Latest Developments: New Issues

FDA Releases Guidance on Patient-Focused Consumer Medication Information Leaflets

  Earlier this month, the Food and Drug Administration (FDA) released a final guidance document on Consumer Medication Information (CMI) leaflets. The document provides guidance to pharmacists and CMI developers on how to create CMI that will be considered “useful” to patients.

  Pharmacists are strongly encouraged to provide CMI, which is often generated by the pharmacy's computer system, to patients with each new prescription. The 1996 law which created the CMI requirement gave pharmacists time to phase in its implementation; to avoid a Federal mandate to distribute FDA-approved information, the private sector was asked to distribute useful written CMI with 75% of new prescriptions by the year 2000 and with 95% of new prescriptions by 2006. While pharmacists exceeded the 2000 goal for distribution – a study found that 89% of patients received CMI – the quality of the information distributed varied and did not meet the criteria for measuring “usefulness”. The new guidance document released by the FDA is designed to help pharmacists and CMI developers examine and evaluate the usefulness of their CMI and make improvements necessary to meet the 2006 goal.

  The guidance document recommends that CMI contain:

•  Drug name

•  Indications for use

•  Contraindications

•  Directions on how to use and store the medication

•  Information about overdose

•  Other drugs and food to avoid because of possible interactions

•  Patient activities and behaviors to avoid

•  Risks to specific patient populations such as pregnant females

•  Common side effects

•  Information on how to monitor for effectiveness

  Information in CMI should also be scientifically accurate, unbiased in tone and content, and up-to-date. The guidance document also provides formatting recommendations including the use of 10-point or larger font, short paragraphs or bullets, and dark text on white or pale yellow paper. A copy of the guidance document is available on the FDA website .

CMS Proposes to Create a DME Competitive Bidding Program

  The Centers for Medicare & Medicaid Services (CMS) proposed a competitive bidding program for durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS). Under the competitive bidding program, DMEPOS suppliers would be required to submit bids for each type of DMEPOS they supply to Medicare beneficiaries. Based on the bids received, CMS would select a “pivotal bid” or reimbursement ceiling for each item of DMEPOS. CMS would only select and contract with suppliers whose bids meet or fall under the pivotal bid.

  APhA submitted comments to CMS at the end of June urging the Agency to make significant revisions to the competitive bidding program. The comments addressed the Agency's failure to protect existing relationships between Medicare beneficiaries and their providers, the fact that t he program does not provide small DME suppliers with sufficient opportunity to participate as required by law, the development of a program that appears to consider cost savings more than quality care, and the negative impact the program will have on patient access to DMEPOS if implemented as proposed .

  CMS is currently reviewing all of the comments it received and developing a final regulation on the competitive bidding program. We will provide additional information on the competitive bidding program and the related DME supplier accreditation program as soon as it becomes available. Background information on the competitive bidding and supplier accreditation programs is available on the APhA Resources: Medicare website.

OIG releases July 2006 report: Review of 340B prices

For full text of the report, click here.

For OPA's response, click here.

New Federal Register Notice

On July 19, 2006, HRSA published a notice in the Federal Register (71 FR 41028) asking for comment on a proposed data collection. The notice focused on the guidelines to permit a manufacturer to audit a 340B covered entity as part of the OPA dispute Resolution process, and included an estimated reporting burden for parties. HRSA asked for comment on the necessity of collecting the information, the accuracy of their estimated compliance burdens, ways to enhance the quality of the information, and ways to minimize the burden of collecting the information.

FDA to Require Drug Pedigrees to Protect Against Counterfeit Drugs

On June 9, 2006, the Food and Drug Administration (FDA) announced new steps to strengthen exsting protections against the growing problem of counterfeit drugs. The measures, which were released as part of a report by the Agency's Counterfeit Drug Task Force, emphasize certain regulatory actions and the use of new technologies to safeguard the integrity of the drug supply. One of the most significant new measures includes the implementation of a drug pedigree requirement for prescription drugs. (A pedigree is a s tatement of origin that identifies each prior sale, purchase, or trade of a drug, including the date of those transactions and the names and addresses of all parties to them.) Under the drug pedigree requirement, wholesale distributors must provide a pedigree to the purchaser (i.e., a secondary distributor or pharmacy).

