participate as an ACO, organizations must:

• Have a formal legal structure to receive and distribute shared savings
• Have a sufficient number of primary care professionals for the number of assigned  beneficiaries (to be 5,000 at a minimum)
• Agree to participate in the program for not less than a 3-year period
• Have sufficient information regarding participating ACO health care professionals as the Secretary determines necessary to support beneficiary assignment and for the determination of payments for shared savings.
• Have a leadership and management structure that includes clinical and administrative systems
• Have defined processes to (a) promote evidenced-based medicine, (b) report the necessary data to evaluate quality and cost measures (this could incorporate requirements of other programs, such as the Physician Quality Reporting Initiative (PQRI), Electronic Prescribing (eRx), and Electronic Health Records (EHR), and (c) coordinate care
• Demonstrate it meets patient-centeredness criteria, as determined by the Secretary.

As POLITICO noted, the idea of ACOs “is to get different kinds of health care providers to band together to provide coordinated care to a population of patients. The ACA says that if they do it “efficiently and in a way that gives better care to the patients, they’d be able to keep a share of any savings they create.”

Consequently, several weeks ago, the Centers for Medicare and Medicaid (CMS) issued a long-awaited proposed rule for entities interested in becoming ACOs,

“The proposed rule goes a step further than the statute, requiring ACOs to be at risk of losing money if their costs wind up higher than expected. It also imposes a high bar before providers can pocket any savings. The savings have to be big enough that they’re clearly the result of real changes to the delivery of care, not just random variation.”

Proposed Rule

Before the rule came out, “it had been eagerly anticipated for months, with many providers signaling they would enroll as soon as there were details.”

At the time, Health and Human Services Secretary Kathleen Sebelius said the “department had spent months carefully digesting all of the feedback so it could write a rule flexible enough to allow many different kinds of providers to take part.”

However, as POLITICO notes, “now that providers have had time to digest it, even the most likely candidates have rejected it as written.”

Specifically, the article noted that providers “biggest concerns include the provisions that are supposed to keep the ACOs from potentially increasing Medicare spending — costing, rather than saving, money — if savings targets aren’t reached.”  While experts say this is “necessary caution, given the potential scope of the program … if this makes it unworkable for providers, the administration will have choked the goose that is supposed to lay the golden savings.”

Moreover, providers only have the proposed rule.  Whether “the final version of the rule is stricter or looser than the current version is not clear and depends on whether the Obama administration can actually get the savings it wants.”

In other words, if the rule is too restrictive and “nobody participates, you’re not going to get the savings,” which appears to be very likely according to Tevi Troy, deputy secretary of HHS under former President George W. Bush.  But if projected savings are reduced because they “loosen up the rule, … you won’t get the same amount of budget savings.”

In response to this concern, Richard Sorian, HHS assistant secretary of public affairs, said the department was “100 percent confident that Accountable Care Organizations will be established on schedule, improve the quality of care and lower costs.”

One of the biggest signs of disappointment in the proposed rule came a few weeks ago when “10 medical groups participating in a Medicare pilot program that paved the way for the ACO program declared that none would participate if the rule were not substantially modified.”

In a letter they wrote to CMS Administrator Donald Berwick, MD, the 10 groups asserted that they “ALL have serious reservations about the economics and the complexity of the Medicare Shared Savings Program/ACO NPRM.”

They further noted that, “as currently proposed, ACOs have a greater potential for incurring losses … than for generating savings. This risk-reward imbalance makes it difficult, if not impossible, for internal decision makers to accept the financial design.”

While the comment period continues, Gail Wilensky, who oversaw Medicare and Medicaid under President George H.W. Bush, noted that Berwick may not have much authority to change what the final rule looks like.  Specifically, POLITICO noted that sources indicated that “at least two of the provisions most worrisome to providers were included in the proposed rule at the Office of Management and Budgets (OMB’s) insistence, and this may make them hard to change.

OMB has the final word on all regulations and is charged with policing their impact on the economy and the federal budget. David Spahlinger of the University of Michigan Medical School, one of the people who signed the May 12 letter to Berwick, explained to POLITICO that “OMB and the other agencies with jurisdiction have most of the responsibility for the proposed rule’s shortcomings.”

Conclusion

Given these recent developments, the future of ACOs remains uncertain, especially given the recent letter from the leaders who pioneered this idea.  As providers continue to submit comments on the proposed rule, the shortcomings of ACOs and the bureaucratic process behind them will come to the forefront, and it will ultimately be up to the public to voice its concerns about controlling costs.  Since this is a major initiative of the Obama Administration, officials will likely begin addressing this issue soon as election activities draw closer.  President Obama will want measurable to deliver to voters, and failing at ACOs will not bode well for his reelection efforts. 

What these events demonstrate is that the government’s focus on saving money and cost effectiveness clearly does not take into account the ability of providers to meet such “idealistic” proposals as ACO’s.  For example, as noted in their letter, there are a large number of quality measures, especially new quality metrics in several domains,

that go into effect starting year one.  As an example, on average, it costs about $30,000 just to program a single new quality metric. The proposed rule has more than 60 new ones, which equates to nearly $2,000,000 for each organization.  Accordingly, ACOs seem to have a long way to go.   The government will have to add many more incentives for providers in order for ACO’s to get off the ground, it will be interesting to see if they can do it.

Affordable Care Act One Year Later

 
It is hard to imagine that one year ago today President Obama signed into law the Affordable Care Act (ACA), the nation’s most sweeping reform since Medicare was passed in 1965.

 POLITICO ran a number of stories addressing health care reform and the impact that the ACA has had on Americans. Some of the stories were written by notable health care stakeholders, including Health and Human Services (HHS) Secretary Kathleen Sebelius, Senator Ron Wyden (D-OR), Senator Tom Harkin (D-IA), and Representative Steve King (R-IA). Below is a summary of each of these articles, as well as some additional commentary on recent developments in Congress relating to the ACA and health care reform.

Kathleen Sebelius

Ms. Sebelius asserted in her article that Americans “are enjoying new protections, greater freedoms and lower costs,” since the ACA was enacted. She noted how “children are now protected from being turned away by insurers because of a pre-existing condition and seniors enrolled in Medicare now have the freedom to get preventive care — such as mammograms and colonoscopies — for free.”

