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How the New HIPAA Regulations Affect Billing Companies and Their Subcontractors as Business Associates - HBMA - Healthcare Billing and Management Association for 1st and 3rd Party Billers - Medical Billing, Practice Management

How the New HIPAA Regulations Affect Billing Companies and Their Subcontractors as Business Associates

Develop an Action Plan for Your Copmany and Subcontractors

An article by Robert A. Polisky, Esq.,  taken from the May/June issue of HBMA Billing.On January 25, 2013, the Office for Civil Rights of the U.S. Department of Health & Human Services (OCR) published the anticipated final omnibus rule (the Final Rule). This rule created significant changes to the Privacy, Security, Breach Notification, and Enforcement Rules under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), many of which are required by the Health Information Technology for Economic and Clinical Health Act (HITECH Act). The Final Rule also implements changes to the Genetic Information Nondiscrimination Act of 2008.
The scope of the Final Rule is extensive, and enhances OCR's ability to enforce HIPAA. In the press release announcing the Final Rule, OCR Director Leon Rodriguez proclaimed that the Final Rule "marks the most sweeping changes to the HIPAA Privacy and Security Rules since they were first implemented" and "strengthen[s] the ability of my office to vigorously enforce the HIPAA privacy and security protections…." Individuals and entities affected by the Final Rule must comply with most of its provisions by September 23, 2013.
This article addresses key provisions of the Final Rule applicable to billing companies and their subcontractors, enforcement changes, and recommended action items needed for compliance by billing companies and their subcontractors.

KEY PROVISIONS

BUSINESS ASSOCIATES AND THEIR SUBCONTRACTORS

Expanded Definition of "Business Associate"
The Final Rule expands the definition of a "business associate" to include any individual or entity that creates, receives, maintains, or transmits protected health information (PHI) on behalf of a covered entity. Companies that code, bill, and/or collect claims on behalf of a health care provider (i.e., a covered entity), are business associates under HIPAA. Notably, the Final Rule includes subcontractors that create, receive, maintain, or transmit PHI on behalf of a business associate as business associates themselves. Thus, any subcontractors that a billing company engages to assist in coding, billing, or collections, and any subcontractors that store or transmit any healthcare records on the billing company's behalf, are business associates of the billing company.

Direct Liability
As business associates, the Final Rule requires billing companies and their subcontractors to comply with the Security Rule's administrative, physical, and technical safeguard requirements as well as with the Security Rule's policies and procedures and documentation requirements. These requirements apply to business associates in the same manner as they apply to covered entities, such that billing companies and their subcontractors can be held civilly and criminally liable for violations of these requirements. Similarly, the Final Rule applies certain Privacy Rule requirements to business associates and establishes direct liability of business associates for violations of these requirements. A billing company does not need to provide a notice of privacy practices or designate a privacy official unless the covered entity designated such a responsibility in the billing company's business associate agreement.

Specifically, billing companies and their subcontractors, as business associates, have direct civil and criminal liability exposure for the following items.

1. impermissible uses and disclosures of PHI
2. failure to provide breach notification to the covered entity
3. failure to provide access to a copy of electronic PHI to either the covered entity, the individual, or the individual's designee (whichever is specified in the business associate agreement)
4. failure to disclose PHI to OCR where required by OCR to investigate or determine the business associate's compliance with HIPAA
5. failure to provide an accounting of disclosures
6. failing to enter into business associate agreements with subcontractors that create or receive PHI on the business associate's behalf
7. failure to comply with the requirements of the Security Rule

Billing companies and their subcontractors also remain contractually liable for all other Privacy Rule obligations that are included in their business associate agreements.
Business Associate Agreements
The Final Rule clarifies that a covered entity is not required to enter into a business associate agreement with a billing company's subcontractor. Rather, the billing company that engaged a subcontractor to perform a function or service involving the use or disclosure of PHI is required to enter into a business associate agreement with the subcontractor. Each business associate agreement in the business associate chain needs to be at least as restrictive as the agreement above it in the chain with respect to permissible uses and disclosures of PHI.
The Final Rule expands the requirements of a business associate agreement by obligating a business associate to comply, where applicable, with the Security Rule with regard to electronic PHI; report breaches of unsecured PHI to the covered entity; and ensure that any subcontractors that create or receive PHI on its behalf agree to the same restrictions and conditions that apply to the business associate with respect to such information.

Transition Period
The Final Rule delays compliance until September 22, 2014 for a covered entity or business associate to enter into a business associate agreement with a business associate or subcontractor if, prior to January 25, 2013, the covered entity or business associate had a business associate agreement with the business associate or subcontractor, as applicable, that complied with HIPAA prior to the Final Rule (unless the business associate agreement was modified or actively renewed between March 26, 2013 and September 23, 2013). In all other cases, covered entities and business associates will need to execute business associate agreements with their business associates and subcontractors no later than September 23, 2013.

MODIFICATION TO THE BREACH NOTIFICATION RULE

Background
Under the HITECH Act, a covered entity is required to notify affected individuals and OCR following discovery of a breach of unsecured PHI; a covered entity also needs to notify the media of a breach involving more than 500 residents of a state or jurisdiction. A business associate, in turn, is required to notify a covered entity following discovery of a breach of unsecured PHI at or by the business associate.On August 24, 2009, OCR issued an interim final rule implementing the HITECH Act's breach notification provisions ("Breach Notification Interim Rule"). In the Breach Notification Interim Rule, a "breach" is defined as the acquisition, access, use, or disclosure of PHI in a manner not permitted under the Privacy Rule that "compromises the security or privacy" of the PHI, with certain exceptions. Moreover, under the Breach Notification Interim Rule, "compromises the security or privacy" of the PHI is defined to mean that an impermissible use or disclosure of PHI poses a significant risk of financial, reputational, or other harm to the individual (the "harm standard").
Revised Definition of "Breach"
The Final Rule significantly revises the definition of "breach" to clarify that an impermissible use or disclosure of PHI is presumed to be a breach unless the covered entity or business associate, as applicable, demonstrates that there is a low probability that the PHI has been compromised. By replacing the "harm standard" with this "low probability" standard, it is more likely under the Final Rule than under the Breach Notification Interim Rule that covered entities and business associates will determine that an impermissible use or disclosure of PHI "compromises the security or privacy" of the PHI, resulting in many required breach notifications that would not have been required previously.
Modification of Risk Assessment
Under the Final Rule, to determine whether there is a low probability that PHI has been compromised, covered entities and business associates need to conduct a risk assessment that considers at least the following factors:

• the nature and extent of the PHI involved, including the types of identifiers and the likelihood of re-identification;
• the unauthorized person who used the PHI or to whom the disclosure was made;
• whether the PHI was actually acquired or viewed; and
• the extent to which the risk to the PHI has been mitigated.

