Key Healthcare Issues and the 2016 Election

The 2016 Presidential election is only a few weeks away. While healthcare has not been central to the Presidential campaign, the election’s outcome will be a major determining factor in the country’s future healthcare policy. The outcome of the 2016 election is likely to influence several key healthcare issues, including the Affordable Care Act (ACA), rising prescription drug costs, and women’s health issues. As Americans go to the voting polls, understanding where each candidate (and party) stands is important as the two parties are in stark contrast with each other on most key issues.

The future of the ACA is one of the biggest healthcare issues likely to be affected by the outcome of the 2016 election. Democratic Presidential Candidate Secretary Hillary Clinton supports policies to maintain and build upon the Act. Specifically, Secretary Clinton would increase premium subsidies in the marketplace so no participant would be required to pay more than 8.5 % of their income for coverage. Secretary Clinton has stated that she would also fix the “family glitch” to allow people to buy coverage through the marketplace regardless of their immigration status. Additionally, Secretary Clinton has maintained that she would incentivize states to expand Medicaid and would make enrollment through Medicaid and the ACA easier by dedicating more funding for outreach and enrollment efforts. Further, Secretary Clinton claims she would make a public plan option available in every state, giving people the option of buying into Medicare starting at age 55.

Republican Presidential Candidate Donald Trump has proposed a much different approach to healthcare policy relying more on the principles of the free market to regulate healthcare and less on government involvement. Mr. Trump supports a complete repeal of the ACA, including the individual mandate to have coverage. In lieu of requiring insurers to provide coverage to everyone regardless of health status, Mr. Trump has stated he would work with states to create high risk pools for individuals who have not maintained continuous coverage.  Specifically, this means to fund pools at the state level that would subsidize premiums for people with pre-existing medical conditions (high risk individuals) so that they can get affordable insurance coverage. Mr. Trump also supports a law that would allow Medicaid to be transformed into a state block grant program, and he would modify existing laws that inhibit the sale of health insurance across state lines. Further, Mr. Trump has maintained that he would encourage increased use of health savings accounts and allow people receive tax deductions for insurance premium payments.

The different positions of both candidates highlight an emerging truth: President Obama’s signature domestic achievement will almost certainly have to change to survive. The Democratic and Republican parties each agree that for too many people, health plans in the individual insurance market are still too expensive and inaccessible.

Another key issue in this election is the rising price of prescription drugs. Secretary Hillary Clinton believes in reducing prescription drugs costs and protecting consumers from unjustified price increases from companies that face little to no competition. The Democratic Presidential nominee has proposed increasing generic competition by prohibiting “pay-to-delay” deals whereby companies make payments to competitors for agreeing to delay market entry. She also supports eliminating tax deductions for direct-to-consumer advertising; requiring approval of advertisements by the Food and Drug Administration; tying federal support for drug companies to their investment in research and development; increasing transparency of the additional value new drugs have over existing treatments; and allowing Medicare to negotiate drugs and biologic prices. To address out-of-pocket spending on prescriptions, Secretary Clinton has proposed a $250 per month cap on cost sharing for covered drugs, and a rebate program for low-income Medicare beneficiaries that mirror those in Medicaid.

To contrast, Mr. Trump supports allowing importation of drugs from overseas that are safe and reliable but priced lower than in the U.S. He also supports greater price transparency from all health providers, especially for medical exams and procedures performed at doctors’ offices, clinics, and hospitals. However, he does not specify whether this policy would also apply to retail prescription drugs, which typically are not considered services or procedures.

Finally, an important topic to consider in the 2016 election is each candidate’s position on women’s health issues. For women, a key provision of the ACA has been the requirement that all new private insurance plans and Medicaid expansion programs cover certain categories of benefits, including maternity care, mental health, and prescription drugs, that were commonly excluded by individual insurers prior to the ACA. Under Secretary Clinton, these policies would remain intact. She has also proposed making maternal depression screening standard practice under Medicaid. Mr. Trump’s plan to repeal the ACA would eliminate minimum scope of benefits standards, jeopardizing coverage of no-cost preventive services.