She also noted that “a Patient’s Bill of Rights is freeing families from some of the worst abuses of insurance companies, including cancelling coverage when you get sick because of a paperwork error.”

With respect to coverage and insurance, she noted that, “the number of small businesses offering coverage to employees is increasing.” Ms. Sebelius also added that the ACA is “demanding transparency and accountability from the insurance industry to bring down premiums.” For example, she noted how HHS has given states almost “$250 million in funding to strengthen their ability to review, revise or reject unreasonable insurance rate hikes.”

In addition, she pointed to “new proposed rules that would force many insurers to justify big increases and post explanations on the Web.” She also recognized that the new rules regarding medical loss ratio, requiring insurers to pay out 80-85 % of premium dollars on health care and quality improvement efforts — rather than marketing and executive bonuses.

In the future, the HHS Secretary noted that in 2014, individuals and small businesses will be able to bring down their health insurance rates through new state-based health insurance exchanges to. In addition, the ACA will give millions of eligible people tax credits, based on need, to help them afford health coverage.

Defending these changes, Ms. Sebelius pointed to data from the Congressional Budget Office (CBO), which showed that a family of four, making $55,000, could save more than $6,000 a year on health insurance in 2014.

Finally, the Secretary acknowledged the ACA’s investment in bringing down costs by investing “in preventive care, and innovative programs aimed at slowing that growth of premiums.” She asserted that new ides to “coordinate care, improve patient safety, and reduce waste, fraud and abuse, will create additional savings for decades to come.”

Interestingly, Ms. Sebelius acknowledged President Obama’s recent remarks at a hearing with governors, providers and patients, where the “president announced his support for legislation that allows states to pursue innovative alternatives to the law, provided they can achieve the same results as the Affordable Care Act — including relief from skyrocketing costs.”

Ultimately, Ms. Sebelius asserted that Americans “can’t afford to take away these benefits, cancel these rights, and return to the days when insurance companies got between you and your doctor.”

Senator Tom Harkin (D-IA)

Mr. Harkin echoed the comments of Secretary Sebelius, and noted that efforts to repeal the ACA are “misguided.” He claimed that “support for health care reform is growing steadily.” However, his article must have missed another POLITICO story that cited a recent survey from the Henry J. Kaiser Family Foundation, which found that 57% of independent voters had an unfavorable view of the law in January, up from 41% in December.

Nevertheless, the focus of his message was to put insurance companies on the hot seat. He noted that if the ACA is repealed, Americans will face discrimination based on pre-existing conditions and access to health insurance for more than 30 million Americans will be lost. Mr. Harkin pointed out that repealing the ACA would also “add hundreds of billions of dollars to the deficit by wiping out the savings in the ACA.”

Mr. Harkin specifically took issue with the provision of the ACA that ends denial of coverage due to pre-existing conditions. This issue is significant because “nearly half of nonelderly Americans have some type of pre-existing condition — like high blood pressure, arthritis or heart disease.” He also championed the ACA’s provisions that ban the practice of canceling policies when people get sick, prohibit insurers from imposing lifetime limits on benefits, and allow parents to keep their children on their policies until age 26.

In response to conservative attacks on the individual mandate, Senator Harkin noted that this provision is just “common sense.” Without this mandate, he noted that people will continue using emergency rooms for treatment and sticking other Americans with the bill—in fact, $1,100 a year to every family’s health insurance premiums comes from uncompensated care.

He noted how Mitt Romney, as governor of Massachusetts, put an individual mandate in his state’s health reform law to eliminate free riders and put everyone in the risk pool, to keep rates down for everyone. Mr. Harkin noted that, “this is the only way people with pre-existing conditions are not denied affordable coverage.”

Ultimately, Senator Harkin urged for continued support of the ACA, to insure that Americans have the freedom to afford a doctor, and so that people do not fear that a major illness will lead to financial ruin. While he admitted that the ACA is not perfect, and is more like “a starter home — suitable for improvement,” he noted that the ACA will replace the current sick care system with a genuine health care system — focused on wellness and prevention, which will reward health care providers for the quality of care they provide, not just the quantity.

As the law is implemented, he asked his colleagues who want to make sensible changes “to bring their tool kits, rather than their sledgehammers, so we can work together to improve the law.”

Senator Ron Wyden (D-OR)

The focus of Senator Wyden’s article was to discuss the bipartisan Empowering States to Innovate Act, which he introduced last year with Senator Scott Brown (R-MA) to advance states’ ability to make changes to the health reform law, has not lacked attention.

Mr. Wyden recognized how there has been too little focus on his bipartisan legislation because there is too much back and forth about whether President Obama is being inflexible (conservatives) or yielding too much (liberals).

In clarifying arguments against his proposed legislation, Mr. Wyden explained how “the legislation would make it easier for states to get waivers for health care reform and Medicaid and allow states to address both in one waiver request.” For example, he noted how a state could use the waiver process to cover Medicaid recipients as part of its new state private insurance exchanges. He further added that, “Wyden-Brown would also lock states into guaranteeing a generous and costly level of benefits.”

According to another article from POLITICO, the State Innovation Waivers will allow states to opt out of key health reform programs, like the mandated purchase of health insurance and building an insurance exchange, if they meet high benchmarks for coverage and affordability. Oregon and Vermont are expected to pursue these waivers and have secured the president’s support on moving their effective date to 2014 from 2017, when they currently kick in.

Consequently, Mr. Wyden noted how the idea of the Waiver for State Innovation provision was first part of his Healthy Americans Act that he introduced in 2006. He recognized then and now that states need “the flexibility to adapt federal health care laws to meet their regional needs,” because health care challenges are different in every part of the country.

Interestingly, Mr. Wyden noted that the provision is currently in the ACA, but wouldn’t take effect until 2017. Accordingly, “Wyden-Brown would allow states to start looking for ways to adapt and improve on the law now — while they are focused on its implementation — rather than years after those decisions and investments have been made.”

Mr. Wyden asserted that, “empowering governors and local lawmakers to improve the law is likely to make reform more successful for all Americans.” As a result, he noted that if states have the ability to invest their time and energy in finding ways to innovate and make health care reform work better, “all Americans would be healthier and more financially secure.”

In addition to innovation waivers, officials at HHS have approved no fewer than 1,040 requests for so-called mini-med waivers. However, the mini-med waivers — which allow people to keep insurance plans that have an annual payout on benefits of less than $750,000 — affect a relatively small group of the privately insured: 2.6 million people.

