Vol. IX | Issue 38                                                                                   September 22, 2020

OCR Settles with Five Providers Over HIPAA Right of Access Claims
The HHS Office of Civil Rights (OCR) recently announced the settlement of five more investigations into violations of the HIPAA requirement that patients be given access to their electronic medical records in a timely manner and at a reasonable cost.

As we first wrote about last year, OCR launched its Right of Access Initiative in an effort to "put patients in the driver's seat," by giving them easier access to their medical records so they can take control of decisions regarding their health. HIPAA rules generally require medical records be provided within 30 days of the request and that providers charge a reasonable cost-based fee.

The settlements range from $3,500 to as much as $70,000. In three of the five cases, the healthcare entities were told by OCR how to provide technical assistance to patients who requested their medical records, but then still did not comply until OCR stepped in a second time. 
OCR considers a number of different factors when determining the amount of a settlement including: the nature and extent of the potential HIPAA violation; the nature and extent of the harm resulting from the potential HIPAA violation; the entity's history with respect to compliance with the HIPAA rules; the financial condition of the entity, including its size; and the impact of the COVID-19 public health emergency. 
Florida DOH
Medicare to save $73.4B with surgery in ASCs through 2028: 5 things to know
Laura Dyrda reports for Becker's ASC:
A new report from the Ambulatory Surgery Center Association shows performing surgery on Medicare patients in ASCs instead of hospital outpatient departments saved $4.2 billion in 2018, and the savings are expected to climb significantly in the next decade.

KNG Health Consulting conducted an analysis of Medicare payment data from 2011 to 2018 on outpatient surgical procedures in ASCs and hospital outpatient departments. The analysis estimated historical and potential savings with a focus on total knee replacements.   
Five key points...
It's Not Just Insulin: Lawmakers Focus on Price of One Drug, While Others Rise Too
Rachana Pradhan
Michael Costanzo, a Colorado farmer diagnosed with multiple sclerosis in 2016, has a well-honed ritual: Every six months, he takes an IV infusion of a medicine, Rituxan, to manage his disease, which has no cure. Then he figures out how to manage the bill, which costs thousands of dollars.

For a time, the routine held steady: The price billed to his health insurance for one infusion would cost $6,201 to $6,841. Costanzo's health insurance covered most of it, and he paid the rest out-of-pocket.

But last fall the cost for the same 20-year-old drug and dosage jumped to $10,320, even though he was covered by the same insurance.

"Why does it have to increase in price all of a sudden?" wondered Costanzo, who lives in a small town about 50 miles north of Denver.

"I think greed is a huge problem," he said.

As drug prices spiral upward, politicians in Washington, D.C., and in state governments across the country have sought to address the problem in limited ways, focusing mostly on one drug: insulin, a drug more than 7 million Americans rely on to manage diabetes and whose price tag more than doubled from 2012 to 2017.

With comprehensive drug price legislation stalled in Washington during the COVID-19 state of emergency, seven states in the midst of the pandemic enacted insulin payment caps of less than $100 per month, bringing the total to eight; five more have proposed legislation. In March, President Donald Trump's health officials announced a Medicare test project limiting seniors' monthly out-of-pocket costs to $35.
COVID-19 vaccine approval and the FDA
JAMA via YouTube
JAMA via YouTube

Hydroxychloroquine and convalescent plasma approvals by the FDA under Emergency Use Authorization (EUA) protocols have raised concerns the agency is under withering political pressure to fast-track a COVID-19 vaccine before it is proven safe and effective. Joshua Sharfstein, MD, Johns Hopkins Bloomberg School of Public Health, and JAMA Associate Editor Preeti Malani, MD, University of Michigan, discuss implications for public health and policy responses to ensure vaccine safety. Recorded September 18, 2020.