Additionally, Secretary Clinton supports women’s access to reproductive health care including access to preventive care, affordable contraception, and safe and legal abortion. She also supports paid leave for parents and caregivers. Mr. Trump supports establishing more federal regulations on women’s access to abortion. He has also proposed a family leave plan that includes six weeks of paid maternity leave that would be paid for by eliminating unemployment insurance fraud.

One thing that is clear this election season is that the candidates (and their respective parties) have contrasting views on several issues. The 2016 election will be important in determining the future of these key healthcare issues.

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From Quantity to Quality: CMS MACRA Rule

On October 14, the Center for Medicare and Medicaid Services (CMS) released its final rule for the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). MACRA marks a comprehensive shift from a fee-for-service based payment system to a value-based payment system for Medicare programs. CMS states in its rule that the change in payment plans “rewards the delivery of high-quality patient care.” The main goal of MACRA is to give incentives to Medicare and CHIP providers to give higher quality healthcare while also decreasing waste through a quality payment system instead of a quantity based payment system.

CMS released a proposed rule in April 2015, which received over 4,000 public comments. Many of the comments were submitted by practitioners who wanted more flexibility, simplicity, and support in transitioning from the Sustainable Growth Rate Formula to MACRA. CMS responded to these comments by creating a two track system, allowing physicians to go at their own pace in the transition process. This option is especially meant to help smaller practices that may need more time to make a full shift in their payment practices.  Physicians and practitioners can either participate in a Merit-Based Incentive Payment System (MIPS) or Alternative Payment Models (AMPs).

  • MIPS: Combines current quality and value Medicare payment programs (Physician Quality Reporting Program, Value-Based Payment Modifier, and Medicare EHR Incentive Program) and streamlines them into MIPS. MIPS works as an adjustment payment for physicians based on four factors: quality of care, resource use, clinical practice improvement activities, and meaningful use of certified electronic health records (EHR) technology. These factors will combine to create a composite performance score that will be used to calculate a positive, negative, or neutral payment adjustment. The adjustments will start at 4% in 2019 and rise to 9% by 2022.

 

  • Advanced AMPs: Some physicians may be considered Qualifying APM Participants (“QPs”) and therefore can participate in Advanced APM. In order to be considered a QP, a practitioner must “base payments on measures comparable to MIPS, require use of certified EHR technology, and either bear more than nominal financial risk for monetary losses, or be a medical home modeled that expanded under CMMI authority.” By 2021, this will require QPs to have a specific percentage threshold of their patients or payments be eligible through AMP. The Advance AMPs carry more risk for practitioners, but it also carries more reward, specifically the 5% lump sum bonus payments for 2019-2024.

 

Although the shift in payment methods will take a lot of work for many practitioners, especially smaller groups, it is a welcomed change. Sustainable Growth Rate Formula, the previous Medicare payment method, has been disliked by both sides of the aisle for many years.  Additionally, CMS responded to the comments on the proposed rule with a much appreciated flexibility for those practitioners who might need longer to make the proper changes.

The final rule will take effect January 1, 2017 and will contain a “transition year” with lower reporting standards.

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The Need for Mental Health Toolkit

In 2015, one out of every four reported fatal shootings by police involved a person with a mental illness. This figure does not include injurious but non-deadly shootings.

Perhaps one of the most high-profile of these cases is that of Charles Kinsey, a mental health caretaker that was shot by the police when he tried to help an autistic man that wandered off in the street. In July of this year, North Miami Police responded to a 911 call indicating that an armed man in the street was threatening to suicide. The police then instructed Kinsey and the man with autism to drop on the ground. When the man with autism did not comply, the police shot three times.