Moreover, many states over the next year will also seek a reprieve from two of the law’s most wide-reaching provisions: the medical loss ratio and the maintenance-of-effort provision. Last week, the agency granted Maine the country’s first medical-loss-ratio waiver, concluding the new regulation could drive insurers away from the state’s small individual insurance market.

POLITICO noted that HHS is weighing similar requests from New Hampshire, Nevada and Kentucky, and that “officials in a third of the states will ask Washington for waivers that will allow insurance companies to set aside more money for administration costs and profits. And more than half of the states are eying waiver requests to the Medicaid requirement.”

Additionally, more than two dozen Republican governors sent HHS a letter in January asking the secretary to waive the maintenance-of-effort provision, which bars states from dropping Medicaid eligibility before the program’s expansion in 2014.

Ultimately, the administration asserted that, “certain waivers and adjustments are necessary to ensure an orderly transition toward 2014, when most of the major health reform provisions come online.

Representative Steve King (R-IA)

Mr. King’s article primarily focused on amendments and legislation he has proposed in the House that would stop the automatic funding provisions of the ACA. Specifically, the ACA includes provisions, “unprecedented in scope,” which automatically spend $105.5 billion over the next 10 years to implement the law.

However, during the continuing resolution debate on funding the federal government for FY 2011, his amendments to cut off this funding were defeated. While two of his other amendments were adopted, which prevented ACA funds from being used to further the implementation of Obamacare, these provisions did not touch Obamacare’s automatic spending provisions. Accordingly, Mr. King emphasized the need to cut off these automatic spending provisions.

Consequently, he asserted that “if the president refuses to sign a continuing resolution that provides for responsible funding of all government functions except Obamacare, Americans will know that serving them is not his priority. Preserving his signature socialized medicine plan is.”

Accordingly, Mr. King explained how he and Representative Michele Bachmann (R-MN) are circulating a letter to House members for language to be in the FY 11 CR that would shut off both the annual and the automatic appropriations for ObamaCare’s implementation. The proposed language reads:

“Notwithstanding any other provision of law, none of the funds made available by this or any previous Act with respect to any fiscal year may be used to carry out the provisions of Public Law 111-148, Public Law 111-152, or any amendment made by either such Public Law.”

The letter also contains a pledge to vote against any CR that lacks this language and it asks that every member of Congress who supports repealing and defunding Obamacare sign the letter and take this pledge.

Rep. Dan Boren (D-Okla.) 

Representative Dan Boren discussed in his article why he voted against the Affordable Care Act and how just “17% of his constituents supported the law,” according to a survey conducted by Public Policy Polling in his district in March 2010. For Mr. Boren, the most disappointing part about the ACA was that there were many bipartisan issues that Republicans and Democrats agreed on, but instead of working on those issues incrementally, Democrats last year pushed a 2,000 page bill through Congress. He noted that the ACA has “dramatically expanded the federal government’s role in the private sector, placed burdensome mandates on small businesses and individuals and increased taxes during an economic downturn.”

As a result, Mr. Boren’s article discussed how he, along with Rep. Mike Rogers (R-Mich.), have introduced the Health Care Waiver Fairness Act. This legislation will allow every small-business owner or average American the opportunity to apply for a waiver from the new health care law if they so desire. The basics of this bill are that if you like the health care reform law, you can take advantage of it. If you want no part of it, you can opt out.

Discussion

Given the ongoing debate about repealing the ACA and constant changes in public perception and opinion about the ACA, the landscape for 2012 is shaping up to be a battle over health care reform. While many Americans are in favor of a number of the provisions—insurance for 26 year-olds, support on premiums for moderate-income Americans and better prescription drug coverage for seniors, no limits on pre-existing conditions, no lifetime limits—many Americans are still uncertain about the legislation.

Republicans will likely be running a campaign that attacks the ACA for being irresponsible and insufficient to address the growing health care costs and inefficiencies. While Democrats will emphasize the key provisions that have already taken effect and are helping Americans. Some say that Republican presidential candidates will likely run on repealing the bill, as many new members in the Senate and House did during the November 2010 elections.

There is also the added factor of the federal courts to issue rulings on the individual mandate, and with the Supreme Court leaning conservative right now, a decision from the federal judiciary finding the individual mandate unconstitutional may give Republicans the extra boost needed to win the election. And interestingly, a recent Kaiser Family Foundation poll found that nearly 90% of Republicans and 69% of independents want to repeal it. Even Democrats aren’t crazy about it — 51% want to repeal it, according to the same poll.

Ultimately, to repeal the ACA and change the political landscape of Congress and the implementation of health care reform, Republicans will have to come up with a replacement plan; a way to control rising Medicare costs, while also balancing the important provisions of the ACA that American’s support.

IOM Report: Leading Health Indicators for Healthy People 2020

 

Last December, the Department of Health and Human Services (HHS) announced  Healthy People 2020, the nation’s new 10-year goals and objectives for health promotion and disease prevention. HHS acknowledged that the Healthy People initiative “in just the last decade, has either progressed toward or met 71 percent of its Healthy People targets.”  

The 2020 initiative includes a number of new topic areas including: Adolescent Health, Blood Disorders and Blood Safety, Dementias, including Alzheimer’s Disease, and several others.

Additionally, the new initiative includes “myHealthyPeople,” a new challenge for technology application developers. This challenge encourages developers to create easy-to-use applications for professionals who are working with the new national health objectives and state- and community-level health data. The idea is that “myHealthyPeople‟ apps challenge will help spur innovative approaches to information technology that will help communities track their progress using Healthy People objectives and targets as well as develop an agenda for health improvement.”

Consequently, HHS requested that the Institute of Medicine (IOM) evaluate the Healthy People 2020 initiative. In response to this request, the IOM established the Committee on Leading Health Indicators for Healthy People 2020 to develop and recommend 12 indicators and 24 objectives for consideration by HHS for guiding a national health agenda and for consideration for inclusion in Healthy People 2020.

