Latest Developments: New Issues

November 18, 2009

Ryan White Reauthorization Becomes Law: On October 30, President Obama signed into law the Ryan White HIV/AIDS Treatment Extension Act of 2009 (Pub. L. 111-87)  reauthorizing the program for four years.  Under the extension act, all parts of the Ryan White program are funded through 2013 and funding authorizations increase by 5 percent each year.  The law also requires states to document HIV and AIDS patients using a name-based reporting system by 2012, provides incentives for early detection of individuals with HIV/AIDS and sets a national goal of testing 5 million individuals for HIV/AIDS through Ryan White programs.  

False Claims Settlement to be shared with 340B Entities: Mylan Pharmaceuticals, UDL Laboratories, AstraZeneca Pharmaceuticals and Ortho McNeil last month agreed to pay $124 million to settle allegations that they underpaid rebates to the Medicaid program by falsely designating "innovator" drugs as "non-innovator" drugs. Manufacturers pay higher rebates on innovator drugs and wrongly classifying them is a violation of the False Claims Act, according to federal prosecutors.  The Department of Justice press release (http://www.aidshealth.org/news/press-releases/complaint-case-no-cv09-08199-r-plax.pdf) about the settlement describes the bulk of the settlement money as coming from Mylan and UDL and involving a dispute over whether the companies’ authorized generics were subject to the non-innovator or the higher, innovator rebate rate. The Safety Net Hospitals for Pharmaceutical Access’ Drug Discount Monitor reports that 340B entities will get a $7.3 million share of the recovery, and that checks will be sent to entities in the next few weeks. 

FDA Unveils Safe Use Initiative to Reduce Harm From Medication Use: On November 4, the Food and Drug Administration (FDA) announced the Safe Use Initiative, a new program aimed at reducing the likelihood of preventable harm from medication use. More information on the program is in the report, "FDA's Safe Use Initiative—Collaborating to Reduce Preventable Harm from Medicines," that outlines how FDA intends to collaborate with health care professionals and others to identify drugs and drug classes that are linked to preventable harm. From the report, FDA plans to develop a list of specific problems, interventions for reducing harm from these problems, and ways to measure success. The report also highlights several projects that may benefit from collaborations, including: evaluating consumer medication information; communicating about the risk of inadvertent overexposure to acetaminophen; applying safeguards against surgery fires caused by alcohol-based surgical preparations; and avoiding contamination of multiple-use medication vials. FDA intends to hold a series of public meetings to gather feedback as the list of problems to be addressed to further advance the Initiative. Read FDA's press release. (http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm189081.htm)    

More Local Efforts Needed to Increase CHIP Enrollment; Advocates Worry About Fate of CHIP Under Health Reform: Speaking at the National Children's Health Insurance Summit on November 4, HHS Secretary Kathleen Sebelius said that while great progress has been made in recent years, states and local communities need to work with HHS to find and enroll the remaining 5 million children who are eligible, but not yet covered by Medicaid or the Children’s Health Insurance Program. As part of HHS strategy, the department has awarded to date $40 million in grants to 69 organizations nationally to fund outreach projects in their communities, with another $90 million in grants being awarded over the next four years.  Several community health centers have received some of this funding.   

Meanwhile, CHIP advocates worry about what broader health reform initiatives might mean for the longer term fate of the program. Both House and Senate health reform proposals include provisions that would end CHIP at some point, moving children into Medicaid or private health insurance “exchanges.”  The House overhaul bill would phase out the program at the end of 2013, while the Senate bill being discussed so far maintains the program, but only through 2019. CHIP advocates fear children would lose affordable coverage through the exchanges.  Proponents of the phase-out argue that, once health reform is in place, the case for a separate insurance for children that excludes their parents is harder to make.  

New Kaiser Family Foundation Safety Net Information: The Kaiser Family Foundation has issued its Medicare Part D Data Spotlights for 2010.  These issue briefs review key aspects of Medicare Part D plans as they will be available to beneficiaries in 2010.  The information can be found at: http://www.kff.org/medicare/med110909pkg.cfm

Another KFF website, statehealthfacts.org, has posted new data on federal funding for HIV/AIDS in the United States.  Included is HIV/AIDS funding by state from the Ryan White Program, the Center for Disease Control and Prevention, the Substance Abuse and Mental Health Services Administration, and the Office of Minority Health.  The updated information on the Ryan White Program can be found at: http://www.statehealthfacts.kff.org/comparemaptable.jsp?ind=534&cat=11

August 5, 2009

NACHC Analysis Explores Issues in Establishing Health Center Fees and Discounts: The National Association of Community Health Centers (NACHC) has completed an analysis of the laws, regulations and Health Resources and Services Administration (HRSA) policies related to setting fees and discounts for services provided at Federally Qualified Health Centers (FQHC). NACHC states that the analysis “is intended to clarify Section 330-required billing and collection requirements generally, with specific attention to issues that health centers frequently encounter in contracting with third party payors.” The analysis includes a considerable focus on fees and reimbursements for pharmacy services, with particular attention on 340B Program considerations. The analysis reminds health centers that the 340B Program is intended to benefit entities and is not a patient discount program per se. It points out, in fact, how providing prescription services to health center patients at 340B cost plus a dispensing fee, violates Section 330 requirements in a number of respects. It also addresses an issue that frequently comes up for entities contracting with Medicare Part D plans and other private insurers. The analysis cautions against “sharing [the 340B] savings” with private health insurers as breaking the Section 330 requirement that these charges be set at “the prevailing rate in the community” without provision of any discount to the insurer. The analysis can be found here.

