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.

4 points crucial to the nimble regulation of GenAI
With generative AI coming into its own, AI regulators must avoid relying too much on principles of risk management—and not enough on those of uncertainty management.
FDA recalls infant incubators due to risk of door falling off
A loose screw on the Giraffe OmniBed is to blame. With updated use instructions and repairs, the incubators are safe to use.
‘A huge win’: CMS significantly increases Medicare payments for cardiac CT
CMS has more than doubled the CCTA payment rate from $175 to $357.13. The move, expected to have a significant impact on the utilization of cardiac CT, received immediate praise from imaging specialists.
Kentucky AG launches criminal probe after conscious man nearly has organs harvested
Three years ago Anthony Hoover was declared brain dead—until he woke up on the operating room table, moments before his organs were removed. His story has spurred a criminal investigation by Kentucky's attorney general.
FDA announces Class I recall of ventilators after 3 patient injuries
An unexpected nickel coating on the breathing circuits of Percussionaire Phasitron 5 ventilators is being blamed for the recall. The FDA is asking providers to stop using them immediately.

Why Trump’s proposed healthcare cuts may go nowhere

President Donald Trump is looking to a rarely-utilized process called “rescission” to cut $15 billion in federal spending he already signed into law earlier this year—with much of the reductions coming from programs like the Centers for Medicare and Medicaid Innovation (CMMI) and the Children’s Health Insurance Program (CHIP).

May 8, 2018

CMS draws line on reforms by rejecting lifetime limits in Medicaid

Kansas’s proposal to impose a three-year lifetime limit on Medicaid benefits has been formally rejected by CMS, with Administrator Seema Verma, MPH, saying the agency has to ensure the program “remains a safety net for those that need it most.”

May 8, 2018

CMS approves New Hampshire to impose Medicaid work requirements

New Hampshire will become the fourth state to impose work requirements on Medicaid beneficiaries, according to a May 7 joint statement from CMS, HHS and New Hampshire Governor Chris Sununu.

May 7, 2018

Trump claims ACA is dead—but IRS still plans to enforce employer mandate

At last week’s campaign-style rally in Michigan, President Donald Trump claimed he’d done away with the Affordable Care Act (ACA) when the 2017 tax bill repealed the individual mandate. But folks at the Internal Revenue Service (IRS), though, would disagree. A recent report from the New York Times examines IRS's plan to send out penalty notices to more than 30,000 businesses in the U.S.

May 7, 2018

Elliott makes $7B all-cash bid for Athenahealth

According to CNBC, Elliott Management made an all-cash deal for Athenahealth on Monday morning. Elliott’s bid is for $160 a share—a 27 percent premium to the Massachusetts-based healthcare technology company’s Friday afternoon price.

May 7, 2018

Partners HealthCare talking merger with insurer Harvard Pilgrim

One of Massachusetts’ largest health insurers, Harvard Pilgrim, has been discussing a merger with the state’s dominant healthcare provider, Partners HealthCare, in a move that could dramatically alter the increasingly consolidated market in and around Boston.

May 4, 2018

HHS sued over failing to release communications on family planning grants, religious freedom

HHS is the target of new lawsuits by a watchdog group for failing to respond to requests to release emails and online messages—one regarding Office of Civil Rights (OCR) officials and launching of its “Conscience and Religious Freedom Division,” the other over HHS communications with outside groups on changes to a federal grant program that provides birth control and other reproductive health services to low-income Americans.

May 4, 2018

Upside-only ACOs will leave if forced to take on downside risk

If participants in the Medicare Shared Savings Program (MSSP) are required to move into a track which involves downside risk for their organization, they’re likely to leave the program altogether, according to the results of a survey from the National Association of Accountable Care Organizations (NAACOS).

May 2, 2018

Around the web

AI in Healthcare

4 points crucial to the nimble regulation of GenAI

With generative AI coming into its own, AI regulators must avoid relying too much on principles of risk management—and not enough on those of uncertainty management.

Cardiovascular Business

Q&A: Why are cardiovascular devices involved in so many recalls? FDA policies may be to blame

Cardiovascular devices are more likely to be in a Class I recall than any other device type. The FDA's approval process appears to be at least partially responsible, though the agency is working to make some serious changes. We spoke to a researcher who has been tracking these data for years to learn more.

Cardiovascular Business

Cardiologist compensation still rising, especially in invasive and interventional cardiology

Updated compensation data includes good news for multiple subspecialties. The new report also examines private equity's impact on employment models and how much male cardiologists earn compared to females.