Life Science Compliance Update

25 posts categorized "Government Agencies"

November 07, 2014

Ebola Update: New Bill to Fast Track Ebola Treatment; FDA Focuses on Importance of "Randomized Trials"


On Wednesday, November 12, HHS Secretary Sylvia Burwell and Homeland Security Secretary Jeh Johnson will appear before the Senate Appropriations Committee to testify on the government’s response to Ebola. CDC Director Dr. Thomas Frieden, National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci, as well as other officials from the State Department, Defense Department, USAID and the Joint Chiefs of Staff are also expected to testify. 

Challenges and Incentives for Development

The companies that are working to come up with vaccines and treatments for Ebola are faced with several challenges that arise from the nature of the disease. The first difficulty is that the disease is unpredictable, so it is difficult to find people who are at high risk to test any vaccine or antibiotic (see ‘No Market’: Scientists Struggle to Make Ebola Vaccines, Treatments). Another challenge that drug companies face is the rarity of Ebola outbreaks. With the infrequency of the outbreaks and the small number of patients being impacted, it is difficult to motivate the private sector into supplying the millions of dollars necessary to research a vaccine or antibiotic.

Senators Tom Harkin (D-IA) and Lamar Alexander (R-TN) are planning to introduce a bill that would fast-track the creation of Ebola treatments by offering incentives to drug companies. The respective bipartisan leaders of the Senate HELP Committee say their bill would accelerate processing a company’s drug application for Ebola within about six months through a program called “priority review.” As an added incentive, companies would also earn a bonus voucher for another drug of their choice to receive priority review, even if it’s not meant to treat a neglected disease like Ebola.  Harkin and Alexander plan to introduce their bill when Congress reconvenes for the post-election lame-duck session.

Vaccine trials- FDA weighs-in on importance of placebos

GlaxoSmithKline, in a joint effort with the US National Institutes of Health and the World Health Organization (WHO), has begun Phase 1 Safety trials in humans. The BBC News just ran an interesting article yesterday entitled Volunteering to test Ebola vaccine in Mali. Dr Samba Sow, an infectious disease epidemiologist and vaccine expert and director of Centre for Vaccine Development (CVD) in Mali, provided some good news: "We know that after two weeks they're starting to have some immune response and there are no adverse reactions."

Currently, however, trials do not involve the use placebos. 

FDA officials speaking at a tropical medicine conference in New Orleans Wednesday said experimental Ebola drugs should be tested in randomized controlled trials -- a "gold standard" form of drug assessment that involves giving some ill patients a placebo. Edward Cox, director of the FDA’s Office of Antimicrobial Products, stated that “[w]hile randomized trials would be ‘challenging,’ they’re needed to understand whether or how well the medicines work.” Trials would compare “the best supportive care versus the best supportive care with a drug,” he said.

Bloomberg's coverage notes that using placebos in West Africa has created an “ethical debate pitting one of the world’s deadliest pathogens against the need to better understand exactly which drugs are most effective."

Other developments

The National Institute of Health also recently announced that they were beginning human trials on a new Ebola vaccine. Human testing of this second investigational Ebola vaccine candidate is under way at the NIH’s Clinical Center in Bethesda, Maryland. Researchers at the National Institute of Allergy and Infectious Diseases (NIAID) are conducting the early phase trial to evaluate the vaccine, called VSV-ZEBOV, for safety and its ability to generate an immune system response in healthy adults who are given two intramuscular doses, called a prime-boost strategy. The Walter Reed Army Institute of Research (WRAIR) is simultaneously testing the candidate as a single dose at its Clinical Trials Center in Silver Spring, Maryland.

Profectus BioSciences has received around $27m, and is working first on the vaccine for Ebola Zaire, the strain that has killed thousands in West Africa this year, with plans to advance it to clinical trials by June 2015. “Unlike previous investments that focused on a vaccine designed specifically for the strain of Ebola present in the outbreak, Profectus' most recent contract focuses on a vaccine that would offer more broad protection against two types of Ebola as well as the Marburg virus, which causes hemorrhagic fever similar to Ebola,” notes the Baltimore Sun. “By fall, the company plans to begin testing of what is a called a "trivalent" vaccine that would build immunity to three pathogens – Ebola Zaire, Ebola Sudan and Marburg,” according to Profectus President Jeffrey Meshulam. 

Across the Atlantic, the Europe Union and pharmaceutical companies pledged yesterday to invest 280 million euros ($350 million) in Ebola research, “with the lion's share going to the testing and manufacture of potential vaccines,” Reuters reports. “The funding will go to projects backed by the Innovative Medicines Initiative (IMI), a public-private scheme jointly paid for by the European Commission and the pharmaceuticals industry.”

April 10, 2014

Takeda, Lilly Hit with $9 Billion Punitive Damages in Actos Lawsuit

Asia's biggest pharmaceutical company, Takeda, and their marketing partner, Eli Lilly, face $9 billion in punitive damages stemming from their Actos diabetes drug. The plaintiffs alleged that Takeda and Lilly concealed their knowledge of the drug's bladder cancer risks and failed to provide adequate warnings. Takeda countered that the plaintiff's bladder cancer wasn't caused by Actos, and that the drugmaker provided proper warnings as they became known over the years. The jury allocated 75% of the liability, $6 billion, to Takeda and 25%, $3 billion, to Lilly.

This startlingly large special damages award stems from a 2011 lawsuit filed by Terrence Allen and his wife, Susan Allen, who alleged that the diabetes medication caused Mr. Allen's bladder cancer. In addition to punitive damages, which seek to punish the wrongdoer rather than reimburse the victim, the jury awarded the Allens about $1.5 million in compensatory damages.

Interestingly, judgments were entered in Takeda's favor in all three previous Actos trials before the $9 billion bombshell. Bloomberg reports that last year, "state juries in California and Maryland ordered Takeda to pay a total of $8.2 million in damages to former Actos users," but "judges in both states threw out the verdicts." This year, jurors in a Las Vegas state court rejected claims that the company failed to properly warn consumers about the risks of Actos.

The litigation in the District Court of the Western District of Louisiana is the first federal case to be tried and the first in the consolidated Actos multidistrict litigation. Lilly, who co-promoted Actos with Takeda from 1999 to 2006, was not named in the previous state actions.

Kenneth D. Greisman, senior vice president and general counsel at Takeda, responded to the verdict: "Takeda respectfully disagrees with the verdict and we intend to vigorously challenge this outcome through all available legal means, including possible post-trial motions and an appeal." He also stated that "[w]e have empathy for the Allens, but we believe the evidence did not support a finding that ACTOS caused his bladder cancer. We also believe we demonstrated that Takeda acted responsibly with regard to ACTOS."