 

Recently, the Committee released its Letter Report, entitled, “Leading Health Indicators for Healthy People 2020.” In conducting its work, the committee was asked to: 

• Review current and past health indicators sets, including Healthy People 2010 Leading Health Indicators, the State of the USA (SUSA) indicators, and the Community Health Status Indicators;
• Give consideration to provisions of the Patient Protection and Affordable Care Act that mandate the establishment of key national indicators and prevention-related measures, goals, and objectives;
• Define basic principles or purposes for Healthy People 2020 Leading Health Indicators;
• Develop criteria for selecting Healthy People 2020 Leading Health Indicators. Such criteria should be actionable and reflect the importance of science, evidence, and public health concerns. Development of such criteria should involve consideration of Healthy People 2010 Leading Health Indicators and reflect the Healthy People 2020 framework that includes new issues and topics (e.g., health communication and health information technology);
•  Choose indicators that, to the extent possible, have annual data sources, with comparable data available at the state and county level; and
• Identify 24 objectives drawn from Healthy People 2020 and 12 topics under which the selected objectives will be organized.

 During the HHS presentation of the charge to the committee on November 8, 2010, the committee was informed that since only 39 of the 42 Healthy People 2020 topics had written objectives, the committee could propose objectives for the three topics under development.

 

Those topics are: social determinants of health; health-related quality of life and well-being; and lesbian, gay, bisexual, and transgender health. The committee also received clarification from HHS that the 12 topics selected by the committee did not need to be drawn from the list of 42 topics listed in Healthy People 2020. 

Healthy People 2020

The mission of Healthy People 2020 strives to identify nationwide health improvement priorities. It also looks to increase public awareness and understanding of the determinants of health, disease, and disability and the opportunities for progress. Additionally, it strives to:

• Provide measurable objectives and goals that are applicable at the national, State, and local levels.
• Engage multiple sectors to take actions to strengthen policies and improve practices that are driven by the best available evidence and knowledge; and
• Identify critical research, evaluation, and data collection needs.

IOM Report

The report consists of the committee’s recommendations concerning topics, indicators, and objectives. It then goes into the discussion of the committee process, the framework and the process used to select objectives, and a discussion of the selection of topics and indicators. The report also includes a detailed discussion of each of the selected objectives as well as suggestions for measures that could be used in the three Healthy People topic areas for which no objectives exist: social determinants of health; health-related quality of life and well being; and lesbian, gay, bisexual, and transgender health.

 

Consequently, the committee developed and recommended 12 indicators and 12 topics, and selected 24 objectives from the Healthy People 2020 objectives that relate to the identified indicators and topics. A list of the objectives with accompanying subobjectives, quantitative goals, and data sources are in the report. Specifically, the committee recommended that the following indicators be used by HHS as the Healthy People 2020 Leading Health Indicators. These indicators are: 

• Proportion of the population with access to health care services
• Proportion of the population engaged in healthy behaviors
• Prevalence and mortality of chronic disease
• Proportion of the population experiencing a healthy physical environment
• Proportion of the population experiencing a healthy social environment
• Proportion of the population that experiences injury
• Proportion of the population experiencing positive mental health
• Proportion of healthy births
• Proportion of the population engaged in responsible sexual behavior
• Proportion of the population engaged in substance abuse
• Proportion of the population using tobacco
• Proportion of the population receiving quality health care services

The committee also recommended the following 24 objectives, selected from the Healthy People 2020 objectives, as important objectives related to these indicators. 

• Increase educational achievement of adolescents and young adults.
• Increase the proportion of persons with health insurance.
• Increase proportion of persons with a usual primary care provider.
• Increase the proportion of persons who receive appropriate evidence-based clinical preventive services.
• Reduce the overall cancer death rate.
• Reduce the number of days the Air Quality Index (AQI) exceeds 100.
• Increase the proportion of children who are ready for school in all five domains of healthy development: physical development, social emotional development, approaches to learning, language, and cognitive development.
• Reduce pregnancy rates among adolescent females.
• Reduce central line-associated bloodstream infections (CLABSI).
• Improve the health literacy of the population.
• Reduce coronary heart disease deaths.
• Reduce the proportion of persons in the population with hypertension.
• Increase the proportion of sexually active persons who use condoms.
• Reduce fatal and nonfatal injuries.
• Reduce the proportion of persons who experience major depressive episodes (MDE).
• Reduce low birth weight (LBW) and very low birth weight (VLBW).
• Reduce the proportion of children and adolescents who are considered obese.
• Reduce consumption of calories from solid fats and added sugars in the population aged 2 years and older.
• Increase the proportion of adults who meet current Federal physical activity guidelines for aerobic physical activity and for muscle-strengthening activity.
• Reduce the proportion of persons engaging in binge drinking of alcoholic beverages.
• Reduce past-month use of illicit substances.
• Increase the proportion of adults who get sufficient sleep.
• Reduce tobacco use by adults.
• Reduce the initiation of tobacco use among children, adolescents, and young adults.

 

Ultimately, the committee concluded that the indicators and selected objectives in Healthy People 2020 should  prove valuable in eliciting interest and awareness  among the general population; motivating diverse  population groups to engage in activities that will  exert a positive impact on specific indicators and, in  turn, improve the overall health of the nation; and providing feedback on progress toward improving  the status of specific indicators.

The committee also stated that HHS may wish to highlight the indicators and objectives in communications to state and local health departments, use them as a guide for funding priorities in department programs, and use them as priority guides for ongoing departmental  public health data collection and reporting activities.

HHS Launches Healthy People 2020 – Health Goals for the Next Decade

 

In 1979, the U.S. Department of Health and Human Services (HHS) began a process to improve the health of Americans through a project known as Healthy People: The Surgeon General’s Report on Health Promotion and Disease Prevention, which provided national goals for reducing premature deaths and preserving independence for older adults. 

In 1980, another report, Promoting Health/Preventing Disease: Objectives for the Nation, set forth 226 targeted health objectives for the Nation to achieve over the next 10 years.  Healthy People 2000: National Health Promotion and Disease Prevention Objectives, released in 1990, identified health improvement goals and objectives to be reached by the year 2000. The Healthy People 2010 initiative, released in 2000, continued in this tradition as an instrument to improve health for the first decade of the 21st century.

Healthy People 2010 looked at the scientific advances that took place over the past 20 years in preventive medicine, disease surveillance, vaccine and therapeutic development, and information technology. It also looked at the changing demographics of the U.S., the changes that have taken place in health care, and the growing impact of global forces on our national health status. A number of scientific experts from federal agencies provided input into the initiative and over 11,000 comments from the public were considered. The outcome of Healthy People 2010 was 467 objectives in 28 focus areas, providing an “encyclopedic compilation of health improvement opportunities for the next decade.”

