Policy & Regulations

This channel includes news coverage of healthcare policy and regulations set by Congress, the states, Centers for Disease Control and Prevention (CDC), the Department of Health and Human Services (HHS), U.S. Food and Drug Administration (FDA), and medical associations and societies. 

Healthcare.gov sets enrollment record despite repeal threat

400,000 more people bought health plans through the Affordable Care Act’s insurance marketplace in 2016 than 2015, according to the final open enrollment figures released by HHS for coverage beginning Jan. 1, 2017.

CMS finalizes cardiac, orthopedic bundles and MSSP ACO Track 1+

Additional opportunities for Advanced Alternative Payment Models (APMs) are now available, as CMS has finalized a number of policies on bundled payments and a new accountable care organization model.

AMGA to CMS: Limit MACRA transition, develop MSSP ACO Track 1+

In its comments to CMS on the final Medicare Access and CHIP Reauthorization Act (MACRA) rule, the American Medical Group Association asked the agency to limit the transition to new payment tracks to only one year and develop a new two-sided risk model in the Medicare Shared Savings Program (MSSP).

Researchers rushing to copy ACA data before Trump takes office

Groups with data-use agreements with HHS and CMS are scrambling to copy healthcare data and documents in case President-elect Donald Trump’s administration erases it once in office—a fear Trump-aligned groups call “paranoid.”

ACA exchange rules finalized for 2018 as repeal threat looms

CMS hopes to strengthen the risk pool on Affordable Care Act’s insurance marketplace for the 2018 plan year, even as insurers remain uncertain about the exchanges with the incoming Congress and President-elect promising to repeal the law.

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5 of the top issues for the healthcare industry in 2017

The annual health issues report from PricewaterhouseCooper’s (PwC) Health Research Institute predicted the coming year will be one of “uncertainty and opportunity” in the industry, both because of the potential repeal of the Affordable Care Act and the continuing transition to value-based care.

Mylan launches generic EpiPen as its sued by 20 states over generics price-fixing

Mylan announced the launch of the authorized generic of its allergic reaction autoinjector treatment, EpiPen. Although the launch fulfilled a promise the pharmaceutical company made months ago, it came only hours after 20 states filed a lawsuit over Mylan’s pricing of other generic drugs. 

ACA replacement—just not repeal—may find Democratic support

Repealing the Affordable Care Act (ACA) can be passed with only Republican votes soon after President-elect Donald Trump takes office. Replacing the law, however, can’t be done by one party.

Around the web

If passed, this bill would help clinician-led clinical registries explore Medicare data for research purposes. The Society of Thoracic Surgeons and American College of Cardiology both shared public support for the bipartisan legislation. 

Cardiologists and other physicians may soon need to provide much more information when ordering remote patient monitoring for Medicare patients.

Why are so many cardiovascular devices involved in Class I recalls? One possible reason could be the large number of devices hitting the market without undergoing much premarket clinical testing. 

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