The Wall Street Journal reported that the news "sent Takeda shares down sharply Tuesday. Takeda shares fell 5.2% to ¥4,572 on the Tokyo Stock Exchange. Motley Fool noted that during 2011, Actos sales peaked with $4.5 billion in sales and accounted for 27% of Takeda's revenue. "The drug has since gone off patent and faces generic competition from Ranbaxy Laboratories and other drugmakers," the article notes. Under Lilly's agreement with Takeda, Lilly will be indemnified by Takeda for losses and expenses related to US litigation.

"There's no way that these [damages] will be $9 billion at the end of the day," said the plaintiff's lawyer, Mark Lanier. The Wall Street Journal's Law Blog notes that the Supreme Court has ruled that punitive and compensatory damages "must bear some relationship to one another." The article states that "[g]enerally speaking, punitive damages that are more than nine times that of compensatory damages have a poor survival rate."

Indeed, in this case the $9 billion punitive damages dwarfs the $1.5 million compensatory damage to an almost absurd degree. These types of damages may reflect particularly bad conduct. However, when deliberating punitive damages, juries are allowed to consider the net worth and profits of the defendants. The Wall Street Journal stated that "[p]erhaps they wanted to scale the award so it would financially sting the pharmaceutical companies, which are each worth tens of billions of dollars."

Punitive damages tend to be reduced on appeal, often drastically so. We will keep you posted on the outcome of the Actos lawsuits.

September 20, 2013

Accuracy in Medicare Physician Payment Act

When you estimate prices for services that involve thousands of services, getting it right can be difficult. The AMA has worked hard to ensure the accuracy of time to conduct a procedure but as you can imagine much of the time spent on a procedure varies greatly from doctor to doctor.

H.R. 2545, introduced in the House by Rep. Jim McDermott, M.D., D-Wash, is designed to supplement the work of the AMA/Specialty Society Relative Value Scale Update Committee (RUC) by establishing an expert panel within Medicare to oversee the valuation of physician services and to help correct distortions in the physician fee schedule. The text of the bill can be found here, and more information about the legislation.

As noted by Rep. McDermott's office: "Currently, the RUC, a committee of 31 physicians empaneled by the American Medical Association (AMA), conducts reviews in closed meetings and provides limited release of the minutes of its proceedings. It is unevenly weighted by procedural specialists over primary care doctors and relies heavily on anecdotal and self-serving survey evidence, rather than forensic data. This causes skewed fees for procedure-based services such as pathology, surgery and imaging, eroding pay to primary care physicians."

"No other area of the Medicare program asks providers to play such an active role in setting their own payments," said McDermott. "Medicare certainly needs clinical expertise in order to fairly set reimbursements, but an outside organization, whose members benefit from $70 billion in annual public spending, needs checks and balances. No matter how well-intentioned, structural biases are inevitable and we're seeing that effect as new doctors flock toward specialty care and away from primary care."

Based on a recommendation from the nonpartisan Medicare Payment Advisory Committee, McDermott's bill would establish a panel of independent experts within the Medicare agency to identify distortions in the fee schedule and develop evidence to justify more accurate updates. The panel would be composed of members without any direct conflicts of interest and would include patient representatives. It would also be subject to the Federal Advisory Committee Act, which requires advisory bodies to hold open meetings and publish minutes. Under the bill, Medicare could continue to request work from the RUC, but the independent experts would both initiate such requests and review RUC's work product.

The American Academy of Family Physicians (AAFP) supports the bill, and in a letter to McDermott, AAFP Board Chair Glen Stream, M.D., M.B.I., of Spokane, Wash., described the bill as "long overdue" and said that it "could make a major difference in how the Medicare payment system supports primary care physicians in offering better quality health care more efficiently."

Stream also said, however, that the legislation's expert valuation panel should include at least one primary care physician to provide a "perspective that has been most underrepresented in previous deliberations of the relative value of physician services."

Stream told McDermott, "We agree with your observation that CMS needs to have the expertise required to evaluate physician services and that this evaluation should be as objective and free as possible from the appearance of conflicts of interest. Your legislative proposal would go a long way toward providing CMS with the independent expertise that it needs, and it is consistent with prior recommendations of the Medicare Payment Advisory Commission and recommendations we made to the RUC last year."

In addition, a post on the Health Affairs Blog also states support for the legislation:

"With the recent release of two mainstream exposes, one in the Washington Post and another in the Washington Monthly, the American Medical Association's (AMA) medical procedure valuation franchise, the Relative Value Scale Update Committee (RUC), has been exposed to the light of public scrutiny. 'Special Deal,' Haley Sweetland Edwards' piece in the Monthly, provides by far the more detailed and lucid explanation of the mechanics of the RUC's arrangement with the Centers for Medicare and Medicaid Services (CMS)."

"For its part, the Post contributed new information by calculating the difference between the time Medicare currently credits a physician for certain procedures and actual time spent. Many readers undoubtedly were shocked to learn that, while the RUC's time valuations are sometimes way off, in some cases physicians may be paid for more than 24 hours of procedures in a single day."

It is unlikely that given the current makeup of congress this bill has much room for success, but is does contribute to the debate to reform the physician payment system, which in the future with the right plan could muster bipartisan support.

April 26, 2013

HHS OIG: Proposed Budget for FY 2014


We previously wrote about President Obama’s FY 2014 budget for the U.S. Department of Health and Human Services (HHS) and its related agencies.  We are reporting separately on the President’s budget for the Office of Inspector General (OIG) for HHS, which issued a 76-page justification for its FY 2014 budget.  In the justification, OIG pointed to its previous FY 2012 reports about its activities, oversight, and success. 

Interestingly, OIG noted that it was responsible for overseeing 24 cents of every Federal dollar spent and that on average, each OIG full-time equivalent (FTE) was responsible for overseeing $478 million.  Eighty-two percent of efforts were dedicated to oversight of the Centers for Medicare and Medicaid Services (CMS) and 18 percent to non-CMS oversight.  For every dollar spent on healthcare fraud and abuse enforcement, the government has returned $7.90. 

OIG called for $320 million, an increase of $82 million above the FY 2012 actual level, for Medicare and Medicaid oversight.  This request supports the joint HHS and Department of Justice Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative and related program integrity efforts, including identifying questionable billings and reducing improper payments.  OIG’s efforts resulted in estimated savings and expected recoveries of approximately $15 billion in FY 2012. 

