Government Health Care United States Buyers Guide

Winter Quarter Publication 2014

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The Government Health Care Buyers Guide for the United States is a quarterly publication that provides relevant, up-to-date information on the nation’s health care industry. This magazine covers every relevant topic: from legislation proposals to advancements in medical research, from policy updates to contract awards, from FDA news to information on industrial and government health care events. Please call our corporate office at (805) 845-4921 for inquiries, comments, and suggestions.

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Government Health Care Publication

Inside this Guide

NewsConnecture Acquires DRX........................………..…….......................................................…..6HHS Strengthens Community Living Options for the Elderly and Disabled…...……..7Report Finds PBM Could Reduce Rx Costs by $35 Million………..8Vantage Health Receives License After NASA and Nanobeak Enter Agreement………...10Independent Pharmacies to Fill Medication Gaps for Obamacare Enrollees ……..…..11DOD Awards Carestream a $70.2 Contract for X-ray Imaging Systems………..12CVS Caremark to Help Customers Access Care with New Affordable Care Coverage……14States Receive $307 Million in Bonuses for Enrolling Children in Health Coverage……….15Partnerships Between Doctors & Hospitals Strengthen Care for Medicare Beneficiaries……16New State Exchange Enrollment Projections Illuminate 2014 Healthcare Marketplace……18Health Centers to Help Uninsured Americans Gain Affordable Health Insurance Coverage………19BioNeutral Announces U.S. Distribution Agreement with BioTech Medical………...20HHS Announces Affordable Care Act Mental Health Services Funding………..22Veterans Affairs Awards 5-Yr Contract to AMC Health.……..............................23More Uninsured African Americans may be Eligible for Credits in the Insurance Marketplace…24FDA Approves Sovaldi for Chronic Hepatitis C………....................................................26Veterans to Receive 1.5 Percent Cost-of-Living Increase………...........................................27FDA Approves New Treatment for Hepatitis C Virus………............................................28VA Offers Dental Insurance Program……….....................................................................30FDA Approves Medical Device to Treat Epilepsy……….................................................32Administration Issues Final Mental Health & Substance Use Disorder Parity Rule…..33FDA Approves Gazyva for Chronic Lymphocytic Leukemia………...........................34

EventsHealth Care Innovation Day........................................................................................................36Next Generation Healthcare Facilities Summit......................................................................37Health Care Project Management..............................................................................................38HIMSS Annual Conference & Exhibition...................................................................................39

Table of Contents

News

Connecture Acquires DRX, a Leading Provider of Information Systems for Medicare

Acquisition Brings Together the Competencies Needed to Create an Integrated Online Health Plan Distribution Platform That Simultaneously Meets the Needs of the Commercial Insurance Industry and Government Health Plan Marketplaces, including Medicare.

January 17, 2013

BROOKFIELD, Wis. – Connecture, Inc., the leader in sales automation technology for the health insurance industry, today announced it acquired DRX (formerly known as DestinationRx), a provider of Web-based shopping and enrollment systems for consumers of Medicare health plans, as well as those used to compare name brand pharmaceuticals with therapeutic alternatives. DRX powers the Medicare.gov PlanFinder and Online Enrollment Center and serves many of the nation’s largest health plans, pharmacy benefit managers, brokers and senior advocacy groups. The company is based in Los Angeles.

“This acquisition brings together the people and skills required to create an integrated distribution platform for health plans that is able to simultaneously address the needs of the commercial insurance and government health plan marketplaces, for the first time,” said Doug Schneider, CEO of Connecture.

The acquisition builds on a natural synergy between the two companies. Connecture is a leader in the commercial insurance market for individual and small group plans, as well as private exchanges, and is one of the first companies to create the shopping and enrollment systems for state and federal partnership exchanges. DRX is a leader in the federal arena and Medicare, the comparison of therapeutic pharmaceuticals, and in multi-payer private exchanges used by large groups.

“President of Connecture and co-founder Dan Maynard will serve as general manager of DRX. Randy Herman, CEO and president of DRX, is leaving the company to pursue other interests.

Policy

HHS Strengthens Community Living for Options for Older Americans and People with Disabilities

January 10, 2014

WASHINGTON DC - The Centers for Medicare & Medicaid Services (CMS) issued a final rule today to ensure that Medicaid’s home and community-based services programs provide full access to the benefits of community living and offer services in the most integrated settings. The rule, as part of the Affordable Care Act, supports the Department of Health and Human Services’ Community Living Initiative. The initiative was launched in 2009 to develop and implement innovative strategies to increase opportunities for Americans with disabilities and older adults to enjoy meaningful community living.

Under the final rule, Medicaid programs will support home and community-based settings that serve as an alternative to institutional care and that take into account the quality of individuals’ experiences. The final rule includes a transitional period for states to ensure that their programs meet the home and community-based services settings requirements. Technical assistance will also be available for states.

“People with disabilities and older adults have a right to live, work, and participate in the greater community. HHS, through its Community Living Initiative, has been expanding and improving the community services necessary to make this a reality,” said HHS Secretary Kathleen Sebelius. “Today’s announcement will help ensure that all people participating in Medicaid home and community-based services programs have full access to the benefits of community living.”