If an evaluation of the above factors, taken together, fails to demonstrate that there is a low probability that PHI has been compromised, breach notification will be required.

RIGHT TO RESTRICT DISCLOSURE TO A HEALTH PLAN

Under the Final Rule, health care providers, upon request from an individual, must agree to restrict disclosure of PHI about the individual to a health plan if the disclosure would be for the purpose of carrying out payment or healthcare operations, and is not otherwise required by law, or the PHI pertains solely to a healthcare item or service for which the individual, or person acting on the individual's behalf (other than the health plan), has paid the covered entity in full. To avoid payment issues, a health care provider may want to require payment in full at the time of the individual's request for a restriction. Health care providers may request assistance from billing companies to comply with this new restricted disclosure requirement.

ENFORCEMENT

Discretion
The Final Rule gives OCR discretion to use informal means to resolve HIPAA violations. However, OCR is permitted to impose a civil monetary penalty without exhausting informal resolution efforts, especially when the HIPAA violation is due to willful neglect. The Final Rule also allows OCR to coordinate with other law enforcement agencies, such as state attorneys general and the Federal Trade Commission, with respect to pursuing remedies against HIPAA violators.
Tiered Penalty Amounts
Under the HITECH Act, there are four tiers of increasing penalty amounts that correspond to the levels of culpability associated with a HIPAA violation. The minimum fines range between $100 and $50,000 per violation, and are capped at $1.5 million for all violations of the same HIPAA provision during any calendar year (see below table). The lowest category of violation covers situations where the covered entity or business associate did not know, and by exercising reasonable diligence would not have known, of the HIPAA violation. The second lowest category of violation applies to violations due to reasonable cause and not to willful neglect. The third category applies to situations where the violation was due to willful neglect and was corrected within 30 days of when the covered entity or business associate knew, or should have known, of the violation. The fourth category applies to situations where the violation was due to willful neglect and not corrected within 30 days of when the covered entity or business associate knew, or should have known, of the violation.
The Final Rule modifies the definition of "reasonable cause" to mean "an act or omission in which a covered entity or business associate knew, or by exercising reasonable diligence would have known, that the act or omission violated [HIPAA], but in which the covered entity or business associate did not act with willful neglect." The Final Rule keeps the definition of "willful neglect" as the "conscious, intentional failure, or reckless indifference to the obligation to comply" with HIPAA.
Counting Violations
In the preamble to the Final Rule, OCR states that how it counts HIPAA violations for purposes of calculating a civil monetary penalty varies depending on the circumstances surrounding the violation. OCR explains that where multiple individuals are affected by a HIPAA violation (e.g., a breach of unsecured PHI), it is anticipated that the number of identical HIPAA violations would be counted by the number of individuals affected. OCR also explained that, with respect to continuing violations (e.g., a lack of appropriate safeguards for a period of time), it is anticipated that the number of identical HIPAA violations would be counted on a per day basis (i.e., the number of days the covered entity or business associate did not have appropriate safeguards in place to protect the PHI). OCR notes that in many HIPAA breach cases, there would be an impermissible use or disclosure as well as a safeguards violation, for each of which OCR would be entitled to calculate a separate civil monetary penalty. Needless to say, the amount of civil monetary penalties that could be imposed against a billing company or one of its subcontractors for a HIPAA violation can be quite substantial.
Factors Used to Determine a Penalty
The Final Rule lists the following five factors that OCR will consider in determining the amount of a civil monetary penalty.

1. the nature and extent of the HIPAA violation, including the number of individuals affected and the duration of the violation
2. the nature and extent of the harm resulting from the violation, including physical, financial, and reputational harm, and any hindrance to an individual's ability to obtain healthcare
3. the history of prior compliance with HIPAA, including whether the current violation is the same/similar to prior indications of noncompliance by the covered entity or business associate and their attempts to correct that noncompliance
4. the financial condition of the covered entity or business associate, including any financial difficulties that could have affected compliance and whether a civil monetary penalty could jeopardize the future provision of healthcare
5. such other matters as justice may require

Agency Liability
The Final Rule makes covered entities and business associates liable for the acts of their business associate agents, regardless of whether the covered entity or business associate knew of the violation or had a compliant business associate agreement in place. According to OCR, the key factor in determining whether an agency relationship exists between a covered entity and its business associate, or between a business associate and its subcontractor, is the principal's right to control the agent's conduct in the course of performing a service on behalf of the principal. OCR observes that a business associate agent's conduct generally is within the scope of agency when its conduct occurs during the performance of the assigned work or incident to such work, regardless of whether the work was done carelessly, a mistake was made in the performance, or the business associate disregarded a covered entity's specific instruction. OCR further observes that, in contrast, a business associate agent's conduct generally is outside the scope of agency when its conduct is solely for its own benefit (or that of a third party), or it pursues a course of conduct not intended to serve any purpose of the covered entity. To protect itself, a billing company's services agreement with a subcontractor should specify that the subcontractor is engaged as an independent contractor, not as an agent, and the billing company does not have the right to control the subcontractor's performance.

