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6/16/2009
The New York Times recently published an article saying that by cutting more than $200 billion in expected reimbursements to hospitals over the next decade, the President intends to pay for his health care overhaul partly by doing so. The President insists that he has the funds to do so, but there is still question by Congress of how exactly the plan will be paid for.
The administration expects to achieve the lowered hospital payments in two ways, by slowing growth of reimbursements;
1. Payments to hospitals will be reduced to work more efficiently and productively; and
2. Payments to hospitals that treat large numbers of low-income patients will be lowered.
6/11/2009
The Washington Post reported the possibility of a filibuster on the proposed legislation is unlikely after a vote this week.
If passed the legislation would give the Food and Drug Administration the authority to regulate tobacco products for the first time. Sources say a final Senate vote could come as early as Thursday June 18th.
Currently the Federal Trade Commission (FTC) regulates tobacco products. A similar bill passed the House last month, and President Obama has expressed support for the legislation. 6/9/2009
On his website, Senator Edward M. Kennedy, Chairman of the Health, Education, Labor and Pensions Committee (HELP), described the 5 elements as:
CHOICE: An important foundation of The Affordable Health Choices Act is the following principle: If you like the coverage you have now, you keep it. But if you don't have health insurance or don't like the insurance you have, our bill will give you new, more affordable options.
COST REDUCTION: The Affordable Health Choices Act will reduce health care costs through stronger prevention, better quality of care and use of information technology. It will also root out fraud and abuse and reduce unnecessary procedures.
PREVENTION: The best way to treat a disease is to prevent it from ever striking, which is exactly why The Affordable Health Choices Act will give citizens the information they need to take charge of their own health. The bill will make information widely available in medical settings, schools and communities. It will also promote early screening for heart disease, cancer and depression and give citizens more information on healthy nutrition and the dangers of smoking.
HEALTH SYSTEM MODERNIZATION: The Affordable Health Choices Act will take strong steps to see that America has a 21st-century workforce for a modern and responsive healthcare system. America must make sound investments in training the doctors, nurses, and other health professionals who will serve the needs of patients in the years to come. It will make sure that patients’ care is better coordinated so they see the right doctors, nurses and other health practitioners to address their individual health needs.
LONG TERM CARE AND SERVICES: The Affordable Health Choices Act will also make it possible for the elderly and disabled to live at home and function independently. It will help them afford to put ramps in their homes, pay someone to check in on them regularly, or any of an array of supports that will enable them to stay in their communities instead of in nursing homes.
An initial draft of a comprehensive healthcare reform bill prepared by Senator Edward Kennedy (D-MA) and the staff of the Senate Health, Education, Labor and Pensions Committee, dubbed the "American Health Choices Act," has been circulated. This legislation is the first of two comprehensive health reform bills expected from Senate leaders. Also to be introduced soon is a major health reform bill in the House of Representatives, a result of extensive negotiations by three House committees with jurisdiction on healthcare: Ways and Means, Energy and Commerce, and Education and Labor.
The Healthcare Reform Educational Task Force will provide forthcoming analysis on this and subsequent draft legislation.
U.S. Health and Human Services (HHS) Secretary Kathleen Sebelius released a new report on health disparities in America and participated in a White House Health Care Stakeholder Discussion on the importance of reform that reduces disparities that exist in our current health caresystem. The new report Health Disparities: A Case for Closing the Gap is available at www.HealthReform.gov.
"Minorities and low income Americans are more likely to be sick and less likely to get the care they need," Secretary Sebelius said. "These disparities have plagued our health system and our country for too long. Now, it's time for Democrats and Republicans to come together to pass reforms this year that help reduce disparities and give all Americans the care they need and deserve."
A Case for Closing the Gap highlights some of the glaring disparities that exist in the current health system. Under the status quo:
o Forty-eight percent of all African Americans adults suffer from a chronic disease compared to 39 percent of the general population.
o Eight percent of white Americans develop diabetes while 15 percent of African Americans, 14 percent of Hispanics, and 18 percent of American Indians develop diabetes.
o Hispanics were one-third less likely to be counseled on obesity than were whites -- only 44 percent of Hispanics received counseling.
o African Americans are 15 percent more likely to be obese than whites.
The report also notes that 40 percent of low-income Americans do not have health insurance. About one-third of the uninsured have a chronic disease, and they are six times less likely to receive care for a health problem than the insured. In contrast, only 6 percent of high-income Americans lack insurance. 6/8/2009The Medical Society of the State of New York is seeking support for proposed legislation that would allow independent physicians to negotiate under the supervision of insurers. To read the full bill please see the link below on the New York State Assembly website:
6/4/2009
Broader adoption of electronic health care records management technology may hinge on how the government defines "meaningful use" of such technology. The BNA Health Law Reporter this week described the challenges involved in determining how to funnel the billions of dollars in incentive payments to hospitals and health care professionals under the American Recovery and Reinvestment Act of 2009. You can read the full article here. 6/3/2009
The Law 360 website published an article this week titled "Obama Pushes For Quick Action on Health Care". The article details a closed-door meeting the president had with roughly two dozen Senate Democrats from the body's Finance Committee and Health, Education, Labor and Pensions Committee. Read the full article here. 6/2/2009
Obama Letter:
June 2, 2009
The Honorable Edward M. Kennedy
The Honorable Max Baucus
United States Senate
Washington, D.C. 20510
Dear Senator Kennedy and Senator Baucus:
The meeting that we held today was very productive and I want to commend you for your leadership -- and the hard work your Committees are doing on health care reform, one of the most urgent and important challenges confronting us as a Nation.
