The health of 44M seniors is jeopardized by cuts to Medicare lab services

PAMA

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The Protecting Access to Medicare Act (PAMA)

Congress passed the Protecting Access to Medicare Act (PAMA) in 2014 to help safeguard Medicare beneficiaries’ access to needed health services, including laboratory tests. Unfortunately, the U.S. Department of Health and Human Services (HHS) has taken a flawed and misguided approach to PAMA implementation. As a result of the Department’s actions, seniors will face an estimated $670 million in cuts to critical lab services this year alone, leaving the health of 57 million Medicare beneficiaries hanging in the balance.

PAMA cuts will be particularly burdensome to the most vulnerable seniors, such as those in skilled nursing facilities, those managing chronic conditions, and seniors living in medically underserved communities. The American Clinical Laboratory Association has raised significant concerns about the impact of Medicare lab cuts on seniors and their access to lifesaving diagnostics and lab services.

Learn more about the harm posed by these cuts on seniors here. Read the lawsuit ACLA has filed against HHS here.

WHAT’S AT STAKE


In 2016, seniors enrolled in Medicare received an average of

16 individual lab tests per year

Test tubes

People

80% of seniors

have at least one chronic disease and 77% have at least two—successful disease monitoring and management requires reliable access to routine testing

House

1 million

seniors are living in assisted living or skilled nursing homes

Hands

3.5 million

homebound seniors
rely on skilled home health care services

Map pin

An estimated

10 million

seniors live in rural areas

LACK OF ACCESS TO LAB TESTS

can result in undiagnosed conditions, lack of treatment for sick patients, and the failure to monitor and treat chronic conditions before they become worse—
resulting in a decline in overall health and longevity.

The PAMA cuts will also have a broad impact on laboratories across the country. Those that will face the brunt of the cuts are the very labs and providers that are uniquely positioned to provide services—like house-calls, 24-hour emergency STAT testing, and in-facility services at skilled nursing facilities—that are particularly important to seniors who are more likely to be homebound, managing multiple chronic conditions, or living in rural areas that are medically underserved.

 

 

 

 

 

Theranos agrees not to operate labs for two years

http://www.sfgate.com/business/article/Theranos-agrees-not-to-operate-labs-for-two-years-11079274.php

The Theranos lab in Newark Calif., seen on April 12, 2015. The company announced a settlement Monday with the Centers for Medicare and Medicaid Services that resolves all legal and regulatory proceedings between the federal agency and the embattled Palo Alto blood diagnostics firm. Photo: CARLOS CHAVARRIA, NYT

Theranos has reached a settlement with the Centers for Medicare and Medicaid Services that resolves all legal and regulatory proceedings between the federal agency and the embattled Palo Alto blood diagnostics firm, the company announced Monday.

Theranos has agreed to pay a penalty of $30,000 and cannot operate a clinical laboratory for the next two years.

As part of the settlement, the federal agency, which regulates blood testing labs, has withdrawn its revocation of Theranos’ lab operating certification.

Theranos, founded in 2003 by CEO Elizabeth Holmes, had been a high-flying startup that promised to revolutionize blood testing before a Wall Street Journal investigation alleged that the company misled people about the accuracy of its blood testing technology.

It is unclear whether the settlement has any bearing on investigations into the company by the Department of Justice and U.S. Securities and Exchange Commission. The company faces lawsuits from investors and Walgreens, its ex-partner that had been using Theranos blood-testing technology in dozens of stores before terminating the relationship.

CMS fines, cuts off testing at Theranos, bans Holmes

CMS fines, cuts off testing at Theranos, bans Holmes

goodbye

The other shoe has dropped for Theranos. Late Thursday night, the embattled diagnostics company disclosed that it is officially being sanctioned by the Centers for Medicare and Medicaid Services.

In a press release issued at 11:35 p.m. Eastern time, the wounded unicorn said CMS has moved to revoke the CLIA certificate for Theranos’ laboratory in Newark, California. Company executives — mainly founder and CEO Elizabeth Holmes — will be barred from owning, operating or directing a clinical lab for two years once the sanctions take effect 60 days from now.