Today's News and Commentary

About health insurance

What's an Individual Coverage Health Reimbursement Arrangement (HRA)? Last June 13, the U.S. departments of Health and Human Services, Labor and the Treasury issued a final rule allowing employers that do not offer a group coverage plan to fund a new kind of health reimbursement arrangement (HRA), known as an individual coverage HRA (ICHRA).
Starting Jan. 1, 2020, employees can these new HRAs to buy individual-market insurance, including ACA exchanges. Previously, employers were forbidden to set up such accounts.

DIFFERENT EMPHASIS ON ACOs DATA IN THE FOLLOWING TWO ARTICLES

Number Of ACOs Taking Downside Risk Doubles Under ‘Pathways To Success’: This information is from CMS administrator Verma: "For the January 1, 2020 start date, CMS approved 53 applications for new ACOs and 100 applications for renewing ACOs. The total number of Medicare beneficiaries served by health care providers in ACOs is now 11.2 million, up from 10.4 million at the start of 2019. Nearly 30 percent of all beneficiaries in fee-for-service Medicare are now served by a health care provider in a Shared Savings Program ACO.
I’m especially proud to report that the number of ACOs taking on risk for cost increases has grown significantly—from 93 ACOs at the start of 2019 to 192 at the start of 2020.” 

Participants continue to drop out of Medicare ACO program: "Just 53 new accountable care organizations joined the Medicare Shared Savings program for the Jan. 1 start date, which is significantly less new entrants compared to previous years. 
There are now 517 ACOs in the Medicare program versus in 2018 when there were 561 ACOs. The drop in new participants follows a recent trend from six months ago when only 66 new ACOs joined. By comparison, in 2018, 124 new ACOs entered the program and in 2017, 99 new ACOs joined. 
The National Association of ACOs blames the changes to the Medicare ACO program for the recent drops in participation. In late 2018, the CMS finalized an overhaul of the program that requires ACOs to take on downside financial risk sooner after years where most organizations were risk averse.”

About pharma

FDA Makes Real-World Data Available on Google Cloud Platform: The FDA has been promoting “real world” data to improve drug evaluations.The FDA’s MyStudies platform is now available on Google Cloud Platform.

Supreme Court to Rule on States’ Right to Regulate Pharmacy Benefit Managers: In what could have profound effects on the way drugs are handled by insurers, the “US Supreme Court has announced it will hear a case in the coming months that could determine whether states have the right to regulate pharmacy benefit managers (PBMs).
The US Court of Appeals for the Eighth Circuit, covering Arkansas and 6 other states, previously ruled on Rutledge v. Pharmaceutical Care Management Association. The Eighth Circuit decision favored the Pharmaceutical Care Management Association (PCMA), ruling that the Employee Retirement Income Security Act of 1974 (ERISA), a federal law that sets minimum standards for voluntarily established retirement and health plans in private industry, superseded an Arkansas law that sought to regulate PBMs.
Passed in 2015, Arkansas Act 900 required PBMs to raise reimbursement rates for drugs if they fell below the pharmacy’s wholesale costs and created an appeal process for pharmacies to challenge PBM reimbursement rates. This effectively prohibited PBMs from reimbursing pharmacies below the pharmacies’ cost of acquisition.
In his brief to the US Supreme Court, Solicitor General Noel Francisco disagreed with the Eighth Circuit decision, stating that the ruling was contrary to higher court’s precedent and should be reviewed and corrected. He urged the court to take up the case, siding with attorney generals from 31 states and the District of Columbia that want the US Supreme Court to reverse the Eighth Circuit’s ruling.”

A ‘radical proposition’: A health care veteran tries to upend the system and bring drug prices down: This story appeared in several news media today. It is about a new company that plans to make “me-too” drugs (those medicines that have a unique composition, but are, perhaps, the 4th or 5th in their chemical class) at lower prices than existing treatments. It is not know which medications the company will initially target; but even these me-too products need to go through the FDA approval process since they are not generics. We will need to wait and see if they can get approval at a fraction of the cost of other drugs, since that is where they hope to achieve the savings to offer the lower prices.

Two Big Drug Flops Show How Health-Care Economics Have Changed: “For years, drug companies have enjoyed the freedom to charge high prices for their latest products. But when Sanofi and Amgen Inc. each marketed a powerful new cholesterol-lowering medicine, something surprising happened: High prices hurt sales. Sanofi’s experience has been especially painful. The French company spent more than five years developing Praluent with Regeneron Pharmaceuticals Inc. before its launch in 2015. But Praluent never caught on. Now Sanofi is cutting its losses, getting out of the U.S. market for the drug, and halting its heart disease research altogether in favor of more lucrative medicines for cancer and other diseases…Praluent’s disappointing sales are the result of insurance giants’ reluctance to pay for expensive new pharmaceuticals that treat chronic disease when far cheaper drugs can often get the job done.” The days of charging whatever the market is thought to bear may be limited.  

CMS Addresses Duplicate Discounts, State Medicaid Rebate Requests: States are submitting requests to the federal government for rebates for 340B drugs- which already carry steep manufacturers’ discounts. New guidance rules are addressing this double dipping.

23andMe licenses 1st drug: Genetic testing company 23andMe licensed a drug to Spanish drugmaker Almirall which is designed to treat autoimmune and inflammatory conditions, such as lupus and Crohn's disease.

About health devices

FDA clears 3D-printed airway stents tailored to patient anatomy: Just a reminder about how 3D printing is making its way into clinical use.

About healthcare IT

A billion medical images are exposed online, as doctors ignore warnings: “Hundreds of hospitals, medical offices and imaging centers are running insecure storage systems, allowing anyone with an internet connection and free-to-download software to access over 1 billion medical images of patients across the world.
About half of all the exposed images, which include X-rays, ultrasounds and CT scans, belong to patients in the United States.”

The Sneaky Genius of Facebook's New Preventive Health Tool: Interesting investigative piece about how the social media company gathers available information and uses it for a preventive health tool.