In addition to defining home and community-based settings, the final rule implements the Section 1915(i) home and community-based services State Plan option. This includes new flexibility provided by the Affordable Care Act that gives states additional options for expanding home and community-based services and to target services to specific populations. It also amends the 1915(c) home and community-based services waiver program to add new person-centered planning requirements, allow states to combine multiple target populations in one waiver, and streamlines waiver administration.

Policy

New Alabama Medicaid Commission Report Finds PBM Could Reduce Rx Costs by $35

Million Annually PBM Option Protects Access to Prescription Drugs

January 7, 2014

WASHINGTON DC - A new report by the Alabama Medicaid Pharmacy Study Commission shows pharmacy benefit managers (PBMs) can reduce costs in the state’s Medicaid program up to $35 million over a one-year period. The commission’s report also emphasized that PBMs can reduce wasteful spending while engaging a robust network of independent pharmacies and protecting patient access to prescription drugs.

“Alabama’s Medicaid program can dramatically reduce costs by simply applying best practices already used by Medicare and other large payers that offer pharmacy benefits,” said Pharmaceutical Care Management Association (PCMA) President and CEO Mark Merritt. “Fortunately, this can be done in a way that protects patient benefits and avoids cutting payments to hospitals and doctors.”

The commission was established by Governor Robert Bentley in June 2013 to review ways to reduce wasteful spending in Medicaid and its findings are in line with other research that finds modernizing state Medicaid programs will lead to significant savings. Of the three proposals submitted to the commission, the PBM option is estimated to save the most overall ($13 million to as much as $35 million over a one-year period).

The National Center for Policy Analysis (NCPA) also recently issued a report on Alabama’s Medicaid program that shows the state could utilize various PBM tools to lower costs. NCPA is a nonprofit, nonpartisan public policy research organization that develops private, free-market alternatives to government regulation that rely on the strength of the competitive, entrepreneurial private sector.

The study projects how much Alabama’s Medicaid program could save by avoiding drugstore overpayments and using pharmacies that offer better rates.

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News

Vantage Health Receives License After NASA and Nanobeak Enter Into an Exclusive Five-Year

Commercial License Agreement January 7, 2014

REDWOOD CITY, CA - Vantage Health Inc., (OTCQB: VNTH) and its parent company Nanobeak Inc. today announced that NASA and Nanobeak have entered into an exclusive 5-year license agreement to commercialize mobile healthcare products derived from NASA patented chemical sensing technology. This exclusive 5-year license agreement has been sublicensed to Vantage Health Inc.

Telemedicine and mobile healthcare is formed by the intersection of medicine and digital technology. Nanobeak and Vantage Health have been developing sensor based mobile applications based on patented NASA technology, for non-invasive disease screening at the earliest stages, to be implemented for point of care and individualized healthcare screening using a proprietary breathalyzer attached to a smartphone.

The initial exclusive commercialization agreement with NASA licenses the use of multiple US Patents relating to inventions in the fields of nanotechnology, chemical sensing, carbon nanotubes, medical diagnoses, environmental sensing and cell phone applications. The commercialization agreement requires that the products be manufactured substantially in the United States, and are subject to certain annual royalty payments to NASA. We will use this sensor technology to focus on certain forms of disease screening and narcotics screening. The initial application will be lung cancer.

The sensor technology won the 2012 NASA Government Invention of the Year, which was announced on April 10, 2013.

Vantage Health is focused on early screening of lung cancer, colon cancer, breast cancer, prostate cancer and ovarian cancer. We are also developing mobile screening capabilities for medical adherence, heart failure, diabetes, tuberculosis, oxidative stress disorder, metabolic impairment, and HIV/Aids.

News

Independent Pharmacies to Help Fill Medication Gaps for New ACA/Obamacare Enrollees

January 3, 2014

ALEXANDRIA, VA -- National Community Pharmacists Association (NCPA) CEO B. Douglas Hoey, RPh, MBA, issued the following statement today regarding the 2014 implementation of new health insurance marketplace plans under the Affordable Care Act (ACA) or Obamacare:

"Helping patients sort through new or revised health insurance coverage is business-as-usual for independent community pharmacies year-round and especially each January. Now more than ever that is the case with the advent of these new health plans.”

"While health plans are the payer of first resort for the newly insured, most independent community pharmacists will provide emergency medication supplies, when appropriate, to their patients confirmed with new insurance coverage through the marketplaces, so that these patients don't fall through the cracks.

"Should any coverage issues arise, patients and pharmacists are advised to contact the federal call center at (800) 318-2596.

"Assisting patients as they navigate their health coverage is just one of the ways independent community pharmacies have garnered the highest satisfaction rates from customers in national surveys. In particular, small business community pharmacies serve many rural areas in which the next closest pharmacy may be 20 miles away or more.

"To help ensure independent community pharmacies can continue serving patients at this critical time, NCPA will continue working closely with federal and state officials at all levels and branches of government."