The FDA will begin implementing the pedigree requirement at the end of this year. The Agency's enforcement of the pedigree regulations will initially focus on products most susceptible to counterfeiting and diversion such as those with high market value and those that have been counterfeited in the past. A draft compliance policy guide that provides guidance on the type of drugs that are currently of greatest concern to the FDA, as well as information on the Agency's enforcement approach, is available on the FDA website . APhA will work with the FDA to evaluate the pedigree requirement's impact on pharmacists. It is important to note that safety net pharmacies will also need to comply with the new requirements.

A copy of the Counterfeit Drug Task Force's full report, which includes a number of other recommendations such as spurring the development and adoption of electronic track and trace technology include radio-frequency identification (RFID), is also available on the FDA website .

United States Supreme Court Refuses to Hear ‘Clawback' Challenge

On June 19, 2006, the United States Supreme Court declined to hear an action that was filed by five states to challenge the ‘clawback' provision of the Medicare Modernization Act (MMA). Five states ( Texas , Kentucky , Maine , Missouri and New Jersey ) filed the suit, claiming that the law was an unconstitutional tax. Although the Supreme Court did not assert original jurisdiction (or hear the original claim) on the matter, it is very likely that they will have the case placed before them again, in the future. As individual states challenge the provision throughout the country, if the various courts reach different conclusions on the matter, it may come back to the Supreme Court for a final decision.

House Ways & Means Committee Holds Part D Hearing

On June 14 th , the House Ways & Means Committee held a hearing to discuss the status of Medicare Part D since the May 15 th enrollment deadline. Witnesses included HHS Secretary Leavitt and CMS Administrator Mark McClellan. Both Sec. Leavitt and Administrator McClellan described the benefit as a great success. A highlight of the hearing was when Cong. Lloyd Doggett (D-TX) expressed concern about pharmacists not being able cover their costs because of low reimbursement levels and slow payments. In response, Administrator McClellan assured the Congressman that CMS would step in if plans were not meeting their contractual obligations. However, he clarified that the reimbursement rate and payment frequency are both contractual issues — something in which CMS will not get involved. Additional information on the hearing, including copies of Leavitt's and McClellan's statements can be found on the Committee's website . PSSC staff worked with APhA to develop a statement for the hearing. APhA's statement for the hearing is posted on the APhA Federal Government Affairs website .

APhA Testifies at AMA House of Delegates

Once again, the American Medical Association (AMA) addressed several issues of interest to pharmacists at their recent House of Delegates.  As in years past, APhA provided our profession's perspective on several of the proposed resolutions.  This year, APhA Member Margaret Tomecki testified on three proposals: 1) a resolution calling on pharmacists to alert prescribing physicians of situations that involved patient referral to an alternative pharmacy; 2) a resolution asking the Centers for Medicare and Medicaid Services to reconsider reimbursement for non-FDA-approved compounded medications; and 3) six r esolutions that address various aspects of immunization administration and distribution.  Copies of the resolutions are posted on the AMA website .  APhA's impact was positive.  The AMA House referred for further discussion the above mentioned compounding resolution and the resolution to require notification of when a pharmacist refers a patient to an alternative pharmacy.  Regarding the immunization resolutions, the AMA House of Delegates adopted policy stating that all health care providers should have access to all vaccines, that all vaccines should be administered by a physician or other qualified health care provider under the supervision of a physician and that the AMA would work with the CDC and others to establish a comprehensive distribution system for vaccines in the U.S. 

