1. Congress

House of Representatives – District Work Period

Senate

Senate HELP Committee Reports Final Five “Cures” Bills

On April 6, the Senate Health, Education, Labor and Pensions (HELP) Committee passed five bills in the final markup of its biomedical innovation work, with a few amendments added along the way. The bills are as follows:

  • S. 2700, the FDA and NIH Workforce Authorities Modernization Act
  • S. 185, the Promise for Antibiotics and Therapeutics for Health Act
  • S. 2713, the Advancing Precision Medicine Act of 2016
  • S. 2745, the Advancing NIH Strategic Planning and Representation in Medical Research Act
  • S. 2742, the Promoting Biomedical Research and Public Health for Patients Act

Sen. Pat Roberts (R-KS) added a change that would force the FDA to explain why it is issuing guidance for industry rather than a formal rule; Sen. Richard Burr (R-VA) added an amendment that would give HHS more power to waive the Paperwork Reduction Act.

An amendment from Sen. Elizabeth Warren (D-MA) and Sen. Mike Enzi (R-WY)—the Genetic Research Privacy Protection Act—exempts genetic data collected for research from the Freedom of Information Act (FOIA) and protects the identities of research participants through NIH’s certificate of confidentiality (CoC) process.

Warren proposed and then withdrew an amendment to increase NIH funding. Chairman Lamar Alexander (R-TN) said the committee is still working on an agreement on that topic. Many Democrats—Warren, Sheldon Whitehouse and Al Franken—have all said they will not support a bill without a funding agreement before it hits the floor.

  1. Administration

NIH Announces Cancer Moonshot Blue Ribbon Panel Members

On April 4, the National Institutes of Health (NIH) announced the formation of a Blue Ribbon Panel of experts that will provide advice on the vision, proposed scientific goals and implementation of the National Cancer Moonshot Initiative. Potential funding opportunities the panel will consider in fiscal year 2017 include the development of single-cell genomic profiling of cancer cells, cancer vaccines and pediatric cancer research. To gather input from the cancer research community, the panel may call upon special consultants, create ad hoc work groups, hold workshops and provide opportunities for public input.

For the list of panel members and for more information, click here.

CMS Finalizes 2017 Payment and Policy Updates for Medicare Advantage and Part D Prescription Drug Program

On April 4, the Centers for Medicare and Medicaid Services (CMS) released the final Medicare Advantage and Part D Prescription Drug Program changes for 2017 that seek to provide stable payments to plans and make improvements to the program for plans that provide high-quality care to the most vulnerable enrollees. CMS will phase in the cuts to Medicare Advantage plans over two years in order to ease the pain for insurers.

The final policies are similar to those proposed in February but incorporate several changes in response to feedback received during the public comment period. On average, CMS estimates there will be a 0.85 percent increase in payments without accounting for the expected growth in coding acuity that has typically added another 2.2 percent. The final revenue increase is down from the 1.35 percent increase estimated in the February Advance Notice.

CMS is also changing its proposal to increase the use of medical claims data in determining payment rates. Instead of increasing the percentage of the formula based on medical claims data next year from 10 percent to 50 percent, it will instead raise the threshold to 25 percent.

New policies aim to improve the accuracy of payments to Medicare Advantage plans that serve vulnerable populations, such as dually eligible or low-income beneficiaries. Specifically, a revised methodology used to risk-adjust payments to plans will more accurately reflect the cost of care for dually eligible beneficiaries. CMS will also implement an interim adjustment to the Star Ratings system that is designed to more accurately compensate plans that attract disproportionately sick, expensive customers. Additionally, CMS’s finalized policies will provide stability to the Medicare Advantage program in Puerto Rico.

Insurers waged a lobbying campaign to roll back some of the changes, most notably the cuts to employer-based plans. The financial stakes are huge, with health plans receiving roughly $170 billion in federal funds each year to cover seniors.