In 2009, health care reform is not a luxury. It's a necessity we cannot defer. Soaring health care costs make our current course unsustainable. It is unsustainable for our families, whose spiraling premiums and out-of-pocket expenses are pushing them into bankruptcy and forcing them to go without the checkups and prescriptions they need. It is unsustainable for businesses, forcing more and more of them to choose between keeping their doors open or covering their workers. And the ever-increasing cost of Medicare and Medicaid are among the main drivers of enormous budget deficits that are threatening our economic future.
In short, the status quo is broken, and pouring money into a broken system only perpetuates its inefficiencies. Doing nothing would only put our entire health care system at risk. Without meaningful reform, one fifth of our economy is projected to be tied up in our health care system in 10 years; millions more Americans are expected to go without insurance; and outside of what they are receiving for health care, workers are projected to see their take-home pay actually fall over time.
We simply cannot afford to postpone health care reform any longer. This recognition has led an unprecedented coalition to emerge on behalf of reform -- hospitals, physicians, and health insurers, labor and business, Democrats and Republicans. These groups, adversaries in past efforts, are now standing as partners on the same side of this debate.
At this historic juncture, we share the goal of quality, affordable health care for all Americans. But I want to stress that reform cannot mean focusing on expanded coverage alone. Indeed, without a serious, sustained effort to reduce the growth rate of health care costs, affordable health care coverage will remain out of reach. So we must attack the root causes of the inflation in health care. That means promoting the best practices, not simply the most expensive. We should ask why places like the Mayo Clinic in Minnesota, the Cleveland Clinic in Ohio, and other institutions can offer the highest quality care at costs well below the national norm. We need to learn from their successes and replicate those best practices across our country. That's how we can achieve reform that preserves and strengthens what's best about our health care system, while fixing what is broken.
The plans you are discussing embody my core belief that Americans should have better choices for health insurance, building on the principle that if they like the coverage they have now, they can keep it, while seeing their costs lowered as our reforms take hold. But for those who don't have such options, I agree that we should create a health insurance exchange -- a market where Americans can one-stop shop for a health care plan, compare benefits and prices, and choose the plan that's best for them, in the same way that Members of Congress and their families can. None of these plans should deny coverage on the basis of a preexisting condition, and all of these plans should include an affordable basic benefit package that includes prevention, and protection against catastrophic costs. I strongly believe that Americans should have the choice of a public health insurance option operating alongside private plans. This will give them a better range of choices, make the health care market more competitive, and keep insurance companies honest.
I understand the Committees are moving towards a principle of shared responsibility -- making every American responsible for having health insurance coverage, and asking that employers share in the cost. I share the goal of ending lapses and gaps in coverage that make us less healthy and drive up everyone's costs, and I am open to your ideas on shared responsibility. But I believe if we are going to make people responsible for owning health insurance, we must make health care affordable. If we do end up with a system where people are responsible for their own insurance, we need to provide a hardship waiver to exempt Americans who cannot afford it. In addition, while I believe that employers have a responsibility to support health insurance for their employees, small businesses face a number of special challenges in affording health benefits and should be exempted.
Health care reform must not add to our deficits over the next 10 years -- it must be at least deficit neutral and put America on a path to reducing its deficit over time. To fulfill this promise, I have set aside $635 billion in a health reserve fund as a down payment on reform. This reserve fund includes a number of proposals to cut spending by $309 billion over 10 years --reducing overpayments to Medicare Advantage private insurers; strengthening Medicare and Medicaid payment accuracy by cutting waste, fraud and abuse; improving care for Medicare patients after hospitalizations; and encouraging physicians to form "accountable care organizations" to improve the quality of care for Medicare patients. The reserve fund also includes a proposal to limit the tax rate at which high-income taxpayers can take itemized deductions to 28 percent, which, together with other steps to close loopholes, would raise $326 billion over 10 years.
I am committed to working with the Congress to fully offset the cost of health care reform by reducing Medicare and Medicaid spending by another $200 to $300 billion over the next 10 years, and by enacting appropriate proposals to generate additional revenues. These savings will come not only by adopting new technologies and addressing the vastly different costs of care, but from going after the key drivers of skyrocketing health care costs, including unmanaged chronic diseases, duplicated tests, and unnecessary hospital readmissions.
To identify and achieve additional savings, I am also open to your ideas about giving special consideration to the recommendations of the Medicare Payment Advisory Commission (MedPAC), a commission created by a Republican Congress. Under this approach, MedPAC's recommendations on cost reductions would be adopted unless opposed by a joint resolution of the Congress. This is similar to a process that has been used effectively by a commission charged with closing military bases, and could be a valuable tool to help achieve health care reform in a fiscally responsible way.
These are some of the issues I look forward to discussing with you in greater detail in the weeks and months ahead. But this year, we must do more than discuss. We must act. The American people and America's future demand it.