HHS National Advisory Committee Issues Report on Rural Pharmacy

The National Advisory Committee on Rural Health and Human Services recently released its 2006 Report to the Secretary of Health and Human Services. Each year, the Committee chooses three topics to study and makes recommendations directly to the Secretary based on their research and findings. For 2005, one of their topics was “Access to Pharmaceuticals and Pharmacy Services in Rural Areas.” Given the broad range of possible topics, it is significant that this group chose to focus on access to pharmaceuticals AND pharmacy services. In addition to access to prescription medications in rural areas, the Committee's report looked at the challenges facing rural pharmacists, and the impact on rural communities that lose their only pharmacy. The chapter also looked at how the Medicare Part D drug benefit (and increasing percentage of rural patients receiving drug coverage from the government instead of private third party payors) may affect rural patients and their pharmacists.

During 2005, PSSC and APhA worked with the Committee on this topic. Additionally, PSSC and APhA submitted formal comments to the Committee. Finally, PSSC 's previous Senior Director Diane Goyette and PSSC Consultant Todd Sorenson attended the Committee's field hearings throughout the year. The full report, including the Committee's recommendations, can be found at http://ruralcommittee.hrsa.gov/ .

OIG Issues Report on Deficit Reduction Act Changes to AMP

On May 30, the HHS Office of the Inspector General (OIG) issued a report on the changes made to Average Manufacturers Price (AMP). The Deficit Reduction Act of 2005 (DRA) amended section 1927 of the Social Security Act, dealing with the Medicaid program. One provision of the DRA required the OIG to issue a report to review the calculation of AMP for Medicaid and to make recommendations for implementing the new AMP provisions. As CMS prepares to implement using AMP to calculate the federal upper limit (FUL) for pharmacy reimbursement for certain drugs under Medicaid, they specifically looked at the 340B program and its use of AMP to calculate the 340B ceiling price. In this review, they found two primary issues. The first is the timely submission of AMP data by manufacturers, and the second is the accuracy of the reported AMP data. The OIG acknowledged that such problems with AMP to calculate the 340B price could also affect pharmacy reimbursement for generic drugs under Medicaid.

The OIG acknowledged in the report that manufacturers used a variety of methods to calculate AMP, and specifically recommended that CMS develop more specific policies for calculating AMP. The report also recommended a clarification in the definition of retail class of trade and the treatment of PBM rebates and other price concessions. APhA met with the OIG and submitted comments on behalf of pharmacy. Additionally, PSSC and OPA have worked on many of the DRA implementation issues, especially as they relate to the 340B drug pricing program.

GAO Report Suggests Oversight on ADAP Prices

In April, the Government Accountability Office (GAO) issued a report examining the prices that AIDS Drug Assistance Programs (ADAPs) pay for medications. ADAPs are eligible to participate in the 340B drug pricing program to purchase their medications. Congress is preparing for the reauthorization of the Ryan White CARE Act that funds AIDS programs, including ADAPs. The Act also specifically identifies 340B as an economical source for AIDS drugs. Consequently, Members of the Senate and the House of Representatives submitted a request for the GAO to study whether participating ADAPs were receiving the 340B ceiling price for their drugs. The GAO noted that OPA does not systematically check whether ADAPs comply with the grant requirements to use 340B, nor whether they actually receive the 340B price. The report noted that prices paid by the ADAPs were sometimes more than prices paid by the prime vendor program (PVP), and by other federal agencies. However, this statement does not, on its own, demonstrate need for greater oversight. In fact, the PVP regularly negotiates sub-ceiling prices for its participants and other agencies typically have prices that fall below the 340B ceiling.

The GAO made recommendations to HRSA to require all ADAPs to report the final prices paid for their drugs (including any other discounts or rebates) and for HRSA to routinely ensure that the ADAPs paid no more than the 340B ceiling price.

OPA Funding in President's 2007 Budget

For the first time, the Office of Pharmacy Affairs has a specific line item in the 2007 budget that the President submitted to Congress. Congress then uses the President's proposal to shape their own budget measures. The House Appropriations Subcommittee on Labor, HHS, Education and Related Agencies on Wednesday June 7, voted 9-7 along party lines to approve the fiscal year 2007 Labor-HHS-Education appropriations bill , which does still contain the OPA line item. The House and Senate versions of the budget typically are different and must go to a conference committee for reconciliation before the final budget is voted upon. We will continue to watch and track the OPA line item as Congress continues its work on the budget.