CMS is also finalizing policies that will further combat opioid overutilization by encouraging safeguards before an opioid prescription is dispensed at the pharmacy and maintaining access to needed medications. Insurers will be required to put systems in place by 2018 that will reject claims for opioid prescriptions at the pharmacy for patients who have reached a threshold for the total amount of painkiller prescriptions they have filled. CMS said it will not approve plan formularies that hinder access to medication-assisted treatment for substance abuse disorder.

For a general fact sheet on the 2017 Rate Announcement and Call Letter, click here.

For more information on Medicare Employer Retiree Plans (Employer Group Waiver Plans) and the 2017 Rate Announcement and Call Letter, click here.

CMS Planning to Exclude Oncology Care Model Physicians From Part B Demonstration

The Centers for Medicare and Medicaid Services (CMS) is planning to exclude from the Part B drug demonstration physician practices participating in the Oncology Care Model. The exclusion of those oncologists would not only improve the integrity of results from the Part B demo, but also serve to ease the nerves of Democratic lawmakers caught between provider lobbyists trying to kill the demonstration and the administration supporting it.

At issue is the proposed rule to test new models to improve how Medicare Part B pays for prescription drugs and supports physicians and other clinicians in delivering higher-quality care. Oncologists oppose the proposed Part B demonstration because Part B drugs account for nearly 80 percent of oncologists’ Medicare fee-for-service revenue. They were among the 300 drug companies and doctor and consumer groups that wrote to Congress in opposition of the proposal.

CMS’s proposal acknowledges the overlap between the Part B demonstration and the Oncology Care Model. However, including the Oncology Care Model makes it more difficult for CMS to avoid messing up test results. CMS must ensure that the demonstration does not hurt patient access to clinically appropriate therapies.

Federal Appeals Panel Unconvinced of Obamacare Lawsuit

A federal appeals panel on Tuesday appeared skeptical of the latest Obamacare lawsuit, which challenges an Obama administration policy allowing health plans not meeting the law’s coverage requirements to remain in place.

On April 5, a three-judge panel of the D.C. Circuit Court of Appeals focused on whether the American Freedom Law Center (AFLC)—a nonprofit legal advocacy group—can show its health insurer hiked premiums because of the Obama administration’s decision to extend expiring health plans. If AFLC cannot show this, it will not have standing to bring the lawsuit and the court will not even consider the claims raised in the case.

AFLC lost on the standing issue during the first visit to a lower federal court. A case brought by the state of West Virginia also failed on the standing issue at the district court level. The case is up for appeal before the D.C. Circuit on April 15. In response to backlash when Americans received notices their health plans were being cancelled, the administration announced it would allow plans that do not meet the ACA’s coverage requirements to stay in place through 2017—if states choose to allow it.

The plaintiffs in this case argue the move was an unconstitutional use of executive authority.

FDA Approves Inflectra Biosimilar to Remicade

On April 5, the U.S. Food and Drug Administration (FDA) approved the second biosimilar that can enter the U.S market. Celltrion’s and Hospira’s infliximab product Inflectra is approved for all the indications treated by the reference product: Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis.

However, the drug is at the focus of litigation. Janssen Pharmaceutica filed suit against the biosimilar sponsors, alleging the companies refused to participate in required statutory procedures. In a brief filed in support of Amgen’s argument against Apotex, Janssen said that Celltrion and Hospira agreed to refrain from entering the market until after June 29, even though their product could be approved before that time

Allergan and Pfizer Call Off $160 Billion Merger

On April 6, drugmakers Allergan and Pfizer called off their $160 billion merger less than 48 hours after the Treasury Department announced harsh rules to stop corporate inversions. This has also been an issue in the presidential campaign: Hillary Clinton, Bernie Sanders and Donald Trump have all spoken out against Pfizer’s inversion.

White House to Transfer Ebola Funds to Fight Zika Virus

The Obama administration announced it will transfer $600 million in leftover money from the fight against Ebola to fight the growing threat of the Zika virus. Most of the funds will go to the Centers for Disease Control and Prevention (CDC), which is researching anti-Zika vaccines, treating those infected with it and addressing mosquitos that spread it.

