Highlight on Idaho: State raring to go for open enrollment

Idaho’s health landscape looks to be in good shape right now, except for a nasty case of salmonella from some contaminated cucumbers. Beyond that, the health exchange has passed an audit and is ready to go for the next open enrollment period while the push for closing the existing coverage gap continues.

Your Health Idaho

Your Health Idaho, the state’s own health insurance exchange established under the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148), just passed its annual audit. The audit was conducted by an independent firm, and revealed no large issues. The report indicated that the exchange submitted a progress report after a federal deadline, but the officials running the exchange used it as a learning experience and responded by expanding the exchange’s staff and making some policy changes.

The success of Your Health Idaho stands in contrast to the struggles of other state exchanges. Several  state exchanges have failed financially, especially the health co-operatives, and those states have resorted to using the federal exchange. Idaho cannot use any state taxpayer funds to keep its exchange operational, but the state has managed to be successful nonetheless.

As the open enrollment period looms, starting November 1, 2015 and running through January 31, 2016, Your Health Idaho is ahead of the game. The exchange held a town hall meeting in Twin Falls September 29, 2015, with the chairman of the board, Stephen Weeg. He spoke to local insurance agents about the future of the exchange, as well as functionality and specific concerns about this year’s enrollment period. The exchange hopes that the agents will see that they are attempting to make the enrollment process as smooth as possible this year.

Medicaid expansion

For those Idahoans that cannot afford care, many are still pushing for the state to accept federal funding and expand Medicaid to cover an additional 78,000 citizens. Some state legislators are reluctant to accept federal funding, concerned that the funding will not remain available. Others have general objections about the ACA itself. Those that advocate for closing the coverage gap say that almost half of the patients at some health care facilities fall into this gap, and need the extra help. During Governor Otter’s visit to Albion, a woman testified about her situation, emphasizing that she and her husband are working hard but need a little extra help to afford care.

The Healthy Idaho proposal would expand health care coverage to low-income workers who do not qualify for current forms of aid or insurance through their employers. This plan would provide financial assistance for those at and slightly above the federal poverty line to purchase coverage on Your Health Idaho, with provisions for the assistance to decrease as incomes grow. Those below the poverty line would enroll in Medicaid’s Care Management Plan, which promotes cost efficiency and personal responsibility. The plan would attempt to save costs by requiring co-pays for emergency room use for non-emergency situations, an assigned primary care provider, cost-sharing, and quality-based payments to providers. According to the website, this plan would save the state $173 million over the next decade.

Don’t eat the cucumbers

A national outbreak of salmonella in cucumbers sold between August 1st, 2015 through September 3rd, 2015 has caused at least 21 Idaho residents to become ill. These cucumbers were grown in Mexico and sold by a San Diego company, Andrew and Williamson, under their “Limited Edition” brand. Idaho officials are concerned that more people may become ill from the contaminated vegetables because they are unaware of the recall. This outbreak involved three different strains of salmonella, and has caused at least 558 illnesses in 33 different states.

Happy fiscal new year: Continuing resolution funds government until Dec. 11

Congress avoided shutting down the federal government by passing the Continuing Appropriations Act of 2016 on September 30, 2015, the last day of federal fiscal year (FFY) 2015. The legislation funds the operations of the government at the level of previous appropriations until December 11, 2015. President Obama signed the bill the same day.

The vote

The Senate vote was 78 to 20. Senators Marco Rubio (R-Fla) and Lindsay Graham (R-SC), who both seek the Republican Party’s nomination for president in the 2016 election, did not vote. The vote in the House was 277 to 151; 91 Republicans joined the Democrats, with seven members not voting.

The law did not contain any language barring funding for Planned Parenthood, a sticking point that held up the vote on the budget. On September 30, the House of Representatives voted again to terminate federal funding to the provider of reproductive health services; there is no expectation that this bill would pass the Senate.

Next steps

Negotiations on the budget will continue. If they are not successful, on December 11, Congress will be in the same position as they on September 30, perhaps with some added pressure not to shut down the government during the holiday season. The election of the new Speaker of the House, who will succeed John Boehner, is likely to affect the outcome of the negotiations.

Health committee hears passionate pleas for Medicaid improvements

The witnesses testifying at a September 18, 2015, Energy and Commerce Committee hearing on four different Medicaid bills all offered moving stories about someone they know whose lives will or would have been affected by the pending legislation. These bills cover a wide range of topics, but all intend to improve access to care for Medicaid beneficiaries.