In more recent news, a New York Police Department sergeant fatally shot Deborah Danner, 66 years old, on October 16, 2016 in her apartment after she allegedly swung a baseball bat at him. According to Mayor Bill de Blasio, it was not the first time that the police responded to Ms. Danner’s home as a result of her behavior. Police had been dispatched to her apartment after a 911 call was placed detailing Ms. Danner’s erratic actions. This was one of more than 100,000 calls to the emergency call center about emotionally disturbed persons that the New York City police respond to every year. It was later determined that Ms. Danner diagnosed schizophrenic.

Police have been closely scrutinized lately amid a national debate about racially motivated use of deadly force. According to Lindsay Holmes, Deputy Healthy Living Editor of the Huffington Post, mental health “stigma” is a form of discrimination, and perhaps why many law enforcement officers do not know how to deal with mentally ill persons during an encounter.

What is being done about this? In 2015, New York City started providing its police officers advanced training on how to deal with people with mental illness. However, only about 4,400 of the 36,000 officers have been trained so far; the sergeant that fatally shot Ms. Danner had not.

In the District of Columbia, more than 650 Metropolitan Police Department officers are also crisis intervention officers. They receive several hours of training to better understand mental illness and how to better and safely respond to persons dealing with it. In surrounding areas, namely Montgomery County in Maryland, crisis intervention training is only voluntary and is offered four times a year. While more police departments are starting to implement crisis intervention programs, only about half of jurisdictions in America have some sort of program addressing mental health issues among police encounters.

Just last week on October 16, 2016 during the annual convention of the International Association of the Chiefs of Police, United States Attorney General Loretta Lynch announced that the Department of Justice would launch a mental health toolkit that would help police departments deal with crisis management involving the mentally ill. Secretary Hillary Clinton, Democratic presidential candidate, has promised to allocate $1 billion of her first federal budget to law, if elected.

Whether such resources and promises will significantly help train police officers nationwide how to deal with mentally ill persons more appropriately and decrease the number of preventable deaths is hopeful. Such better training will not only help mentally ill persons and the community at large – it will also help police officers themselves.

As the mother of Laval Hall, a schizophrenic young man fatally shot by the police, said, “I think the police officerstheir lives are changed forever when they take the life of somebody like this. They deserve a chance at knowing how to handle these situations and many of them are not given that chance by being given the proper training.

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Labelling It Healthy

What does the word “healthy” mean? The word is almost ubiquitous and is on every food, drink, or clothing label. However, there is little consensus on what the word “healthy” actually means. Does “healthy” mean low fat, low sugar, and low salt? While the word will likely still be used to describe a list full of foods and drinks, the Food and Drug Administration (FDA) is planning to create some clarity and redefine the word. FDA published a Federal Register (FR) notice announcing that the agency will be receiving information and comments on the use of the term “healthy” in the labeling of human food products. Currently, the FDA defines the term “healthy” when used as an implied nutrient content claim in labeling human food products at 21 C.F.R. §101.65(d)(2).

The FR notice comes a year after the FDA’s Center for Food Safety and Nutrition (CFSAN) issued a Warning Letter to KIND LLC, a producer of ‘Kind’ bars and other fruit and nut snacks, because the labels and labeling of KIND’s nutrition bars bore a variety of nutrient content claims, including “healthy,” but the products did not meet the requirements to make such claims.  KIND LLC subsequently sent a citizen petition to the FDA Commissioner requesting that the FDA update the FDA’s existing requirements related to food labeling to become consistent with current federal dietary guidance as set forth in the 2010 Dietary Guidelines for Americans and with the latest scientific evidence discussed in the Scientific Report of the 2015 Dietary Guidelines Advisory Committee (2015 DGAC Report).

As stated in KIND LLC’s letter to the FDA, the FDA’s current regulatory approach for food labelling is inconsistent with the DGAC recommendations. With obesity rates in the United States continually increasing at alarming rates, educating consumers about how to carry out a “healthful” diet is essential to public health. KIND LLC requested in the letter that the FDA take a holistic approach when reviewing the healthfulness of foods, instead of identifying and demonizing one food ingredient or nutrient.