AHRQ Data Shows Costs of Health Insurance Coverage: New numbers released July 22 by the Agency for Healthcare Research and Quality (AHRQ) showed the average annual total cost of employer-sponsored insurance for a family of four last year was slightly over $12,000. The 2008 private-industry data also showed the cost of an employee-plus-one plan was $8,535 and single-coverage plans cost an average of $4,386. The data also revealed that employees with single-coverage contributed a smaller percentage of the costs than did employees with family or employee-plus-one coverage. In 2008, 62.5 million workers were enrolled in employer-based insurance; nearly 20 million of them had family plans, 11 million had employee-plus-one plans, and 31.5 million had single-coverage plans. The report also examined employer contributions to coverage and looked at private coverage by state, with Florida workers contributing the most to their family insurance plans, with $4,412 on average, while Indiana workers contributed the least, $2,472 on average. The data for the AHRQ News and Numbers summary were taken from the insurance component of the Medical Expenditure Panel Survey, a source of detailed information on employer-sponsored health insurance coverage and costs at the national, state, and metropolitan area levels. The summary can be found here.

Report Shows Individual Coverage Unaffordable to Most Uninsured Adults: Another report, this one from the Commonwealth Fund, shows that adults who purchased health insurance in the individual market spend far more on premiums and out of pocket than those with employer-based coverage, and such individual insurance is unaffordable for the majority of uninsured adults. The report, Failure to Protect: Why the Individual Insurance Market Is Not a Viable Option for Most U.S. Families, gives statistics and summarizes the costs and challenges involved in finding individual coverage. It can be found here.

July 17, 2009

Rural Clinic CEO Nominated to be US Surgeon General: On July 13, President Obama announced the nomination of Regina Benjamin MD, the founder and chief executive officer of a rural health clinic, as the next U.S. surgeon general. Benjamin holds a medical degree from the University of Alabama, Birmingham, has been a medical educator and served as the president of the Medical Association of the state of Alabama. Benjamin founded and was CEO of Bayou La Batre Rural Clinic, in Bayou La Batre, Alabama. The clinic serves a population of about 2,500 and was rebuilt twice due to damage caused by hurricanes Georges and Katrina. The American Hospital Association praised her nomination, noting her “tremendous grasp of our health care system, from how care is delivered in rural and underserved areas to how it is delivered in the hospital and health care system setting.” Benjamin‟s nomination, which requires confirmation by the Senate, is another sign that rural health issues will be among the nation‟s top health care priorities in the coming years. 

Geneticist Collins Nominated to Head NIH: President Obama has nominated Francis S. Collins, the physician-geneticist who led U.S. efforts to complete the sequencing of the human genome and was the keynote speaker at APhA’s Annual Meeting in San Antonio, to become the next director of the National Institutes of Health (NIH). Collins is one of the world's most famous geneticists and directed NIH's genome research institute for 15 years. He addressed pharmacists in San Antonio about the future of pharmacogenomics and „personalized medicine.‟ His laboratory has discovered the genes associated with cystic fibrosis, Huntington‟s disease, and genes for adult onset diabetes, among others. Collins will have to be confirmed by the Senate as NIH director and his nomination is currently pending before the Senate Health Education Labor and Pensions committee

July 3, 2009

850 Million Additional Recovery Act Funding Released for Health Center Construction: On June 29, Michelle Obama visited Unity Health Care, Inc., a 340B-participating community health center in Washington, D.C. to highlight the critical role health centers play in meeting the nation‟s health care needs, and to announce the release of more than $850 million worth of Recovery Act grants to help health centers around the country with some much needed capital improvements. According to the First Lady, every clinic that applied for the capital improvement funding will receive at least $200,000. The Recovery Act set aside approximately $2.5 billion for health center operational needs and construction projects, and two earlier sets of grants have already awarded around $500 million in funding. For more information including funding allotment per state, go to the HHS Recovery Act website.

HHS Secretary Sebelius Announces Release of $6 Billion in New CHIP Funds to Insure Children: On June 19, 2009, HHS Secretary Kathleen Sebelius announced that $6 billion in new federal funds will be made available to states and U.S. territories for fiscal year 2009 to provide health care to millions of children across America through their Children‟s Health Insurance Programs (CHIP). The new funds for CHIP were made available by the Children‟s Health Insurance Program Reauthorization Act of 2009 (CHIPRA), which was signed into law by President Barack Obama on February 4. CHIPRA provides additional funding that will help states and territories maintain existing CHIP enrollment and expand their programs. Of the $6 billion in new funding under CHIPRA, HHS has released more than $1 billion and expects to allocate the remainder to the states and territories by the end of September. CHIP provides health insurance for children of working families whose incomes are too high for traditional Medicaid, but too low for either employer-sponsored family plans or other private coverage.

CHIP is optional, but each state and every territory operates a program. Similar to Medicaid, CHIP is jointly funded by states and the federal government. However, the federal government pays states a higher share of their CHIP costs than for their Medicaid programs. A list of funding by state for CHIP programs can be viewed here. 

 June 19, 2009

HHS, Kaiser Reports Look at Minorities’ Health Disparities: On June 9, the Department of Health and Human Services (HHS) released a report documenting current disparities minorities face in the quality of and access to health care and health insurance.

Some of the key findings in the report, titled Health Disparities: A Case for Closing the Gap, were:

• Forty-eight percent of African American adults suffer from a chronic disease compared with 39 percent of the general population.

• African Americans are diagnosed with AIDS at nine times the rate of whites, and Hispanics are diagnosed at three times the rate of whites.

• Vietnamese women are half as likely as white women to have had a Pap smear test in the past three years. Vietnamese women have the highest rate of cervical cancer—twice the rate of whites—and are twice as likely to die from the disease once it develops.