I know that you have reached out to Republican colleagues, as I have, and that you have worked hard to reach a bipartisan consensus about many of these issues. I remain hopeful that many Republicans will join us in enacting this historic legislation that will lower health care costs for families, businesses, and governments, and improve the lives of millions of Americans. So, I appreciate your efforts, and look forward to working with you so that the Congress can complete health care reform by October.
Sincerely,
BARACK OBAMA
--------------------------------------------
3 Baucus reports are available on the finance committee website.
- Summary of Financing Policy Options
Complete Text of Policy Options for Financing Comprehensive Health Care Reform: Proposed Health System Savings and Revenue Options
-
Summary of Coverage Policy Options
Complete Text of Policy Options for Expanding Health Care Coverage: Proposals to Provide Affordable Coverage to All Americans
-
Summary of Delivery System Reform Policy Options
Complete Text of Policy Options for Transforming the Health Care Delivery System: Proposals to Improve Patient Care and Reduce Health Care Costs
On May 20, 2009, President Barack Obama signed the Fraud Enforcement and Recovery Act into law, introducing sweeping changes to the False Claims Act and providing hundreds of millions of dollars for enforcement. Also on May 20, 2009, Attorney General Eric H. Holder Jr. and Health and Human Services Secretary Kathleen Sebelius announced a new and aggressive interagency task force called the Health Care Fraud Prevention and Enforcement Action Team (HEAT) to combat Medicare and Medicaid fraud. Health-care fraud enforcement is clearly a top priority of President Obama's administration. Providers should expect to come under increased scrutiny. The attached Alert provides details on the enacted legislation and HEAT initiatives.
Click here to read the full article on nixonpeabody.com.
For more information, please contact:
5/1/2009
Three-month compliance extension
On April 30, 2009, the Federal Trade Commission (FTC) agreed to delay enforcement of the new “Red Flag Rules” from May 1, 2009, to August 1, 2009, to give creditors, including health-care providers, more time to develop and implement written identity theft prevention programs.
There is no dispute: Red Flag Rules apply to health-care providers
The Fair and Accurate Credit Transactions Act of 2003 directed the FTC to promulgate rules requiring “creditors” with “covered accounts” to implement identity theft programs to identify, detect, and mitigate medical and personal identity theft. The FTC and the American Medical Association (AMA), joined with other related professional associations, have been in discussions regarding whether the Red Flag Rules apply to health-care providers. On February 4, 2009, the FTC, in a letter addressed to the AMA, declared that the Red Flag Rules apply to physicians and health-care providers. The FTC has postponed the compliance date of the Red Flag Rules as a result of the uncertainty surrounding whether health-care providers were covered under the Red Flag Rules, which caused some providers not to implement policies.
The Red Flag Rules require hospitals and physician practices to develop and implement a written program of policies and procedures to detect, prevent, and mitigate identity theft, including:
- identifying relevant Red Flags and incorporating those Red Flags into their program;
- detecting Red Flags that have been incorporated into the program;
- responding appropriately to any Red Flags that are detected, to prevent and mitigate identity theft; and
- ensuring the program is updated periodically.
A Red Flag Rules Program must be approved by the board of director or other governing body; should be overseen, implemented, and administered by a member of the board or senior level management; and employees should be trained with respect to applicable Red Flags and how to respond to them.
For further information, contact your Nixon Peabody attorney or:
2/23/2009
The HITECH Act of the American Recovery and Reinvestment Act imposes more stringent regulatory requirements under the security and privacy rules of HIPAA, increases civil penalties for a violation of HIPAA, provides funding for hospitals and physicians for the adoption of health information technology, and requires notification to patients of a security breach. These broad new requirements will necessitate compliance by covered entities, business associates and related vendors in the health care industry.
On February 17, 2009, President Obama signed into law the Health Information Technology and Clinical Health Act (HITECH) as part of the American Recovery and Reinvestment Act. HITECH codifies and funds the Office of the National Coordinator for Health Information Technology (ONC) and provides for the infusion of $19 billion over a four-year period, in grants and loans, for infrastructure and incentive payments under Medicare and Medicaid for providers who adopt and use health information technology (HIT). It also expands security and privacy provisions and penalties to HIPAA business associates of covered entities. The implications of HITECH for hospitals, health care providers, vendors, health information exchanges (HIEs), and Regional Health Information Organizations (RHIOs) are far-reaching. Provisions of HITECH are summarized below.
Although the ONC was established by Executive Order in 2004, HITECH appropriates $2 billion to the ONC and codifies the duties of the National Coordinator, with the stated goal of “the utilization of an electronic health record for each person in the United States by 2014.” The ONC strategic plan is to include “the development of a nationwide health information technology infrastructure that allows for the electronic use and exchange of information” that ensures that patients’ health information is secure and protected.
The ONC is responsible for:
- establishing national standards for the exchange of health information;
- coordinating HIT policy and programs, and updating and implementing the Federal Health IT Strategic Plan through collaboration with public and private entities;
- ensuring that privacy and security protections are incorporated in the electronic exchange of health information;
- implementing strategies to enhance the use of HIT;
- assessing the impact of HIT in communities with health disparities;
- evaluating the benefits and costs of the exchange of health information;
- appointing a Chief Privacy Officer of ONC within 12 months;
- establishing an HIT Policy Committee, responsible for making policy recommendations to the ONC on the implementation of a nationwide HIT infrastructure; and
- establishing an HIT Standards Committee, responsible for making recommendations to the ONC regarding standards, implementation specifications and certification criteria for HIT.