The Ebola funds have been a point of contention between Congress and the White House, with GOP leaders repeatedly rejecting President Obama’s $1.9 billion emergency Zika funding request and urging him to use the Ebola funds instead. The White House has maintained that those funds were already intended to help contain and fight outbreaks abroad.

On April 5, a group of major public health and physician organizations wrote a letter to members of Congress requesting immediate emergency funding to guard against the threat from the Zika virus, arguing there is only a brief window of opportunity to “avert a wave of preventable birth defects.”

HHS, DOL, Department of Treasury Finalize New Version of the Summary of Benefits and Coverage

On April 6, the U.S. Department of Health and Human Services (HHS), the Department of Labor (DOL) and the Department of the Treasury announced key enhancements to the Summary of Benefits and Coverage (SBC) template and Uniform Glossary. The improvements include an additional coverage example and language and terms to improve consumers’ understanding of their health coverage.

Under the Affordable Care Act (ACA), issuers and health plans are required to provide a brief summary of what the plan covers and the cost-sharing responsibility of the consumer, in order to help individuals make more informed choices among health plan options and better understand their coverage. Plans and issuers are also required to provide a comprehensive uniform glossary of commonly used health coverage and medical terms.

The SBC includes coverage examples that demonstrate the cost-sharing amounts an individual might be responsible for in three common medical situations. In addition to the current coverage examples that address diabetes care and childbirth, the updated template has a new coverage example that addresses coverage for a foot fracture so that a consumer understands what a plan covers in an emergency scenario.

Changes have also been made to the SBC to improve readability for consumers. The new templates include more information about cost sharing, such as enhanced language to explain deductibles and a requirement that plans address individual and overall out-of-pocket limits in the SBC. These improvements reflect input from consumer groups, the National Association of Insurance Commissioners and other stakeholders. Health plans and issuers will use this final SBC template beginning on the first day of the first open enrollment period that begins on or after April 1, 2017.

The SBC is available for every Marketplace plan and most non-Marketplace plans.

For more information regarding the SBC and supporting materials, click here.

  1. State Activities

Arkansas: Governor’s Medicaid Plan Approved by Arkansas House and Senate

The state legislature held its special session on Medicaid last week, where lawmakers considered extending coverage for the Medicaid expansion population, among other reforms. Gov. Asa Hutchinson’s managed care proposal was not considered after lawmakers urged him to drop the plan. House and Senate leaders said there was no consensus on managed care, so they only considered Arkansas Works.

Both chambers passed Arkansas Works on April 7, and funding for the program will be voted on during the fiscal session starting April 13 — appropriation requires a 75 percent majority.

California: State Exchange Analysis Reveals Challenges for Undocumented Waiver

On April 7, California exchange board members cleared the way for an Affordable Care Act waiver (Section 1332) that would let undocumented immigrants purchase plans at full cost. The board’s recommendations sent the issue to the California Legislature, which must pass a bill authorizing the state to submit the waiver request to the federal government.

A Section 1332 waiver allowing undocumented immigrants in California to purchase Affordable Care Act (ACA) plans at full cost would likely take until 2018 to implement even if the federal government accepted it, according to an analysis by Covered California.

The state may consider other waiver ideas in later years, including a fix of the ACA’s so-called family glitch, which prevents some individuals from obtaining subsidized coverage on the exchanges if a family member receives affordable job-based coverage.

The health care law explicitly prohibited undocumented immigrants from enrolling in ACA coverage, so federal approval of the undocumented coverage waiver is uncertain. Gov. Jerry Brown’s stance is also unclear, although last year he expanded Medicaid coverage to undocumented children.

Covered California—the state’s exchange—prepared the analysis of several Section 1332 waiver options before an April 7th exchange board meeting where members voted on initial recommendations. Implementation would require changes to Covered California’s marketing campaign and the state’s eligibility and enrollment system. The analysis also points out that California is quickly running out of time to get a waiver submission prepared for this year.

