Health and Human Services announced a final rule from the Centers for Medicare and Medicaid Services (CMS) that will require direct-to-consumer television advertisements for prescription pharmaceuticals covered by Medicare or Medicaid to include the list price if that price is equal to or greater than $35 for a month’s supply or the usual course of therapy.

In May 2018, the Trump administration introduced the American Patients First blueprint to bring down prescription drug prices. The blueprint laid out four strategies for solving the problems patients face: boosting competition, enhancing negotiation, creating incentives for lower list prices, and bringing down out-of-pocket costs.

Less than a year later, this final rule has been published to implement the vision laid out in the blueprint. Up until now, drug companies were required to disclose the major side effects a drug can have.

The new rule takes effect in 60 days, The information should appear in text large enough for most people to read and include a statement that patients with health insurance may pay a different sum.

The rule allows companies to include list prices of competitor products, and says HHS will publicize companies that create false or misleading ads. But primary enforcement will be left to industry. If a drug company fails to include required information, a competitor can file suit under the deceptive and unfair trade practice provisions of the Lanham Act.

HHS Secretary Alex Azar told reporters he could not provide an estimate of whether or how much the rule would change drug prices because “the behavioral aspects of this are too unpredictable” to quantify. But when combined with other steps the administration is taking on drug costs, the rule will lower medication prices, he said.

He dismissed statements from drug companies that the ads could cause some insured patients to stop filling their prescriptions out of the mistaken belief the drugs would cost them too much.

“If a drug company is afraid that their prices are so excessive and abhorrent that they will scare patients away from using their drugs, well they ought to look inside themselves and think about whether they should be lowering their prices,” Azar said.

“If you are ashamed of your drug prices, change your drug prices, it’s that simple,” he said.

The drug lobby PhRMA has been pushing a different plan that would not put prices directly in ads, but direct patients to more nuanced information, such as a website that includes the drug’s list price, an expected range of patient out-of-pocket costs and financial support available to patients.

PhRMA has as indicated it may mount a First Amendment challenge to the administration’s plan – but HHS says it believes the rule is consistent with Supreme Court precedent.

The drug industry spent more than $5.5 billion on advertising in 2017, including nearly $4.2 billion on television ads, according to HHS.

A new study published in the JAMA Internal Medicine and reviewed by Reuters Health suggests that Physician Compare, a U.S. website created to help patients find high-quality doctors, is missing so much information on individual providers that it may not be helpful.

Quality reporting has been a work in progress for almost three decades since a landmark 1999 report from the Institute of Medicine, `To Err is Human,’ concluded that tens of thousands of patients deaths each year were the direct result of medical errors.

Physician Compare is the flagship effort by the U.S. Centers for Medicare and Medicaid Services. But while more than 1 million clinicians care for Medicare enrollees, only about 239,000, or 23 percent, had any quality information at all available on the Physician Compare website, researchers report in JAMA Internal Medicine.

And virtually none of the doctors had data tied to their individual job performance.

“To truly be able to inform patient decision-making, it is imperative that the data accessible to patients and their caregivers capture a large swath of clinicians,” said lead study author Jun Li of the University of Michigan in Ann Arbor.

In the current study, only about 21 percent of primary care providers reported some individual or group information related to outcomes from their practice. But almost all of this data was at the practice level, making it hard for patients to know who might be a better or worse choice among several physicians at one clinic.

And half of them provided details on no more than one or two quality outcomes.

Doctors who did share individual level outcomes tended to have very high quality scores, suggesting that physicians may only opt into the voluntary reporting system when they know the results will make them look good, the study authors note.

Clinicians also aren’t required to report data on outcomes for every patient, and they may choose only to submit information for cases that turned out well, researchers point out.

“Given its voluntary nature, it is not a surprise few doctors submit to this platform,” said Dr. Vineet Arora of the University of Chicago Medicine.

The Commission on Health and Safety and Workers’ Compensation (CHSWC) has released its 197 page twenty-fourth Annual Report for 2018. The Report presents information about the health and safety and workers’ compensation systems in California and makes recommendations to improve their operations.

The Annual Report summarizes the state of all the relevant areas of the workers’ compensation and health and safety systems. The Annual Report includes several Special Studies of targeted areas of interest. One of the Special Studies involved the PQME process. Key findings in the study of the PQME system included the following.

— The number of providers registered as QMEs continues to decline (17% since 2007), but less rapidly than it did prior to 2007.
— The number of requests for QME panels has increased rapidly, 87 percent since 2007.
— The decline in QMEs and increase in panel requests means that the number of requests per QME has doubled (+101%).
— Coupled with a continuing increase in the average paid amount for QME reports, the average QME earns 240 percent more from panel reports now than in 2007.
— All the increase in panel requests is from represented track cases, up 400 percent despite the elimination of panels for most medical treatment issues (replaced by the IMR process). This increase was equally driven by requests from both applicants and defendants.
— Panel requests for unrepresented cases declined 55 percent, driven entirely by a decline in requests by injured workers. The number of requests by claims administrators in unrepresented cases changed little.
— The DWC began collecting the reasons for panel requests on represented cases in 2015. Those data show that the primary reasons for panels are: compensability (42.5%), permanent disability (21.4%), and Permanent & Stationary (P&S) status (11.4%).