The proposed law in FY 2014 includes (1) $25,000,000 to continue oversight of activities previously funded through expired appropriations, and (2) $52,751,000 to support the Administration’s HEAT initiative, including  

  • sustaining Medicare Fraud Strike Forces; 
  • leveraging technology and data to continue program integrity efforts to  address emerging trends; 
  • adapting to a changing health care system; 
  • increasing efforts to address improper payments and other waste;    
  • improving patient safety and quality of care; and
  • improving IT security at health care organizations.  

The funds will ensure that resources are available to sustain Strike Forces and expand other program integrity efforts.  OIG noted that in 2012, the agency entered into 35 new corporate integrity agreements (CIAs) and is now monitoring compliance with 214 CIAs.

In addition to Medicare Fraud Strike Force efforts and other investigative efforts, possible issues and areas of oversight to be considered for 2014 include the following:  

Leveraging Technology and Data To Continue Program Integrity Efforts and Address Emerging Trends: Advances in data analysis have changed the way OIG investigates health care fraud and significantly reduced the time from investigation to indictment.  However, health care fraud itself has become more sophisticated, as criminals use advances in technology, including electronic health records, to their advantage.  Evidence collection is moving increasingly away from paper files to an unprecedented amount of electronic evidence to be seized and analyzed. As such, there is an increasing demand for forensic enhancements to more effectively analyze investigative data.  

Advances in data analysis have the potential to provide OIG, and its law enforcement partners, with more leads to investigate than ever before.  It is anticipated that advances in OIG’s efforts in this area, along with those of CMS, through its Fraud Prevention System, will make it imperative that OIG have the resources needed to analyze data and to investigate allegations of fraud.  

One example of recent work on using data to analyze trends and possible program vulnerabilities involves CMS payments for evaluation and management (E/M) services. Between 2001 and 2010, Medicare payments for Part B items and services increased by 43 percent, from $77 billion to $110 billion.  During this same time, Medicare payments for E/M services increased by 48 percent, from $22.7 billion to $33.5 billion. E/M services have been vulnerable to fraud and abuse.  In 2009, two health care entities paid over $10 million to settle allegations that they fraudulently billed Medicare for E/M services.  CMS also found that certain types of E/M services had the most improper payments of all Medicare Part B service types in 2008.  While this study did not determine whether these E/M claims were inappropriate, recommendations were made to CMS to address the potential vulnerabilities.  

Adapting the Oversight Approach to a Changing Health Care System: Changes are taking place across the health care industry and are fueled by innovations in science and IT, the need to address health care spending, the shift from volume-based to value-based payment, advances in quality measurement, and increasing access to care. Others changes include growth in Medicaid enrollment, an emphasis on coordinated care, and an increased use of electronic health records.  OIG will need to adopt oversight approaches that are suited to an increasingly sophisticated health care system and that are tailored to protect programs and patients from existing and new vulnerabilities.  

Identifying Questionable Billing and Reducing Improper Payments: OIG continues to conduct targeted reviews to determine the scope of improper payments and areas of questionable billing for specific service types and recommend actions to improve program safeguards.  By reviewing billing data, medical records, and other documentation associated with claims, OIG identifies services that are questionable, undocumented, not medically necessary, or incorrectly coded, as well as duplicate payments and payments for services that were not provided.  In doing so, OIG uncovers payment vulnerabilities and makes recommendations to address them.  

One example of work in uncovering payment vulnerabilities is OIG’s report on retail pharmacies with questionable Part D billings.  In 2009, retail pharmacies each billed Part D an average of nearly $1 million for prescriptions.  Over 2,600 of these pharmacies had questionable billing.  These pharmacies had extremely high billing for at least one of the eight measures we developed.  For example, many pharmacies billed extremely high dollar amounts or numbers of prescriptions per beneficiary or per prescriber.  This could mean that a pharmacy is billing for drugs that are not medically necessary or were never provided to the beneficiary. Although some of this billing may be legitimate, pharmacies that bill for extremely high amounts warrant further scrutiny. The Miami, Los Angeles, and Detroit areas were the most likely to have pharmacies with questionable billing.  

On the topic of drug diversion in both Part D and Medicaid, OIG has seen a significant increase in its investigative caseload in FY 2012.  These cases range from drug-seeking beneficiaries to large-scale criminal enterprises engaged in high-dollar drug trafficking. HEAT and Strike Force efforts have also increased in this area.  As a result, an increased caseload, continued use of Strike Force resources, and proactive data analysis of drug diversion activity is expected in the coming fiscal year and beyond.  

Improving Patient Safety and Quality of Care: The challenge of ensuring that beneficiaries receive quality health care has many dimensions, including overseeing providers’ compliance with quality-of-care standards, ensuring patient safety, and identifying opportunities for improvements in quality of care. OIG work in this area includes:  

  • examining nursing facilities’ compliance with selected Federal requirements for quality of care and
  • reviewing the extent to which Medicaid-enrolled children are prescribed atypical antipsychotic drugs.

Improving IT Security at Health Care Organizations: The challenge of ensuring that health care organizations have adequate IT security to protect their systems and sensitive data is an ongoing endeavor.  OIG work in this area includes reviews at hospitals and Medicare, Medicaid, and Part D providers.

January 31, 2013

HHS Unveils Final HIPPA Omnibus Rule

In late January, the U.S. Department of Health & Human Services (HHS) issued four final rules, combined to create an omnibus final rule addressing several aspects of patient privacy under the Health Insurance Portability and Accountability Act of 1996 (HIPAA).  The rules were combined—563 pages—to “reduce the impact and number of times certain compliance activities need to be undertaken by regulated entities.”  The new rule will be effective March 26, with a compliance date of Sept. 21.  As reported by FierceHealthIT, the rules include: 

  • Modifications to the HIPAA Privacy, Security, and Enforcement Rules mandated by the Health Information Technology for Economic and Clinical Health Act, and certain other modifications to improve the rules, which were issued as a proposed rule on July 14, 2010.
  • Changes to the HIPAA Enforcement Rule to incorporate the increased and tiered civil money penalty structure provided by the HITECH Act, originally published as an interim final rule on Oct. 30, 2009.
  • A final rule on Breach Notification for Unsecured Protected Health Information under the HITECH Act, which replaces the breach notification rule’s “harm” threshold with a more objective standard and supplants an interim final rule published on Aug. 24, 2009.
  • A final rule modifying the HIPAA Privacy Rule as required by the Genetic Information Nondiscrimination Act (GINA) to prohibit most health plans from using or disclosing genetic information for underwriting purposes, which was published as a proposed rule on Oct. 7, 2009. 