For 2016, 1.6 million people signed up through the state exchange, a number that includes nearly 440,000 new enrollees;90 percent of enrollees qualified for subsidies.

For more information, click here.

Florida: Legislature Passes Prescribing Bill

The Florida state legislature passed a bill that grants nurse practitioners and physician assistants prescribing authority for controlled substances. Florida is the only state in the country that does not give that authority to nurse practitioners, and both Florida and Kentucky still do not give physician assistants the authority. Gov. Rick Scott has until April 14 to sign or veto the legislation.

In other news, Florida has reached a settlement in a class-action lawsuit over access to providers for children enrolled in Medicaid. In the lawsuit, lasting over 10 years, the state admitted to no wrongdoing but agreed to pay $12 million in attorneys’ fees for the plaintiffs. This includes the Florida Pediatric Society and the American Academy of Pediatrics. Florida’s Agency for Health Care Administration (AHCA) will make attempts to reach specific thresholds for provider participation in the Medicaid program within 30 months of the settlement’s implementation. Florida will have to create a corrective action plan with the plaintiffs if it fails to meet this goal. The AHCA will seek increases in payments to Florida’s Medicaid managed care plans if it does not meet provider participation goals. Florida also agreed to improve outreach efforts to enroll additional children in Medicaid.

Additionally, there are requirements related to children’s access to dental services—within 30 days of the settlement’s implementation, AHCA agreed to start a study of network adequacy for dental plans to determine what changes should be made in Medicaid contracts for 2016.

Minnesota: Increased Losses for Health Insurers in Individual Market

Minnesota health plans say their financial losses for the individual market grew last year. Nonprofit health insurers lost $351.8 million in the individual market on revenues of around $1.1 billion. However, they expect losses to be closer to $133 million after taking into account ACA programs that are shielding insurers from financial risk. The Minnesota Council of Health Plans released these figures. They reflected financial performances of seven health insurers in Minnesota: Blue Cross and Blue Shield of Minnesota, HealthPartners, Metropolitan Health Plan, Medica, PreferredOne, UCare and Sanford Health Plan of Minnesota.

New York: Budget Agreement Allows Federal Waiver for Medicaid Inmate Exclusion

The budget agreement announced by Gov. Andrew Cuomo and legislative leaders authorizes New York to seek a federal waiver for Medicaid’s inmate exclusion. Federal Medicaid law prohibits the payment of federal Medicaid matching funds for the medical costs of inmates, unless the inmate is in an inpatient hospital setting or other medical institution. The New York budget allows the state to seek a federal waiver in order to provide transitional services to high-needs inmates 30 days before being released. Services could include medical care, prescription drugs and care coordination services.

Ohio: Gov. Kasich to Release Medicaid Waiver Proposal

Republican Gov. John Kasich’s administration is going to release a Medicaid expansion waiver proposal that would require certain Medicaid enrollees to pay into a health savings account (HSA) regardless of their income. House Republicans added the plan to the state budget last year. If approved by the federal government, more than 1 million low-income people would be required to pay the new monthly cost beginning in 2018. A draft of the waiver proposal will be made available for public comment on April 15.

Oklahoma: Medicaid Agency Proposing to Adopt Medicaid Expansion

Oklahoma’s Medicaid agency—Oklahoma Health Care Authority—is proposing to adopt Obamacare’s Medicaid expansion. Titled “the Medicaid Rebalancing Act of 2020,” the proposal relies on the enhanced federal Medicaid funding to cover 175,000 uninsured Oklahomans earning up to 133 percent of the federal poverty level. Enrollees would have a choice of commercial insurance plans and premiums based on their income on a sliding scale. The plan would also move 175,000 pregnant women and children into private insurance plans, which the agency estimates would save Oklahoma $60 million.

The expansion would be an option under the state’s existing Insure Oklahoma Medicaid 1115 waiver, which covered over 19,000 low-income adults as of March 2016.