To learn more go to www.ncpanet.org

Contract Award

U.S. Defense Dept. Awards Carestream a $70.2 Million Contract for X-ray Imaging Systems

January 2, 2014

ROCHESTER, N.Y.— Carestream Health has been awarded an extension of its contract with the U.S. Defense Department that allows the federal government and federal agencies to spend up to $70.2 million for digital radiography and computed radiography medical imaging systems.

The extension, which ends Dec. 15, 2014, is part of a six-year contract that includes the U.S. Army, U.S. Navy, U.S. Air Force, U.S. Marine Corps and federal agencies.

Medical imaging systems involved in this contract include Carestream’s versatile family of digital radiography systems that deliver rapid access to X-ray exams by radiologists and physicians, which is designed to improve patient care. Carestream offers wireless detectors that can be used with new or existing room-based or mobile imaging systems. Carestream’s specialized imaging software can help improve visualization of soft tissue in the chest and also helps physicians verify correct placement of tubes and lines used in treating patients. Carestream offers healthcare providers the flexibility to move its digital radiography detectors among X-ray imaging systems located throughout a facility—including systems from other suppliers—to maximize equipment utilization and help reduce costs.

Carestream also offers a fully featured family of computed radiography systems that can accommodate a variety of imaging workflows. These CR systems include reliable, compact tabletop solutions as well as high-volume, multi-cassette systems. Carestream’s CR and DR imaging systems offer the same user interface, which can improve productivity and help allow technologists to proficiently use any system with minimal training.

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News

CVS Caremark Prepared to Help Customers Access Care with New Affordable Care Coverage CVS Pharmacists directing patients who need information to the right resource and providing bridge medication supplies as needed with MinuteClinic providing care for patients who may be in transition with their health care coverage December 31, 2013

WOONSOCKET, R.I. - As coverage under the Affordable Care Act (ACA) gets underway on January 1 for millions of Americans, CVS Caremark (NYSE: CVS) is ready to help patients who may experience coverage issues or have questions as they access care and prescription medications under new plans for the first time.

"CVS/pharmacy is committed to assisting our patients who may encounter disruptions in their prescription insurance coverage beginning January 1," said Helena B. Foulkes, President, CVS/pharmacy and Executive Vice President, CVS Caremark. "Our pharmacy teams will provide information to help patients contact the appropriate health plan or insurance exchange, and we are actively communicating with insurance plans and government agencies to help minimize disruption to care whenever possible."

In some circumstances and based on clinical considerations, CVS/pharmacy will assist patients who are experiencing a temporary disruption in insurance coverage with a transitional or "bridge" supply of medication to support their continuity of care. A bridge supply is a prescription of 15 or 30 days. For patients who express financial hardship, a bridge supply may be provided as a courtesy to help them remain adherent to their medication therapy while they resolve their coverage issues.

MinuteClinic, the medical clinic inside select CVS/pharmacy stores, will be providing similar flexibility for patients who may be in transition with their health care coverage.

Contract Award

23 States Receive Over $307 Million in Bonuses for Enrolling Children in Health Coverage

December 30, 2013

23 states receive over $307 million in bonuses for enrolling children in health coverage

WASHINGTON DC - The Centers for Medicare & Medicaid Services (CMS) has awarded over $307 million in performance bonuses to 23 states for improving access to children’s health coverage and successfully enrolling eligible children in Medicaid, CMS Administrator Marilyn Tavenner announced today.

The performance bonuses were authorized under the Children’s Health Insurance Program Reauthorization Act of 2009 (CHIPRA), one of the first pieces of legislation signed into law by President Obama. This is the fifth and final year of performance bonus awards. States could qualify for a bonus by implementing procedures to simplify Medicaid and CHIP enrollment and renewal processes to improve eligible children’s access to coverage. The amount of a state’s bonus corresponds to the increase in children’s Medicaid enrollment over a specified target.

Such efforts have been paying off. The bonuses help states by offsetting the costs of insuring the lowest income children and encouraging them to adopt sustainable improvements in their children’s health coverage programs.

Many of the simplifications that states adopted to qualify for performance bonuses will be in place in all states in 2014 and applied consistently across Medicaid, CHIP, and the Marketplace. These simplifications have led to improved coverage for children and have helped lay the groundwork for outreach efforts aimed at enrolling people now eligible for coverage under the Affordable Care Act.

For more information on today’s CHIPRA performance bonus awards, visit http://www.insurekidsnow.gov/professionals/eligibility/performance_bonuses.html.

News

More Partnerships Between Doctors & Hospitals Strengthen Care for Medicare Beneficiaries

New Accountable Care Organizations Join Program to Improve Care for Medicare beneficiaries

December 23, 2013

Washington DC - Doctors, hospitals and other health care providers have formed 123 new Accountable Care Organizations (ACOs) in Medicare, providing approximately 1.5 million more Medicare beneficiaries with access to high-quality coordinated care across the United States, Health and Human Services Secretary Kathleen Sebelius announced today.