House Energy & Commerce Subcommittee Holds Pharmacy Hearing

On May 23, the House Energy and Commerce Health Subcommittee held a hearing to examine the Federal Government's Partnership with America 's Pharmacists. Witnesses included CMS Deputy Administrator Leslie Norwalk, and representatives from pharmacy associations, PBMs, health plans, drug manufacturers, retailers and wholesalers. Many of the Members of the Committee praised pharmacists' efforts during the Part D drug implementation, and focused on ways to improve the program. CMS was pressed about delays for pharmacy payments under Part D, and was specifically asked about medication therapy management (MTM) provisions of the program. Norwalk 's response was that the plans were given wide discretion for MTM for 2006, because the entire program was new. CMS wanted to give them flexibility and to see how each plan developed their own MTM program. Rep. Allen (D-ME) specifically asked about individuals that are eligible for the low-income subsidies, and the need to continue outreach to bring them into the program. CMS agreed with the need for more outreach, and specifically mentioned working with community health centers. Concerns were also raised about the plight of small, rural pharmacies, and their unequal bargaining power with plan sponsors.

Pharmacy Groups Meet with OIG on Medicaid Changes

In mid-March, APhA met with representatives from the HHS Office of Inspector General (OIG) to discuss changes made to Medicaid reimbursement and other matters in the Deficit Reduction Act of 2005. (P.L. 109-171). APhA staff in the meeting included Susan Winckler, Vice President of Policy and Communications. The OIG wanted to meet with APhA and other pharmacy groups to talk about the changes to how AMP is calculated and how it will be used to calculate pharmacy reimbursement for dispensing generic drugs under Medicaid after January 1, 2007. The meeting will assist the OIG in preparing a report by June, as required by the DRA. Although PSSC staff did not take part in the meeting, we have worked closely with APhA staff throughout the Medicaid reform debate, and have drawn attention to the specific concerns of safety net providers as the new law is implemented.

Congress Adopts New Federal Standard to Curb Meth Production

After working throughout 2005, the House and Senate passed the ‘ Combat Methamphetamine Epidemic Act of 2005' as part of the legislation to reauthorize the U.S. Patriot Act (Public Law 109-177). Unlike earlier versions of the proposal, the enacted version does not make ephedrine, pseudoephedrine (PSE), or phenylpropanolamine Schedule V products under the Controlled Substances Act (CSA). Instead, it places these chemicals in a new CSA category of ‘ scheduled listed chemical products' . Drug products whose ingredients include chemicals on this list and that may be marketed as a nonprescription drug are subject to sales restrictions, storage requirements and record keeping requirements.

Specifically, the ‘ Combat Methamphetamine Epidemic Act of 2005'

• limits daily retail sales to 3.6 grams per person;
• limits 30-day retail purchases to 9 grams per person;
• requires non-liquid forms to be sold in blister packs (with some exceptions);
• requires sellers to place the product behind-the-counter;
• requires sellers to maintain a written or electronic list ‘logbook' of sales that identifies
• the product name,
• quantity sold,
• names and addresses of purchasers, and
• dates and times of sales;
• and requires purchasers to present a photo ID and sign the logbook.

Mobile sellers (such as kiosks in airports) must place the product in a locked cabinet and are subject to a 7.5 gram sales limit per customer during a 30-day period. Similarly, mail-order sellers must, prior to shipping the product, confirm the identity of the purchaser and may not sell more than 7.5 grams of products per customer during a 30-day period.

The U.S. Attorney General is directed to establish criteria for the logbook and training programs that all sellers must take and to promulgate regulations to address the privacy issues that could arise with the logbook. The legislation was signed into law by the President on March 9 th ; the sales limits and blister pack requirements will go into effect 30-days after this date; the ‘behind-the-counter' and other requirements go into effect by September 30, 2006.