Consistent with other existing incentive programs developed by the federal government for the adoption of electronic health records (EHRs), and to implement the ONC’s strategic plan for the national adoption of HIT, HITECH also provides for $19 billion in grants and loan funding for incentives for the use of HIT. The entities that will be eligible for such grants and loan funding include those that support the HIT architecture that will enhance the nationwide electronic exchange of health information, including connecting HIEs; health care providers participating in Medicare, Medicaid, and the State Children’s Health Insurance Program (including hospitals and physicians); community health centers; clinical data repositories and registries; and public health departments. The funds provided must meet applicable standards determined by the HIT Standards Committee. Funds distributed will support technology architecture, development and adoption of certified EHRs for providers not otherwise eligible, training, infrastructure, and overall expansion and promotion of technology.
The Health Information Technology Extension Program will also be established to provide assistance and support to accelerate the adoption of HIT through regional centers of technical assistance. These regional centers will be associated with existing or new nonprofit groups and funding provided will be up to 50 percent of the capital, operating, and maintenance funds for up to four years. The criteria for determining qualified applicants will be published within the next 90 days. Beginning on January 1, 2010, the ONC may award grants and loan programs to states for the purchase of certified EHR technology used to exchange health information. Finally, the National Science Foundation is directed to provide assistance in the creation and expansion of medical health informatics education programs at institutions of higher education.
In a substantial change to the current security and privacy regulations under the Health Information Portability and Accountability Act (HIPAA), and in response to increased public awareness and debate over the privacy and security of electronic health information, HITECH requires the application of HIPAA security and privacy provisions and penalties directly to business associates of covered entities. Before HITECH, the security and privacy requirements were imposed on business associates through contractual provisions with covered entities. HITECH requires business associates to restrict the use and disclosure of protected health information (PHI) and subjects business associates directly to civil and criminal penalties for violating HIPAA requirements in the same manner as covered entities. The Secretary of Health and Human Services (HHS) will provide guidance on this requirement within the next year.
Another key requirement imposed by HITECH is for covered entities and business associates to notify individuals and the HHS if an individual’s unsecured or unencrypted protected health information “has been, or is reasonably believed…to have been, accessed, acquired, or disclosed as a result of such breach.” If the breach affects more than 500 individuals, the notification can be through media outlets. Further, personal health record vendors must notify the individual and the Federal Trade Commission of a breach. Of note is the fact that this provision is far more stringent than the breach notification laws that have been passed by numerous states, which require individual notification if the personal information is reasonably believed to have been used for identity theft purposes. Most states that have implemented breach notification laws require that the information be used for identity theft purposes before imposing civil or criminal penalties. Compliance with this provision of HITECH may be difficult for covered entities and business associates, although HITECH does not include, in the definition of a breach, an inadvertent disclosure or access to information provided that there is no further access or disclosure.
Other new privacy and security requirements in HITECH include:
- covered entities must honor a patient’s request to withhold PHI from a health plan if the patient paid for the medical care;
- covered entities must limit use or disclosure of PHI to a “limited data set” or, if needed, to the minimum necessary to accomplish an intended purpose;
- when requested, covered entities must provide patients with an audit trail of all disclosures of PHI made within the past three years;
- covered entities may not receive payment for communicating with patients for marketing purposes without the specific authorization of the patient (including fundraising solicitations);
- employees of covered entities or other individuals who knowingly access, use, or disclose PHI for improper purposes will be subject to criminal penalties; and
- civil penalties for violations under HIPAA are increased, depending on the conduct. The federal government must impose penalties if the violation of the conduct was willful. State attorneys general (most of whom already have the jurisdiction to prosecute under state privacy laws) are authorized to prosecute and seek civil penalties. The penalties are tiered according to conduct, from $100 per violation with a maximum of $25,000 per year, to the maximum penalty of $50,000 per occurrence and $1.5 million per year.
HITECH pronounces that organizations that access PHI from covered entities, such as HIEs, RHIOs, e-prescribing gateways, or vendors that contract with covered entities to offer personal health records (PHRs) must have written contracts with the covered entity and will be treated like a business associate. This clears up existing confusion and further promotes the wider adoption of HIT.
In general, the effective date of HITECH is February 17, 2010. However, the incentive payments for practitioners and hospitals will commence in 2011 and phase out through 2015.
HITECH applies to covered entities, including hospitals, health care providers, health plans, business associates, vendors, HIEs, RHIOs, and PHRs. To comply with HITECh, we recommend the following:
- develop and implement a Red Flag Rules Compliance Program;
- develop and implement a Breach Notification Compliance Program;
- review and amend existing business associate agreements and determine if new business associate agreements are needed;
- strategize and position yourself to obtain loan and grant funding through the stimulus; and
- ensure your technology is CCHIT certified.
Further updates, including proposed regulations pertaining to HITECH, will be issued by the government in the near future. We will continue to provide you with updates on HITECH as developments occur.