Doctors, hospitals and health care providers establish ACOs in order to work together to provide higher-quality coordinated care to their patients, while helping to slow health care cost growth. Since passage of the Affordable Care Act, more than 360 ACOs have been established, serving over 5.3 million Americans with Medicare. Beneficiaries seeing health care providers in ACOs always have the freedom to choose doctors inside or outside of the ACO. ACOs share with Medicare any savings generated from lowering the growth in health care costs when they meet standards for high quality care.

“Accountable Care Organizations are delivering higher-quality care to Medicare beneficiaries and are using Medicare dollars more efficiently,” Secretary Sebelius said. “This is a great example of the Affordable Care Act rewarding hospitals and doctors that work together to help our beneficiaries get the best possible care.”

“This program puts the control in the hands of physicians and allows them to take the lead in an innovative way to deliver the right care to the right patient at the right time,” said Kelly A. Conroy, executive director of the Palm Beach ACO and South Florida ACO.

The next application period for organizations interested in participating in the Shared Savings Program beginning January 2015 will be in summer 2014. More information at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/sharedsavingsprogram/News.html.

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News

New State Exchange Enrollment Projections Illuminate 2014 Healthcare Marketplace

State-Specific "Exchange Profiles" from Decision Resources Group Highlight Potential Winners and Expose a Few Surprises

December 17, 2013

BURLINGTON, MASS - Decision Resources Group's projections of 2014 enrollment reveal national trends that are hard to ignore—while simultaneously illustrating the unique nature of each state's exchange. State Exchanges, which opened for enrollment October 1, 2013, are both state- and federally-run. Within many states, there are significant regional advantages for carriers with strong ties to health systems and providers.

Key Facts:

Blue plans will likely be among the leaders in the states where they are dominant and able to leverage that clout into narrow-network plans with a price advantage over competitors.

Humana is projected to be within the five largest carriers in enrollment for each exchange it is competing in.

Centene is poised to capitalize on its position as a leading managed Medicaid carrier and could become a major exchange player nationally through its Ambetter plans.

Aetna, through its acquisition of Coventry, is in a prime position to be a top exchange player in several states and is particularly strong in the Southeast.

A just-released pdf download, "Exchange Profiles: A National Look," elaborates on these findings.

Decision Resources Group's projection model uses proprietary enrollment data, brand recognition metrics and pricing.

Download the latest "Report Card" at www.hl-isy.com/State-Exchange-Report-Card.

Policy

Health Centers to Help Uninsured Americans Gain Affordable Health Insurance Coverage

$58 million to provide expanded enrollment assistance

December 13, 2013

WASHINGTON DC - Health and Human Services (HHS) Secretary Kathleen Sebelius today announced $58 million in grants to 1,157 health centers across the nation currently working to enroll uninsured Americans in new health insurance coverage options made available by the Affordable Care Act. With these funds, health centers can expand their enrollment assistance efforts as more Americans enroll in affordable health insurance coverage.

“Today’s awards build upon the efforts of health centers across the country as uninsured Americans gain health insurance coverage,” Secretary Sebelius said. “This investment means that health centers can provide expanded assistance for people in communities nationwide looking for resources to help them understand their insurance options and enroll in affordable coverage.”

With these awards, health centers will be able to meet immediate needs, including expanding the hours of existing outreach and enrollment assistance workers, and hiring new or temporary outreach and enrollment assistance workers. Today, health centers operate more than 9,000 service delivery sites nationwide and serve more than 21 million patients annually.

“Having more opportunities for face-to-face enrollment assistance from trusted resources at local health centers means that more people will get the help they need to sign up by the end of the open enrollment period on March 31, 2014,” said Health Resources and Services Administration (HRSA) Administrator Mary Wakefield, Ph.D, R.N.

These awards, issued by HRSA, complement and align with other federal efforts to help Americans get access to affordable health insurance coverage.

Contract Award

BioNeutral Announces U.S. Distribution Agreement with BioTech Medical

December 12, 2013

NEWARK, NJ - BioNeutral Group, Inc. today announced that it has entered into a product distribution agreement with BioTech Medical Inc. (BTM), a manufacturer and national distributor of products to medical facilities, federal government agencies and cost containment organizations.

The new agreement will allow BioNeutral to drive a deeper relationship with our YGIENE™ and OGIENE™ lines into the health care marketplace.

Andrea L. Goren, Executive Director of BioTech Medical, Inc., said, "According to the EPA (Environmental Protection Agency) 100% of all types of mold have the potential to cause harmful health effects. This can be minor to severe and even death in some rare cases. YGIENE 206 is the first product we have found that kills ALL types of mold in less than five-minutes. In fact, compared with traditional antimicrobial agents, YGIENE 206 has superior efficacy, reduced toxicity and is labeled by the EPA as a cleaner, disinfectant, and sterilant. A sterilant kills all forms of microbial life on inanimate environmental surfaces." Ms. Goren closes by saying, "We are passionate about raising health standards through the identification and distribution of new and innovative infection control technologies and BioNeutral has proved to be strides ahead of their competition."