The major goals of each of these programs have been to increase the quality and years of healthy life (i.e. growing elderly population) and to eliminate health disparities (i.e. more diverse population).

Healthy People 2020

Earlier this month, HHS announced Healthy People 2020, the nation’s new 10-year goals and objectives for health promotion and disease prevention. HHS acknowledged that the Healthy People initiative “in just the last decade, has either progressed toward or met 71 percent of its Healthy People targets.”  

The 2020 initiative includes a number of new topic areas including: Adolescent Health, Blood Disorders and Blood Safety, Dementias, including Alzheimer’s Disease, and several others.

Additionally, the new initiative includes “myHealthyPeople,” a new challenge for technology application developers. This challenge encourages developers to create easy-to-use applications for professionals who are working with the new national health objectives and state- and community-level health data. The idea is that “myHealthyPeople‟ apps challenge will help spur innovative approaches to information technology that will help communities track their progress using Healthy People objectives and targets as well as develop an agenda for health improvement.”

Mission

The mission of Healthy People 2020 strives to identify nationwide health improvement priorities. It also looks to increase public awareness and understanding of the determinants of health, disease, and disability and the opportunities for progress. Additionally, it strives to:

•  Provide measurable objectives and goals that are applicable at the national, State, and local levels.
• Engage multiple sectors to take actions to strengthen policies and improve practices that are driven by the best available evidence and knowledge; and
• Identify critical research, evaluation, and data collection needs.

Overarching Goals

The overarching goals of the new initiative are to:

• Attain high-quality, longer lives free of preventable disease, disability, injury, and premature death.
• Achieve health equity, eliminate disparities, and improve the health of all groups.
• Create social and physical environments that promote good health for all; and
• Promote quality of life, healthy development, and healthy behaviors across all life stages.

Collaboration

The goals set by Healthy People 2020 hold promise for the future of health care, especially in light of health care reform. However, with 30 million people soon to be enrolled in America’s health care system, our country will face significant obstacles dealing with diverse populations, more elderly patients, and a wide variety of untreated or chronic conditions.

To overcome these challenges and to meet the goals set by Healthy People 2020, we will need to encourage and promote strong communication and partnerships between multiple stakeholders. As HHS recognized, for the past three decades, Healthy People has established benchmarks and monitored progress over time in order to “encourage collaborations across sectors, guide individuals toward making informed health decisions, and measure the impact of prevention activities.”

Since the mission of Healthy People 2020 is to “engage multiple sectors to take actions to strengthen policies and improve practices that are driven by the best available evidence and knowledge,” policymakers should not put forth obstacles that will make this engagement difficult. Federal agencies and health experts need to communicate with multiple sectors to help identify critical research, evaluation, and data collection needs.

Conclusion

The success that Americans have experienced in health care and the progress in medicine thus far is largely a result of industry-physician collaboration and government/industry funded research. Accordingly, while health care reform is being implemented and institutions, agencies, and academic medical centers consider new policies, these stakeholders should consider policies that will enhance the collaboration of government, academia, and industry to continue encouraging collaborations across sectors that will help our country meet the goals set by Healthy People 2020.

Recent proposals from academic medical centers, institutions, and agencies have threatened the ability of the private sector to work with the government or academia. In light of initiatives such as Healthy People 2020, which recognize the need to engage multiple sectors, these parties should seriously reconsider the limitations they have placed on their faculty and staff, and other counterproductive measures. Leaving out stakeholders such as industry and cutting off communication between the private sector and government or academia will make achieving the mission of Healthy People 2020 difficult, and could end up hurting Americans instead of helping them.

HHS Turning up the HEAT on Healthcare Fraud Charges

 

Since the health care reform debate began almost two years ago, the Obama Administration has identified fighting fraud committed against public health care programs as a top priority. Both the Recovery Act and Affordable Care Act include significant provisions to fight health care fraud. Among many other changes, the ACA amended the False Claims Act’s public disclosure provision and strengthened the provisions of the federal health care Anti-Kickback Statute.

One of the main reasons for this is because the Obama Administration largely asserted during the debate that significant reductions in health care fraud and abuse could help pay for part of the health care reform legislation.

These goals were further expressed in President Obama’s FY 2011 budget, which included $561 million in discretionary resources to the Department of Health and Human Services (HHS), an increase of $250 million. HHS Secretary Kathleen Sebelius acknowledged that this increase would strengthen the Medicare and Medicaid program integrity activities, with a particular emphasis on fighting health care fraud in the field, increasing Medicaid audits, and strengthening program oversight while reducing costs. 

Such an investment against fraud and abuse claims to help save $9.9 billion over ten years. According to HHS, the additional funding will better equip the Federal government to minimize inappropriate payments, pinpoint potential weaknesses in program integrity oversight, target emerging fraud schemes by provider and type of service, and establish safeguards to correct programmatic vulnerabilities.

Additionally, the HHS budget will install a set of new program integrity proposals that will give HHS the necessary tools to fight fraud by enhancing provider enrollment scrutiny, increasing claims oversight, improving Medicare’s data analysis capabilities, and reducing over-utilization of Medicaid prescription drugs. These proposals will claim to save approximately $14.7 billion over 10 years.

Consequently, the Department of Justice (DOJ) has been busy trying to reach that goal, securing more than $3 billion in civil settlements and judgments in cases involving fraud against the government in the fiscal year ending Sept. 30, 2010. Announcing this accomplishment, Tony West, Assistant Attorney General for the Civil Division, announced in a press release that this total includes $2.5 billion in health care fraud recoveries—the largest in history—and represents the second largest annual recovery of civil fraud claims.

West also mentioned that the amounts recovered under the False Claims Act since January 2009 have eclipsed any previous two-year period with $5.4 billion in taxpayer dollars returned to federal programs and the Treasury. Of that total, $4.6 billion were under the False Claims Act from health care providers and others in the industry, a two-year health care fraud record. DOJ also secured 25 criminal convictions. Since 1986, when Congress substantially strengthened the civil False Claims Act, recoveries now total more than $27 billion.