For further information, contact your Nixon Peabody attorney or:
12/2/2008Do your residency programs have duty hour citations? Do the results of your ACGME Resident Surveys reflect noncompliance with duty hour requirements? Could your program or even the sponsoring institution be at risk for an immediate ACGME site visit? What recommendations did the Institute of Medicine make last week about adjustments to duty hour limits? How has the ACGME responded? Teaching institutions should be asking all of these questions and more as they prepare for increased scrutiny and enforcement of resident duty hour limits.
By Lindsay Maleson
Last week, the Institute of Medicine (IOM) issued a long-anticipated report on patient safety and medical residents’ duty hours that is sure to affect the graduate medical education landscape.[1] “Resident Duty Hours: Enhancing Sleep, Supervision, and Safety” (the “Report”) includes a number of recommendations that the IOM believes should be adopted and implemented within 24 months by the Accreditation Council for Graduate Medical Education (ACGME), the organization that accredits 8,500 medical residency programs training approximately 105,000 residents.
Given the speed with which the IOM expects its recommendations to be adopted, as well as the ACGME’s recent release of a protocol identifying the serious and swift accreditation consequences of duty hour violations, teaching institutions must be aware of what is at stake and quickly prepare for increased scrutiny and enforcement of resident duty hours. Institutions must also prepare for the potential for additional oversight from the federal Centers for Medicare and Medicaid Services (CMS) and the Joint Commission.
The last time resident duty hours were given such intense attention was 2003, when the ACGME implemented common duty hour standards for all specialties and subspecialties under pressure of impending Congressional intervention. Five years later, Congress is still concerned about resident work hours; indeed, the IOM study was commissioned by the House Committee on Energy and Commerce and sponsored by the Agency for Healthcare Research and Quality.
In a public briefing held on December 2, 2008, Dr. Michael M.E. Johns, the chair of the IOM committee that was responsible for the Report, the Committee on Optimizing Graduate Medical Trainee (Resident) Hours and Work Schedules to Improve Patient Safety (the “Committee”), explained that the “overarching conclusion [of the Committee] is that the science clearly shows that fatigue increases the chances of errors, and residents often work long hours without rest and regular time off.”[2]
The IOM’s recommended adjustments to duty hour rules
The ACGME’s current rules limit resident work hours to 80 hours per week (averaged over a 4-week period); require training programs to provide one day off every seven days (averaged over a 4-week period); limit continuous on-call periods to 30 hours; limit call to every third night (averaged over a 4-week period); and require a 10-hour rest period between shifts. Some states, including New York, have implemented their own duty hour requirements that differ slightly from the ACGME standards; ACGME-accredited programs in those states must follow the more stringent of the two sets of rules.
While the IOM does not recommend a decrease in the total number of hours residents may work per week as some expected it would, it does recommend a number of significant adjustments to the current duty hour rules. Highlights include:
- Continuous duty limit. The Committee recommends limiting long shifts to 16 hours. Shifts may extend up to 30 hours if an uninterrupted, 5-hour sleep break between 10 p.m. and 8 a.m. is provided. The sleep break would be counted toward the 80-hour limit, and residents would only be permitted to admit patients for up to 16 hours.
- Time off between shifts. The Committee recommends enhancing the amount of time off between shifts to give 10 hours off after a day shift, and 12 hours off after a night shift. A 14-hour break would be given after a 30-hour shift, with the resident not returning until 6 a.m. of the next day.
- On-call frequency. The Committee’s recommendations maintain the current every-third-night rule, but would not permit averaging over a 4-week period, which the ACGME currently allows.
- Frequency of night shifts. The frequency of in-house night shifts (night float) has not been addressed by ACGME standards. The Committee recommends that after 3 or 4 nights of consecutive duty (night float), a resident should be given 48 hours off.
- Days off. The Committee recommends 5 days off per month, with a guaranteed one day off in every week and one 48-hour period off per month.
Supervision, patient caps, & handoffs
The IOM Report makes clear that the Committee does not believe that adjusting duty hours alone is sufficient to improve patient safety. Thus, the Report also recommends increased supervision of residents, limits on resident patient loads (i.e., patient caps), and more structured and effective handoffs of patients at shift changes. In addition, the Committee recommends that resident moonlighting be restricted and that moonlighting hours, whether inside or outside the resident’s training institution, be counted toward all duty hour limits.
Enforcement plans
In his statement at last week’s public briefing, Dr. Johns said that the Committee had heard from “many sources” that violations of current duty hour limits are “frequent” and “underreported,” so the Committee “call[ed] for the [ACGME] to strengthen its monitoring efforts by making more frequent duty hour audits and making these visits unannounced.” [3]
The Committee also called for increased protection for whistleblowers and oversight of the ACGME’s enforcement efforts by CMS and the Joint Commission. The Report suggests that CMS could perform evaluations of adherence to resident duty hours, the effectiveness of the ACGME in its monitoring role, and the acceptability of program rationales for variances in duty hour limits. The Report suggests that the Joint Commission “should seek to ensure that duty hour monitoring is linked to broader activities to improve patient safety in hospitals, including the use of ACGME’s adherence data as part of the Joint Commission’s hospital surveys and accreditation actions.”