RECOMMENDED ACTION ITEMS

Although billing companies and their subcontractors have until September 23, 2013 to fully comply with the Final Rule, they should begin preparing soon in light of the significant number of new or modified compliance obligations. In particular:

• Covered entities will need to revise, negotiate, and execute business associate agreements with billing companies compliant with the Final Rule by September 23, 2013 to the extent they did not have business associate agreements in place as of January 25, 2013 that were HIPAA compliant. They have until September 22, 2014 to do so to the extent they had business associate agreements in place as of January 25, 2013 that were HIPAA compliant. OCR gives a fair amount of latitude in the content of business associate agreements, so it is important for billing companies to ensure that they are not overcommitting to responsibilities or deadlines that are not required under HIPAA.
• Billing companies that use subcontractors that create, receive, maintain, or transmit PHI on their behalf will need to draft, negotiate, and execute business associate agreements with them by September 23, 2013. Billing companies will need to ensure that these business associate agreements are at least as stringent as their business associate agreements with covered entities, and enable billing companies to meet deadlines in their business associate agreements with covered entities.
• Billing companies, including subcontractors, will need to conduct a security risk assessment, implement a written HIPAA security plan, designate a security official, and create certain written HIPAA privacy policies by September 23, 2013 to the extent they have not already done so. OCR has posted guidance on compliance with the HIPAA Security Rule found at www.hhs.gov/ocr/privacy/ hipaa/administrative/securityrule that may be helpful to billing companies and their subcontractors and facilitate their compliance efforts.
• Billing companies and their subcontractors will need to perform a gap analysis to determine what HIPAA policies and procedures need to be revised to comply with the Final Rule, and then will need to revise them by September 23, 2013 based on the gap analysis.
• Billing companies and their subcontractors will need to update by September 23, 2013 their breach notification policies and any tools concerning how to conduct a risk assessment to determine whether breach notification is required.
• Healthcare providers may ask billing companies to implement by September 23, 2013 a method to flag or make a notation in the record with respect to PHI concerning an item or service paid in full by an individual – or person acting on the individual's behalf (other than a health plan) – to ensure that such information is not inadvertently sent to or made accessible to a health plan for payment or healthcare operations purposes, such as audits by the health plan.
• Billing companies and their subcontractors will need to update their HIPAA training materials and then train their workforce members (i.e., employees, volunteers, trainees, and other persons under their direct control) by September 23, 2013 to comply with HIPAA.

Given the breadth and potential penalties under the Final Rule, billing companies and their subcontractors should review their data flows (i.e., the complete lifecycle of PHI that they create, receive, maintain, or transmit) and then perform an updated risk analysis based on that review, including a risk analysis of mobile devices. Billing companies and their subcontractors will need to determine whether to encrypt these devices in light of the increasing prevalence of large penalties imposed by OCR on entities whose mobile devices, such as laptop computers and smartphones, containing unencrypted PHI have been lost or stolen. Further, covered entities and business associates should consider whether it would be cost-effective for them to purchase HIPAA liability insurance given the risk of substantial penalties for HIPAA violations.

---

Robert A. Polisky, principal of the Law Offices of Robert A. Polisky (www.rphealthlaw.com), is a healthcare attorney based in Los Angeles. Robert represents healthcare providers and companies, including billing companies and their subcontractors, in healthcare transactions, healthcare regulatory (including HIPAA, Medicare enrollment and reimbursement, and fraud and abuse), and general business law. Robert opened his law firm last April after spending over 8 years in-house at Alliance HealthCare Services and, for several years before that, working at healthcare law firms, clerking for a federal judge, and interning at the U.S. Department of Justice. 

How the New HIPAA Regulations Affect Billing Companies and Their Subcontractors as Business Associates - HBMA - Healthcare Billing and Management Association for 1st and 3rd Party Billers - Medical Billing, Practice Management

ATTENTION GROUP HEALTH PLAN SPONSORS: ACTION REQUIRED TO COMPLY WITH FINAL HIPAA REGULATIONS

Group health plan sponsors have been focusing to a great extent upon the various
significant requirements imposed by the Patient Protection and Affordable Care Act,
most notably the “play or pay” provisions which become effective in 2014. However,
such sponsors with self-insured plans (including FSAs and HRAs) also need to focus
upon changes to the Health Insurance Portability and Accountability Act (HIPAA)
privacy and security rules which become effective later this year.
Earlier this year, the Department of Health and Human Services (HHS) published
a final rule modifying HIPAA, as amended by the Health Information Technology
for Economic and Clinical Health Act (HITECH) and the Genetic Information
Nondiscrimination Act (GINA). Group health plans, as well as their business
associates, are subject to various changes and generally must comply by September
23, 2013. Accordingly, prompt action is recommended.

The rules are of less concern to fully insured plans, since in those cases plan
sponsors rarely receive protected health information (PHI) other than enrollment and
summary information. Under those circumstances, most HIPAA privacy and security
compliance responsibility rests with the insurer. However, it is of significant relevance
to self-insured health plans maintained by an employer, since the employer then
has access (either directly or through a third party administrator) to the medical
information of its employees and is responsible for complying with HIPAA’s privacy
and security rules.
This Bulletin is not intended to provide an exhaustive summary of the changes
Rather, it is intended to highlight the most significant changes and to suggest action
steps.

Business Associates
The final regulations change the rules for the business associates of group health
plans. Third-party administrators and other consultants or health plan service
providers that have access to PHI in performing services are now directly liable for
the civil and criminal penalties for certain violations of HIPAA. Previously, compliance
had been a contractual obligation pursuant to the written agreement with the covered
entity relative to HIPAA compliance. Therefore, business associates must establish
and maintain policies and procedures to implement required safeguards. Business
associates must enter into written agreements with group health plans and with their
own subcontractors to ensure compliance with HIPAA. Business associates will also
often have a major role in breach notification compliance for group health plans.

The final rule allows for a transition period to renegotiate and revise existing
agreements. Generally, agreements in place as of January 25, 2013 that are not
renewed or modified before September 23, 2013 are considered to be compliant
until they are renewed or modified, or September 22, 2014 if earlier. Agreements
renewed or modified before September 23, 2013 must comply by September 23,
2013. The HHS website contains a revised model business associate agreement.

GINA Compliance
The final regulations implement rules under GINA as it applies to the use and
disclosure of PHI by group health plans and business associates. PHI that is genetic
information may not be used or disclosed for underwriting purposes.

Privacy Policies and Procedures
Self-funded health plans are required to have policies and procedures in place
to protect PHI from unauthorized use and disclosure. Some of those policies and
procedures will need to be revised to reflect the new requirements.

Notice of Privacy Practices
Notices of Privacy Practices will need to be updated to include the following:

• Individuals will be notified upon a breach of PHI.
• The use or disclosure of genetic information for underwriting purposes is
prohibited.
• Written authorization is required for disclosures for marketing purposes and for
the sale of PHI.