Ray Dunning, Sr. Vice President of Sales, commented, "BioNeutral is very excited to be working with an organization like BioTech Medical with their reach to over 1,000 customers and distributors. BioTech Medical is well respected in our industry and has a sales team that possesses the professionalism and technical knowledge required to bring our new technologies to the medical marketplace."

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Contract Award

HHS Announces Affordable Care Act Mental Health Services Funding

$50 million from the health care law will expand mental health and substance use disorder services in approximately 200 Community Health Centers nationwide

December 12, 2013

WASHINGTON DC - The U.S. Department of Health and Human Services (HHS) today announced that it plans to issue a $50 million funding opportunity announcement to help Community Health Centers establish or expand behavioral health services for people living with mental illness, and drug and alcohol problems. Community Health Centers will be able to use these new funds, made available through the Affordable Care Act, for efforts such as hiring new mental health and substance use disorder professionals, adding mental health and substance use disorder services, and employing team-based models of care.

“Most behavioral health conditions are treatable, yet too many Americans are not able to get needed treatment,” said Health Resources and Services Administration (HRSA) Administrator Mary K. Wakefield, Ph.D., R.N. “These new Affordable Care Act funds will expand the capacity of our network of community health centers to respond to the mental health needs in their communities.”

It is estimated these awards will support behavioral health expansion in approximately 200 existing health centers nationwide. Over the past year the Obama administration has taken a number of steps to reduce the barriers that too often prevent people from getting the help they need for behavioral health problems. The Affordable Care Act expands mental health and substance use disorder benefits and parity protections for approximately 60 million Americans.mental health and substance use conditions that is comparable to their medical and surgical coverage. The Administration also launched www.mentalhealth.gov a new website featuring easy-to-understand information about basic signs of mental health problems, how to talk about mental health, and how to find help.

Contract Award

Five-Year Contract Effective through May 31, 2018

December 9, 2013

WASHINGTON DC - AMC Health, a leading provider of telehealth solutions, has received approval from the U.S. Department of Veterans Affairs (VA) to be included on its authorized Federal Supply Schedule (FSS). By being listed on the FSS, AMC Health can offer telehealth services to the VA and other federal government agencies.

As a VA Schedule contractor, AMC Health offers discounted pricing to all federal agencies and eligible users for equipment used with the following technologies:

• Biometric remote patient monitoring, using devices best suited to the patient population to measure vital health information including, but not limited to, blood pressure, blood glucose, weight, heart rate, temperature and oxygen saturation at home. Data is automatically transmitted wirelessly to AMC Health’s secure web portal and can subsequently be integrated with other electronic health record (EHR) systems.

• A U.S. Food and Drug Administration-cleared web portal that integrates with EHR systems to provide patients with access to important health information.

• An interactive voice response (IVR) solution that provides an automated, customizable option that:

• Allows patients to provide information about their symptoms; identifies care gaps; tracks adherence; and sends reminders about physician appointments and tests; and

• Alerts case managers when an intervention is needed to prevent a serious health problem.

• A personal emergency response system (PERS) that automatically alerts a call center when an individual is experiencing a medical emergency. The alert triggers a two-way conversation with certified emergency medical dispatch attendants who can arrange for any needed assistance.

For more information, visit www.amchealth.com

Veterans Affairs Awards Five-Year Contract to AMC Health for Multiple Technologies

Policy

Six out of Ten Uninsured African Americans may be Eligible for Medicaid, CHIP or Tax Credits in

the Health Insurance Marketplace 95 percent of uninsured African Americans might qualify for lower costs on coverage if all states expanded Medicaid December 9, 2013

WASHINGTON DC - According to a new report released today by the Department of Health and Human Services, six out of ten (4.2 million) uninsured African Americans who may be eligible for coverage through the Health Insurance Marketplace might qualify for Medicaid, the Children’s Health Insurance Program (CHIP), or tax credits to help with the cost of premiums. If all states took advantage of new opportunities to expand Medicaid coverage under the Affordable Care Act, 95 percent of uninsured African Americans who may be eligible for the Marketplace might qualify for Medicaid, the Children’s Health Insurance Program (CHIP), or tax credits to help with the cost of premiums.

“The health care law is working to address long standing disparities in health care coverage and improve the health of the African American community,” said Secretary of Health and Human Services Kathleen Sebelius. “Through the Health Insurance Marketplace, 6.8 million uninsured African Americans have new options for affordable health coverage that covers a range of benefits, including important preventive services with no out-of-pocket costs.“

Nationwide, about 2 million uninsured African Americans may be eligible for coverage through Medicaid or the Children’s Health Insurance Program (CHIP). States have new opportunities to expand Medicaid coverage to include Americans with family incomes at or below 133 percent of the federal poverty level (generally $31,322 for a family of four in 2013). This expansion includes adults without dependent children living at home, who have not previously been eligible in most states.

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FDA Approves Sovaldi for Chronic Hepatitis C Drug is third with breakthrough therapy designation to receive FDA approval December 6, 2013 WASHINGTON DC - The U.S. Food and Drug Administration today approved Sovaldi (sofosbuvir) to treat chronic hepatitis C virus (HCV) infection. Sovaldi is the first drug that has demonstrated safety and efficacy to treat certain types of HCV infection without the need for co-administration of interferon.