This plan comes after the Medicaid agency notified providers that it wants to cut reimbursement rates by 25 percent, as the state tries to plug a $1.3 billion budget hole. A fact sheet detailing the plan notes that it would restore provider rates back to the current 86.5 percent of Medicare as soon as possible.

Tennessee: Departure of TennCare Director Darin Gordon

Tennessee Gov. Bill Haslam announced TennCare Director Darin Gordon will leave his post at the end of June and enter the private sector. Gordon spent 10 years leading the state’s Medicaid program and is the longest-serving Medicaid director in the country.

  1. Regulations Open for Comment

Food and Drug Administration (FDA) Issues Final Rule to Phase Out Trans Fats

FDA issued a final rule June 16 that gives the food manufacturers three years to phase out partially hydrogenated oils (PHOs), which are still used in a wide variety of food products from microwave popcorn to cake frosting. The decision finalizes an agency determination that PHOs, the primary dietary source of artificial trans fat in processed foods, are not “generally recognized as safe” or GRAS for use in human food. Since 2006, manufacturers have been required to include trans fat content information on the Nutrition Facts label of foods. Between 2003 and 2012, the FDA estimates that consumer trans fat consumption decreased about 78 percent and that the labeling rule and industry reformulation of foods were key factors in informing healthier consumer choices and reducing trans fat in foods. Comments on the final rule are due by June 18, 2018.

More information on FDA’s decision can be found in the agency’s press release.

HHS Posts Guidance for State Innovation Waivers

On Dec. 11, the Department of Health and Human Services (HHS) posted guidance for states interested in seeking a State Innovation Waiver under Section 1332 of the Affordable Care Act (ACA). State Innovation Waivers allow states to receive federal funding to implement alternative models of health care coverage that provide affordable coverage to their residents. The notice clarifies that the minimum length of public notice and comment periods for waiver applications is 30 days.

To see the guidance, click here.

CMS Releases Proposed Rule for Provider Enrollment Process

On Feb. 25, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule to implement additional provider enrollment provisions of the Affordable Care Act (ACA) to help make sure that entities and individuals who pose risks to the Medicare program are kept out of it or removed for extended periods. This rule is part of CMS’s effort to prevent questionable providers and suppliers from entering the Medicare program.

If finalized, the regulations would allow CMS to remove or prevent enrollment of those who try to circumvent enrollment requirements through name and identity changes or through inter-provider relationships. It will also address vulnerabilities such as when providers and suppliers avoid paying their Medicare debts by reenrolling as a different entity.

Major provisions of the proposed rule include:

  • Disclosure of Affiliations: Would require health care providers and suppliers to report affiliations with entities and individuals that: (1) currently have uncollected debt to Medicare, Medicaid or CHIP; (2) have been or are subject to a payment suspension under a federal health care program or subject to an Office of Inspector General (OIG) exclusion; or (3) have had their Medicare, Medicaid or CHIP enrollment denied or revoked. CMS could deny or revoke the provider’s or supplier’s Medicare, Medicaid or CHIP enrollment if CMS determines that the affiliation poses an undue risk of fraud, waste or abuse.
  • Different Name, Numerical Identifier or Business Identity: CMS could deny or revoke a provider’s or supplier’s Medicare enrollment if CMS determines that the provider or supplier is currently revoked under a different name, numerical identifier or business identity.
  • Abusive Ordering/Certifying: Would allow CMS to revoke a physician’s or eligible professional’s Medicare enrollment if he or she has a pattern or practice of ordering, certifying, referring or prescribing Medicare Part A or B services, items or drugs that is abusive, represents a threat to the health and safety of Medicare beneficiaries or otherwise fails to meet Medicare requirements.
  • Increasing Medicare Program Re-enrollment Bars: Would improve protection of the Medicare Trust Funds and program beneficiaries by: 1) raising the existing maximum re-enrollment bar from three years to 10 years; 2) allowing CMS to add three more years to the provider’s or supplier’s re-enrollment bar if the provider attempts to re-enroll in Medicare under a different name, numerical identifier or business identity; and 3) imposing a maximum 20-year re-enrollment bar if the provider or supplier is being revoked from Medicare for the second time.
  • Other Public Program Termination: Would permit CMS to deny or revoke a provider’s or supplier’s Medicare enrollment if: (1) the provider or supplier is currently terminated from participation in a particular Medicaid program or any other federal health care program under any of its current or former names, numerical identifiers or business identities; or (2) the provider’s or supplier’s license is revoked in a state other than that in which the provider or supplier is enrolled or enrolling.
  • Expansion of Ordering/Certifying Requirements: Would permit CMS to require that physicians and eligible professionals who order, certify, refer or prescribe any Part A or B service, item or drug must be enrolled in or validly opted out of Medicare.