• African Americans are 15 percent more likely to be obese than whites.

In releasing the report, HHS Secretary, Kathleen Sebelius observed that disparities like these have long plagued the US health care system and need to be a focus of reform efforts.

The Kaiser Family Foundation also released a report on Women‘s Health Care which found a general inequality of health care for minority women, analyzing women‘s health care on daily health status, access to and use of health care. The report, Putting Women's Health Care Disparities On the Map: Examining Racial and Ethnic Disparities at the State Level, found that all female groups have lower incomes than men, are more reliant on government programs, have higher rates of chronic conditions, and are more likely to be raising children alone. Several states in the South as well as Montana, South Dakota, and Indiana scored far below the national average in health care disparities, while Virginia, Maryland, Georgia, and Hawaii were above average.

The HHS report is available on the Web here. The Kaiser Family Foundation report is available here. 

GAO Report Finds IHS Not Accountable for Equipment: In an unusually stern report released at the end of May, the Government Accountability Office (GAO) found that the Indian Health Service (IHS) is continuing to lose medical and other equipment at an alarming rate despite efforts for better accounting, which were supposed to have been put in place following a June 2008 GAO report. The GAO said the IHS lost about 1,400 items worth $3.5 million between October 2007 and January 2009 -- including $37,000 in lab equipment at a Navajo health care facility and a $7,300 trailer in Nashville, Tenn. Those losses came after an estimated $15.8 million in equipment was unaccounted for between the 2004 and 2007 budget years. Those losses were described in the June 2008 report, when investigators also charged that the Indian Health Service had falsified documents to cover up some of the missing property. The GAO report says the agency "has failed to implement most of its recommendations from last year or hold staff accountable for losses." The IHS responds that it is implementing a ―more effective electronic property tracking system that will be able to find equipment that was previously reported as lost -- often because it was being used in a remote location." The GAO report, Indian Health Service: Millions of Dollars in Property and Equipment Continue to be Lost or Stolen, is available here.

House Debate on Generic Biologics: The House debate over legislation to create a pathway for generic versions of biologic drugs will continue into the fall of 2009, members of the Energy and Commerce Subcommittee on Health said June 11. Rep. Frank Pallone Jr. (D-N.J.), chairman of the subcommittee, said his panel will hold additional hearings on generic biologics legislation but he is not sure when, because of health care reform debates. He added that no more hearings will be held on generic biologics until after the August recess. The Federal Trade Commission released a report on potential effects of generic biologic competition, called Follow-on Biologic Drug Competition, on June 10, and that report will be considered when the subcommittee continues its deliberations.  The FTC report is available here.  FTC's written testimony is available here. 

GE Will Offer No-interest Loans for HIT Systems: General Electric Company‘s GE Capital division has announced it will make no-interest loans to hospitals, community health clinics, doctors and other health care providers that purchase GE’s Centricity electronic health care system. An initial commitment of $100 million in loans will go to providers for projects expected to qualify for the $19 billion in health information technology funds set aside by the American Reinvestment and Recovery Act (aka, the ―stimulus bill) signed into law a few months ago. The GE loans are meant to help hospitals and others get started on projects until the stimulus funds start flowing. The loans ―will carry no interest until the institutions begin receiving government money, according to the New York Times. IBM has also announced it would make funds available to help providers ―jump-start their HIT projects. More information from GE can be found here.  

June 5, 2009

Wyeth Accused of "Best Price‟ Violations; 340B Refunds Possible: In a legal action that could benefit 340B entities, the United States and more than a dozen individual states joined in two whistleblower alleging that Wyeth illegally avoided paying millions of dollars in rebates to the Medicaid program between 2001 and 2006 by reporting fraudulent prices for its drug, Protonix. According to a Department of Justice press release, Wyeth gave steep discounts to thousands of hospitals to purchase a bundled package of oral and intravenous Protonix, but failed to provide this “best price” to the Medicaid program, as required by law. The government‟s complaint says that Wyeth used its “Protonix Performance Agreement” program as a marketing tool to increase retail sales of oral Protonix, which Medicaid and others insurers then covered at much higher prices. By “hiding” the huge discounts from the Medicaid program, Wyeth caused state Medicaid programs to pay much more for Protonix than they should have, according to DOJ attorneys. The six-count complaint charges Wyeth with three separate counts under the False Claims Act, as well as common law fraud, unjust enrichment, and disgorgement. It seeks three times the amount of the loss sustained by Medicaid for each of the false claims counts, an amount equivalent to the loss for each of the other counts, plus penalties and interest. Because the 340B ceiling price calculation is based on „best price‟ information reported by Wyeth to CMS, 340B entities were likely overcharged during the period covered by the lawsuit. Although 340B entities are not mentioned in connection with this suit so far, DOJ has included payments to entities in best price settlements in the past. Wyeth says it believes its price calculations were correct under the law and plans a “vigorous defense.”

Study Finds Few Retail Health Clinics Located in Low-Income Areas: Although touted as an answer to health care access issues for the medically underserved, most retail health clinics are located in more affluent areas of the U.S., rather than in low-income, medically underserved neighborhoods, according to a study published on May 25 in the Archives of Internal Medicine. The study looked at 930 retail clinics operating in 2008 and U.S. census data for the areas in which the clinics were located. Of these, 123 clinics were in communities considered medically underserved under federal government criteria. Most communities with clinics had high home ownership rates and higher median incomes. An abstract of the study is available here. 