The notices will need to be revised and posted on the employer’s website, and copies
of its revised notice should be provided to participants and beneficiaries.

Breach Notification
The final regulations modify the factors that plans and business associates are to
take into account in conducting a “risk assessment” to determine whether a breach
requiring notice to affected individuals, the Department of Health and Human
Services, and in some cases the media, has occurred. A breach requiring notice will
be presumed to have occurred whenever PHI maintained by the plan or business
associate is acquired, accessed, used or disclosed in a manner that violates the
privacy rule. This presumption may be rebutted if the plan or business associate can
demonstrate, pursuant to factors provided under the regulations, that there is a “low
probability” that PHI has been compromised. The previous standard, which required
the violation to pose a “significant risk” of financial, reputational or other harm to the
individual, was eliminated.

Enforcement
The regulations include the civil and criminal penalties that apply to HIPAA violations
by group health plans and their business associates. Monetary penalties vary
according to the number of violations, the cause of such violations, and whether the
group health plan or business associate takes timely action to correct the violation.
Civil penalties can be up to $1.5 million per year for each violation of a standard or
requirement. HHS will continue to conduct random audits and investigate complaints,
and increasingly aggressive enforcement is expected.

Action Items for Group Health Plans
The regulations require immediate action by employers sponsoring self-insured
group health plans and their business associates. Plans need to:

• Update their HIPAA Policies and Procedures, and related administrative forms,
to reflect the final rules.
• For breach notification, replace the “significant risk” standard with the “low
probability” standard in conducting a risk assessment.
• Confirm that genetic information is not used for underwriting purposes.
• Update Notices of Privacy Practices.
• Train personnel who have access to PHI.
• Review business associate agreements and incorporate the final rule’s new requirements. Keep in mind the one year transition rule described above.

Business associates will need to come into compliance with the new rules as well,
including establishing policies and procedures of their own. Business associates will
also need to enter into business associate agreements with their subcontractors. In
that connection, business associates should identify which of their subcontractors
will access, use or disclose PHI in performing their services. Business associates
should also consider whether their existing liability insurance provides coverage for
HIPAA violations and whether new or additional coverage is needed.
Please contact any member of the Health Care Group if you need assistance in
complying with the new HIPAA requirements applicable to self-insured group health
plans.

http://www.murthalaw.com/files/hc__action_required_to_comply_with_final_hipaa_regs_6_2013_copy1.pdf

$585 Million to support Destination Medical Center, a Mayo Clinic project...

Mayo Clinic expansion shows local costs of growth

Published 6:11am Saturday, June 22, 2013

ROCHESTER — In the heart of this southeastern Minnesota city, the Mayo Clinic is building a massive radiation treatment facility that’s expected to draw cancer patients from across the country and perhaps around the world.

The development spotlights a difficult issue faced by clinic officials and the state.

The Legislature in May approved $585 million in future taxpayer support for an economic development project called Destination Medical Center. The plan is to make Rochester a more appealing destination not just for people seeking radiation treatments, but also for the many other faraway patients who travel here for care.

Minnesota policymakers are also dabbling with what experts say is a more fundamental dilemma for the nation’s health care system. The state is now looking for Mayo Clinic to dramatically expand the regional economy, just as doctors and hospitals are being asked to rein in runaway health costs.

“If the costs grow less rapidly, so do the jobs,” Mark Pauly, a professor of health care management at the University of Pennsylvania’s Wharton School said of the national dilemma. “From a policy point of view, that hasn’t been reconciled.”

Mayo Clinic officials contend they’re uniquely prepared to simultaneously satisfy both demands.

By providing high-quality, efficient care while expanding operations in Rochester, the clinic plans to survive and prosper even as cost pressures might force other medical centers to shrink, said Dr.

Brad Narr, Mayo Clinic’s medical director for Destination Medical Center.

“I think there are going to be winners and there are going to be people that are going to be left in the dust,” Narr said. “And it’s going to hinge on what we’re actually doing as a medical system that improves people’s lives and provides value.”

Unclear plans

There are still many unanswered questions about Destination Medical Center.

Mayo Clinic officials haven’t said exactly how they will invest the $3.5 billion

they’ve committed to spend over 20 years. It’s also not clear what sort of investment will come from other private parties who are expected to spend up to $2.1 billion.

All told, the project will create about 30,000 jobs, supporters predict, but it’s not clear when that will happen.

State and local taxpayers are being asked to invest in infrastructure projects that could range from land purchases and building demolitions to the construction of a large atrium where Mayo Clinic visitors could escape harsh Minnesota winters.

Next steps include the appointment of board members to a nonprofit economic development corporation for Destination Medical Center and creation by the clinic of a nonprofit economic development agency.

“This (agency) is what will do the legwork — tee the projects up, make it easy for this public funding … to align with the goal of a destination medical center,” Narr said.

He added that it’s “similar to what the city of Anaheim (Calif.) aligned with to make sure that Disneyland came to be what it is.”

Narr isn’t alone in making references to Disney when talking about Destination Medical Center.

“When Disney World was built (in Orlando, Fla.), it was $311 million,” said state Sen. David Senjem, R-Rochester. “If you fast forward and do the inflation calculator, that’s $1.7 billion today.”

“Mayo is saying, ‘We’re going to invest $5.5 billion’ ” combined with other private parties, Senjem said. “By today’s cash values, that’s three Disney Worlds in downtown Rochester.”

Export potential

Such dreams of growth are tantalizing communities across the country. Mayo Clinic’s pitch at the Legislature referred to public funding for economic development projects connected to big-name hospitals and clinics in Baltimore, Cleveland and Houston.

Pittsburgh turned to its health care sector for growth after the demise of the steel industry. Even Detroit has discussed trying to become a medical mecca — a development that caught the attention of researchers at the Center for Studying Health System Change, a health policy group in Washington, D.C.

In 2011, researchers at the center published an article about how localities hope that health care expansions will create high-paying jobs as the population ages. To the extent the projects can draw patients from outside the region — or even the country — health care can serve as an export product that creates local jobs paid for by faraway patients.

But there’s a limit to this export potential, the researchers wrote, because most patients opt for care close to home.