Clinical trials

The Ensuring Access to Clinical Trials Act of 2015 (H.R. 209) would remove the sunset provision of a similar act passed in 2009 that creates an income exclusion provision for up to $2,000 received in exchange for participation in clinical trials. According to Dr. Michael Boyle, Vice President of Therapeutics Development for the Cystic Fibrosis Foundation, current clinical trial participants and future candidates will be forced to discontinue or decline to participate for fear of losing their Supplemental Security Income (SSI) or Medicaid benefits due to income restrictions if the exclusion is allowed to expire on October 5, 2015. In his testimony, Boyle pointed out that precision medicine allows very targeted and specific therapies to be developed to treat rare diseases and specific groups of patients. The possible trial population for these drugs is limited by the rarity of the disease and the specificity sought. Further reducing the pool of trial participants due to fears of losing vital benefits will limit scientific advancements and efforts to cure these devastating diseases. The Senate has already passed identical legislation.

PACE programs

H.R. 3243 would expand the Program of All-Inclusive Care for the Elderly (PACE) to include those with disabilities under age 55. PACE provides comprehensive in-home care to those who are 55 or older who would otherwise require institutional care. Tim Clontz of the National PACE Association testified about the importance of allowing those with disabilities to remain in their homes, surrounded by their loved ones, as opposed to the strain that moving into a nursing facility puts on both the patient and their families. When asked how PACE would adapt to serving younger patients, Clontz admitted that creative solutions would be necessary but hopes to use pilot programs to determine the best models of care. While some larger programs may be able to create a division dedicated to patients under 55 years of age, he noted that programs in more rural areas would likely need to use existing resources to treat the new patient population.

Special needs trust

The Special Needs Trust Fairness Act of 2015 (H.R. 670) would allow for non-elderly disabled individuals to establish special needs trusts on their own behalf. Special needs trusts, unlike most other trusts, are not considered an asset for Medicaid eligibility determinations. Currently, only parents, grandparents, a legal guardian, or a court may establish a special needs trust on behalf of a non-elderly disabled individual. Richard Courtney, President of the Special Needs Alliance, testified before the committee on the bill and stated that these individuals are mentally capable of making a contract and should be allowed to do so to protect their interests. He noted that some courts have been hesitant to establish these trusts, leaving those without surviving parents little recourse.

Medicaid directory

The Medicaid Directory of Caregivers Act would require state Medicaid programs to establish an electronic list of physicians that accept Medicaid patients. This list would include doctors who have billed Medicaid in the last six months. The Government Accountability Office (GAO) found that Medicaid enrollees encounter difficulties in attempting to access various types of specialty care, and the Centers for Disease Control and Prevention (CDC) noted that physicians are less likely to accept Medicaid patients than those covered by Medicare or private insurance. This updated list of providers accepting Medicaid patients would reduce the time and effort required to find a provider.

HELP subcommittee hearing looks for signs of life in FDA’s biosimilar pathway

A subcommittee hearing on biosimilar implementation was held by the U.S Senate Committee on Health, Education, Labor, and Pensions subcommittee on Primary Health and Retirement Security. The hearing, titled “Biosimilar Implementation: A Progress Report from FDA” addressed the FDA’s efforts to implement its biosimilar approval pathway and inquired as to the cause of the FDA’s delay in providing guidance on the nature of the pathway. The hearing also addressed concerns that the market will not have sufficient confidence in biosimilars as they become more widely available.

Opening statements

Senator William Cassidy (R-La), a physician, chaired the hearing and discussed the fact that since the Biologics Price Competition and Innovation Act (BPCI Act) was passed under Section 7002 of the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148), only one biosimilar has been approved and is on the market. Additionally, the FDA has not issued final guidances on many parts of the approval pathway including: “naming, labeling, interchangeability, and data extrapolation.”


The only witness was Janet Woodcock, the Director of the FDA’s Center for Drug Evaluation and Research (CDER). Woodcock testified that the FDA strongly supports the creation of a meaningful biosimilar pathway and has been working on it since the 1990s. As a rheumatologist, Woodcock acknowledged the significance of biologics in treating diseases like rheumatoid arthritis and commended their success in eliminating the need for things like joint replacements and for increasing the likelihood of disease remission. However, Woodcock also noted that biologics and biosimilars require complex regulation and often have prohibitive costs.