ACGME response to the IOM report & recently released protocol
In its statement on the IOM Report, the ACGME announced that in early March of 2009, it will convene a duty hours symposium during which conference participants “will carefully review the IOM report as part of discussions on possible refinements to the duty hour standards.”[4]
Before the release of the IOM Report, the ACGME had already announced a protocol allowing it to perform accelerated site visits and to take expansive accreditation action with respect to potential duty hour violations apparent in programs’ Resident Survey results.[5] The Resident Survey is an anonymous, electronic survey administered by the ACGME to all residents and fellows every other year.[6] According to the protocol, when a program’s Resident Survey results demonstrate that it has met the ACGME’s threshold for “potential duty hour violations,” it will receive a letter of warning, and the Resident Survey will be repeated the next year. If violations are evident in the results of the next Resident Survey, the program’s accreditation cycle will be shortened to no more than 9 months, and the ACGME’s Institutional Review Committee, which governs the sponsoring institution’s accreditation, could take action based on the deficiencies and the results of the program’s accelerated site visit. For programs receiving repeated (three in a row) noncompliant results on Resident Surveys, there could be an immediate full site visit of the program with a simultaneous institutional review focusing on institutional oversight of duty hours.
Conclusion
Regardless of whether the ACGME implements the recommendations of the IOM, it is clear that teaching institutions should expect increased scrutiny and enforcement of duty hour limits, as well as the likelihood of unprecedented enforcement, oversight, and monitoring by CMS and the Joint Commission. Further, enforcement protocols now being used by the ACGME could place programs and institutions in accreditation jeopardy swiftly, with serious consequences for an entire teaching institution.
Institutions or programs with Resident Survey or state survey results indicating potential noncompliance with duty hour rules should address such violations immediately and proactively and are advised to seek outside assistance when necessary. When a letter of warning or a letter advising a program or an institution of an accelerated site visit is received, an institution should recognize that the relevant program’s accreditation is at risk as well as the institution’s accreditation.
- See http://www.nationalacademies.org/morenews/
20081202.html. [Back to reference]
- The Opening Statement by Michael M.E. Johns, M.D., is available at http://www8.nationalacademies.org/onpinews/
newsitem.aspx?RecordID=12022008a. [Back to reference]
- Emphasis supplied. [Back to reference]
- See ACGME statement on IOM resident duty hours report (12/02/08), available at www.acgme.org. [Back to reference]
- The ACGME protocol was approved by the ACGME Board of Directors at its September 2008 meeting and released on September 18, 2008, in the form of a “Special Message from the Chief Executive Officer to All Program Directors, Designated Institutional Officials, and Residents” entitled “Standard Approach to Programs Across All Specialties with Potential Duty Hour Violations Identified in the Resident Survey.” It is available at http://www.acgme.org. [Back to reference]
- According to the ACGME protocol released in September, failure to ensure that 70% of program residents complete the Survey may result in a letter of warning. Repeated failure to reach the 70% threshold for completion of the Survey may result in administrative withdrawal of the program. [Back to reference]
For further information, contact your Nixon Peabody attorney or:
7/31/2008
CMS will begin providing financial bonuses to physicians who e-prescribe and reduce payments to physicians who fail to e-prescribe in January, 2009.
By Linn Freedman and Rebecca Simone
The federal government’s most recent effort to encourage e-prescribing can be found in Section 132 of the recently enacted Medicare Improvements for Patients and Providers Act of 2008 (H.R. 6331) (the Act). Although the Bush administration did not support the Act as a whole, President Bush did endorse the e-prescribing provision of the Act. According to HHS Secretary Michael Leavitt, “The widespread adoption of electronic prescribing is expected to save taxpayers as much as $156 million over the next five years, and save lives.” Under the Act, physicians who use qualified e-prescribing methods will receive a 2-percent incentive payment in 2009 and 2010, a 1-percent incentive payment in 2011 and 2012, and a .5-percent incentive payment in 2013. The incentive percentages will be based on the allowed Medicare charges for covered professional services furnished by an eligible practitioner or practice.
Starting in 2012, there will be a financial disincentive for practitioners and practices who do not use qualified e-prescribing systems. In 2012, these practitioners will receive 99 percent of Medicare fee schedule amounts that they would otherwise collect, and in 2013 and thereafter, they will receive 98.5 percent. The Act contains a waiver for practices that Medicare determines would experience significant hardship by becoming successful e-prescribers. The Act cites the example of an eligible professional who practices in a rural area without sufficient Internet access.
With the potential for Medicare incentives and disincentives, it is expected that physicians will begin to implement acceptable e-prescribing measures in their practices. The incentives should help absorb the cost of implementation. However, as American Medical Associate Board of Trustees member Steven J. Stack, M.D. said, “…additional government payments alone likely will not provide enough financial support for what can be an expensive undertaking … Private industry partners need to provide doctors with extra assistance.”[1] Kerry Weems, CMS acting administrator, has publicly stated that there are plans for a CMS conference this fall to provide education about the e-prescribing technology and how to use it, including set-up costs, which she estimates will cost $3,000 per prescriber. The terms of the incentives program will be outlined in Medicare’s final rule on the 2009 physician fee schedule, scheduled to be released this fall.