“Much has changed in healthcare since HIPAA was enacted over 15 years ago," HHS Secretary Kathleen Sebelius said in a statement. "The new rule will help protect patient privacy and safeguard patients' health information in an ever expanding digital age."

According to HHS, contractors, subcontractors and other business associates of healthcare entities that process health insurance claims now will be liable for the protection of private patient information under the updated rule.  In addition, monetary penalties for noncompliance with the rule have increased, with a maximum penalty of $1.5 million per violation. 

Individual rights are expanded in important ways.  Patients can ask for a copy of their electronic medical record in an electronic form.  When individuals pay by cash they can instruct their provider not to share information about their treatment with their health plan.  The final omnibus rule sets new limits on how information is used and disclosed for marketing and fundraising purposes and prohibits the sale of an individuals’ health information without their permission.   

The FDA Law Blog posted an interesting analysis explaining that the new rule places dramatic revisions to marketing practices and research authorizations.   For example, previously, “pharmaceutical companies could pay pharmacies to communicate with their patients for the purpose of either reminding patients to refill their prescription (“refill reminders”), or to recommend switching to alternative therapies (“switch communications”).”

The final rule “now requires patient authorization before using protected health information for all paid communications that recommend a product or service to the patient, regardless of whether the purpose is treatment or health care operations.”  There are several exceptions, however for: 

  • Refill reminders,
  • Adherence communications, and
  • Other communications about a drug or biologic that is currently prescribed for the individual do not require authorization, provided that the payment received by the covered entity is “reasonably related to the covered entity’s cost of making the communication.”   

The post explained that “reasonably related” most likely “means the covered entity cannot profit from the communication.  If the covered entity receives a financial incentive beyond their cost, they must obtain the patient’s authorization.”   

“HHS also clarified that communications about a drug or biologic currently prescribed includes communications about generic equivalents.  They also clarified that for self-administered drugs or biologics, communications about the entire drug delivery system, such as an insulin pump are considered communications about the drug itself.” 

“This final omnibus rule marks the most sweeping changes to the HIPAA Privacy and Security Rules since they were first implemented,” HHS Office for Civil Rights Director Leon Rodriguez said in a statement.  “These changes not only greatly enhance a patient's privacy rights and protections, but also strengthen the ability of my office to vigorously enforce the HIPAA privacy and security protections, regardless of whether the information is being held by a health plan, a health care provider, or one of their business associates.” 

The final rule was accepted for review by the Office of Management and Budget last March and had been dubbed as moving to its final clearance hurdle by Susan McAndrew, Deputy Director for Health Information Privacy at OCR at that time.  It had been anticipated that the rule would be published last summer. 

Executing the New Rules 

In response to the new rules, several healthcare stakeholders expressed concern about the challenges executing them.  Todd Richardson , vice president and CIO of Wausau, Wis.-based non-profit health system Aspirus, Inc., told FierceHealthIT that “providers and vendors that use and create electronic health record systems already walk a tight balance between complying with HIPAA and meeting the requirements of the HITECH Act and Meaningful Use regulations.” 

“On one hand we have 'protect, protect, protect' and on the other hand we have 'share, share, share,” Richardson said to FireceHealthIT.  “While the balance is ‘protect and share,’ the devil is always in the details.  The reality is that all of the information is not under the tight control of the covered entity.” 

Richardson added that “while all healthcare professionals understand the responsibility to protect patient information, as more systems come online with information, inevitably, there will be more opportunity for data breaches.”   Donna Staton, CIO at Warrenton, Va.-based Fauquier Health, noted that the rules “may require a lot of payers and vendors to rethink their positions under reform, where there is already a lot of momentum.”  “Patients will definitely see this as an improvement, though, giving them increased control, which supports the goal of improved patient engagement under reform,” she said. 

Joseph Kvedar, director of Partners HealthCare's Center for Connected Health in Boston, noted that while privacy is important, “the more privacy we have, the less data liquidity--and that could be a challenge.” 

Angela Rose, MHA, RHIA, CHPS, director of health information management practice excellence at the American Health Information Management Association (AHIMA), told Medpage Today that the health information management industry is “breathing a sigh of relief” after the final rule was released, noting that final rules have been anticipated since 2009. 

“The final rule ... strengthens patient privacy and security protections that were established under [HIPAA],” said Renae Moch, practice management strategist at the American Academy of Family Physicians in an email.  “This rule is presumed to increase workability and flexibility, decrease burden, and better standardize the requirements of the rule for covered entities such as healthcare providers, health plans, or healthcare clearinghouses.” 

Impact on Clinical Trials 

Analyzing the final rules, RAPs noted that clinical trial sites “will also be exempted from certain requirements, such as those limiting the use of single authorizations ("compound authorizations") for the release of PHI. (Page 175 of the rule).”

“Permitting the use of protected health information is part of the decision to receive care through a clinical trial, and health care providers conducting such trials are able to condition research-related treatment on the individual’s willingness to authorize the use or disclosure of protected health information for research associated with the trial,” DHHS explained in its rule. 

These exemptions could prove crucial to companies hoping to use collected data for “corollary research activity,” such as for research databases or repositories used to find common genetic markers or other information used to generate new information on therapies.  “However, trial sites will still be prohibited from using compound authorizations for tissue banking purposes, though they can ask for such samples in a separate authorization form or in the same package so long as it is unconditional,” RAPs writes.  DHHS suggested the use of separate check boxes and authorization signature lines for entities that wish to simplify the enrollment process. 

Impact on EHRs, HIT 

FierceHealthIT also noted that the final omnibus rule has a number of important provisions that directly affect electronic health records (EHRs) and related health information technology (HIT), including: 

  • Health information exchanges (which the rule calls health information organizations) and electronic prescribing gateways will be considered business associates and thus directly subject to many of HIPAA's privacy and security provisions. The obligation applies upon creation of the business associate relationship, not when a business associate agreement is signed. A personal health record vendor may or may not be a business associate, depending on the services that the vendor is providing to the covered entity.
  • Business associate agreements are necessary despite this new direct liability [i.e. EHR vendors that qualify as business associates need to sign these contracts]
  • A provider does not have to use an EHR to comply with the new rule, but if the provider does use an EHR, patients have the right to obtain copies of their records in electronic format, in a form requested by the patient. If that format is not available, then the format provided shall be as agreed upon by the provider and the patient. The provider can only charge the patient the labor costs involved.
  • The final rule sets 30 days (down from 60) for providers to provide patients with access to their records, but "encourages" providers to take advantage of their technologies and provide them sooner, considering that the Meaningful Use program contemplates much faster access than 30 days. 