Senator Murphy (D-Conn) acknowledged the promise of biologics but noted that they have led to unprecedented costs for the health care industry. Murphy explained that although biologics constitute less than one percent of prescriptions, expenditures on biologics amount to 28 percent of prescription drug spending, with forecasts of increased spending in the coming years. Murphy suggested that the high cost is due in part to higher cost sharing burdens imposed by insurance companies on biologics. Thus, he explained, the success of biosimilars—which will serve as competitors of reference biologics—is crucial to driving down drug costs.


Cassidy explained that biosimilars raise more complex issues than drugs because of their biologic nature. He noted that, due to the complexity of biologic products, biosimilars can never be deemed truly identical to another biological reference. According to Cassidy, this results in a tension for the FDA, where, although dealing with a biologic, the agency must make certain that a biosimilar has comparable efficiency and effectiveness such that that it can be used in lieu of its reference product. Cassidy explained that while some biosimilars can be deemed interchangeable—meaning the biosimilar can be more safely exchanged with its biologic reference product—biosimilars can only be “similar” and can never be truly identical to a reference.

Reference products

However, not all biosimilars are interchangeable. Those that are not will require specific prescribing and, unlike a generic, cannot be swapped out with the biologic reference product without a separate prescription. However, biosimilars, even when not deemed interchangeable, are still expected to produce the same clinical effect as they biologic they reference. At present, many biosimilars will likely not be deemed interchangeable because of unknowns about immune responses that biologics may cause.

Immune response

Woodcock testified, in response to questions about interchangeability, that biosimilars present complicated risks due to unexpected immune responses. The issues result when switching between a biosimilar and a biologic reference product or another biosimilar. Woodcock explained that, because of their biologic nature, biosimilars are all (on some level) unique and therefore pose a greater risk than generic drugs. Woodcock testified that subtle variation between a biosimilar and a reference drug can cause unwarranted immune responses. Cassidy inquired about the cause of these responses and the problem of demonstrating interchangeability on a biochemical level. Woodcock explained that the problem results from the fact that, while two biologics (a reference and a biosimilar) may seem to be twins, some tiny variation could be perceived by the immune system and result in a harmful immune response. In other words, very small manufacturing changes in a biosimilar drug can lead to negative responses, making the approval and regulatory pathway very complex when compared to the pathway for generic drugs.

Cost savings

Senator Warren (D-Mass) noted that if the pathway starts moving effectively, the ACA pathway for biosimilars could have the potential to save the U.S. $44 billion over the next ten years. However, she also noted that—if the biosimilar market follows the lead of the generic market—cost reductions are not expected to occur until two or more follow-along competitor biosimilars join the market. Thus, Warren warned that drug makers need to “know the rules of the road,” so that competitors can enter the market soon. As result, Warren criticized the FDA for not having issued a draft guidance describing the standard for interchangeability. Warren asked Woodcock why the FDA has not completed this work in five years. After Woodcock responded without directly addressing the question, Warren contrasted the FDA delay to the relative speed of the European Union, which completed its pathway in 2003 and approved its first biosimilar in 2006.


Murphy raised concerns about patient education and the risk that, even if biosimilars reach the market, physicians and consumers may not be willing to prescribe and use biosimilars. Murphy suggested that biologic manufacturers may be encouraged to flood the consumer space with information about why biosimilars are not a safe and effective alternative to their referenced biologic product. Murphy asked Woodcock how to get the truth out. Woodcock, who acknowledged that the responsibility of educating clinicians and consumers fell to the FDA, testified that the FDA was developing a plan of education. Woodcock testified that the FDA was consulting focus group to identify who to reach out to and what the message should be to persuade interested parties regarding the efficacy and promise of biosimilars.

Unnecessary spending

Murphy repeatedly warned Woodcock of the importance of “getting the word out.” Murphy explained that, in the next year, eight of the top 10 drugs could be biologics, which on average cost 22 times that of a traditional drug. Thus, Murphy explained, if biologic advertising was successful in reducing the prescribing of biosimilars, the resulting unnecessary spending would be in the billions. Warren echoed Murphy’s concerns and warned that the if the biosimilar market takes the shape of the generic market, where the majority of physicians retain negative perceptions about generics, public confidence in biosimilar products could be disastrous for prescription drug spending. Murphy explained that the savings and stakes are high because, if biosimilars could achieve the success of generics, which now represent 85 percent of dispensed prescriptions in the U.S., the enormous cost of biologics could be reduced.