April 30, 2009

NACDS, FMI Sue to Stop AWP Settlement: On April 2, 2009, the National Association of Chain Drug Stores (NACDS) and the Food Marketing Institute (FMI) filed a motion in the U.S. District Court for the District of Massachusetts to stop the implementation of “the AWP settlement,” set to go into effect on October 1, 2009. Under the AWP settlement, First DataBank, Inc and Medispan agreed to roll back published AWP from the currently used 125% WAC to 120% WAC on over 1400 separate products. The April 2 motion asks the Court to stop implementation of the settlement pending an appeal which the pharmacy groups intend to pursue challenging the approved settlements as “fundamentally unfair, unreasonable, inadequate and inconsistent” with federal rules of legal procedure. The groups say that Court action is necessary to stop implementation because the settlement terms will cause irreparable financial harm to pharmacies. NACDS has estimated that the “AWP reductions will cut Medicaid reimbursement by about $68 million each year. In addition, pharmacies that are unable to renegotiate their private sector reimbursement contracts will face a net 4 % reduction in AWP-based reimbursement.” More information about the settlement and efforts to stop it from going into effect can be found at: www.nacds.org.

Kansas Gov. Sebelius Confirmed as HHS Secretary: On April 28, the Senate voted 65-31 to approve the nomination of Kansas Gov. Kathleen Sebelius (D) as Department of Health and Human Services (HHS) secretary and President Obama swore her into office that afternoon. The Senate vote was largely along party lines, with nine Republicans voting to confirm. Although Senate Republicans had attempted to delay Sebelius' confirmation because of concerns about her stance on abortion, they opted not to continue procedural objections in light of the recent swine flu emergency. Sebelius was the last member of Obama's Cabinet to be confirmed and sworn in. Nineteen additional positions at HHS that require Senate confirmation remain open, including deputy HHS secretary, FDA commissioner, CDC director, and surgeon general. Although Sebelius' first focus as HHS secretary will be on the swine flu emergency, her larger task will be helping to pass health care reform initiatives. 

April 17, 2009

Report Shows One-Fifth of U.S. Adults Underinsured in 2007: About one-fifth of American adults—or 25 million people—were underinsured in 2007, a 60 percent increase since 2003. The report from the nonprofit advocacy organization Community Catalyst, concludes that insufficient coverage is causing individuals to delay needed tests, treatments, and physician visits and was a factor in one-half of all bankruptcies in 2007. The report said the federal government could reduce the number of underinsured Americans by setting minimum standards for coverage, including limits on deductibles and other cost-sharing, and guaranteeing health insurance policies provide access to certain health services. In addition to those who are underinsured, about 45.7 million Americans lacked coverage of any kind in 2007, according to the latest report by the Census Bureau, issued in August 2008. The report, “When Coverage Fails: Causes and Remedies for Inadequate Health Insurance” is available here. 

HHS and HRSA Announce Release of Increased Demand for Services Grants: The Department of Health and Human Services announced March 27 that it will release $338 million under the American Recovery and Reinvestment Act (Pub. L. No. 111-5) to expand services at the nation's community health centers. The Increased Demand for Services (IDS) grants will provide care to an additional 2.1 million patients over the next two years, including approximately 1 million uninsured people. Health centers serviced more than 16 million people in 2007, about 40 percent of whom had no health insurance, according to HHS. Funds will be distributed to 1,128 federally qualified health center grantees to be used over the next two years to create or retain approximately 6,400 health center jobs. Among the ways centers might use the funds are by adding new providers, expanding hours of operations, or expanding services.

The IDS awards are the second set of health center grants provided through the economic stimulus law. President Obama March 2 announced grants worth $155 million to establish 126 new health centers. A list of grantees by state is available on the Web here. 

FTC Commissioner Backs Bill to Ban Payments to Delay Generic Drug Marketing: In testimony before the House Energy and Commerce Subcommittee on Commerce, Trade and Consumer Protection on March 31, Federal Trade Commissioner Thomas Rosch backed HR 1706, a bill that would prohibit brand-name drug companies from compensating generic drug companies to delay the market entry of a generic drug. In his testimony, Rosch said the FTC “strongly supports” the proposed “Protecting Consumer Access to Generic Drugs Act of 2009” which was introduced by subcommittee Chairman Bobby L. Rush (D-Ill.). The payments, called reverse payments, or exclusionary payments, are part of patent settlements between branded and generic drug companies. The legislation would prohibit generic drug companies from receiving “anything of value” from brand-name drug companies for agreeing not to research, develop, manufacture, market, or sell, for any period of time, a generic drug.

FTC has sought to use antitrust enforcement to stop these payments, but “since 2005, court decisions have treated such agreements in drug patent settlements too leniently,” according to Rosch. He believes the bill will clarify issues and provide a way to combat “anticompetitive conduct” that is costly to consumers and the health care system. PhRMA objects to the bill, which according to their spokesperson “could stop pro-consumer settlements, reduce the value of patents, and reduce incentives for innovation.” PhRMA suggested that instead of banning all patent settlements, settlements should be evaluated on a case-by-case basis. The FTC commissioner's testimony on the bill is available here. 

Kaiser Foundation Study Shows Surge in Health Center Use in Massachusetts: Community health centers in Massachusetts experienced a significant caseload increase during the first year of the state's health reform law, playing a key role in caring for newly insured patients but also serving an increasing share of the state's shrinking uninsured population, according to a new study. The 34 federally qualified centers in Massachusetts, which provide comprehensive primary care for low-income and uninsured patients, served 482,503 patients in 2007, up more than 51,000 from two years earlier, said the report commissioned by the Kaiser Family Foundation's Commission on Medicaid and the Uninsured.