“Today’s approval represents a significant shift in the treatment paradigm for some patients with chronic hepatitis C,” said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.

Sovaldi is the second drug approved by the FDA in the past two weeks to treat chronic HCV infection. On November 22, the FDA approved Olysio (simeprevir). Sovaldi is the third drug with breakthrough therapy designation to receive FDA approval.

Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. Most people infected with HCV have no symptoms of the disease until liver damage becomes apparent, which may take several years. Some people with chronic HCV infection develop scarring and poor liver function (cirrhosis) over many years, which can lead to complications such as bleeding, jaundice (yellowish eyes or skin), fluid accumulation in the abdomen, infections or liver cancer. According to the Centers for Disease Control and Prevention, about 3.2 million Americans are infected with HCV.

Sovaldi is a nucleotide analog inhibitor that blocks a specific protein needed by the hepatitis C virus to replicate. Sovaldi is to be used as a component of a combination antiviral treatment regimen for chronic HCV infection. There are several different types of HCV infection. Depending on the type of HCV infection a patient has, the treatment regimen could include Sovaldi and ribavirin or Sovaldi, ribavirin and peginterferon-alfa. Ribavirin and peginterferon-alfa are two drugs also used to treat HCV infection.

Sovaldi is marketed by Gilead, based in Foster City, Calif. Olysio is marketed by Raritan, N.J.-based Janssen Pharmaceuticals.

Policy

Veterans to Receive 1.5 Percent Cost-of-Living Increase

New Rates for Compensation and Pension Benefits in 2014

December 4, 2013

WASHINGTON – Veterans, their families and survivors receiving disability compensation and pension benefits from the Department of Veterans Affairs will receive a 1.5 percent cost-of-living increase in their monthly payments beginning Jan. 1, 2014.

“We’re pleased there will be another cost-of-living increase for Veterans, their families and their survivors,” said Secretary of Veterans Affairs Eric K. Shinseki. “The increase expresses in a tangible way our Nation’s gratitude for the sacrifices made by our service-disabled and wartime Veterans.”

For the first time, payments will not be rounded down to the nearest dollar. Until this year, that was required by law. Veterans and survivors will see additional cents included in their monthly compensation benefit payment.

For Veterans without dependents, the new compensation rates will range from $130.94 monthly for a disability rated at 10 percent to $2,858.24 monthly for 100 percent. The full rates are available on the Internet at www.benefits.va.gov/compensation/rates-index.asp.

The COLA increase also applies to disability and death pension recipients, survivors receiving dependency and indemnity compensation, disabled Veterans receiving automobile and clothing allowances, and other benefits.

Under federal law, cost-of-living adjustments for VA’s compensation and pension must match those for Social Security benefits. For more information about VA benefits, visit www.benefits.va.gov or call 1-800-827-1000.

News

FDA Approves New Treatment for Hepatitis C Virus

November 26, 2 013 WASHINGTON DC - The U.S. Food and Drug Administration today approved Olysio (simeprevir), a new therapy to treat chronic hepatitis C virus infection.

Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. Most people infected with the hepatitis C virus have no symptoms of the disease until liver damage becomes apparent, which may take several years. Most of these people then go on to develop chronic hepatitis C.

Olysio is a protease inhibitor that blocks a specific protein needed by the hepatitis C virus to replicate. It is to be used as a component of a combination antiviral treatment regimen. In clinical studies, Olysio was evaluated in combination with peginterferon-alfa and ribavirin, two drugs also used to treat hepatitis C virus infection. Olysio is intended for adults with compensated liver disease (a diseased liver that is still functioning), including cirrhosis, who have not received treatment for their infection (treatment naïve) or for whom previous treatment has not been effective (treatment experienced).

“Olysio is the third FDA-approved protease inhibitor to treat chronic hepatitis C virus infection, and provides health professionals and patients with a new, effective treatment for this serious disease,” said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.

In 2011, the FDA approved Victrelis (boceprevir) and Incivek (telaprevir) for the treatment of hepatitis C. Olysio was reviewed under the FDA’s priority review program, which provides for an expedited review of drugs that, if approved, would provide safe and effective therapy when no satisfactory alternative therapy exists, or offer significant improvement compared to available therapies.

Olysio is marketed by Janssen Pharmaceuticals, based in Raritan, N.J.

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News

VA Offers Dental Insurance Program November 15, 2013

WASHINGTON – VA is partnering with Delta Dental and MetLife to allow eligible Veterans, plus family members receiving care under the Civilian Health and Medical Program (CHAMPVA), to purchase affordable dental insurance beginning Nov. 15, VA officials announced today.

“VA continues to explore innovative ways to help Veterans get access to the care and services they have earned and deserve,” said Secretary of Veterans Affairs Eric K. Shinseki. “This new dental program is another example of VA creating partnerships with the private sector to deliver a range of high-quality care at an affordable cost, for our Nation’s Veterans.”