The health label on packaging is an easy, but possibly misleading, tool that food companies can use to help educate consumers and give them easily accessible information about the food that they choose. A food may be low in salt, sugar and/or fat, but it doesn’t mean that it has the nutrients to create a healthful diet, which is why it is so important for the FDA to properly address this issue. It is likely that there will be an increase in regulation or scrutiny around food labels in order to create a more transparent food system, as well as attempt to stifle the upward trend of obesity.

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Averting Antimicrobial Anarchy: The War on Antibiotic Resistance has Begun

On September 2, 2016, the Food and Drug Administration (FDA) issued a press release on the safety and effectiveness of antibacterial soaps, calling for the removal of 19 active ingredients, including the much used triclosan and triclocarban, from over-the-counter antibacterial hand and body washes, determining that the risks of using these products outweigh their benefits. This is perhaps one of the Agency’s boldest steps yet toward fighting the phenomenon of antimicrobial resistant superbugs, an issue of increasing global frustration.

In its official final rule, issued in the Federal Register on September 6, the FDA noted that the investigation into the risk-benefit analysis of antiseptic began in 2013. “New information on potential risks posed by the use of certain consumer antiseptic washes prompted us to reevaluate the data needed for classifying consumer antiseptic wash active ingredients as generally recognized as effective (GRAE). As a result, we proposed that the risk from the use of a consumer antiseptic wash drug product must be balanced by a demonstration—through studies that demonstrate a direct clinical benefit (i.e., a reduction of infection)—that the product is superior to washing with [non-antibacterial] soap and water in reducing infection [].” As a result of considering recommendations from the public, evaluating available literature, data and comments, the FDA determined that “the data and information submitted for these active ingredients are insufficient to demonstrate that there is any additional benefit from the use of these active ingredients in consumer antiseptic wash products compared to [non-antibacterial] soap and water. Consequently, the available data do not support a GRAE determination for these consumer antiseptic wash active ingredients.” Likewise, with regard to safety, the FDA declared that “the available information and published data for the 19 active ingredients . . . are insufficient to establish the safety of long-term, daily repeated exposure to these active ingredients used in consumer wash products,” and thus could not be considered generally recognized as safe (GRAS).

“[W]e have no scientific evidence that [antibacterial washes] are any better than plain soap and water…In fact, some data suggests that antibacterial ingredients may do more harm than good over the long-term,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER).

This announcement comes at a time when the spread of antibiotic-resistant strains of bacteria, or superbugs, have proliferated, causing international concern. Antibiotic resistance occurs when bacteria evolve, becoming immune to what was used to treat the infections they cause. While a nature occurrence, it is believed that the widespread use of antibacterials, including soaps, exacerbate the problem.

Some bacterial infections once thought to be relatively benign, or at the very least curable, are having much more dire consequences. On July 26, 2016, professional football player Daniel Fells ended a short career with the NFL after contracting an antibiotic resistant strain of MRSA from a cortisone shot for an ankle injury. Further, in earlier this month, gonorrhea patients in Hawaii made up the first known US case cluster in which the sexually transmitted infection showed reduced susceptibility to the only available effective treatment option, the Centers for Disease Control and Prevention said, though their conditions were ultimately positively resolved.

On September 21, heads of state from across the globe convened at the United Nations General Assembly in New York, alongside experts in the field, for a one-day, high-level meeting to address the issue of antibacterial resistance. A rare occurrence, the UN has only met for public health issues three times before for reasons which included the HIV and Ebola pandemics. In a historic agreement, the U.N.’s declaration required nations to develop a two-year plan to protect themselves against antibiotics. After two years, the U.N.’s secretary-general would evaluate each country’s plan and monitor progress.

At this time, hand sanitizers, antibacterial wipes, and antiseptic products used in healthcare settings are not subject to the new regulation, though the FDA has called for additional research.

The effective date of this rule is September 06, 2017.

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