While the overall number of uninsured people in Massachusetts fell by about half between 2006 and 2007, the number of uninsured patients served by health centers fell by only 25 percent over that period, the study said. As a result, the proportion of uninsured residents served by health centers grew from 22 percent in 2006 to 36 percent in 2007. The data show that safety-net providers will continue to be a vital source of care in any national health coverage expansion plan. The report, entitled How Is the Primary Care Safety Net Faring in Massachusetts? Community Health Centers in the Midst of Health Reform, is available on the Web here.  

Study Finds Most Hospitals Fail to Meet Quality, Safety Standards: Although hospitals have made some gains in safety and quality, many still fail to meet national standards, according to the Leapfrog Group‟s annual voluntary survey of hospitals. The Leapfrog Group is a nonprofit business coalition that works to increase transparency and improve the quality of health care by providing information from volunteer surveys regarding hospital safety and quality to large companies that purchase health care, as well as to consumers. The Leapfrog Hospital Survey Results 2008, found most hospitals do not meet efficiency standards that measure quality and resource use, and have low adoption rates for medical error prevention technology. The survey showed improvements in some areas, such as more hospitals meeting guidelines on intensive care unit staffing and prevention of hospital-acquired infections (HAI), but overall, the results were called “disappointing” by the Leapfrog Group’s spokesperson.

The hospital survey, released on April 15, includes voluntarily reported results from 1,276 hospitals in 37 major metropolitan areas, representing 48 percent of urban,  general acute-care hospitals. The survey found that 7 percent of hospitals meet Leapfrog's standards for medication error prevention through use of computerized prescriber order-entry (CPOE) systems, up from 2 percent in 2002. In addition, the survey reports the percentage of hospitals that met Leapfrog's high-risk procedure standards for eight conditions such as heart bypass surgery and aortic valve replacement. The procedure standards are based on state, regional, and national outcomes-assessment registries; adherence to nationally endorsed quality-of-care process measures; and the number of each procedure type performed at each facility. The survey also found that 65 percent of hospitals have not implemented all of the policies recommended to prevent HAIs, but the adherence rate of 35 percent is up from 13 percent in 2007.

The report is available on the Web here.

Lilly Settlement with the Department of Justice

The Department of Justice announced a civil settlement agreement with Eli Lilly to settle allegations that it caused invalid claims for payment for Zyprexa to be submitted to various government programs.  As part of the settlement, Eli Lilly agreed to mail checks to affected Public Health Service entities the aggregate sum of $751,543.88 plus interest accrued thereon at a rate of 3% per annum from October 20, 2008, continuing until and the including the day before checks are mailed.  Within 60 days of the date in which the Court accepts the Eli Lilly’s guilty plea in connection with the Federal Criminal Action and imposes the agreed-upon sentence, Eli Lilly agreed to mail to each affected Public Health Service entity a check in the amount of its proportionate share along with a cover letter referencing the Settlement Agreement and providing that by cashing the check, the entity is releasing Eli Lilly, from liability for the Covered Conduct.

Link to the DOJ press release: http://www.usdoj.gov/usao/pae/News/Pr/2009/jan/lillyrelease.pdf

Link to the Settlement Agreement: http://www.usdoj.gov/usao/pae/News/Pr/2009/jan/lillysignedsettlementagreement.pdf

Link for additional information: http://www.usdoj.gov/usao/pae/News/Pr/2009/jan/jan09.html

(Posted 2/2009)

EPA's Proposes Rule on Adding Pharmaceuticals to the Universal Waste Rule

On December 2, the Environmental Protection Agency (EPA) released a proposed rule which would add hazardous pharmaceutical wastes to the Agency's "Universal Waste Rule". The Universal Waste Rule established a set of requirements for the collection of certain hazardous wastes, called "universal wastes". EPA suggests that the proposed rule would facilitate management of pharmaceutical wastes by streamlining requirements and encouraging generators of hazardous pharmaceutical wastes to manage them under the provisions of the Universal Waste Rule. EPA states this change will better ensure that hazardous wastes are disposed of properly. The Agency also believes that the rule will streamline the disposal of all pharmaceutical waste, will facilitate implementation of pharmaceutical take-back programs, and will facilitate collection of pharmaceutical waste from households (including non-hazardous waste).

Comments are due February 2, 2009. However, comments to the Office of Management and Budget (OMB) on the potential burden of this proposed rule are due on January 2, 2009. Comments to OMB on the accuracy of the provided burden estimates, and any suggested methods for minimizing burden, should be submitted using Docket ID No. EPA-HQ-RCRA-2007-0932. Send comments to Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW., Washington, DC 20503, Attention: Desk Office for EPA.

Albuterol (CFC) Inhalers
As of December 31, 2008, albuterol CFC-propelled inhalers will no longer be available in the United States. Food and Drug Administration (FDA) set the December deadline to end the manufacturing, marketing, and sales of all CFC-containing albuterol inhalers due to their effects on the ozone layer. The Food and Drug Administration (FDA) launched a media and educational campaign aimed at patients, caregivers, and health care professionals to urge the transition of patients from chlorofluorocarbon (CFC)-propelled albuterol inhalers to hydrofluoroalkane (HFA)-propelled albuterol inhalers.

In preparation for the transition, FDA has approved 3 types of HFA inhalers that have similar medication strengths to CFC inhalers and is working to ensure that an adequate supply of HFA inhalers is available. These medications are "BX" rated and are not substitutable for each other. Given that HFA inhalers are more expensive and do not have a generic alternative, FDA has identified three sources for patients to receive financial assistance to aid in the transition:

www.inhalertransition.org; www.transitionnow.org; and www.pparx.org.  

For more information, read APhA's article "Switch from CFC inhalers now; alternative HFA products need more maintenance ".

