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.

Americans in favor of end-of-life discussions, split on ACA

Americans overwhelmingly believe that Medicare should cover end-of-life advance planning discussions with physicians, although few have actually engaged in such discussions, according to a September 2015 Kaiser Family Foundation (KFF) poll. However, they remain split in their overall views of the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148), with 41 percent expressing favorable views and 45 percent expressing unfavorable views. Americans also differ as to their support of various, specific provisions. For example, although they tend to oppose certain ACA-imposed taxes, their views on these taxes are less firm than their views on other aspects of the law. The poll is the latest of KFF’s monthly health tracking polls, which survey Americans on their views of the U.S. health care system overall, and the ACA, in particular.

End-of-life care

In its July 15, 2015, physician fee schedule (PFS) proposed rule, CMS included provisions for Medicare coverage of advance care planning (ACP) discussions with physicians through the use of two new Current Procedural Terminology (CPT) codes (see Proposed rule, 80 FR 41686). The ACA originally encouraged such discussions, and CMS intended to include coverage for APT discussions as part of annual wellness visits, but the regulation was never implemented, as opponents raised discussions of “death panels” (see Medicare wellness coverage no longer includes advance care planning, Health Law Daily, January 11, 2011). According to the KFF poll, conducted from September 17 to September 23, 2015, 89 percent of respondents believed that doctors should engage in APT discussions and 81 percent believed that Medicare should cover such discussions. However, only 17 percent said they had actually engaged in APT discussions, including only 27 percent of seniors and 31 percent of people with debilitating disabilities or chronic conditions. Respondents were significantly more comfortable having APT discussion with spouses, with 83 percent claiming they would be “very comfortable” discussing APT with spouses, as opposed to 57 percent with physicians or other health care providers.


The public overall supported various ACA transparency provisions requiring insurance companies to make certain information publicly available. Eighty-four percent are in favor of the release of data on the availability of in-network doctors and hospitals, 83 percent would like to see data on how often claims are denied or appealed, 82 percent believe the public should know how quickly the company pays claims, and 73 percent think insurance companies should release data on what a typical person pays to see a doctor not in the plan network. Roughly 70 percent say they would be at least somewhat likely to use these types of information when seeking insurance.


Overall, respondents opposed the Cadillac and medical device taxes authorized by the ACA. Section 9001 of the ACA created the Cadillac tax, which imposes a tax beginning in 2018 on higher-cost employer-sponsored health plans. Only 37 percent of respondents had followed Cadillac tax news in the past month, but 60 percent opposed the tax. However, many were easily swayed by arguments for or against the tax. Twenty-seven percent of those who opposed the tax changed their minds to favor the tax after being told that it could lower health care costs, bringing overall support to 55 percent. Fifteen percent of those in favor of the tax switched to oppose the tax after being told that it would likely cause employees to pay more in out-of-pocket expenses.

Fifty-seven percent of respondents opposed the medical device tax imposed by ACA section 9009, which imposes a 2.3 percent excise tax on medical device manufacturers.

Food company Nestle building credibility in the health industry

Food company Nestle, through the Nestle Institute of Health Sciences (NIHS), is taking steps to enter the health business, most recently by signing a research collaboration agreement with AC Immune, a Swiss biotech company. The agreement will support the development of an Alzheimer’s disease diagnostic test. This is the second medical deal in one week for the world’s largest packaged food company, as sales in processed foods are slowing in many markets.

Alzheimer’s disease

Alzheimer’s disease develops as a result of a complex series of events taking place in the brain over a long period of time, according to AC Immune. Alzheimer’s disease results when tangles and other abnormal forms of Tau protein accumulate inside and spread between brain cells and beta-amyloid creates plaques and oligomers outside the brain cells. There are 9.9 million new cases of dementia each year, and the incidence and prevalence of Alzheimer’s increase with age. There are currently 46.8 million people living with Alzheimer’s globally, a number that is expected to rise to 131.5 million by 2050. Estimates show that the annual societal and economic costs of dementia rose from $604 billion in 2010 to $818 billion in 2015.

Research collaboration

AC Immune is a leading Swiss-based biopharmaceutical company focused on neurodegenerative diseases, such as Alzheimer’s disease, Parkinson’s disease, Down’s syndrome, and glaucoma. It designs, discovers, and develops both therapeutic and diagnostic products to prevent and modify diseases caused by misfolding proteins. It currently has three products in clinical trials.

The collaboration will develop a minimally invasive diagnostic assay for Tau. The test will have the potential to identify Alzheimer’s patients at a very early and potentially pre-symptomatic stage of the disease. The development of a test to identify patients in the early stages is one of the most pressing needs in Alzheimer’s disease, said Prof. Andrea Pfeifer, CEO of AC Immune. Early diagnosis is equally needed for the development of both pharmaceutical and nutritional approaches.

“We are very pleased about this research collaboration with NIHS, which marks our fourth partnership involving the Tau protein, endorsing our capability to develop both diagnostics and therapeutics for neurodegenerative diseases,” Pfeifer said. Nestle’s medical products are estimated to eventually make up 10 percent of sales or more.

CEO changes course on Daraprim® pricing after gouging claims spread

After claims of price gouging were directed at the CEO of Turing Pharmaceuticals, who had previously announced his intention to raise the price of the drug Daraprim® from $13.50 to $750 per pill, the CEO has indicated that the price hike will not take place. The CEO and founder of the drug company, Martin Shkreli, admitted that this new decision not to carry out the planned price increase was a reaction to the public outrage caused by the proposed rise in price.

Daraprim and Turing Pharmaceuticals

In August 2015, Turing Pharmaceuticals acquired Daraprim, a drug used to treat toxoplasmosis, a life-threatening parasitic infection that is especially dangerous for those with a weakened immune system, such as AIDS patients and pregnant women. The drug has been in use for 65 years and is the standard course of treatment for toxoplasmosis. After paying $55 million to the drug’s previous owner, Impax Laboratories, Shkreli announced an overnight price increase of approximately 5,000 percent. The CEO said the increase was necessary because the profits from the drug would go toward development costs for a similar drug with fewer side effects. He also argued that drugs like Daraprim could not exist if small companies such as his could not make a profit to act as a return on their investment in the drug.


Initially, Shkreli, a former hedge fund manager, attempted to defend the attacks against this dramatic rise in price, arguing, “this isn’t the greedy drug company trying to gouge patients, it is us trying to stay in business.” However, after pushback from the media and the public, he announced his change of heart in a phone interview with NBC News. When asked whether the change in course was a reaction to the pushback he responded, “Yes, it is absolutely a reaction. There were mistakes made with respect to helping people understand why we took this action. I think that it makes sense to lower the price in response to the anger that was felt by the people.” However, Shkreli also added that “it is very easy to see a large price increase and say ‘gosh, those people must be gouging,’ But when your company is not really making any money, what does that mean? It’s very hard stuff to understand.”

Political pushback

Presidential hopeful Hillary Clinton was also quick to respond to the proposed price hike, calling the increase “outrageous” and announcing her intention to put together legislation that would guard against such high prescription drug prices. Before the spread of the proposed price increase, Clinton brought up concerns about “skyrocketing prescription drugs” on a recent edition of CBS’s Face the Nation. A study released in May of 2015 found approximately 576,000 Americans spent more on prescription drugs than the median household income in 2014 (see For some, prescription drug costs outpace household income, Health Law Daily, May 13, 2015).

Though Shkreli has vowed to not carry out the intended increase to $750 per pill for Daraprim, he has not indicated what the final price will be.