Mayo Clinic is famous for attracting patients from afar. Yet even the clinic draws only 20 percent of its Medicare patients from outside its home base in Minnesota, Iowa and Wisconsin, researchers wrote, and only about 2 percent of surgery patients come from overseas.

Unless regional health care projects draw new patients from afar, expanded services might simply lead to greater use of those services by local patients. Health insurance premiums would go up as a result, researchers wrote, and costs would be shifted to the federal government through Medicare payments for services.

“If all of the costs of increased health spending were financed by local residents, the attractiveness of strategies to expand the health care sector would be diminished,” researchers wrote.

“Health care spending and costs are a big deal, and we need to address them,” said Alwyn Cassil of the Center for Studying Health System Change. “Yet the state hospital associations are constantly putting out reports on the economic benefits that the health industry provides to local economies.

“There’s a huge disconnect there.”

‘Positioned to grow’

At the Mayo Clinic, the plan for growth with Destination Medical Center is focused on drawing patients from outside Minnesota, said Narr, the project’s medical director.

Mayo wants to be a destination for patients seeking second opinions and dealing with “curveballs” that have stumped hometown medical centers, Narr said. The clinic will also maintain expertise, he said, in treating complex medical conditions for which patients need care that’s well-coordinated among different medical specialties.

Mayo Clinic in 2011 launched a subscription service through which hospitals around the country can consult with doctors in Rochester about complicated patient care issues. Currently, 18 medical centers are part of the Mayo Clinic Care Network, which is meant to allow most patients to stay at local hospitals while directing a few to Rochester for advanced care when needed.

With Destination Medical Center, how many more patients might come to Rochester?

In an April interview, Senjem said he was told the Mayo Clinic needs to double its patient base in Rochester to about 600,000 patients per year. Mayo Clinic officials, however, would not comment on the projection or offer specifics about growth plans.

“As the public reporting of outcomes, quality, safety (and) service occurs, we are positioned to grow,” said Karl Oestreich, a clinic spokesman, in a prepared response to questions.

Lowering risks

Over the years, Mayo Clinic has made big investments in reporting systems to gauge health care quality and efficiency, Narr said, and physicians believe the data will help prove their value to patients. With the proof, Mayo Clinic expects to distinguish itself from other hospital and clinic systems and thereby survive whatever consolidation comes to the industry.

The status quo in health care is “bankrupting the nation,” Narr told state legislators in April. The concern helps explain why Mayo Clinic in January announced an agreement with Minnetonka-based health insurance giant UnitedHealth Group for research on getting more value from health care spending.

Mayo Clinic doctors are in a position to focus on efficiency and quality because they are paid salaries, Narr said, rather than collecting fees for each service they provide. Critics of the fee-for-service payment system say it creates an incentive for non-salary doctors to provide unnecessary and wasteful care.

A case in point is prostate cancer surgery. Up until a few years ago, surgical removal of the prostate to treat cancer, Narr said, was the single most common operation performed by Mayo Clinic surgeons in Rochester.

The surgery brings a significant risk of impotence and incontinence for men who undergo the procedure, but Mayo Clinic was at the forefront of improving the operation, Narr said. The high volume of surgeries generated significant revenue for the clinic in the process.

But over time, the clinic and experts across the country started realizing that screening tests were directing far too many men down a path toward surgery when they may not have needed it. Mayo Clinic abruptly changed course.

“We were doing 1,100 (surgeries) per year,” Narr said. “Over the last three years, we’ve gone from 1,100 to 950 to 600. We are doing the ones, I believe, that are indicated right now, and we do them safely and effectively because we’re tracking the outcomes.”

“In smaller areas, what they do with the prostate is between the patient, the doctor and the malpractice attorney — and they’re not tracking those things,” he said. Quality tracking systems that gauge value are “a huge cost to us — it’s part of our big cost infrastructure. But eventually, that’s going to be the norm, and we want to be ready for it.”

Focusing on value

The focus on value is where the U.S. health system needs to go, said Dr. David Goodman, a health policy expert at Dartmouth Medical School.

Mayo Clinic has a reputation for being very efficient in treating Rochester patients covered by Medicare, Goodman said. The clinic’s quality scores for treating Medicare patients also are good, he said.

If Destination Medical Center means the clinic gets bigger so it can provide high-quality, efficient treatment to more patients, that could be good for Rochester and the nation, Goodman said. But the focus needs to remain on value, he said, not jobs.

“Thirty thousand jobs sounds great to the local area,” Goodman said. “But it represents a tremendous amount of money that could be coming out of other health care systems, if they aren’t providing that care, or from employers and the government.”

“Rochester’s gain might be the nation’s loss,” he said, “if there isn’t substantially greater value in the services they’re providing.”

http://www.austindailyherald.com/2013/06/22/mayo-clinic-expansion-shows-local-costs-of-growth/

Part C Medicare Advantage Reporting Requirements and Supporting Regulations

This Notice document was issued by the Centers for Medicare Medicaid Services (CMS)

For related information, Open Docket Folder 

Action

Notice.

Summary

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in theFederal Registerconcerning each proposed collection of information (including each proposedextension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

Dates

Comments must be received by August 20, 2013.

Addresses

When commenting, please reference the document identifier or OMB control number (OCN). To be assured consideration, comments and recommendations must be submitted in any one of the following ways:

1. Electronically. You may send your comments electronically to http://www.regulations.gov. Follow the instructions for “Comment or Submission” or “More Search Options” to find the information collection document(s) that are accepting comments.

2. By regular mail. You may mail written comments to the following address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: Document Identifier/OMB Control Number ___, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850.

To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following:

1. Access CMS' Web site address at http://www.cms.hhs.gov/PaperworkReductionActof1995.

2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to Paperwork@cms.hhs.gov.

3. Call the Reports Clearance Office at (410) 786-1326.

For Further Information Contact

Reports Clearance Office at (410) 786-1326.

Supplementary Information

This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (seeADDRESSES).

CMS-10116Conditions for Payment of Power Mobility Devices, including Power Wheelchairs and Power-Operated Vehicles.

CMS-R-245Medicare and Medicaid Programs OASIS Collection Requirements as Part of the CoPs for HHAs and Supp. Regs. in 42 CFR 48.55, 484.205, 484.245, 484.250.

