By Ashley Fuoco Antonelli, associate editor
From new ways to pay physicians under Medicare to a long-discussed legislative package aimed at supporting U.S. medical innovations, 2016 brought major health care reform efforts that could shape the U.S. health system for years to come. Here are American Health Line's list of the top players who shook up the industry in 2016.
CMS in October released a final rule to implement new value-based payment programs under the Medicare Access and CHIP Reauthorization Act (MACRA). The final rule establishes the Quality Payment Program (QPP), under which eligible professionals will choose from two different quality reporting paths.
Some stakeholders lauded the final rule as a significant step toward shifting the U.S. health system toward paying providers based on quality of care instead of service volume. For example, National Coalition on Health Care CEO John Rother said the final rule marks "a milestone in the shift away from volume-based, fee-for-service physician payment" and "represents an important victory in ongoing efforts to improve the affordability of Medicare and health care generally."
However, others expressed concerns that the new payment programs will increase providers' administrative burdens, and that small and rural providers will have difficulty complying with the programs' requirements.
Regardless of where you stand on MACRA, one thing is clear: The health care industry is advancing toward value-based care models, and that will mean big changes for provider payments going forward.
The Center for Medicare and Medicaid Innovation
The Center for Medicare and Medicaid Innovation (CMMI) also shook up Medicare payments this year. CMMI in 2016 launched mandatory payment reforms, including the Comprehensive Care for Joint Replacement Model, a bundled payment system for heart attack treatments, and new Medicare Part B prescription drug models.
The moves didn't sit well with some lawmakers, who argued that CMMI does not have the power to mandate health care providers' participation in the payment models without congressional approval, and who also expressed concern about the payment models' potential effects on Medicare beneficiaries' care.
However, Obama administration officials and others have defended CMMI's proposals, saying the mandated changes will help accomplish the agency's cost-saving goals. Supporters also argued that the payment reforms must be mandatory to drive real change in the health care industry.
Despite its influence in 2016, CMMI's future is unclear, as Republicans under President-elect Donald Trump could nix CMMI as part of their proposals to repeal the Affordable Care Act.
21st Century Cures Champions
Senate Health, Education, Labor, and Pensions Committee Chair Lamar Alexander (R-Tenn.) and House Energy and Commerce Committee Chair Fred Upton (R-Mich.) were driving forces behind Congress' passage of the 21st Century Cures Act (HR 34), which President Obama signed into law earlier this month. The law authorizes billions of dollars in funding to accelerate the development and regulatory approval of medical innovations.
For example, the law allocates funding for the Obama administration's cancer "moonshot" initiative, the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative, and the All of Us Research Program, formerly known as the precision medicine initiative. The law also includes $500 million over the next 10 years for FDA to accelerate its drug and medical device approval processes.
Further, the law seeks to improve mental health reform efforts by creating new administrative positions at the Substance Abuse and Mental Health Services Administration, which will help coordinate mental health initiatives, and by providing incentives to increase the number of mental health professionals in the United States and to better integrate mental health and primary care services.
Obama said when signing the Cures Act into law, "We are bringing to reality the possibility of new breakthroughs to some of the biggest health challenges of our time," adding that the bipartisan support for the legislation "indicates the power of this issue and how deeply it touches every family across America."
Mosquitoes became a major focus of both global and local health care this year due to the emergence of the Zika virus. The Zika virus primarily is spread by infected mosquitos, but it also can be spread through sexual activity. Symptoms of active Zika virus infection include fever, headache, and rash. Symptoms usually are mild, and for 80 percent of infected individuals no symptoms appear at all.
However, Zika is not easily diagnosed, and it does not have a cure or vaccine. Further, CDC scientists in a study published in the New England Journal of Medicine in April confirmed that the Zika virus causes microcephaly, a sometimes fatal anomaly in which a fetus develops an abnormally small head and brain, as well as other severe fetal brain defects.
While Florida, which first reported local Zika transmission in the country, has since declared the state free of local transmission, Texas recently reported its first cases of local Zika transmission. CDC Director Tom Frieden has said the Zika virus likely will continue to surface in the United States, and he has encouraged local officials to bolster mosquito-prevention efforts to combat the virus.
Major health care insurers
Major health care insurers this year also prompted conversation about the ACA's future.
Several major health insurers—including Aetna, Blue Cross Blue Shield insurers, Humana, and UnitedHealth Group—this year announced that they would scale back their participation in the ACA's exchanges for the 2017 coverage year. In addition, Anthem in November said it would reconsider its participation in the exchanges for the 2018 coverage year. The insurers said they were reducing their exchange participation because of financial losses they incurred on their exchange business.
In light of the exits, some experts have questioned the exchanges' stability—even before Republican victories in November threatened the exchanges' very existence. Industry observers are at odds over whether the exits and premium increases signal that the exchanges have reached a tipping point where they would collapse without intervention, or whether these are one-time adjustments that would achieve equilibrium if lawmakers allow the exchanges to continue in their present form. Still, the moves prompted calls from supporters of the ACA for policy fixes and a new automatic enrollment policy to ensure exchange plan enrollees do not experience coverage gaps.
Major insurers also made headlines this year for a separate issue: insurance mergers.
In August, the Department of Justice filed lawsuits challenging two proposed mergers: one between Aetna and Humana, which would make Aetna the nation's second-biggest insurer by revenue, and another between Anthem and Cigna, which would make the combined company the largest in the U.S. in terms of enrollment. The court proceedings should wrap up by the end of January 2017.
Cooperative health plans (co-ops) also stirred up the health insurance market this year. Their closures and financial issues generated concern about competition in the exchanges, and some advocates used their closures to call for a public option health plan. Several co-ops also filed lawsuits against the federal government over unpaid risk corridors payments.
U.S. Surgeon General Vivek Murthy this year sent a letter to millions of health care providers across the country calling for a "national movement of clinicians" to fight the opioid misuse epidemic, which he called "an urgent health crisis." Murthy also issued two first-of-their-kind reports: one that called for a shift in how the United States addresses substance use disorders, and another that called the rising use of electronic cigarettes among young people in the United States "a major public health concern."
While Sen. Bernie Sanders (I-Vt.) might not have captured the Democratic nomination for president in 2016, he did spark renewed support for implementing a universal health care system in the United States. Sander's proposal drew support from various stakeholders and U.S. residents, prompting conversations about whether the federal government should implement a public option health plan. Both President Obama and Democratic presidential nominee Hillary Clinton called for a public option health plan this year, and the Democratic National Committee's draft 2016 party platform on health care issues suggested a push toward a single payer health care system. Despite the show of support, any effort to implement a public health option could be dead on arrival next year when Republicans control the White House and Congress.
Former Turing Pharmaceuticals CEO Martin Shkreli, perhaps the most infamous entry on our list, received widespread condemnation this year over Turing's decision to increase the price of the 62-year-old drug Daraprim—which is used to treat malaria and is considered the standard of care for treating toxoplasmosis, a life-threatening parasitic infection—by more than 5,000 percent from $13.50 to $750 a tablet. The increase caused the media and policymakers to more heavily scrutinize prescription drug prices, and that attention likely will continue next year.
Though President Obama's signature health reform law took effect six years ago, this year brought a new look at how the ACA has affected the health care industry. A White House Council of Economic Advisers report released this month touted the "historic progress" the ACA has made toward expanding health coverage and improving health care delivery under the Obama administration, such as by reducing the uninsured rate to a historic low and by pushing the U.S. health system toward value-based care.