Comments on the proposed rule must be submitted no later than 5 p.m. on April 25.

For more information, click here.

ONC Releases Proposed Rule Expanding Role in Health IT Certification Program

The Office of the National Coordinator for Health Information Technology (ONC) released a proposed rule that would enable the agency to conduct direct reviews of certified health IT products. Such direct review would also include how certified health IT interacts with other systems. The rule increases ONC’s oversight of health IT testing bodies to improve alignment and more successfully deal with issues, and seeks to increase transparency associated with the surveillance—it plans to make results of surveillance of electronic health records (EHRs) publicly available. The reviews would focus on situations posing health or safety risks. Depending on the findings, the office says it may require corrective action or suspend or terminate certification for an EHR or health IT module.

ONC hopes this move will enhance public confidence in health IT testing and certification. The U.S. Department of Health and Human Services (HHS) said the rule will empower consumers by improving availability of certification information. ONC is proposing a “strict process” for health IT recertification or replacement versions, and a program ban for those that don’t fix problems pointed out by ONC. Comments on the rule will be accepted through May 2.

To see the proposed rule, click here.

CMS Proposes to Test New Medicare Part B Prescription Drug Models

On March 8, the Centers for Medicare and Medicaid Services (CMS) announced a proposed rule to test new models to improve how Medicare Part B pays for prescription drugs and supports physicians and other clinicians in delivering higher-quality care. Medicare Part B covers prescription drugs that are administered in a physician’s office or hospital outpatient department, such as cancer medications, injectables like antibiotics, or eye care treatments. The proposed Medicare Part B Model would test new ways to support physicians and other clinicians as they choose the drug that is right for their patients. The proposed rule is designed to test different physician and patient incentives to do two things: drive the prescribing of the most effective drugs and test new payment approaches to reward positive patient outcomes. Among the approaches to be tested are the elimination of certain incentives that work against the selection of high-performing drugs, as well as the creation of positive incentives for the selection of high-performing drugs, including reducing or eliminating patient cost sharing to improve patients’ access and appropriate use of effective drugs.

Prescription drug spending in the U.S. was around $457 billion in 2015, or 16.7 percent of overall health spending. In 2015, Medicare Part B spent $20 billion on outpatient drugs administered by physicians and hospital outpatient departments. The proposed rule seeks comments on testing six different alternative approaches for Part B drugs to improve outcomes and align incentives to improve quality of care and spend dollars wisely:

  1. Improving incentives for best clinical care
  2. Discounting or eliminating patient cost sharing
  3. Feedback on prescribing patterns and online decision support tools
  4. Indications-based pricing
  5. Reference pricing
  6. Risk-sharing agreements based on outcomes

CMS is accepting comment on the proposed rule through May 9, 2016.

To see the press release, click here.

For a fact sheet on the proposed rule, click here.

  1. Reports

MedPAC Recommends Changes in Medicare Drug Part D

On April 7, the Medicare Payment Advisory Commission (MedPAC), which advises Congress on Medicare payment, unanimously passed a package of Part D recommendations estimated to save $10 billion over five years.

Both PhRMA, which represents drug manufacturers, and the Partnership for Part D Access, which includes patient groups and others, came out against the proposals.