CMS-1572Home Health Agency Survey and Deficiencies Report.

CMS-250-254Medicare Secondary Payer Information Collection and Supporting Regulations.

CMS-379Financial Statement of Debtor and Supporting Regulations.

CMS-4040Request for Enrollment in Supplementary Medical Insurance.

CMS-10174Collection of Prescription Drug Event Data from Contracted Part D Providers for Payment.

CMS-10261Part C Medicare Advantage Reporting Requirements and Supporting Regulations.

CMS-R-285Request for Retirement Benefit Information.

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a 60-day notice in theFederal Registerconcerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice.

Information Collections

1. Type of Information Collection Request: Reinstatement without change of a previously approved collection; Title of Information Collection: Conditions for Payment of Power Mobility Devices, including Power Wheelchairs and Power-Operated Vehicles; Use: We are renewing our request for approval for the collection requirements associated with the final rule, CMS-3017-F (71 FR 17021), which published on April 5, 2006, and required a face-to-face examination of the beneficiary by the physician or treating practitioner, a written prescription, and receipt of pertinent parts of the medical record by the supplier within 45 days after the face-to-face examination that the durable medical equipment (DME) suppliers maintain in their records and make available to CMS and its agents upon request. Form Number: CMS-10116 (OCN: 0938-0971); Frequency: Yearly; Affected Public: Private Sector—Business or other for-profits; Number of Respondents: 90,521; Number of Responses: 173,810; Total Annual Hours: 34,762. (For policy questions regarding this collection contact Susan Miller at 410-786-2118.)

2. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: OASIS Collection Requirements as Part of the CoPs for HHAs and Supporting Regulations; Use: The OASIS data set is currently mandated for use by Home Health Agencies (HHAs) as a condition of participation (CoP) in the Medicare program. Since 1999, the Medicare CoPs have mandated that HHAs use the OASIS data set when evaluating adult non-maternity patients receiving skilled services. The OASIS is a core standard assessment data set that agencies integrate into their own patient-specific, comprehensive assessment to identify each patient's need for home care that meets the patient's medical, nursing, rehabilitative, social, and discharge planning needs. Form Number: CMS-R-245 (OCN: 0938-0760); Frequency: Occasionally; Affected Public: Private Sector (Business or other for-profit and Not-for-profit institutions); Number of Respondents: 12,014; Total Annual Responses: 17,268,890; Total Annual Hours: 15,305,484. (For policy questions regarding this collection contact Robin Dowell at 410-786-0060.)

3. Type of Information Collection Request: Reinstatement with change of a previously approved collection; Title of Information Collection: Home Health Agency Survey and Deficiencies Report; Use: In order to participate in the Medicare Program as a Home Health Agency (HHA) provider, the HHA must meet federal standards. This form is used to record information and patients' health and provider compliance with requirements and to report the information to the federal government. Form Number: CMS-1572 (OCN: 0938-0355); Frequency: Yearly; Affected Public: State, Local or Tribal Government; Number of Respondents: 3,830; Total Annual Responses: 3,830; Total Annual Hours: 958. (For policy questions regarding this collection contact Patricia Sevast at 410-786-8135.)

4. Type of Information Collection Request: Reinstatement without changeof a previously approved collection; Title of Information Collection: Medicare Secondary Payer Information Collection and Supporting Regulations; Use: We are seeking to renew approval to collect information from beneficiaries, providers, physicians, insurers, and suppliers on health insurance coverage that is primary to Medicare. Collecting this information allows us to identify those Medicare beneficiaries who are in situations where Medicare is statutorily required to be a secondary payer (MSP), thereby safeguarding the Medicare Trust Fund. Specifically, we use the information to accurately process and pay Medicare claims and to make necessary recoveries in accordance with § 1862(b) of the Act (42 U.S.C. 1395y(b)). If an active MSP situation is identified and Medicare is inappropriately billed as primary, the claim will be rejected. The hospitals, other providers, physicians, pharmacies, and suppliers use the information collected (and furnished to them on the denial) to properly bill the appropriate primary payer. Completing an MSP questionnaire and making an accurate MSP determination helps hospitals, other providers, physicians, pharmacies, and suppliers to bill correctly the first time, saving the Medicare Program money and affording Medicare beneficiaries an enhanced level of customer service (which, again, is particularly important in Part D due to the real-time adjudication of claims and the complicated nature of its benefit administration). Insurers, underwriters, third party administrators, and self-insured/self-administered employers use the information to ensure compliance with the law by refunding any identified mistaken payments to Medicare. Form Number: CMS-250-254 (OCN: 0938-0214); Frequency: Occasionally; Affected Public: Individuals and Households, Private Sector, State, Local or Tribal Governments; Number of Respondents: 143,070,217; Total Annual Responses: 143,070,217; Total Annual Hours: 1,788,057. (For policy questions regarding this collection contact Ward Marsh at 410-786-6473.)

5. Type of Information Collection Request: Reinstatement without change of a previously approved collection; Title of Information Collection: Financial Statement of Debtor and Supporting Regulations; Use: The form CMS-379 is used to collect financial information which is needed to evaluate requests from physicians and suppliers to pay indebtedness under an extended repayment schedule, or to compromise a debt less than the full amount. Normally, when a Medicare Administrative Contractor (MAC) overpays a physician or supplier, the overpayment is associated with a single claim, and the amount of the overpayment is moderate. In these cases, the physician/supplier usually refunds the overpaid amount in a lump sum. Alternatively, the MAC may recoup the overpaid amount against future payments. A recoupment is the recovery by Medicare of any outstanding Medicare debt by reducing present or future Medicare payments and applying the amount withheld to the indebtedness. The recoupment can be made only if the physician or supplier accepts assignment since the MAC makes payment to the physician or supplier only on assigned claims.