More than 8 million Veterans who are enrolled in VA health care can choose to purchase one of the offered dental plans. This three-year pilot has been designed for Veterans with no dental coverage, or those eligible for VA dental care who would like to purchase additional coverage. Participation will not affect entitlement to VA dental services and treatment.

Historically VA’s free dental services have gone to Veterans with dental problems connected to a medical condition that’s officially certified as “service connected.” Free dental services will continue for those Veterans.

For more information on VADIP, visit www.va.gov/healthbenefits/vadip, or contact Delta Dental at 1-855-370-3303 or MetLife at 1-888-310-1681.

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News

FDA Approves Medical Device to Treat Epilepsy November 13, 2013 WASHINGTON DC - The U.S. Food and Drug Administration today approved a device to help reduce the frequency of seizures in epilepsy patients who have not responded well to medications.

The RNS Stimulator consists of a small neurostimulator implanted within the skull under the scalp. The neurostimulator is connected to one or two wires (called electrodes) that are placed where the seizures are suspected to originate within the brain or on the surface of the brain.

“The neurostimulator detects abnormal electrical activity in the brain and responds by delivering electrical stimulation intended to normalize brain activity before the patient experiences seizure symptoms,” said Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health.

Epilepsy produces seizures affecting varied mental and physical functions. Seizures happen when clusters of nerve cells in the brain signal abnormally, which may briefly alter a person's consciousness, movements or actions. According to the Epilepsy Foundation, epilepsy affects nearly 3 million people in the United States and is the third most common neurological disorder, after Alzheimer’s disease and stroke. Approximately 40 percent of people with epilepsy are severely affected and continue to have seizures despite treatment.

The FDA’s approval is supported by a three-month randomized control trial of 191 patients with drug-resistant epilepsy.

Patients with RNS Stimulators cannot undergo magnetic resonance imaging (MRI) procedures, nor can they undergo diathermy procedures, electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS). The energy created from these procedures can be sent through the neurostimulator and cause permanent brain damage, even if the device is turned off.

The RNS Stimulator is manufactured by Neuropace, Inc. of Mountain View, Calif.

Policy

Administration Issues Final Mental Health and Substance Use Disorder Parity Rule

Final rules break down financial barriers and provide consumer protections

November 8, 2013

The Departments of Health and Human Services, Labor and the Treasury today jointly issued a final rule increasing parity between mental health/substance use disorder benefits and medical/surgical benefits in group and individual health plans.

The final rule issued today implements the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act, and ensures that health plans features like co-pays, deductibles and visit limits are generally not more restrictive for mental health/substance abuse disorders benefits than they are for medical/surgical benefits.

By issuing this rule, the administration has now completed or made significant progress on all 23 executive actions included in the President and Vice President’s plan to reduce gun violence. An updated report summarizing the status of all 23 executive actions is available here: http://www.whitehouse.gov/sites/default/files/docs/november_exec_actions_progress_report_final.pdf.

The Affordable Care Act builds on the Mental Health Parity and Addiction Equity Act and requires coverage of mental health and substance use disorder services as one of ten essential health benefits categories. Under the essential health benefits rule, individual and small group health plans are required to comply with these parity regulations.

“This final rule breaks down barriers that stand in the way of treatment and recovery services for millions of Americans,” said Health and Human Services Secretary Kathleen Sebelius. “Building on these rules, the Affordable Care Act is expanding mental health and substance use disorder benefits and parity protections to 62 million Americans. This historic expansion will help make treatment more affordable and accessible.”

News

FDA Approves Gazyva for Chronic Lymphocytic Leukemia

Drug is first with breakthrough therapy designation to receive FDA approval

November 1, 2013

WASHINGTON DC - The U.S. Food and Drug Administration today approved Gazyva (obinutuzumab) for use in combination with chlorambucil to treat patients with previously untreated chronic lymphocytic leukemia (CLL).

CLL is a blood and bone marrow disease that usually gets worse slowly. According to the National Cancer Institute, 15,680 Americans will be diagnosed and 4,580 will die from the disease this year. Gazyva works by helping certain cells in the immune system attack cancer cells. Gazyva is intended to be used with chlorambucil, another drug used to treat patients with CLL.

Gazyva is the first drug with breakthrough therapy designation to receive FDA approval. This designation was requested by the sponsor and granted soon after the biologic license application to support marketing approval was submitted to the FDA. The FDA can designate a drug a breakthrough therapy at the request of the sponsor if preliminary clinical evidence indicates the drug may offer a substantial improvement over available therapies for patients with serious or life-threatening diseases.

The FDA also granted Gazyva priority review because the drug demonstrated the potential to be a significant improvement in safety or effectiveness in the treatment of a serious condition. And the FDA granted Gazyva orphan product designation because it is intended to treat a rare disease. Gazyva is marketed by Genentech, a member of the Roche Group, based in South San Francisco, Calif.