- Quoted by Glendinning, David, E-prescribers see Medicare bonus, but law adopters will face pay cut…, amednews.com, http://www.ama-assn.org/amednews/2008/08/04/
gvl10804.htm (last visited July 28, 2008). [Back to reference]
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7/21/2008
The Drug Enforcement Administration (DEA) recently issued proposed regulations for the electronic prescribing of controlled substances and is seeking comment from the industry on certain requirements by September 25, 2008. It is imperative that pharmacies, physicians, hospitals and software developers provide comment and insight to DEA so that the final regulations adopted set forth a regulatory framework that promotes the adoption of electronic prescribing while balancing the regulatory concerns of the government.
By Linn Foster Freedman
The long-awaited Drug Enforcement Administration (DEA) proposed regulations for the electronic prescribing of controlled substances were published on June 27, 2008. They have been in the making for the past nine years. The proposed regulations affect four distinct industries: pharmacy, software developers and vendors, hospitals, and physicians.
Since the pronouncement in the Medicare Modernization Act (MMA; Public Law 108-173) of the federal government’s goal for the rapid adoption of e-prescribing, a number of governmental initiatives have been implemented, including exceptions to and safe harbors under the Stark Law and Anti-Kickback Statute (click here to see Health Law Alert dated 10/5/06) to promote donations to providers using electronic-prescribing software, and the issuance of final e-prescribing standards for the Medicare Prescription Drug Program (click here to see Health Law Alert dated 4/16/08).
Despite these efforts, e-prescribing adoption has been slower than anticipated, partly due to the fact that 20-25 percent of all prescribed medications are controlled substances, which presently cannot legally be prescribed electronically. This prohibition has been a barrier for physicians who heartily embrace electronic prescribing but prescribe a significant amount of controlled substances.
Industry pressure on the DEA to adopt regulations to enable electronic prescribing of controlled substances has resulted in the published proposed regulations. The regulations are lengthy and cumbersome, and industry analysts are voicing disappointment in the proposed regulations due to their burdensome requirements.
The proposed regulations outline specific requirements for pharmacies, software vendors and service providers, hospitals, and physicians pursuant to the Comprehensive Drug Abuse Prevention and Control Act (CSA) and the Controlled Substances Import and Export Act (21 U.S.C. 801-971), as amended. The proposed regulations state in numerous places that, although the DEA supports the adoption of electronic prescriptions for controlled substances, it must be in a manner that will minimize the risk of drug diversion. The cited reason for this concern is the fact that national studies, including the National Survey on Drug Use and Health (NSDUH), estimate that 20.4 million Americans have been classified with substance dependence or abuse and that more than 20 percent of people aged 12 or older have used psychotherapeutic drugs non-medically in their lifetimes. Further, it is estimated that 33 million Americans have used prescription painkillers for non-medical reasons in their lifetimes, and controlled substances represent 66 percent of the estimated hospital emergency department visits nationally. Correspondingly, prevention of drug diversion activities by the DEA and state drug-diversion units has increased. Accordingly, the DEA insists that the electronic prescribing of controlled substances must have sufficient safeguards to prevent any further contributions to the drug diversion problem in the United States.
DEA’s requirements are detailed and potentially cumbersome; click here for a summary of the DEA requirements.
DEA has requested comment on specific sections of the proposed regulations. These include:
- DEA’s assessment of risk for the six categories of harm for the electronic prescribing of controlled substances.
- Whether in-person identity-proofing requirements consistent with, but not equivalent to, Level 3 are sufficient to address the DEA’s concerns, or whether more stringent requirements, such as those imposed under Level 4, are necessary.
- Whether authentication protocol requirements, use of a hard token, and two-factor authentication meeting the requirements of Level 4 are sufficient to address the DEA’s concerns, or whether a more stringent requirement, such as those imposed in a public key infrastructure system, are necessary.
- The requirements for in-person identity-proofing of practitioners, and the effect on practitioners, particularly those practicing at multiple locations.
- Alternatives to in-person identity-proofing.
- The current industry practices used to “sign” electronic prescriptions for non-controlled substances, and whether and how such practices present risks for non-controlled substance prescription forgery, fraud, and other related crimes.
- The extent to which service providers and intermediaries store electronic records of uncontrolled substance prescriptions.
DEA states in the proposed regulations that the requirements: “will protect both practitioners and pharmacies by ensuring that they can meet their legal obligations and lessen the threat of someone misusing their authorities to divert controlled substances. DEA emphasizes that its electronic prescription requirements do not alter the responsibilities of the practitioner and pharmacy in regard to controlled substance prescriptions.”
The DEA has regulatory oversight over pharmacies and physicians prescribing controlled substances. Responsibility for a violation of the regulations, once adopted, will rest on pharmacies and prescribers. Therefore, it is important for those industries that will be affected by the final regulations to provide comment to DEA as requested, to have meaningful dialog about a practical and non-burdensome regulatory system that meets the needs of both industry and the government.
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6/5/2008
CMS concludes that a hospital's proposal to pay for a customized software interface with staff physicians' EHR systems to communicate lab results is not prohibited by Stark Law.
By Linn F. Freedman
In 2006, the Centers for Medicaid and Medicare Services (CMS) and the Office of the Inspector General (OIG) established rules creating exceptions to the Physician’s Self-Referral Law (Stark) and a new safe harbor to the Anti-kickback Statute. In essence, the exception and safe harbor allowed physicians to accept donations from hospitals and other qualified donors for establishing electronic prescribing and electronic health-record capabilities (see Nixon Peabody Health Alert,
October 5, 2006.