Flexible Spending and Health Savings Account Debit Cards
Beginning January 1, 2009, the Internal Revenue Service (IRS) will require pharmacies to operate an inventory information approval system (IIAS) when using health benefits payment card transactions [such as flexible spending accounts (FSA) and health saving accounts (HSA)] that allow for point-of-sale deductions from a debit card for qualified medical items. Pharmacies will also need to obtain certification for IIAS. Certification will ensure that a pharmacy can accept all types of FSAs and HSAs and allows retailers to identify products in their inventory that can be deducted as a qualified medical expense. The Special Interest Group for IIAS Standards (SIGIS) is a voluntary industry standard solution designed to help meet the IRS requirement. SIGIS certification requires the completion of an application as well as a $250 annual certification fee. In addition, some pharmacy card readers may need to be upgraded in order to connect to the IIAS system. For more information, visit SIGIS Web site.

FDA Releases Study on Consumer Medication Information

On December 16, the FDA released a study on the usefulness of printed consumer medication information (CMI) that is voluntarily provided by pharmacies. In 1996, Congress set a goal that 95% of patients, when receiving their prescriptions, should also receive written information that meet specific criteria for usefulness. FDA's study, which was conducted by the National Association of Boards of Pharmacy and subcontracted with the University of Florida, College of Pharmacy, showed that 94% of patients were receiving written information when receiving their prescriptions but only 75% of these CMIs met the usefulness criteria as determined by a panel of stakeholders. The Study also found that much of the information in CMIs lacked consistency, making the information less comprehensible for patients. In response to this study, FDA intends to initiate a new plan to meet the goals mandated by Congress. Next steps include a new public comment period open until June 1, 2009; the launch of a new CMI Web site that includes: links to the Study, an Executive Summary, and additional background materials; and further discussions with stakeholders. In addition, on February 26-27, 2009, FDA plans to discuss the Study's findings during its Risk Communication Advisory Committee Meeting addressing different types of prescription drug information currently available to patients.

FDA Meeting Notice on MedGuides, PPIs, and CMIs

On December 8, the FDA announced that the Risk Communications Advisory Committee (RCAC) will host a meeting on February 26-27, 2009 to discuss different types of prescription medication information currently available to patients, including Medication Guides (MedGuides), Patient Package Inserts (PPIs), and Consumer Medication Information (CMI). The Agency is seeking the advice of the Advisory Committee, and commentary from stakeholders and the public, as it considers the next steps to improve communication of information about prescription medications to patients. While the deadline to comment is March 31, 2009, comments received before February 12 will be provided to the Advisory Committee prior to their February 26-27 meeting.

FDA Information on Avoiding Drug Interactions

The FDA recently released a consumer update on Avoiding Drug Interactions. The consumer-friendly document reminds patients to be careful of three main types of drug interactions: drugs with food and beverages, drugs with dietary supplements, and drugs with other drugs.

FDA Sentinel Initiative Workshop

On December 16, the FDA held a public workshop on the Sentinel Initiative: Structure, Function, and Scope. The workshop was co-sponsored by FDA and the eHealth Initiative Foundation and was convened by the Engelberg Center for Health Care Reform at the Brookings Institution. The workshop was intended to bring together interested parties for an update on the current status of the Sentinel Initiative and to allow for public comment. The Sentinel Initiative will enable FDA to query multiple, existing data sources, including electronic health record systems and medical claims databases, for information about medical products. The system is intended to strengthen the Agency's ability to monitor the post-marketing performance of a product. Read more information on the Sentinel Initiative.

Pharmacy Groups Respond to FDA Correspondence with Compounding Pharmacies

The American Pharmacists Association (APhA), the American College of Apothecaries (ACA), the International Academy of Compounding Pharmacists (IACP), the National Alliance of State Pharmacy Associations (NASPA), and the National Community Pharmacists Association (NCPA) recently sent a joint letter to Andrew von Eschenbach, M.D., the Commissioner of the Food and Drug Administration (FDA), regarding the Agency's correspondence to nine pharmacies that dispense pharmacist compounded preparations containing the drug ingredient estriol. APhA and the other organizations are concerned with FDA's opposition to the use of estriol as an ingredient in compounding and have asked the Agency to refrain from taking enforcement action against pharmacies that, pursuant to valid prescriptions, dispense preparations compounded by pharmacists with estriol or any other ingredient compounded in accordance with the 1997 Food and Drug Administration Modernization Act (FDAMA) Section 503A. The groups challenged FDA's actions based on the following:

• The Compliance Policy Guidance (CPG) lacked public input, and is an inappropriate basis for enforcement actions;
• The Investigational New Drug (IND) requirement for estriol - containing pharmacist compounded preparations remains unworkable; and
• Pending litigation changes the legal landscape.

The groups asked the Agency for the opportunity to discuss these issues.

Update: Methamphetamine Production Prevention Act Passed

On October 18, President Bush signed the Methamphetamine Production Prevention Act (P.L. 110-415) into law. This law expands current requirements that pharmacists maintain a written or electronic log of purchasers of pseudoephedrine containing products in order to help identify individuals who may be illegally producing methamphetamine. According to APhA's review of the new law, it provides greater clarity regarding log book signatures, including how the information can be captured, what must be captured, and verification of the information. Pharmacists are required to log the name and address of purchaser, date and time of sale, and quantity sold. An electronic logbook must capture signatures in an electronic format, but a written log must include a clear line for the purchaser's signature and a sticker affixed to the book at the time of sale that displays the name of each product sold, the quantity sold, the name and address of the purchaser, and the date and time of the sale or a unique identifier that can be linked to electronic or written information. Pharmacists must also verify the accuracy of information entered and maintain entries in written logbooks or electronic formats for at least two years.