The largest fiscal year 2010 False Claims Act recoveries came from the pharmaceutical and medical device industries, which accounted for $1.6 billion in settlements, including the $669 million from Pfizer Inc., $302 million from AstraZeneca, and $192.7 from Novartis Pharmaceutical Corporation. These numbers may appear to be deceptive however, as some have predicted that the era of big pharma settlements may be ending. For example, many companies such as Pfizer have entered into lengthy corporate integrity agreements that span over the next several years.

While it is certainly important for revenue purposes that DOJ continues to successfully prosecute wrongful acts of companies, the agreements these companies have entered into require more of an oversight role than investigative, to ensure compliance with the agreement. Without large settlements, the DOJ might not be able to sustain its ‘profitability’ of fraud collections. For example, without a large settlement like Pfizer’s, DOJ’s claims may not cover the $500 million plus the government put in. In other words, if the administration is to continue such efforts, they will first have to recover $500 million to break even.

Much of the success for recovering this money stems from the Department of Health and Human Services (HHS) creation of a new interagency task force, the Health Care Fraud Prevention and Enforcement Action Team (HEAT). On May 20, 2009, Attorney General Eric Holder and HHS Secretary Kathleen Sebelius created HEAT to increase coordination and optimize criminal and civil enforcement, which they argue results in higher quality health care at a more reasonable price. DOJ and HHS also assert that HEAT is used as a tool to protect the Medicare Trust Fund for seniors and the Medicaid program for the country’s neediest citizens.

West further acknowledged the role of HEAT by recognizing that Since January 2009, the Civil Division, together with the U.S. Attorneys’ offices, commenced more health care fraud investigations, secured larger fines and judgments, and recovered more taxpayer dollars lost to health care fraud than in any other two-year period." Most of the cases resulting in recoveries were brought to the government by whistleblowers under the False Claims Act, the federal government’s primary weapon in the battle against fraud.

In 1986, Senator Charles Grassley and Representative Howard Berman led successful efforts in Congress to amend the False Claims Act to revise the statute’s qui tam (or whistleblower) provisions, which encourage whistleblowers to come forward with allegations of fraud. Since 1986, recoveries in qui tam cases have exceeded $18 billion, and relators (whistleblowers) have obtained more than $2.8 billion in awards. They were awarded $385 million in 2010.

Impact of Settlements

Ultimately, while the success of the DOJ is clear, how much this will continue down the road depends on a number of factors. Nevertheless, it is important that the DOJ and HHS continue to work with companies on solutions to prevent fraud, waste and abuse to reduce costs and improve efficiency in the health care system. While the recoveries may help to pay for some of the provisions in health care reform, it is more important that the companies maintain their trust and integrity with the public by adhering to their agreements and making a concerted effort to prevent fraud and abuse.

PhRMA, Hospitals and Physician Organizations Promote Repeal of Independent Payment Advisory Board (IPAB)

 
Congress created the Independent Payment Advisory Board (IPAB) within the Affordable Care Act (health care reform), in an effort to help restrain growth in Medicare expenditures. Specifically, as the law states, “It is the purpose of this [Board] to . . . reduce the per capita rate of growth in Medicare spending.”  This is where the $500 billion in savings for the Affordable Care Act was going to come from.

IPAB has the authority to develop proposals to save costs in the Medicare program that become law unless Congress acts to adopt alternative cost saving proposals that would save at least as much as the IPAB proposals. IPAB is required to consult with the Medicare Payment Advisory Commission (MedPAC) and with the Department of Health and Human Services (HHS) when making such proposals, and is required to submit its proposals to the President and Congress.  They will also develop advisory reports and issue recommendations pertaining to Medicare payments to providers and suppliers not subject to “proposals” and also pertaining to private or public/non-federal health care programs.

After last Tuesday’s elections however, “the drug industry, hospitals and doctors’ groups are setting their sights on the elimination of IPAB that some experts identify as the biggest cost-cutter of all,” according to the New York Times.

The Times specifically reported that the “Pharmaceutical Research and Manufacturers’ Association (PhRMA) said that elimination of the payment board was its top priority in next year’s Congress, and the American Hospital Association (AHA) and American Medical Association (AMA) have also spoken out against the board.

Some of the concern about IPAB comes from the fact that if the Actuary of the Centers for Medicare and Medicaid Services (CMS) determines that Medicare expenditures will exceed a target rate of growth, the IPAB is required to develop proposals to save costs to achieve a minimum reduction in excess expenditures.  In other words, IPAB “could cut payments to health care providers.”

When IPAB was proposed during the health care reform debate, Republicans offered amendments to cut the board, and some Democrats have come out against it, too, “making it possible the new Congress could repeal that section of the law.” It is also possible that the Republican-controlled House “could also try to choke off its funding, although the health care law already appropriated $15 million to set up the board in 2012.”

Senator John Cornyn, (R-TX), introduced legislation in July to eliminate the board, called the Health Care Bureaucrats Elimination Act. The American Hospital Association has endorsed the legislation, but PhRMA has not taken a position on it, although Wes Metheny, senior vice president of PhRMA told the Times that IPAB was “definitely a priority.”

While the stars are aligning to take action against IPAB, “the drug industry is generally sticking to the deal it struck with the administration and Senator Max Baucus, chairman of the Finance Committee. This deal included drug makers agreeing to pay $80 billion (later raised to $90 billion) over 10 years in rebates and cost savings in return for the Democrats’ promise not to push for drug price controls or direct negotiation of drug prices by the Medicare system.

To reduce Medicare expenditures while maintaining quality and access and without raising out-of-pocket costs for Medicare beneficiaries, IPAB will be forced to propose reductions in provider and supplier payments, as McDermott Will & Emery noted. 

As a result, they predicted that reductions will be targeted in areas considered to be drivers of cost growth, such as high-volume and high-cost services.  Accordingly, they recommended that Medicare providers and suppliers—as well as vendors who sell items and services to them—monitor carefully MedPAC reports and reports by other organizations looking at drivers of Medicare utilization and cost, as items and services identified in those reports as cost drivers are likely to be early targets of the IPAB. 

Their newsletter also anticipates that the IPAB will target providers and suppliers under payment methods that are structured in ways that more easily allow for program savings (e.g., items and services under national fee schedules). 

With the creation of IPAB, Congress has given the board the ability to make difficult choices to achieve Medicare program savings to assure program solvency. Since changes will be taking place in 2013, it is important that all stakeholders begin to prepare for the implications IPAB may bring to patient care.