The new standards do not pre-empt state laws; they will be considered a minimum standard. Tougher state laws, such as the Oregon law that requires a prescription to obtain pseudoephedrine-containing products, will continue to remain in force. The federal law also establishes tougher penalties for individuals who make methamphetamine illegally and commits additional federal resources to finding and shutting down so-called “super labs” in Mexico , which supply most of the methamphetamine for U.S. users.

Budget Update –President Signs 2005 Budget Bill and Presents 2007 Budget Proposal

On February 8 th President Bush signed the Deficit Reduction Act (S. 1932) into law. The large budget bill includes provisions that will cut pharmacy reimbursement under Medicaid, and add Children's Hospitals to the list of entities eligible to purchase discount drugs under 340B. However, in an unprecedented legislative error, the version of the bill that the President signed is different than the version approved by the House and the Senate. While a public law number (P.L. 109-171) was assigned and most are proceeding as if the language was properly enacted, a lawsuit challenging the Constitutionality of the provision has been filed.

To recap, the legislation set a new Federal upper limit of 250% of Average Manufacturer's Price (AMP) for multiple source drugs that would go into effect January 1, 2007.  The proposal also will permit some Children's Hospitals to purchase discount prescription drugs through the 340B program.

Unfortunately, the Administration has not finished targeting pharmacy to find budget savings. The President's proposed 2007 budget includes more cuts to pharmacy by reducing the recently enacted reimbursement formula for multi-source drugs in the Medicaid program [250% of Average Manufacturer Price (AMP)] to 150% of AMP. Fortunately, reports indicate that neither chamber of Congress is expected to pursue another savings package; it is a very difficult process, and one that many Members facing an election this fall would like to avoid.

Internet Pharmacy Legislation Introduced
On February 16 th , Congressmen Norwood (R-GA) and Strickland (D-OH) introduced legislation (H.R. 4769) to address aspects of Internet access to prescription drugs. The ‘ Prescription Drug Abuse Elimination Act of 2006' seeks to have online pharmacies meet the same requirements as traditional pharmacies before shipping controlled drugs. The legislation would require an Internet pharmacy to provide the following information on its website: contact information for the pharmacy and its supervising pharmacist; all States in which the pharmacy is licensed or otherwise authorized to dispense prescription drugs; contact information for the practitioners to whom the pharmacy refers and the State in which such practitioners are licensed to prescribe; and a statement that the pharmacy will dispense drugs only upon showing of a prescription.

Sellers of Schedule II, III, or IV drugs would be required to limit their sales to those in accordance with a prescription of the patient's treating provider. The seller would have to verify that the prescription is legitimate through direct communication with the provider and keep a record of that communication for at least two years. Persons selling prescription drugs through an Internet site would also be required to inform the appropriate State licensing authorities that they are selling the drugs and their contact information.

Each of the above requirements would be deemed to have been met if the Internet site or pharmacy is certified by the National Association of Boards of Pharmacy's Verified Internet Pharmacy Practice Sites (VIPPS) program.

In addition to creating requirements for online pharmacies and health care providers, the legislation creates new jurisdiction for the courts over websites and creates new chain-of-custody requirements for manufacturers, importers, distributors, and retailers for these Schedule II, III, and IV drugs. Finally, the bill would direct the Secretary of Health and Human Services to conduct studies on pharmaceutical counterfeiting to determine the best methods to ensure that unused controlled substances are not diverted for unlawful use, and on issues related to prescription drug abuse. There is some sense that because the bill is focused on controlled substances, it will have greater support than other, more broadly applicable proposals.

APhA Update on Medicaid Payment Reform (Dec 21, 2005)

States consider importation programs as alternative access to lower-cost drugs

Prescription drug importation programs, although prohibited by federal law, have long been considered by some

as a means to help people (especially seniors and people with limited incomes) access costly medications. Despite passage of the Medicare Part D prescription drug benefit in 2003 (which will go into effect on January 1, 2006 ) the desire for imported drugs has not abated. In 2005, many states continue to consider legislation that would institute, expand, or refine Canadian and internet drug programs. Now, at least 12 states have websites that direct citizens to Canadian prescription drugs.