Sometimes, however, an overpayment to a physician or supplier is exceptionally large, and it cannot be recovered in the normal fashion. The large overpayment usually results from aberrant billing practices, such as billing for more expensive services than were rendered. This could be discovered during routine review of a statistically valid sample of claims. The physician or supplier may be unable to refund a large overpaid amount in a single payment. The MAC cannot recover the overpayment by recoupment if the physician/supplier does not accept assignment of future claims, or is not expected to file future claims because of going out of business, illness or death. In these unusual circumstances, the MAC has authority to approve or deny extended repayment schedules up to 12 months, or may recommend to that we approve up to 60 months. Before the MAC takes these actions, the MAC will require full documentation of the physician's or supplier's financial situation. Thus, the physician or supplier must complete form CMS-379. Form Number: CMS-379 (OCN: 0938-0270); Frequency: Occasionally; Affected Public: Private Sector—Business or other for-profits; Number of Respondents: 500; Total Annual Responses: 500; Total Annual Hours: 1,000. (For policy questions regarding this collection contact Ronke Fabayo at 410-786-4460.)

6. Type of Information Collection Request: Reinstatement without change of a previously approved collection; Title of Information Collection: Request for Enrollment in Supplementary Medical Insurance; Use: Form CMS-4040 (and CMS-4040SP) is used to establish entitlement to and enrollment in Medicare Part B for beneficiaries who file for Part B only. The collected information is used to determine entitlement for individuals who meet the requirements in section 1836(2) of the Social Security Act as well as the entitlement of the applicant or their spouses to an annuity paid by OPM for premium deduction purposes. Form Number: CMS-4040 (OCN: 0938-0245); Frequency: Once; Affected Public: Individuals or households; Number of Respondents: 10,000; Total Annual Responses: 10,000; Total Annual Hours: 2,500. (For policy questions regarding this collection contact Lindsay Smith at 410-786-6843.)

7. Type of Information Collection Request: Reinstatement without change of a previously approved collection; Title of Information Collection: Collection of Prescription Drug Event Data from Contracted Part D Providers for Payment; Use: The information users would include Pharmacy Benefit Managers, third party administrators and pharmacies and prescription drug plans, Medicare Advantage plans that offer integrated prescription drug and health care coverage, Fallbacks and other plans that offer coverage of outpatient prescription drugs under the Medicare Part D benefit to Medicare beneficiaries. The data is used primarily for payment, but is also used for claim validation as well as for other legislated functions such as quality monitoring, program integrity, and oversight. Form Number: CMS-10174 (OCN: 0938-0982); Frequency: Monthly; Affected Public: Private sector (business or other for-profits and not-for-profit institutions); Number of Respondents: 747; Total Annual Responses: 947,881,770; Total Annual Hours: 1,896. (For policy questions regarding this collection contact Ivan Iveljic at 410-786-3312.)

8. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Part C Medicare Advantage Reporting Requirements and Supporting Regulations; Use: There are a number of information users of Part C reporting, including CMS central and regional office staff that use this information to monitor health plans and to hold them accountable for their performance, researchers, and other government agencies such as GAO. Health plans can use this information to measure and benchmark their performance. We intend to make some of these data available for public reporting as “display measures” in 2013. Form Number: CMS-10261 (OCN: 0938-1054); Frequency: Yearly and semi-annually; Affected Public: Private sector (business or other for-profits); Number of Respondents: 588; Total Annual Responses: 6,715; Total Annual Hours: 200,918. (For policy questionsregarding this collection contact Terry Lied at 410-786-8973.)

9. Type of Information Collection Request: Reinstatement without change of a previously approved collection; Title of Information Collection: Request for Retirement Benefit Information; Use: Section 1818(d)(5) of the Social Security Act provides that former state and local government employees (who are age 65 or older, have been entitled to Premium Part A for at least 7 years, and did not have the premium paid for by a state, a political subdivision of a state, or an agency or instrumentality of one or more states or political subdivisions) may have the Part A premium reduced to zero. These individuals must also have 10 years of employment with the state or local government employer or a combination of 10 years of employment with a state or local government employer and a non-government employer. Form CMS-R-285 is an essential part of the process of determining whether an individual qualifies for the premium reduction. The Social Security Administration will use this information to help determine whether a beneficiary meets the requirements for reduction of the Part A premium. Form Number: CMS-R-285 (OCN: 0938-0769). Frequency: Once. Affected Public: State, Local, or Tribal Governments; Number of Respondents: 500; Total Annual Responses: 500; Total Annual Hours: 125. (For policy questions regarding this collection contact Lindsay Smith at 410-786-6843.)

Dated: June 18, 2013.

Martique Jones,

Deputy Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs.

[FR Doc. 2013-14878 Filed 6-20-13; 8:45 am]

BILLING CODE 4120-01-P

A hub for healthcare innovation is taking shape - Business Monday - MiamiHerald.com

Robert Chavez, executive director of ProjectLift Miami, works with accelerator entrepenuers at the Miami Innovation Center at the UM Life Science & Technology Park. Alex M Sanchez / Miami Herald Staff

BY KAREN BURKETT

KBURKETT@MIAMIHERALD.COM

Many U.S. cities are competing to bring biotech companies and jobs to their communities, places like Phoenix, Buffalo, Gainesville and of course, Miami. They all want to develop an industry cluster, and while cities like San Diego and Boston have already successfully grown theirs, Miami’s efforts are still somewhat nascent.

Less than a year ago though, the Miami Innovation Center opened its doors for business at the University of Miami Life Science & Technology Park. The Miami Innovation Center caters to startups and small businesses with a mix of offices, labs and co-working spaces.

UM’s Life Science & Technology Park sits on about 10 acres near Jackson Memorial Hospital and UM’s medical school, between Northwest 17th and 20th streets and between Seventh Avenue and Interstate 95 in Miami. The signage for the Life Sciences building is prominent, visible to most highway drivers, but it doesn’t tell the full story of just who owns what. This is a project very much born out of partnerships. The university owns the land, but Wexford Science & Technology developed the building. So far, the developer says 75 percent of the office space has been leased, and tenants are mostly from the biotech sector. One of the most recent companies to locate in the park is DaVita, which focuses on kidney disease and dialysis treatments.

Dr. Joshua Hare, the director of the UM Interdisciplinary Stem Cell Institute, and his company Vestion, is also one of the tenants. Vestion is focused on developing regenerative therapies for conditions like heart attacks.

Richard Schuchts, co-founder of the Miami Innovation Center, describes Hare as one of the research park’s superstars. “I think one day we’re going to tell children there was a time people died from heart disease and we didn’t have stem cells and children won’t believe it,” says Schuchts.