“Today’s approval represents an important new addition to the treatments for patients with CLL,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

Event

HCI-DC 2014: Igniting an Interoperable Health Care System

February 6, 2014: Washington, D.C. The Health Care Innovation Day (HCI-DC 2014) conference, co-hosted by the Gary and Mary West Health Institute and the Office of the National Coordinator for Health Information Technology, will bring together leading government agencies with industry experts, hospital leaders and patient advocates to drive medical interoperability. The Feb. 6, 2014 conference will be held at the Omni Shoreham Hotel in Washington, D.C. and promises to be an exciting day.

HCI-DC 2014 will feature a top-tier of speakers, including bestselling author Malcolm Gladwell as the keynote speaker. Gladwell is the author of five New York Times bestsellers — The Tipping Point, Blink, Outliers, What the Dog Saw, and now, his latest, David and Goliath: Underdogs, Misfits and the Art of Battling Giants. The New Yorker staff writer has been named one of the 100 most influential people by TIME magazine and one of the Foreign Policy’s Top Global Thinkers. Join us to learn Gladwell’s thoughts on how interoperability can strengthen our nation’s healthcare system.

The agenda includes inspiring keynotes, innovative panels, special ignite talks and hot topic debates. Some of the featured speakers include:

Karen DeSalvo, MD, National Coordinator for Health Information Technology Jacob Reider, MD, Chief Medical Officer, Office of the National Coordinator for Health

Information Technology (ONC) Nick Valeriani, Chief Executive, West Health John D. Halamka, MD, MS, Chief Information Officer of Harvard Medical School, Chief

Information Officer of Beth Israel Deaconess Medical Center Alistair Erskine, MD, Chief Clinical Informatics Officer, Geisinger Health System Gregory Moore, MD, PhD, Chief Emerging Technology and Informatics Officer and

Director of the Institute for Advanced Application, Geisinger Health System Jeffrey E. Shuren, MD, JD, Director, Center for Devices and Radiological Health, Food

and Drug Administration

HCI-DC 2014 is a free event brought to you by the West Health Institute and ONC. Click here to register. For more info, visit: www.hcidc.org.Learn More/Register

Event

Next Generation Healthcare Facilities Summit February 10-12, 2014: Santa Monica, CA

Health Care Professionals, Engineers, and Architects Gather to Discuss

Over $1 Billion in Healthcare Facility Construction Projects.

Healthcare facilities are one of the most complex building structures that require integrated designs, while meeting the needs of hospital staff and providing a therapeutic environment for patients. Despite significant cost constraints, healthcare facilities have begun to implement procedures into their design and construction that enable them to attract the best doctors, health care plans, and patients.

Not only is it necessary to update a healthcare facility to comply with a variety of regulations, but also adhere to emerging technologies and a changing population resulting in design and construction of newer, more flexible facilities. IQPC’s Next Generation Healthcare Facilities is a distinctive conference that unites architects, engineers, healthcare professionals, real estate developers, facility managers, and more. Next Generation Healthcare Facilities summit will ensure that these professionals fulfill their quest to get answers pertaining to areas such as profitability, quality assurance of hospitals and outpatient construction projects.

Our expert speaking faculty will discuss the principles of healthcare facility design with regard to architectural vision, cleanliness, indoor environmental quality, energy efficiency, day lighting, acoustic control and much more. For more info visit: http://www.aia.org/education/ces/index.htm

Event

Health Care Project Management: The Intersection of Strategy, People, and Process

February 10 - 13, 2014: Boston, MA

This program provides participants with both the project management skills needed to improve the performance of health care delivery organizations and the people management skills necessary to create an effective project management environment. At the heart of this program is the belief that strong project managers are strong people managers. The program weaves together the topics of creating and managing teams, delegation, motivation, conflict resolution, and negotiation into the technical approach to project management so that they work together to generate maximum results.

Harvard School of Public Health, FXB Building

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For more information, visit: https://ecpe.sph.harvard.edu/Project-Management

Event

HIMSS Annual Conference & Exhibition 2014 Feburary 23-27, 2014: Orlando, FL

Overview: With knowledge as power, HI MSS Annual Conference & Exhibition is in lockstep with today's industry and is the most comprehensive and authoritative knowledge event in healthcare IT today. HIMSS educational content will feature top leaders who will share their insights and lessons learned on the most critical topics today. With more than 300 education sessions to choose from,

healthcare professionals at all levels can customize their own agenda to meet their individual needs.

Exhibits: Experience thousands of products and services on the HIMSS14 exhibit floor. Don't miss the Interoperability Showcase, Knowledge Centers - powerhouses of education, product solutions, resources and industry experts. New this year is the Meaningful Use Experience, a section of the showfloor dedicated to products and education to help you meet mandatory Meaningful Use criteria. About HIMSS HIMSS is a cause-based, not-for-profit organization exclusively focused on providing global leadership for the optimal use of information technology (IT) and management systems for the betterment of healthcare. Founded 52 years ago, HIMSS and its related organizations are headquartered in Chicago. represents nearly 50,000 individual members in healthcare provider, governmental and not-for-profit organizations.

Visit the event website at: http://www.himss.org/Events/