In June, Nevada enacted legislation that would allow state residents to buy prescription drugs through Canadian pharmacies over the internet. The law provides that the Nevada Board of Pharmacy will send representatives to Canada to license pharmacies that meet the state's licensure standards.

Additionally, Rhode Island has long been working on regulations implementing legislation passed in 2004 that would allow residents to buy drugs imported from Canada , as it moves to license Canadian pharmacies. The U.S. Food and Drug Administration (FDA) has already warned the state that such a move would violate federal law.

However, not all states (and not all patients) agree that importation is the best solution. According to the National Conference of State Legislatures, nationwide introductions of importation legislation are down this year, compared to last year. For example, last year, California Governor Schwarzenegger (R) vetoed one piece of Canadian importation legislation that was passed by the legislature, which was one of several introduced. This year, only one legislative proposal was introduced that included importation, and the issue will not be a part of the November ballot initiatives on health care.

Multi-state importation program expanding global reach

The I-SaveRx program, created by Illinois to facilitate citizens importing prescription drugs from Canada , Britain , and Ireland , has announced that it is expanding to add Australia and New Zealand to the list of suppliers for the program. The I-SaveRx program, which is less than a year old, was created in Illinois , and has expanded to include Wisconsin , Kansas , Missouri and Vermont . The move to include Australia and New Zealand is not surprising, since Canada recently announced its own plans to introduce legislation that may limit bulk prescription drug exports to the United States . Illinois has consistently stated that the nations included in the I-SaveRx Program have comparable safety standards to those of the United States Food and Drug Administration's (FDA), and that the program will only work with foreign pharmacies that comply with Illinois pharmacy standards. The state also argues that the drugs dispensed must originate in the countries that are parties to the agreement, so that the participating nations will not be able to pass-through prescription drugs from other non-contracting nations.

Although the program is growing, it still has not met expectations for the volume of prescriptions that it could deliver. About 10,000 orders have been placed so far through the nine-month old program, but observers have commented that it has had a slow start. According to Illinois , the I-SaveRx program has secured an average savings of 25 to 50 percent on prescription drugs for citizens who use the service. Illinois officials have blamed pressures by the FDA and pharmaceutical manufacturers for the less than robust numbers, claiming that seniors and others have been unduly scared away from using the service. However, both FDA officials and manufacturers continue to oppose importation plans that sidestep current law and FDA provisions on importing prescription drugs.

Texas Governor Leads Efforts on “Clawback”

Texas Governor Rick Perry (R) has called for the nation's governors to join his efforts on changing the “clawback” formula. In the new Medicare Part D prescription drug benefit, individuals who are fully eligible for coverage under both Medicare and Medicaid, will be transitioned from Medicaid to Medicare Part D on January 1, 2006 . Consequently, states will be required to make monthly payments to the Federal Government for the costs of coverage for these patients.

In its 2006-2007 budget provisions, the Texas legislature approved funding of $440 million to cover the state's “clawback” payments to the Centers for Medicare and Medicaid Services (CMS). However, Governor Perry vetoed the funding, and sent a letter to all governors explaining his objections and asking for their support in seeking changes to the funding mechanism. So far, the governors of around 20 states have responded positively to his message. However, it is unclear what changes to the funding mechanism can be secured at this time.

In the message accompanying his veto, Perry protested that the current formula is unfair and does not recognize states' efforts to reduce prescription drug costs for Medicaid patients, such as use of prior authorization, supplemental rebates, and preferred drug lists. The current formula is based on the estimated amount states would have paid in drug expenses in 2006. Additionally, the formula does not take into account the costs states will incur to establish systems to deal with the new administrative burdens that come with making determinations about which patients are eligible for the Medicare benefit.

Despite his position on the “clawback” and his veto of the funding provision, Perry has vowed to continue to work with President Bush, Department of Health and Human Services Secretary Michael Leavitt (both former governors) and current governors on other reform proposals.

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.