MedPAC approved three groups of recommendations that commissioners said should be viewed as a comprehensive package. The Congressional Budget Office (CBO) estimates the recommendations would be expected to save more than $10 billion over five years.

The first group of proposals says Congress would change Part D to:

  • Lower Medicare’s individual reinsurance subsidy from 80 percent to 20 percent, while maintaining Medicare’s overall 74.5 percent subsidy of basic benefits.
  • Exclude manufacturers’ discounts in the coverage gap from enrollees’ true out-of-pocket spending.
  • Eliminate enrollee cost sharing above the out-of-pocket threshold.

Stakeholders had previously raised concerns about removing coverage gap discounts from beneficiaries’ true out-of-pocket spending, and drugmakers hit the recommendation for increasing beneficiary cost sharing. Some commissioners also said they had concerns with increasing costs for beneficiaries in the donut hole.

The second group of recommendations urges Congress to change Part D to:

  • Modify copayments for Medicare beneficiaries with incomes at or below 135 percent of the poverty level to encourage the use of generic drugs, preferred multisource drugs or biosimilars when available in selected therapeutic classes.
  • Direct the HHS secretary to reduce or eliminate cost sharing for generic drugs, preferred multisource drugs and biosimilars.
  • Direct the HHS secretary to determine appropriate therapeutic classifications for the purposes of implementing the policy and to review the therapeutic classes at least every three years.

The third group of recommendations says the HHS secretary should change Part D to:

  • Remove antidepressants and immunosuppressants for transplant rejection from the classes of clinical concern.
  • Streamline the process for formulary changes.
  • Require prescribers to provide standardized supporting justifications with more clinical rigor when applying for exceptions.
  • Permit plan sponsors to use selected tools to manage specialty drug benefits while maintaining appropriate access to needed medications.

The Commission will be looking at Part B drug policies in future months.

Reuters Analysis Shows Price Increases for Widely Used Medications

Reuters analyzed proprietary data from major drug companies and found that manufacturers took large price increases for widely used medications over the past five years. Prices for four of the country’s top 10 drugs increased more than 100 percent since 2011—with the highest increase being 126 percent—and six others went up more than 50 percent. The drugs are to help treat common conditions such as asthma, high cholesterol and arthritis.

To see the analysis, click here.

Insulin Price Increases

Over the last decade the price of insulin tripled, exceeding the costs of alternative medications, according to a new JAMA study. Between 2002 and 2013, the price of insulin jumped from $4.34 per milliliter to $12.92. Total spending on insulin also dramatically increased from an average of $231.48 per person to $736.09 over that same time period, likely because the quantity per year per patient also increased from 171 milliliters to 206 milliliters. Researchers suggested examining whether insulin alternatives would be more cost effective if people continue to seek treatment at higher rates.

FTC Releases Guidance For Mobile Health Apps

On April 5, the Federal Trade Commission released a new online tool for health app developers that clarifies which laws and regulations apply to their software. The FTC guidance, developed with the FDA, the ONC and HHS’s Office for Civil Rights, asks developers questions about their apps’ function and the data they collect. It uses their answers to point them to relevant information from HIPAA, as well as FDA and FTC laws and rules.

For more information, click here.

AAMC Predicts Physician Shortage

Once again, a new report from the Association of American Medical Colleges (AAMC) predicts that the United States will face a physician shortage over the next decade. It estimates a shortfall of between 14,900 and 35,600 primary care physicians, and a shortfall of between 37,400 and 60,300 non-primary care specialists by 2025.

To see the report, click here.

“Coordinating Center” to Evaluate Medical Devices Proposed

The National Medical Device Evaluation System Planning Board—created by the U.S. Food and Drug Administration (FDA), the Brookings Center for Health Policy and the Duke-Margolis Center for Health Policy—is proposing a voluntary system that would launch a “coordinating center” to create a national system to evaluate medical devices.