Not only is Schuchts, who has a background in commercial real estate, sold on the wonders of science and research, but he’s bullish about the physical assets of the Life Science & Technology Park building and its location. The facility offers equipment specifically designed for research scientists: an autoclave, an industrial ice machine, an emergency shower and eye wash, and ventilated fume hoods.

The land was strategically chosen in the area now referred to as Miami’s Health District, not simply because of its proximity to UM and Jackson but also for sheer numbers. Between those two systems, Ryder Trauma Center and the VA Hospital, Miami’s Health District is the second-largest in the country, serving more patients than any other metro area besides Houston.

Every company in the Life Science Park does not have to be a health or biotech company, as there is also a push to diversify the mix of tenants to create a dynamic collaborative overlap. K Hage, a Brazilian-owned fashion technology company that leased office space last year, is one example of a non-science business whose employees walk the halls. The Miami-Dade Chamber of Commerce, which serves local minority entrepreneurs and businesses, also has offices in the building.

The park, which also hosts technology, entrepreneurship and healthcare-related events, is also home to more than just seasoned entrepreneurs. Six weeks ago, five startups entered the facility’s inaugural seed accelerator program, called ProjectLift Miami, which is located within the Miami Innovation Center. ProjectLift initially intended to accept 15 startups but realizes now how much more attention the smaller number of companies get.

“Leadership wants to shepherd all of them now,” says Robert Chavez, executive director of ProjectLift Miami. “If there were 15 in this early stage, mentors would have probably focused on one or two companies.”

The crew of entrepreneurs went through rigorous testing and an extensive application process to make sure their ideas were solid and their personalities were flexible. Companies selected get a package of funding, mentoring, services and work space in exchange for 7 percent equity.

Chavez says he has learned a lot working with this first class, but he wanted to be sure he evaluated the businesses on the potential for job growth and industry impact. Venture capital raised comes much further down on his list of priorities. “This is the healthcare sector. If they’re saving lives and creating jobs, dollars will come,” says Chavez.

The five companies have about 90 days to get instruction and mentoring, business resources, technology services, warm introductions and access to the health district.

Crystal Ice, CEO of Alert.MD, was living off savings and faith until ProjectLift came along. She and partner Dr. Dale Taylor, the company’s chief medical officer, didn’t necessarily consider themselves “businesspeople” when they got started.

Ice and Taylor developed their Alert.MD emergency identification system because of professional experiences.

As a resident, Dr. Taylor remembered having to care for patients without any information about their medical history. He thought what if there was a button you could just push.

“If an elderly person were to come in the ER and we just have a license to go by we have no one to contact to let them know they’re even in the hospital. Much less find out past medical history, medication allergies,” says Taylor.

Alert.MD is an app for your cellphone.

Read more here: http://www.miamiherald.com/2013/06/22/v-fullstory/3465795/a-hub-for-healthcare-innovation.html#storylink=cpy

A hub for healthcare innovation is taking shape - Business Monday - MiamiHerald.com

The Digital Takeover of America’s Health Care System

6/23/2013 – Kameron Gifford, CPC

Eric Schmidt of Google recently pointed out that from the dawn of civilization to 2003 there were a total of 5 exabytes or 1 billion gigabytes of data total. Today, we are producing a minimum of 5 exabytes every 2 days. That is incredible. This powerful explosion into “Big Data” was made possible by advancements in technology such as the smart phone, cloud servers and remarkable biosensors. Consumers have harnessed this technology to drive revolutions in every industry outside of healthcare. The internet allowed a frontier for the convergence of influence and technology capable of altering an entire culture. Could the internet be the one technology that has fundamentally changed the clinical practice of medicine more than any other advancement? Will a new generation of tech savy consumers finally force a transition from population based health into a new era of individualized medicine? Will the next generation of patient-centered care focus on what is best for the individual patient and not big business?
Consider these statistics from 2011:

•   42% of Internet users went online to find health information for self-diagnosis or treatment.
•  38% of users ages 65 and older went online for medical research.
• 48% of Internet users with an annual income over 100,000 used the internet to research information on health plans or practitioners.
• 37% of internet users between the ages 25 and 44 and 35% of users between the ages of 45 and 64 also went online to find information on health plans and physicians.

Powerful indications that the internet does have the ability to engage users and improve overall healthcare outcomes. An open space filled with collective tools that lay the groundwork for a new era of medicine. This is the end of generalized, population based approaches to care. The future will be dominated by those with a vision of something better. This new journey will be empowered by the digitalization of human beings.  Influenced and controlled by those who understand innovation. The convergence of this technology to decode and define individual granularity at the molecular level, from womb to tomb, will enhance the experience for all stake holders.

In 2010, Dr. Richard Ablin, the pathologist who discovered the PSA in 1970, wrote an Op-Ed that was published in the New York Times entitled, “The Great Prostate Mistake”. Dr. Ablin wrote, “The tests popularity has led to a hugely expensive public disaster. The medical community must confront reality and stop the inappropriate use of PSA screening. Doing so would save billions of dollars and rescue millions of men from unnecessary, debilitating treatments.”

In “The Creative Destruction of Medicine” Dr. Eric Topol introduces us to his friend who is 1 of 250,000 men in America every year who are subjected to serial prostate biopsies subsequent to a false positive PSA test. This mass screening of 30 million men every year costs the United States $3 billion annually and that doesn’t include the cumulative costs of all the biopsies, surgeries, treatments and the complications of the surgery such as urinary incontinence or impotence. Is this the best that we can do?

A mediocre healthcare system that wastes billions and is incapable of meaningful engaement. A system in which we allow pharmaceutical companies to spend $14 billion a year to influence the 600,000 people who can write a prescription.  A system in which we have enabled corporations to dictate treatment plans of friends and family members.

Science and technology have provided consumers with the crucial tools for disruption. The hostile takeover of our health care system is as inevitable as it is necessary. We must embrace this unique opportune, moment in medicine, a once in a lifetime Kairos.

***the entire report from the US Dept. of Commerce can be downloaded here:  Exploring the Digital Nation: America's Emerging Online Experience - See more at: http://www.ermconsultinginc.com/resources/