“If a covered entity belongs to a HIE, and the HIE suffers a breach, the covered entity is the one obligated to notify patients.  However, since multiple covered entities may be involved due the data sharing inherent in an HIE, the covered entities may delegate to the HIE the notification obligation since that way a patient will only receive one notice.”


March 30, 2012

HHS Regulatory Priorities for 2012

Priority 2

The Department of Health and Human Services (HHS) recently released a report of its Regulatory Priorities for FY 2012.    

HHS operates more than 300 programs covering a wide spectrum of activities, manages almost a quarter of all Federal outlays, and administers more grant dollars than all other Federal agencies combined.  The Department’s major program responsibilities include: 

  • Medicare and Medicaid;
  • Control and prevention of communicable and chronic disease;
  • Support for public health preparedness and emergency response;
  • Biomedical research;
  • Substance abuse and mental health treatment and prevention;
  • Assuring safe and effective drugs, devices, and other medical products;
  • Protecting the food supply;
  • Assistance to low-income families;
  • The Head Start program; and
  • Improving access to health care services to the uninsured, isolated, or medically vulnerable. 

HHS is also the principal agency charged with implementing one of the President’s signature achievements—transformative health care reform through the Affordable Care Act of 2010. 

To implement this vast program portfolio, HHS develops an active regulatory agenda each year, driven largely by statutory mandates and interactions with stakeholders. The President also called upon Federal agencies to reform the regulatory process in his January 18, 2011, Executive Order 13563 “Improving Regulation and Regulatory Review.”  A key directive in that Executive order was to require agencies to conduct an inventory of existing regulations to determine whether such regulations should be modified, streamlined, expanded, or repealed to make an agency's regulatory scheme more effective or less burdensome in achieving its programmatic objectives. 

With these regulatory drivers in mind, HHS Secretary Kathleen Sebelius has worked with HHS agencies to craft a regulatory agenda that reflects her commitments to implementing meaningful health care reform, access to health care coverage, and high value health care services that are safe and effective for all Americans.  The agenda also reflects her other strategic initiatives, which include: 

  • Securing and maintaining health care coverage for all Americans;
  • Improving quality and patient safety;
  • More rapidly responding to adverse events;
  • Implementing a 21st century food safety system;
  • Helping Americans achieve and maintain healthy living habits;
  • Advancing scientific research; and
  • Streamlining regulations to reduce the regulatory burden on industry and States.   

Within the agenda, the Secretary has also been mindful of the need to reform the ongoing regulatory process through retrospective review of existing regulations, and this agenda reflects her commitment to that review by incorporating some of the most significant burden reduction reforms across all Federal agencies.  In fact, of the $10 billion in savings from retrospective regulatory review across all Federal agencies announced by the Administrator of the Office of Information and Regulatory Affairs, $5 billion was attributable to regulations contained within HHH’s current regulatory agenda.  Below is a brief overview of mainly the health related priorities. 

Making Health Insurance Coverage More Secure for Those Who Have Insurance and Extending Coverage to the Uninsured 

As a result of the Affordable Care Act, HHS is making affordable health care coverage more stable and secure through insurance market reforms designed to protect consumers against unreasonable insurance premium increases, provide them with more comprehensive and understandable information with which to make decisions, and enable eligible consumers to receive financial support for health insurance easily and seamlessly.  In 2014, all people who suffer from chronic conditions will no longer be excluded from insurance coverage or charged higher premiums because of a pre-existing condition or medical history. 

Already, insurers are prohibited from putting lifetime dollar limits and restrictive annual caps on what they will pay for health care services needed by the people they insure, ensuring that those people have access to medical care throughout their lives, especially when it is most needed.  HHS is working with States to help identify and put a stop to unreasonable health insurance premium rate increases and will require new health plans to implement a comprehensive appeals process for those beneficiaries who have been denied coverage or payment by the insurance plan.  

New health insurers will also be required to spend the majority of health insurance premiums on medical care and health care quality improvement, not on administration and overhead.  As well, the Affordable Care Act is providing reimbursement to employers that offer health benefits to early retirees, providing insurance coverage through the Pre-existing Condition Insurance Plan to people who would otherwise be locked out of the insurance market because of their pre-existing health conditions, and requiring plans that offer dependent coverage to make that coverage available to young adults up to age 26. 

In addition, the Centers for Medicare & Medicaid Services (CMS) will finalize three rules that will expand access to health insurance and provide consumers with better options and information about insurance: 

-       CMS will issue standards for the establishment of the Affordable Insurance Exchanges (Exchanges) to provide competitive marketplaces for individuals and small employers to directly compare available private health insurance options on the basis of price and quality.  These Exchanges will help enhance competition in the health insurance market, improve choice of affordable health insurance, and give small businesses the same purchasing clout as large businesses. 

-       Another rule helps to make coverage more secure by offsetting market uncertainty and risk selection to maintain the viability of Exchanges.  Under risk adjustment, HHS, in consultation with the States, will establish criteria and methods to be used by States in determining the actuarial risk of plans within a State to minimize the negative effects of adverse selection.  Under reinsurance, all health insurance issuers, and third-party administrators on behalf of self-insured group health plans, will contribute to a nonprofit reinsurance entity to support reinsurance payments to individual market issuers that cover high risk individuals. 

-       To extend health insurance to greater numbers of low-income people, Medicaid eligibility in 2014 will expand to cover adults under the age of 65 earning up to 133 percent of the Federal poverty level, and those who earn above that level may be eligible for tax credits through the Exchanges to help pay their premiums.  New, simplified procedures for determining Medicaid, CHIP, and tax credit eligibility will be forthcoming in 2012.  CMS will simplify eligibility rules to make it easier for eligible individuals and families to obtain premium tax credits and Medicaid coverage, including ensuring that Medicaid uses the same eligibility standards as other insurance affordability programs available through the Exchange, as directed by law.  The rule further outlines how Medicaid and CHIP will coordinate closely with the Exchange, including sharing data to ensure that individuals are determined eligible for the appropriate insurance affordability program regardless of where an applicant submits the application. 

Improving Health Care Quality and Patient Safety 

Across America and for all Americans, HHS is working to improve patient outcomes, ensure patient safety, promote efficiency and accountability, encourage shared responsibility, and reduce health care costs.  Through improved administrative processes, reforms, innovations, and additional information to support consumer decision making, HHS is supporting high-value, safe, and effective care across health care settings and in the community. 