In response to the earlier study, SB 863 placed limits on the number of locations (10) at which QMEs can be registered. This has had the effect of distributing QME panels more evenly and widely among registered providers.

— Very-high-volume QMEs (with 11-100+ registered locations) have been eliminated.
— However, a high proportion of panel assignments (55%-60%) are still assigned to the busiest 10 percent of QMEs, nearly all of whom have exactly 10 offices and are in orthopedic specialties.
— Unlike the very-high-volume QMEs studied earlier, the top 10 percent and 5 percent of QMEs by the number of panels in the current system produce reports that show less bias. Even the top 5 percent of QMEs by volume give ratings that are only slightly more conservatively than average.

Some of the first of several trials against opioid drugmakers and distributors were set for trial this year to determine how juries would react to the charges. Others remain under the supervision of the federal court system.

It was assumed that the defendants would not budge on settlement. That assumption has proven to be wrong as now drug distributor McKesson Corp has agreed to pay $37 million to resolve a lawsuit by the state of West Virginia seeking to hold it responsible for contributing to the opioid epidemic, the state’s attorney general said on Thursday. The West Virginia accord may set an industry-favoring benchmark for other claims.

The McKesson settlement comes more than a month after Purdue agreed to pay $270 million to resolve the Oklahoma attorney general’s lawsuit alleging the drug maker of fueling the opioid crisis in the state. Oklahoma is pushing ahead with a May trial against Johnson & Johnson and Teva Pharmaceutical Industries Ltd., which are accused of fueling a wave of overdoses tied to opioid painkillers.

The settlement was the largest that a distributor has struck with a state in the litigation. West Virginia in 2017 settled similar cases against rival distributors Cardinal Health Inc and AmerisourceBergen Corp for $20 million and $16 million, respectively.

McKesson did not admit wrongdoing as part of the settlement. “McKesson is committed to working with others to end this national crisis … and is pleased that the settlement provides funding toward initiatives intended to address the opioid epidemic,” the company said in a statement.

Opioids, including prescription painkillers, heroin and fentanyl, were involved in a record 47,600 overdose deaths in 2017, according to the U.S. Centers for Disease Control and Prevention.

The epidemic has prompted lawsuits by state and local governments accusing drug manufacturers like Purdue Pharma of deceptively marketing opioids and distributors like McKesson of failing to detect the diversion of the drugs for illicit purposes.

McKesson in January 2017 agreed to pay $150 million to resolve a federal investigation by the U.S. Drug Enforcement Administration into whether it failed to report suspicious orders of addictive painkillers.

Gordon and Rees reported that effective April 1, the Medicare Secondary Payer Recovery Portal (MSPRP) is equipped to accept electronic payments for Medicare conditional payment reimbursements.

Answers to common inquiries were subsequently released by CMS on April 12, 2019 called “Electronic Payments on the Medicare Secondary Payer Recovery Portal (MSPRP) and Commercial Repayment Center Portal (CRCP) Frequently Asked Questions and Answers.” Such functionality was originally referenced in the Strengthening Medicare and Repaying Taxpayers (SMART) Act of 2012.

In the alert, CMS specifically indicated that to make an electronic payment through the MSPRP, one does not need a new or updated user access. The option is available to any user on any matter to which the user already has access.

Payments are not required to be made through the MSPRP. Payers may continue to remit a paper check to satisfy Medicare conditional payment demands. However, any refund issued by the Medicare recovery contractor will still be made via paper check and will not be made electronically, to date.

In order to make an electronic payment through the MSPRP, the matter to which you wish to apply payment must be in “demand” status. There is no option to remit payment electronically unless the amount has been demanded.

Therefore, if payment is desired to be made on a Conditional Payment Notice instead of a Demand for Reimbursement, a written check still must be mailed to the CRC/BCRC for application to the claim.

Furthermore, CMS clarifies that when paying online, this does not mean that the full demand amount must be paid. If a Redetermination Request has been submitted on a portion of the conditional payments being asserted, a user can still submit a partial electronic payment.

Finally, CMS reported that the electronic payments utilize Pay.gov to secure the transaction, where payments can be made utilizing a savings/check account, debit card, or PayPal linked to a bank account. Credit cards, however, are not being accepted for payment at present. Also, the limit for each payment method is posted, as well.

Once payment has been made. a confirmation of payment will be posted to the MSPRP on the Payment Status page. Additionally, an Electronic Payment History status will list the status of all electronic payments, as well as the amount and payment date.

In summary, the new electronic payment system appears to streamline the payment process significantly, with much quicker application times and updates to the portal.