What is important to realize about IPAB is that any decisions to cut payments to providers will result in negative consequences to patients. Doctors, who are already understaffed and barely have fifteen minutes to see patients, and who are already declining to take new patient, including those covered by Medicare or Medicaid, will only continue cutting these kinds of patients if IPAB is to lower reimbursement to doctors. And with the present shortage of physicians likely to be exacerbated by adding 30 million people to the health care system, the last thing patients want is another reason for doctors to stop seeing them and taking new patients.

Summary of IPAB

IPAB is also required to issue an annual report—beginning July 2015—on system-wide health care costs, patient access to care, utilization and quality-of-care that compared by region, services and providers, across both private payers and Medicare. 

The Government Accountability Office (GAO) is required to issue reports studying the effect of changes recommended by IPAB on access, affordability, quality and on payers other than Medicare beginning July 2015, and periodically thereafter.

The target rate of growth is set out in the law, for years prior to 2018, as the average of the consumer price index for all urban consumers (CPI-U) and the medical care component of the CPI-U.  For years 2018 and thereafter, the target rate of growth is set as the Gross Domestic Product plus 1.0 percent. 

If these growth targets are exceeded, the proposals developed by the IPAB must be designed to achieve savings targets, which Congress specified as the lesser of the excess growth rate (projected growth minus target growth) or a defined percentage of program spending (0.5 percent in 2015, 1.0 percent in 2016, 1.25 percent in 2017 and 1.5 percent in 2018 and beyond). The three-year time horizon for IPAB proposals is set forth below:

-       Year 1 - Determination Year: Beginning in 2013, IPAB determines that estimated expenditures looking over 5 year period ending with the Implementation Year (Year 3) will exceed target rate of growth

 

-       Year 2 - Proposal Year: Beginning in 2014, IPAB issues proposal to reduce expenditures to achieve target savings; and

 

-       Year 3 - Implementation Year: Beginning in 2015, IPAB proposal goes into effect unless Congress passes law with greater savings

IPAB proposals affecting providers (e.g., hospitals, skilled nursing facilities) will not be implemented before 2020.  IPAB proposals affecting other suppliers (e.g., physicians) may commence in 2015. Proposals from IPAB must include:

(a) A recommendation for savings;

(b) The rationale for believing the proposal will achieve the target savings;

(c) Legislative language to implement the proposal; and

(d) An actuarial opinion to support the belief that the targeted savings are   expected to be achieved with the proposal. 

The health reform law instructs the IPAB to develop proposals that:

-       Improve the health care delivery system and health outcomes;

-       Protect and improve Medicare beneficiaries’ access to necessary and evidence-based items and services; and

-       Target reductions in Medicare program spending to sources of excess cost growth.

IPAB proposals cannot recommend:

-       Rationing health care;

-       Raising revenues and Medicare beneficiary premiums;

-       Increasing Medicare beneficiary cost-sharing (including deductibles, coinsurance and copayments); or

-       Otherwise restrict benefits or modify eligibility criteria

IPAB will consist of 15 members appointed to six-year terms by the President, subject to approval by the Senate.  Physicians, health care practitioners, consumer representatives and representatives of the elderly are to be included among the members; the majority of members are to be non-providers.  The President is instructed to nominate 12 of the 15 members after consultation with majority and minority leaders of the Senate and House. 

The Chair of the IPAB is appointed by the President, and the Secretary of HHS, the Administrator of CMS, and the Administrator of the Health Resources and Services Administration (HRSA) are specified as ex-officio members of the Board.  The Chair is authorized to appoint an Executive Director and staff for the IPAB.

In addition, there will be a 10-member Advisory Committee appointed by the Comptroller General to advise the IPAB.  The Advisory Committee will comprise one member for each of the 10 HHS geographic regions.  The Advisory Committee must meet at least twice per year.

Patient Centered Outcomes Research Institute: Names their Board of Governors

Within the Patient Protection and Affordable Care Act [Section 6301 and Section 10602, Public Law 111-148], Congress created a Patient-Centered Outcomes Research Institute (PCORI). According to the legislation, the PCORI will act as a non-profit organization to assist patients, clinicians, purchasers, and policy-makers in making informed health decisions by carrying out research projects that provide quality, relevant evidence on how diseases, disorders, and other health conditions can effectively and appropriately be prevented, diagnosed, treated, monitored, and managed.

Under this provision, the Comptroller General of the United States was required to appoint 19 members to the Board of Governors of the. The Act also provides that the Directors of the Agency for Healthcare Research and Quality (AHRQ) and the National Institutes of Health (NIH), or their designees, be members of the Board.

Last week, the Government Accountability Office (GAO) announced the 2010 appointments to the PCORI Board. Members of the Board appointed by Gene L. Dodaro, Acting Comptroller General, serve six-year terms and are eligible for reappointment for one subsequent six-year term.  The terms of the PCORI Board members first appointed are staggered, with the appointments made in September 2010 set at two, four, and six year terms. Board members must meet the qualifications listed in the Affordable Care Act.

The Act also directs the Comptroller General to appoint not more than 15 members to a Methodology Committee of PCORI.  A Federal Register notice calling for nominations to this Committee is expected to be issued by September 30th.

In making this announcement, Mr. Dodaro noted that, “The research to be developed by PCORI has the potential to improve the quality of health care for people across the nation.” Accordingly, he pointed to the “outstanding group of individuals” chosen, which bring “an impressive range of knowledge, expertise, and professional experience to this important initiative.” Short biographies of these individuals are located at the bottom of the GAO press release. Most of the members are in academia or non-profit organizations, with a few from the health care industry. Commissioners whose first term will expire in September 2016 are:

-    Eugene Washington, MD, MSc, Vice Chancellor, UCLA Health Sciences, and Dean, David Geffen School of Medicine, University of California Los Angeles. Dr. Washington will serve as the chair of the PCORI Board of Governors.

-    Steven Lipstein, MHA, President and Chief Executive Officer, BJC Health Care, a non-profit health care delivery system. Mr. Lipstein will serve as the vice chair of the PCORI Board of Governors.

-    Christine Goertz, DC, PhD, Vice Chancellor for Research and Health Policy, Palmer College of Chiropractic and Palmer Center for Chiropractic Research.