In 2011, the Department published a key regulation to advance this priority—the final rule for Accountable Care Organizations (ACOs).  This rule establishes a system of shared savings for qualified organizations that deliver primary care services to a given patient population.  The objective is to promote accountability and shared responsibility for the delivery of care, especially to those with co-morbidities of chronic health problems in order to prevent unnecessary and costly in-patient hospital care, reduce health care acquired conditions, and improve the quality of life for those individuals.  

This rule serves as a companion to additional demonstration programs designed to explore alternative services delivery and payment systems that are being sponsored by the new Center for Medicare and Medicaid Innovation.  Several more key regulations are on the agenda to move forward in meeting these quality and patient safety goals:

-       CMS is implementing value-based purchasing programs throughout its payment structure in order to reward hospitals and other health care providers for delivering high-quality care, rather than just a high volume of services.  The payment rules scheduled for publication this year will reflect a mix of standards, processes, outcomes, and patient experience of care measures, including measures of care transition and changes in patient functional status. 

-       The Department continues to encourage health care providers to become meaningful users of health information technology (IT) by accelerating health IT adoption and promoting electronic health records to help improve the quality of health care, reduce costs, and ultimately, improve health outcomes.  Electronic health records and health information exchange can help clinicians provide higher quality and safer care for their patients.  By adopting electronic health records in a meaningful way, clinicians will know more about their patients to better coordinate and improve the quality of patient care, and they can make better decisions about treatments and conditions.

 Improving Response to Adverse Events 

In a related activity, the FDA will be proposing a new rule to establish a unique identification system for medical devices in order to track a device from pre-market application through distribution and use.  This system will allow FDA and other public health entities to track individual devices so that when an adverse event occurs, epidemiologists can quickly track down and identify other users of the device to provide guidance and recommendations on what steps to take to prevent additional adverse actions.   

 Advancing Scientific Research 

To effectively address the challenges HHS faces in crafting the best, evidence-based approaches to advance health services delivery, protect the public health, ensure essential human services, promote biomedical research, and ensure the availability of safe medical and food products, HHS must rely on research.  The lynchpin of this research is found in the ethical rules governing research on human subjects. 

In a major undertaking, HHS is in the process of reviewing and revising those ethical rules, commonly referred to as the Common Rule.  The Common Rule serves to guide researchers and investigators in the Department, but also throughout the Federal Government, in the conduct and protocols for doing research on human subjects.  The proposed revisions will be designed to better protect human subjects who are involved in research, while facilitating research and reducing burden, delay, and ambiguity for investigators. 

Streamlining Regulations to Reduce Regulatory Burdens 

Consistent with the President’s Executive Order 13563, HHS continues its commitment to reducing the regulatory burden on the health care industry through the use of modern technology.  As part of this effort, FDA will advance several rules designed to reduce the reporting and data submission requirements from manufacturers of drugs and medical devices. 

In one such rule, FDA will permit manufacturers, importers, and users of medical devices to submit reports of adverse events to the FDA electronically. This proposed change will not only reduce the paper reporting burden on industry, but also allow FDA to more quickly review safety reports and identify emerging public health issues.  

Under another proposed rule, FDA would revise existing regulations to allow clinical study data and bioequivalence data for new drug applications and biological license applications to be provided electronically.  Again, this rule will reduce the reporting burden on industry and also permit FDA to more readily process and review applications. 

CMS is also engaged in regulatory reduction and streamlining activities.  Of particular note are several rules on conditions of participation for hospitals and other providers.  The most comprehensive of these rules is the one reducing regulatory burdens on hospitals, which is expected to save as much as $940 million annually over the next 5 years.  This rule will implement changes to hospital conditions of participation to reflect substantial advances in health care delivery and patient safety knowledge and practices.

November 29, 2011

HHS to Begin HIPAA Audits

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.

November 04, 2011

Government Targeting Pharmaceutical Executives with Renewed Enthusiasm

Over the past several years, we have seen an increasing focusing on litigation and prosecution of large pharmaceutical and medical device manufacturers ranging from off-label promotion, to fraud and abuse, and a number of other legal and regulatory issues. 

Many of these cases, in fact, almost all of them, have settled, largely because companies face the threat of debarment—the inability of a company to do business with the federal government (i.e. the Centers for Medicare and Medicaid).  These kinds of prosecutions of "responsible" officers trouble defense lawyers in the health sector because the threat can be career ending.

For example, last December, the U.S. District Court in Washington affirmed a federal health-care program exclusion of three Purdue Frederick Co. executives who had earlier pled guilty to misdemeanor violations of the food and drug laws associated with the misbranding of the drug OxyContin.

The Justice Department didn't allege that the three officers participated in or were even aware of the misbranding, but rather that they were "responsible" corporate officers at the time the conduct occurred.

"The exclusion of these individuals by HHS is unprecedented and unjust," said Andrew Good of Good & Cormier, the lawyer for one of the three executives. The exclusions have been appealed to the D.C. Circuit Court of Appeals, he added.

Additionally, a large portion of money contained in the American Recovery and Reinvestment Act, as well as the Affordable Care Act, went towards funding more attorneys and investigators at the Department of Justice and Department of Health and Human Services (HHS) to root out fraud, abuse and waste.  Over the past few years, these efforts have yielded billions of dollars and extremely large settlements, with virtually every company out there.  But the company money is not enough.

Consequently, a recent article from the Wall Street Journal noted that, the “U.S. authorities are now stepping up enforcement of a little-used law—the so-called "responsible corporate officer doctrine"—to hold executives personally and criminally responsible for corporate violations of U.S. food and drug laws.”

According to the article, “the development has triggered a new wave of worry among defense lawyers representing health-care executives.”

Congress authorized criminal sanctions against corporate officers in 1938 under the Food, Drug and Cosmetic Act.

The Supreme Court has since interpreted the law to allow prosecutions without evidence that executives knew a crime was committed—a lower standard than for other industries — because of the potential for health-care and food products to cause death and injury.

The doctrine is the prosecutors' "ticket around the need to prove criminal intent," says Michael W. Peregrine, a lawyer at McDermott Will & Emery LLP. "It puts the pistol to the head of the very senior executives." During the 1960s and 1970s, the government used the doctrine in a series of liability cases involving dirty food warehouses. But by the late 1980s, its use had declined.