The National Medical Device Evaluation System Planning Board (Planning Board) was originally convened in 2014 by the Center for Health Policy (CHP) at the Brookings Institution, in partnership with the FDA. The goal of the first phase of work was to create a long-term vision for a sustainable national system to evaluate the risks and benefits of medical devices.

The voluntary system would create a hub for different parts of the field to share information, which would ideally better health care and decrease costs, according to the report. Through the coordinating center, manufacturers would have their devices approved faster, because the FDA and other agencies will have faster and easier access to information. It will then be easier to collect data once the devices are on the market, which will make physicians more knowledgeable about the devices they’re using or recommending, the report states.

Among the steps that the coordinating center would take are data use agreements that let members share standardized data including electronic health records, claims, patient outcomes and clinical trial data. The center would also serve as a “clearinghouse of expertise and advanced methods, tools, standards and best practices,” the report states. 

The board recommended that the National Medical Device Evaluation System be run as a public-private partnership, organized as a nonprofit, with members from both sides on its board. 

“All NMDES activities should be based on partnerships. Therefore, it is critical that NMDES be founded on a clear set of principles and priorities shared by those partners,” the report states. “Most importantly, NMDES must gain the trust of the public and other stakeholders through clear expectations and transparent communication that reflect a focus on relevant evidence for patients. NMDES should be part of the wider learning health care system and continually evolve as technology changes.”

For more information, click here

World Health Organization Advocates Governments Fight Diabetes

The World Health Organization (WHO) called on governments to take more aggressive steps in fighting the rising number of diabetes cases worldwide. The number of people living with diabetes has almost quadrupled since 1980 to 422 million people, or 8.5 percent of the population, according to the WHO’s first “Global Report on Diabetes” released last week.

As part of the United Nations Sustainable Development Goals, WHO member states have pledged to reduce premature mortality from non-communicable diseases such as diabetes by one-third by 2030.

The WHO stressed that type 2 diabetes, the most common form of the disease, was largely preventable if people exercised more, ate healthier foods and cut down on smoking.

It recommends, among other measures, implementing policies that promote breastfeeding and healthy diets and that discourage the consumption of unhealthy foods, such as sugary drinks.

“Policy action to increase the price of foods high in fat, sugar and salt can decrease their consumption,” said the report, highlighting encouraging results from Mexico’s recent move to tax sugary drinks.

Uninsured Rate Continues to Fall According to Gallup

The percentage of uninsured adults continues to drop under the Affordable Care Act (ACA). Eleven percent of Americans between ages 18 and 64 lacked coverage in the first quarter of this year, down from 11.9 percent in the last quarter of 2015, according to Gallup. The uninsured rate among nonelderly adults has plunged by 6.1 percentage points since the fourth quarter of 2013, just prior to the full implementation of ACA’s coverage expansion programs.

The percentage of adults reporting self-funded coverage was 21.8 percent, up 4.2 percentage points since the exchanges opened. In addition, the percentage of nonelderly adults enrolled in Medicaid was 9.4 percent in the first quarter of this year, up 2.5 percentage points since eligibility expanded.

To see the report, click here.

Coverage Gains Made Under ACA, But Need for Safety Net Remains

New research from Georgetown University’s Center on Health Insurance Reforms shows the Affordable Care Act (ACA) has not significantly reduced the need for safety net providers and charity care programs, despite coverage gains.

Researchers interviewed health care officials in three midsized cities: Columbus, OH; Richmond, VA; and Tampa, FL. Their findings are only anecdotal, but suggest simply obtaining coverage doesn’t eliminate barriers to accessing affordable care.

That means safety net providers, such as free clinics and community health centers, are continuing to play a major role. Free clinics in Richmond and Columbus, for example, found the number of patients decreased shortly after open-enrollment season, but that many returned later in the year because they had dropped their marketplace plans.

Researchers said more data is needed to understand the extent of the problems affording care, and pointed out that the Centers for Medicare and Medicaid Services (CMS) has not taken advantage of the authority it has under the ACA to collect more information from insurers about areas of concern, such as out-of-pocket costs and adequacy of provider networks.