-    Sharon Levine, MD, Associate Executive Director for The Permanente Medical Group of Northern California, a large multi-specialty group practice within Kaiser Permanente’s integrated delivery system.

-    Ellen Sigal, PhD, Chairperson and founder of Friends of Cancer Research, a cancer research think tank and advocacy organization.

-    Harlan Weisman, MD, Chief Science and Technology Officer, Medical Devices and Diagnostics, for Johnson & Johnson.

-    Robert Zwolak, MD, PhD, a vascular surgeon at Dartmouth-Hitchcock Medical Center and professor of surgery at the Dartmouth Medical School.

Commissioners whose first term will expire in September 2014 are:

-    Lawrence Becker, Director, Strategic Partnerships and Alliances, Xerox Corporation.

-    Arnold Epstein, MD, the John H. Foster Professor and Chair of the Department of Health Policy and Management at Harvard University School of Public Health, and practicing internist at Brigham and Women’s Hospital.

-    Andrew Imparato, JD, President and Chief Executive Officer of the American Association of People with Disabilities.

-    Robert Jesse, MD, PhD, Principal Deputy Under Secretary for Health and National Program Director for Cardiology, Department of Veterans Affairs.

-    Freda Lewis-Hall, MD, Chief Medical Officer and Senior Vice President of the Pfizer Medical Division.

-    Grayson Norquist, MD, MSPH, Professor and Chairman, Department of Psychiatry and Human Behavior, University of Mississippi Medical Center.

Commissioners whose first term will expire in September 2012 are:

-    Debra Barksdale, PhD, RN, Associate Professor, University of North Carolina (UNC) at Chapel Hill School of Nursing.

-    Kerry Barnett, JD, Executive Vice President of Corporate Services and Chief Legal Officer, The Regence Group.

-    Allen Douma, MD, Chief Executive Officer of Empower, LLC, and a member of the AARP Board of Directors.

-    Leah Hole-Curry, JD, Program Director for the Health Technology Assessment (HTA) program, Washington State Health Care Authority.

-    Harlan Krumholz, MD, Harold H. Hines, Jr. Professor of Medicine and Epidemiology and Public Health at Yale University School of Medicine.

-    Richard E. Kuntz, MD, Senior Vice President and Chief Scientific, Clinical, and Regulatory Officer of Medtronic, Inc.

The board includes representatives from academia, hospitals, patient organizations and industry. Overall the makeup represents a balanced panel.

Many United States based comparative effectiveness research is still in the early phases.  Much of the current CE trials are retrospective Meta analysis’s and sample sizes vary by type of trial, and often don’t answer the question they are looking for.  In the case of one example PCI vs. CABG in diabetic patients the comparative effectiveness trials brought on more questions than answers.

As the PCORI board begins on this endeavor, it is crucial that they do not blur the differences between scientific and policy debates. The PCORI must not discourage innovation in research, discovery, and development in new medicines and devices.

While it is important that we find effective treatments for physicians to use, the motivations of these decisions must be scientific, not policies designed only to save money.

Is Medical Student Creating a Shortage of Primary Care Physicians?

 
Over the past few years, rising medical school costs have caused a significant discrepancy in the number of primary-care physicians practicing in the U.S. In fact, according to American Association of Medical Colleges (AAMC), recent data has shown that medical school tuition is up between 4% and 7% from last year. Adding to the burden of paying for this education and a shortage in primary-care physicians is also the fact that “a continually widening gap between general-practitioner and specialist salaries is growing, making the career choice for medical students a fairly easy one: get a specialty.”

These numbers are particularly disturbing because as a recent article in Time Magazine addressed, it “will lead to an acute shortage of these doctors in the years ahead, when retiring baby boomers will need them most.” And a recent study conducted by Dr. Karen Hauer, published in the Journal of the American Medical (JAMA) did not show much hope.

For example, the study found that in the education pipeline, “less than 2% of current medical students are interested in general internal medicine and 4.9% in family-care practice.” For some, this data is no mystery. They clearly acknowledge that the reason why “the general practitioner (GP) is a dying breed, is because of rising medical-school costs.”

Demonstrating the difference in salaries, the Medical Group Management Association's 2010 physician-compensation report showed that in 2009, primary-care doctors earned a median salary of $191,401; Cardiologists earned a median of $457,310 and dermatologists made $385,088 — doctors who owned their practices earned much more, on average. This income, while high, does not say much to medical-school student graduates who have $200,000 in loans, which does not include debt related to college loans, which can bring the total to nearly $500,000.

Another reason why students are turning away from GP or family medicine is because what income they do make is often “not enough to cover costs of running a clinic because the insurance is high.” As a result, a number of clinics have already closed over the past few years.” The ones that have stayed open have had to take on more patients to pay the bills, and this causes “the quality of care to go down, which is a huge deterrent," for GPs.

Consequently, “the trend away from family practice is already producing shortages in rural areas and could produce a national doctor crisis in just a few years.” As Dr. Atul Grover, chief advocacy officer for the AAMC noted, "unless more primary-care physicians are recruited, the AAMC estimates a shortage of 30,000 doctors by 2015, and in 10 years, this shortage could go up to 150,000.” Accordingly, since it takes seven years to train a doctor, Dr. Grover asserted that action needs to be taken now.

While “the recent passage of health care reform legislation offers some improvement to primary-care doctors,” most of the reform is insufficient. Despite the fact that "the new legislation adds a 10% bonus to primary-care physicians' Medicare reimbursement salaries,” these changes  “are nowhere near enough.” Dr. Lori Heim, president of the AAFP asserted that doctors in primary care “need to see a 30% to 50% increase in salaries overall to make any real change in the system."

There also need to be similar changes to work demands, so that primary care physicians see similar schedules as specialists. GPs and family practitioners also need to have better incentives to maintain their practices and clinics, and resources to afford staff, and the ability to handle a reasonable number of patients.

Ultimately, if Congress had only listened to AAMC of AAFP when it was drawing up health care reform, this crisis may have been averted. Instead, we have to bring 150,000 primary care physicians into the system over the next few years because we are adding 30 million people to our health care system. Since it takes seven years to make a physician, our future appears troubled. Accordingly, policymakers must begin discussing ways to increase reimbursement for GPs and family physicians, create incentives for their practices, and find ways to entice medical students to enter into this field before our shortage of doctors turns into a crisis.