Earlier this year, however, Marc Hermelin, the former chief executive of a Bridgeton, Mo., pharmaceutical maker, pleaded guilty to two misdemeanor violations of the food and drug laws as a "responsible corporate officer" in a case involving KV Pharmaceutical Co.'s production and distribution of two oversized morphine sulfate tablets.  A judge ordered Mr. Hermelin to pay a $1 million fine, forfeit $900,000 and serve a sentence of less than 30 days in jail.

Lawyers concerned about the revival of the so-called "corporate-officer responsibility doctrine" cite other recent health-sector cases, including one in Philadelphia involving medical-device maker Synthes Inc. and Norian Corp., a subsidiary.

In 2009, federal prosecutors accused the two companies of running an unauthorized trial of a bone filler in spinal procedures. Three patients died, although prosecutors said they couldn't prove the Synthes product was the cause. The companies pleaded guilty and agreed to pay more than $23 million to settle with the government.

Four Synthes executives were accused of wrongdoing. Acknowledging that they were "responsible corporate officers," the employees each pleaded guilty in federal court to a misdemeanor associated with shipping the misbranded product, Norian XR, across state lines.

But prosecutors and defense lawyers are now fighting over what they can introduce in their arguments to the judge about sentencing, which could come as soon as this fall. Under current law, misdemeanor cases carry sentences for company executives of up to a year in prison and a maximum fine of $100,000 per count.

"If the government asks the court to impose jail time in this case, it will have a chilling effect on future 'responsible corporate officer' pleas," said Adam Hoffinger of Morrison & Foerster LLP, lead attorney for Thomas Higgins, a former Synthes division president, who is one of the defendants.

"You're going after defendants who by definition had no idea they [were] committing a violation," said Robert J. Becerra, a Miami-based lawyer who represented ChemNutra Inc., a Nevada pet-food company, and one of the two executives who pleaded guilty to a misdemeanor and got three years' probation in connection with the import of tainted wheat gluten that killed thousands of dogs and cats.

"There's more focus now on trying to identify whether it's a case where it's appropriate to charge corporate officials with wrongdoing," said John J. Pease, chief of the health-care fraud unit in the U.S. Attorney's Office in Philadelphia, which brought one of the recent prosecutions.

Ultimately, as the recent trend of going after company executives picks up, businesses will have to look closely at their practices.  A number of provisions contained in the Affordable Care Act, such as the Physician Payment Sunshine Act, along with the Foreign Corrupt Practices Act, and the increased scrutiny on fraud and abuse, all lead to heavier regulation of the health industry and greater oversight.  With the added threat of going after company executive’s, the need for compliance from the top down has never been greater.  Now that the government will be tracing every $10 that a company spends, and will know who that money goes to and for what, executives can be on the hook for anything considered to be a kickback or fraudulent claim.

Companies must begin changing their cultures now, before it is too late.  Training and education, as well as new policies adapting to the new regulatory culture are necessary.  To be able to continue doing business successfully today, the drug and medical device industry will need to focus on complying with federal rules, laws and regulations, otherwise the boardroom could soon be the jail cell.

February 11, 2011

HHS Secretary Sebelius: Improving Healthcare through Medical Innovation

Innovation in medicine and medical technology has led to tremendous achievements in American’s quality of life and health care. Over the past century, the life expectancy went from just over forty-seven years to nearly seventy-eight in 2006. “Diseases that had once been a death sentence were eradicated or cured. Conditions that had once been disabling were now manageable.”

As Kathleen Sebelius, Secretary of the Department of Health and Human Services (HHS) recently pointed out, “Many of these gains were made possible by the great leaps in biomedical science, from the discovery of insulin to the identification of effective therapies for HIV.” What she forgot to mention is that the pharmaceutical and medical device industry have overwhelmingly been responsible for this progress and improvements.

Consequently, in a recent article in the Journal of Health Affairs, Secretary Sebelius noted that America now has the chance to improve healthcare and medicine with even “bigger opportunities.” She pointed to “new treatments, such as cell-based therapies, which introduce new cells into body tissues to treat diseases such as diabetes, show great promise.” In addition, Secretary Sebelius championed “unlocking the human genome” as a way to “facilitate personalized treatments for diseases such as cancer, based on each person’s unique DNA.”

However, she recognized that gains from these breakthroughs “are not guaranteed.” Instead, she acknowledged that new “treatments and cures for cancer, Alzheimer’s disease, and HIV/AIDS will be made only if there is a robust pipeline that carries promising ideas forward from the microscope to the medicine chest.”

The only way to accomplish this robust pipeline according to the Secretary, “is with a new level of coordination among all of the partners in the research process.”

From Research To Final Product

Part of the problem why America is facing a challenge with discovering new drugs is that the “road from the research lab to an approved and marketable drug is a long one, and today there are many detours and obstacles along the way.” As Secretary Sebelius acknowledges, “despite billions of dollars invested every year in research and development, just twenty-one new drugs made it to market in 2008.”

She noted however that the Obama administration supports innovation and the potential of biomedical research, evidenced by the American Recovery and Reinvestment Act of 2009, which invested an additional $10.4 billion over two years in the National Institutes of Health (NIH), with the vast majority of those funds going directly to scientific research.

Despite this investment, Secretary Sebelius acknowledged that “more is needed than writing bigger checks” to enhance the drug pipeline.  She asserted that “resources must be invested so they will have the largest impact possible and will deliver greater numbers of cutting-edge drugs, therapies, and medical devices more quickly to the patients who need them the most.”

Stronger Public-Private Partnerships

To accomplish this kind of impact, Secretary Sebelius noted that the government has begun to “broaden its role from funding discovery to building innovative networks of all of the stakeholders in the development process.” Members of the networks include “foundations, such as the Bill & Melinda Gates Foundation, which are deploying funds to generate treatments and cures for diseases that disproportionately affect people in the world’s poorest countries; and patient advocacy groups, which can help collect patient blood, tissue, and other samples for basic research and connect their members with clinical trials.”

One such network is the Biomarkers Consortium, a public-private partnership that includes scientists from the National Cancer Institute, the Food and Drug Administration (FDA), major pharmaceutical companies, and nearly twenty major cancer research centers across the country. The consortium is now working on a clinical trial to improve the odds of survival for women with high-risk, fast-growing breast cancers.

Another example of partnership is the NIH Therapeutics for Rare and Neglected Diseases program, which links small companies or academic labs doing basic research on diseases such as sickle-cell disease and hookworm, with government researchers who can use high throughput screening and medicinal chemistry to move these discoveries closer to clinical trials.

The Cures Acceleration Network, which was enacted in the Affordable Care Act of 2010, is another example of private-public partnership.  It gives the NIH director the flexibility to fund a variety of innovative projects from the public, private, nonprofit, and academic sectors, with the goal of advancing research in areas where success is not a given but the payoff could be very high.