FDA Announces Drug Safety Web site

On October 15, 2008, as required by the Food and Drug Administration Amendments Act (FDAAA) of 2007 (110-85), the Food and Drug Administration (FDA) launched a single Web site designed to give patient and health care providers access to a broad range of drug safety information on prescription medications. This new Web site features: links to information on drug labeling; Risk Evaluation and Mitigation Strategies (REMS); Medication Guides; information on studies and clinical trails for approved drugs; current clinical trials; and up-to-date safety information including new quarterly reports on drugs that the FDA has identified for evaluation for potential safety issues. The Web site also features information for health care providers advising patients on drug products and features a section for consumers to obtain information on the medications that they are prescribed. The Web site also includes information on unapproved drugs that are marketed in the U.S. and have not obtained FDA approval. Visit FDA's Drug Safety Information Web site. >> 

Update: FDA Issues Final Rule Delaying Compliance Deadline of 1-800 Number for Adverse Event Reporting until July 1

On October 28, 2008 the Food and Drug Administration (FDA) issued a final rule regarding the toll-free number for reporting adverse events on labeling.  This final rule delays the original compliance date of January 1, 2009 to July 1, 2009 to allow additional time for implementation.

This final rule implements the January 3, 2008 interim final rule requiring pharmacists and other authorized dispensers to distribute the 1-800 number side-effects statement to consumers with prescription medications and over-the-counter (OTC) products that do not already list the manufacturer's contact information. The prescription labeling must include the statement: "Call your doctor for medical advice about side-effects. You may report side effects to FDA at 1-800-FDA-1088." Pharmacists and other authorized dispensers may distribute the side-effects statement in one of five ways:

1. On a sticker attached to the unit package, vial, or container of the drug product;

2. On a pre-printed pharmacy prescription vial cap;

3. On a separate sheet of paper;

4. In consumer medication information; or

5. In the appropriate FDA-approved Medication Guide that contains the side effects statement.

Manufacturers and distributors of affected OTC products that do not already include the manufacturer's contact information must either include a 1-800 number to contact the manufacturer or FDA' s OTC side-effect statement in the warnings section of the drug facts format labeling. FDA's OTC side-effect statement is: "Stop use and ask a doctor if side-effects occur. You may report side-effects to FDA at 1-800-FDA-1088."

Update on National Provider Identifiers and National Plan and Provider Enumeration System

The Centers for Medicare & Medicaid Services (CMS) recently released information for health care practitioners who have obtained a National Provider Identifier (NPI) and have records in the National Plan and Provider Enumeration System (NPPES). In order to maintain security of the information provided, CMS recommends that practitioners:

• Know and maintain their NPPES user IDs and passwords;
• Reset their NPPES passwords at least once a year; and 
• Review their NPPES records in order to ensure accurate information.

Health care providers can view their NPPES information by accessing their records or by accessing the NPI Registry.  Additional information is available by calling 1-800-465-3203.  

DEA Releases Updated Electronic Version of Form 106 for Reporting Theft or Loss of Controlled Substances

The Drug Enforcement Administration (DEA) issued a modified electronic version of DEA Form 106 which is used to report theft or loss of controlled substances. The new form is available on the DEA Web site. Pharmacists should be aware that the new form requests additional information in order to track controlled substances that are reported as lost or stolen. The new version requires registrants to include the National Drug Code (NDC), which identifies the manufacturer, product, dosage form, and package size. While the paper version is still available, the Agency is encouraging all registrants to utilize the updated electronic version. Registrants who submit paper copies will be notified to discontinue use of the older form. 

AHRQ Issues Interim Guidance on Becoming a Patient Safety Organization

On October 14, the Agency for Healthcare Research and Quality (AHRQ) issued interim guidance on implementing the Patient Safety Act of 2005 (P.L. 109-41). The guidance includes information on becoming a Patient Safety Organization (PSO) and how information about a patient safety event submitted to a PSO may be protected as a Patient Safety Work Product by providing confidentiality protections to information reported to a PSO. Specifically, the guidance establishes a process by which the Secretary of the Department of Health and Human Services can list a PSO to which providers can voluntarily submit information for patient safety event analysis. This data will be aggregated by the PSO with other providers' patient safety event data in an attempt to identify systematic patterns to create quality improvements.

CMS National E-Prescribing Conference Materials Available Online on October 16

On October 6-7, 2008, the Centers for Medicare and Medicaid Services (CMS) hosted a national e-prescribing conference in Boston, MA, in which APhA participated and co-sponsored. The conference aimed at assisting health care providers in implementing provisions electronic prescribing incentive of the Medicare Improvements for Patients and Providers Act (MIPPA) of 2008 (110-275). Specifically, the conference focused on promoting the adoption of and identifying potential challenges to e-prescribing, and assisting providers in integrating e-prescribing into their business model by addressing privacy, security, and risk management issues. The conference included over 1,400 health care professionals participants.

Featured speakers at the conference included Health and Human Services (HHS) Secretary Michael Leavitt, CMS Acting Administrator Kerry N. Weems, Former Speaker of the House and health care advocate Newt Gingrich, Senator John Kerry (D-MA), Governor Deval Patrick (D-MA) , Governor Donald Carcieri (R-RI), Prematics, Inc. President & CEO Kevin Hutchinson, Pharmaceutical Care Management Association, President & CEO Mark Merritt, and Health Evolution Partners Chairman David Brailer.

Videos of the conference will be posted online on the meeting's Web site starting October 16. 