On May 28, 2008, CMS issued an Advisory Opinion (Advisory Opinion No. CMS-AO-2008-01), relating to the development of customized software given by a hospital system to members of a hospital’s staff.
The facts behind the Advisory Opinion are as follows: A nonprofit hospital system proposed to contract with a third-party vendor to install a proprietary health-care software information system that was customized for the hospitals in the system, including a software interface engine that allowed custom access by physician practices on the staffs of the hospitals. The system would have allowed members of the medical staffs of the hospitals to view laboratory reports ordered by a physician and performed by the hospital. The vendor would develop, and the hospitals would pay the costs of the development of, the physician practice interface customized to the existing EHR software of the physician’s practice. In addition, the hospital system proposed to purchase licenses to authorize affiliated physicians to use the customized interface during the term of the license agreement with the hospitals. Importantly, CMS noted in the Advisory Opinion that the customized interface would be used only to order or communicate the results of tests and procedures performed by the hospitals, and could not be used for any other purpose. In addition, the hospital system certified that the interface would not be applied or altered by the physician to perform any alternate functions, nor would the physician re-sell, transfer, or assign the license.
The CMS Advisory Opinion concluded that the proposed arrangement did not meet the definition of a “compensation arrangement” for purposes of the Stark Law, as defined in Section 1877(h)(1)(A) of the Social Security Act, and was not prohibited. CMS qualified the opinion by stating that the analysis was limited to the use of the interface to communicate results of tests and procedures furnished by the hospital. CMS made no determination as to compliance with the Stark Law if the software interface was used for any other purpose.
Although limited and qualified, the CMS Advisory Opinion offers additional guidance to hospitals and physicians regarding the donation of software and other forms of information technology, provided that certain guidelines and criteria are met.
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4/16/2008
The final CMS e-prescribing standards for Medicare Part D individuals have the potential to lower prescription drug costs, decrease adverse drug events due to drug-to-drug interactions, and monitor patients’ compliance with taking their prescription medications.
By Linn Foster Freedman
CMS released a new final rule on e-prescribing entitled “Medicare Program; Standards for E-Prescribing under Medicare Part D and Identification of Backward Compatible Version of Adopted Standard for E-Prescribing in the Medicare Prescription Drug Program” on April 2, 2008. The new standards will take effect on April 1, 2009.
Although there is no requirement for prescribers, dispensers or healthcare providers to implement e-prescribing, those who do must comply with the new Medicare standards when e-prescribing for Part D-eligible individuals.
The four standards adopted in the final rule for e-prescribing are:
- Formulary and benefits. This standard allows prescribers to communicate with Part D sponsors about drugs that are covered by the Medicare-eligible individual’s prescription drug benefit plan. Prescribers can also learn which generic prescriptions might offer lower-cost options for the Medicare Part D-eligible individual.
- Medication history. This standard allows providers, dispensers and Part D sponsors to communicate with each other about prescribed medications that the Medicare Part D-eligible individual is taking, including medications prescribed by other providers. This standard is implemented to ensure that the prescriber has the necessary information about the prescription medications the Medicare Part D beneficiary is taking to help reduce the number of adverse drug events from drug-to-drug interaction.
- Fill-status notification. This standard allows providers to receive an e-mail notice from a pharmacy or dispenser indicating whether or not a prescription has been retrieved and/or filled by the patient. The goal with the implementation of this standard is to assist healthcare providers in monitoring patients with chronic conditions by determining whether or not the prescribed medication is being taken by the Medicare Part D beneficiary.
- Provider identifier. This standard requires providers, dispensers, and Part D sponsors to use the National Provider Identifier (NPI) to identify individual healthcare providers in Part D e-prescribing transactions, which ideally will speed up workflows between provider and dispensers by eliminating call-backs to pharmacies and medical offices to verify the identity of the individual prescribers.
In addition, the rule finalizes the National Council for Prescription Drug Programs (“NCPDP”) Prescriber/Pharmacist Interface Script Standard Implementation Guide, Version 8.1 as a backward compatible update of the NCPDP Script 5.0 until April 1, 2009.
The final e-prescribing standards supplement the “foundation” standards published in November 2005, which took effect with the start of Part D on January 1, 2006.
The e-prescribing standards adopted under the final rule will apply to all Part D sponsors, as well as to prescribers and dispensers engaged in e-prescribing for Part D-eligible individuals, including free-standing prescription drug plan sponsors, Medicare advantage prescription drug plans and other Part D sponsors.
CMS has indicated that through testing of the new standards by providers and pharmacies, the standards should be easily incorporated into existing e-prescribing systems.
The final e-prescribing rule is one of several initiatives of the federal government to encourage the broader use of e-prescribing to improve the quality of patient care, following the adoption of final Stark and anti-kickback safe harbor for electronic health records and e-prescribing implemented by CMS in August of 2006. These series of rules were implemented in response to a provision in the Medicare Modernization Act (MMA) that directed the Secretary of Health and Human Services (HHS) to adopt standards for electronic prescribing and to create an exception to help promote widespread adoption of e-prescribing.
For more information on the final Stark exception and anti-kickback safe harbor for electronic health records and e-prescribing, please click here to see the Nixon Peabody Health Law Alert of 10/5/06.
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