The Secretary also discussed how HHS will be forging stronger partnerships inside government, such as the NIH and FDA working together on translational efforts and developing standards for safety and effectiveness. However, the Secretary did not mention industry’s role in this partnership. It is crucial that industry has a seat at the table in discussing solutions and ideas for increasing the pipeline as well.

She also discussed a recommendation that NIH create a new center devoted to translational science that would generate new approaches for building bridges to link basic discovery research with the development of new therapeutics and clinical care. NIH is currently gathering input from the public and a broad range of stakeholders, and if all goes as planned, the new center will be established by October 1, 2011.


As Secretary Sebelius acknowledged, “some of the roadblocks that have held back the development of new medicines can be eliminated” by projects and partnerships with industry. Specifically, she recognized that “Public-private partnerships are needed to build new paradigms for drug development, not just when it’s time to manufacture and market a product, but from the beginning of the development process.”

Moving forward, policymakers must continue to include industry in regulatory discussions so that America can continue to develop a new generation of cures and treatments that could dramatically improve the lives of Americans and people around the world. By having “a broader conversation among stakeholders in government, academe, industry, and nonprofits about how everyone can do better,” America can fill its pipeline once again and create new jobs, revenue and medicine that will improve our health care system.  

January 10, 2011

National Prevention, Health Promotion and Public Health Council: Draft Recommendations Call for Comment

Public Health Council 
On June 10, 2010, the President signed an Executive Order creating the National Prevention, Health Promotion, and Public Health Council. On June 25, 2010, the Council ratified its first status report during a teleconference, and submitted its Annual Status Report  on July 1, 2010. 

An important component of the Affordable Care Act, the National Prevention, Health Promotion, and Public Health Council (National Prevention Council) brings together seventeen federal departments and agencies to plan and coordinate prevention efforts across the government and the nation through the development of the National Prevention and Health Promotion Strategy (National Prevention Strategy). 

Additionally, to provide guidance to the National Prevention Council, the President will establish an Advisory Group on prevention, health promotion, and integrative and public health composed of no more than 25 non-federal members. It is anticipated that the Advisory Group will be announced early in 2011. 

Members of the National Prevention Council include Department of Health and Human Services Secretary Kathleen Sebelius, Department of Veterans Affairs Secretary Eric Shinseki, and a number of other Secretaries and directors. The National Prevention Council, chaired by Surgeon General Regina Benjamin, is charged with providing coordination and leadership at the federal level and among all executive departments and agencies with respect to prevention, wellness and health promotion practices.

The Council is also responsible for making recommendations—with continual public input—to the President and the Congress concerning the nation’s most pressing health issues and on changes to federal policy that will promote health and achieve public health goals, including reducing tobacco use, sedentary behavior, and poor nutrition

Consequently, with input from the public and interested stakeholders, the National Prevention Council is charged with developing a National Prevention and Health Promotion Strategy (National Prevention Strategy) by March 23, 2011. The National Prevention Strategy seeks to shift the nation from a focus on sickness and disease to one based on wellness and prevention. It will present a vision, goals, recommendations and action items that public, private, nonprofit organizations and individuals can take to reduce preventable death, disease and disability in the United States.

The National Prevention Strategy brings together the many sectors that affect the health of Americans, including transportation, education, housing, and health. Implementation of the National Prevention Strategy must include the participation, coordination, leadership, and commitment of all parts of society, including public and private partners, in order to successfully improve the health of Americans.

A Draft Framework to guide the development of the National Prevention Strategy was made available for public comment from October 1 – December 5, 2010. Guided by this public input, the National Prevention Council has now developed a preliminary set of Draft Recommendations- overarching priorities with a focus on communities - that will greatly improve health and wellness in the United States. They have been posted online for public comment. Comments will be accepted until January 13, 2011.

The final National Prevention Strategy will also include specific actions that the federal government and others in the public, private, and non-profit sectors can take to achieve these priority Recommendations.  

The Recommendations and Action Items in the final National Prevention Strategy will be based on evidence-based interventions. It will also reflect the importance of tracking progress to ensure accountability. As National Prevention Council members and Designees receive public input, they will continue to refine the content and plan to release the final National Prevention Strategy in 2011.

National Prevention Strategy

Currently, chronic diseases and conditions account for at least 7 of every 10 deaths in the United States and for more than 75% percent of medical care expenditures. Many of these conditions are preventable. The National Prevention Strategy is designed to bring a focus on the prevention of disease and promotion of wellness to the forefront of efforts that will help lead to longer, healthier, and more productive lives for all Americans.

The National Prevention Strategy will also be aligned with the national health objectives set forth in Healthy People 2020, the First Lady’s Let’s Move! Campaign to combat the epidemic of childhood obesity, the National HIV/AIDS Strategy, the Department of Transportation’s Sustainable Communities, the Office of the National Drug Control Policy’s 2010 National Drug Control Strategy, and many others.

Additionally, four cross-cutting strategic directions, each containing specific recommendations, form the foundation for the National Prevention Strategy.

Healthy Physical, Social and Economic Environments: Create healthy physical, social and economic environments that encompass safe and healthy neighborhoods, worksites, schools, homes and public and green space. These environments should address physical (air, water, land, buildings and other structures) and economic (availably, affordability, fair market, opportunity) factors and social norms that promote health.

Eliminate Health Disparities: Eliminate health disparities experienced by populations (e.g., based on  race/ethnicity, gender, disability status, sexual orientation, socio-economic status, geography) in order to achieve  health equity. These disparities are exacerbated by poverty and inequities in employment, education, housing and others.

Prevention and Public Health Capacity: Build prevention capacity that supports state, Tribal, local, and Territorial efforts to promote health, prevent disability and disease and ensure preparedness for natural and man-made threats and emergencies.

Quality Clinical Preventive Services: Increase use of the most effective and highest impact/priority  evidence-based clinical preventive services and medications, such as the preventive use of aspirin; screening and  treatment for high blood pressure and cholesterol; cancer screening; screening and treatment for HIV, chronic viral  hepatitis, and STDs; and immunizations, among others.

These strategic directions are important in their own right and are applicable to each of the six targeted strategic directions, which include recommendations for:

  • Tobacco-free living
  • Reducing alcohol and drug abuse
  • Healthy eating
  • Active Living
  • Injury-free living, and
  • Mental and emotional wellbeing

Public comments on the Draft Recommendations can be submitted here until January 13, 2011.



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