FDA Holds Public Hearing and Press Conference on OTC Cough and Cold Medications for Pediatric Use

On October 2, 2008 the Food and Drug Administration (FDA) held a public hearing to obtain feedback regarding over-the-counter (OTC) cough and cold medications marketed for pediatric use. For the past several months, FDA has reviewed data related to the effects of pediatric use of OTC cough and cold medicines following the submission of a Citizen Petition that raised concerns about the safe use in children. As a result of the hearing, on October 7, FDA held a press conference with the Consumer Healthcare Products Association to announce that the leading cough and cold manufacturers have agreed to a voluntary label change that would adjust the recommended age restriction for pediatric cough and cold use from over 2 years old to 4 years old. FDA is accepting comments until December 2, 2008. Click here for meeting materials and a list of specific questions >>

Reminder: Albuterol Inhalers that Use CFCs to be Phased Out by January 1, 2009

As of December 31, 2008, albuterol chlorofluorocarbon (CFC)-propelled inhalers will no longer be available in the United States, and all patients should be switched to hydrofluoroalkane (HFA)-propelled albuterol inhalers. Due to CFC-containing albuterol inhalers effects on the ozone layer, the Food and Drug Administration (FDA) decided in 2005 to end the production, marketing, and sale of all CFC-containing albuterol inhalers by December 31, 2008. FDA has encouraged all health care professionals to start their patients on HFA inhalers now to help facilitate transition, and has launched a media and educational campaign aimed at patients, caregivers, and health care professionals. For more information, read APhA's article "Switch from CFC inhalers now; alternative HFA products need more maintenance ".

Notice: IRS Requires Inventory Information Approval Systems by January 1, 2009 for Pharmacies Accepting Flexible Spending and Health Savings Account Debit Cards

Beginning January 1, 2009, the Internal Revenue Service (IRS) will require pharmacies to operate an inventory information approval system (IIAS) when using health benefits payment card transactions [such as flexible spending accounts (FSA) and health saving accounts (HSA)] that allow for point-of-sale deductions from a debit card for qualified medical items. Pharmacies will also need to obtain certification for IIAS. Certification will ensure that a pharmacy can accept all types of FSAs and HSAs and allows retailers to identify products in their inventory that can be deducted as a qualified medical expense. The Special Interest Group for IIAS Standards (SIGIS) is a voluntary industry standard solution designed to help meet the IRS requirement. SIGIS certification requires the completion of an application as well as a $250 annual certification fee. In addition, some pharmacy card readers may need to be upgraded in order to connect to the IIAS system.

For more information, visit SIGIS Web site.>> 

Latest Developments: Studies and Reports

Office of Pharmacy Affairs Studies and Reports

Evaluation of HRSA's Clinical Pharmacy Demonstration Projects - Volume 1: Synthesis Report is the final evaluation report of the Clinical Pharmacy Demonstration Projects (CPDP) managed by HRSA's Office of Pharmacy Affairs, formerly the Pharmacy Affairs Branch.

The purpose of these projects was to examine the effects of expanded access to clinical pharmacists and comprehensive pharmacy services on the health outcomes of medically underserved populations.  This report is an evaluation of expanded access and improved outcomes due to the Clinical Pharmacy Demonstration Projects.

Volume II: Case Studies:, presents five case studies of Clinical  Pharmacy Demonstration Project networks whose experience may prove beneficial to other Community Health Centers and  providers exploring the potential for clinical pharmacy service.

The PHS 340B Drug Pricing Program: Results of a survey of Eligible Entities: This report describes the results of a survey conducted on 340B Covered Entities eligible to purchase prescription drugs under the 340B Drug Pricing Program and contains recommendations for improving the Program. The survey was conducted between October 2003 and March 2004 by Mathematica Policy Research, Inc. on behalf of the Pharmacy Affairs Branch (now the Office of Pharmacy Affairs (OPA) in HRSA's Healthcare Systems Bureau). This report is part of OPA's effort to improve outreach, communication and services to all entities eligible to participate in the 340B Program.

Other Studies and Reports

Quality Through Collaboration: The Future of Rural Health Care (2005) offers a strategy to address the challenges in rural communities by assessing the quality of health care and providing a framework and recommendations to deliver services to those rural communities. Read It Online Free.

Medicaid: A Critical Source of Support for Family Planning in the United States: This reports provides updated information on Medicaid and family planning across the nation done by the Kaiser Family Foundation and Alan Guttmacher Institute.

IOM Report: Quality Through Collaboration: The Future of Rural Health: This report assesses the quality of health care in rural areas and offers a strategy to address quality challenges in theses areas.

Uninsured and Underserved: The Health Care Experiences of Latinos in the Nation's Capital: A summary of Latino experiences and opinions regarding access to health care in the District of Columbia, this brief also contrasts the experiences of Latinos in the District of Columbia with those of Latinos nationally.

Doughnut Holes and Price Controls: This Health Affairs report by Gerard Anderson, a professor at Johns Hopkins University's Bloomberg School of Public Health, Dennis Shea, a professor at Pennsylvania State University , and colleagues examines how government price controls could affect the gap in Medicare prescription drug coverage. The report says that, if Medicare could negotiate drug prices similar to those in Canada and other nations, where they often are 34% to 59% cheaper, "Congress could eliminate the doughnut hole in the Medicare drug benefit.”

Closing the Doughnut Hole: No Easy Answers: There are no simple ways for Congress to reduce drug prices, and legalizing prescription drug reimportation "will appear to be the easiest, least regulatory 'fix,'" according to a Health Affairs report by Patricia Danzon, a professor at the University of Pennsylvania's Wharton School. The report notes that reimportation "would be ineffective" at lowering drug costs and could lead to "serious health risks to U.S. consumers," a reduction in drug research and development and less access to drugs for foreigners in their home countries.