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Friday, June 14, 2019

MedPAC urges Medicare Advantage data, ER, primary care reforms

  • In its annual report to Congress, the Medicare Payment Advisory Committee issued three recommendations impacting Medicare Advantage plans, ER spending and primary care.
  • The commissioners recommended Congress allow advanced practice registered nurses and physician assistants to bill Medicare directly, to shed light on current treatment and help ease primary care access issues.
  • Concerned about the accuracy of Medicare Advantage encounter data, commissioners want MA plans to meet certain thresholds for submitting complete and accurate information. Commissioners are also pushing for national guidelines on coding for ER visits.

MedPAC commissioners are concerned about the quality of data CMS receives from the numerous health insurance plans that sell Medicare Advantage coverage to a growing number of seniors throughout the country.
Commissioners want MA plans to submit more complete and accurate information that could ultimately improve oversight and better inform future policymaking.
“Detailed encounter data are the best vehicle for learning about how, and how much, care is provided to the one-third of Medicare beneficiaries who receive their benefit through an MA plan,” the 2019 MedPAC report states.
Commissioners also zeroed in on curbing spending among Medicare’s fee-for-service population.
An increase in ER visits has led to an uptick in spending, according to the report. In 2017, $4.1 billion was spent on providing emergency room care to Medicare in fee-for-service. Just five years prior that figure was $2.4 billion.
The commissioners noted that a sizable portion of the growth (20% to 25%) in ED spending is tied to visits being coded at higher levels. The higher the level of coding, the higher the payment, which is why the commissioners are recommending establishing national guidelines for how to code emergency room visits.
In years prior, CMS has encouraged hospitals to develop their own coding guidelines, and the levels of coding have gradually shifted over time.
“From 2005 to 2017, the share of ED visits coded as Level 1 or Level 2 decreased from 28.0 percent to 7.5 percent, and the share coded as Level 5 increased from 11.2 percent to 30.0 percent,” the report notes.
Credit: MedPAC
As concerns about the supply of primary care physicians persist, MedPAC points out that the supply of nurses and physician assistants has “increased rapidly” and is expected to continue. The commissioners are also recommending allowing certain nurses and physician assistants to bill Medicare directly.
Yet Medicare has little data to know the depth and breadth of the services nurses and PAs provide Medicare beneficiaries due to the way the current billing system is set up. Fixing this issue could later aid in identifying how best to allocate resources toward primary care services.

Regeneron, Mayo Ink Pact to Sequence, Genotype 100K Patient Samples

Mayo Clinic and Regeneron Pharmaceuticals are collaborating to sequence the exomes and genotype 100,000 DNA samples from patients who have consented to partake in research and have submitted samples to Mayo’s biobank.
“Research findings from this database may lead to new knowledge about which genes put people at risk for certain diseases, and which ones affect how people respond to treatment,” Keith Stewart, director of the Mayo Clinic Center for Individualized Medicine, said in a statement.
Regeneron is covering the cost of the sequencing and genotyping, and both partners will have access to the data for research purposes. The data will be used to research diseases, such as cancer, heart disease, and mental health conditions. Researchers can use the sequencing data to propose studies that investigate how genetic variants are associated with the risk of developing these diseases or with long-term disease outcomes, according to Mayo.
The exome sequencing data will not be incorporated in participants’ medical records, but Mayo said that there are plans for a research study on return of results.
This is not the first time Regeneron and Mayo have joined up. Several years ago, they teamed up with Pittsburgh-based non-profit research organization Curable to sequence the genomes of at least 5,000 patients with a rare autoimmune disease called primary sclerosing cholangitis, as well as healthy controls, to try to identify genetic contributors to the disease.
In 2014, Regeneron inked a collaboration with Geisinger Health to sequence patients in that Pennsylvania healthcare system. Within Geisinger’s MyCode Community Health Initiative, consenting patients have their exomes sequenced by Regeneron, and around 2 percent of participants have received results indicating they have a likely pathogenic or pathogenic variants in 76 genes associated with 27 conditions. By next month, Regeneron will have sequenced the exomes of 145,000 MyCode participants, and more than 1,000 patients have received results so far.
Also this week, Decode Genetics and Intermountain Healthcare announced plans to perform whole-genome sequencing on 500,000 patients in Utah and Idaho in a population health initiative called HerediGene. Similar to what Regeneron is doing with Geisinger and Mayo, the aim of the Intermountain/Decode effort is to improve understanding of the underlying causes of disease and develop better drugs.

Employers can fund workers’ individual plans under new Trump rule

Employers will be able to hand their workers a chunk of tax-sheltered health reimbursement money and send them off to buy an individual health plan under a controversial rule issued by the Trump administration Thursday.
The final rule, which takes effect Jan. 1, 2020, will prompt an estimated 800,000 large and small employers to fund individual coverage through health reimbursement accounts, or HRAs, for more than 11 million workers, nearly 800,000 of whom would be newly insured.
It includes a complex set of provisions designed to prevent employers from reducing their benefit costs by sending older and sicker workers into the Affordable Care Act individual markets, thereby driving up costs and premiums in those markets. The Trump administration acknowledged that it will have to closely watch how the changes play out and assess whether further regulation is needed.
Reversing prior policy, the 497-page rule lets employers dole out HRA funds—previously used to reimburse out-of-pocket medical expenses—to employees to buy individual-market plans.
President Donald Trump issued an executive order in October 2017 commanding HHS, the Labor Department and the Internal Revenue Service to develop the rule as part of his administration’s broader effort to offer businesses and individuals cheaper, leaner health insurance options that don’t necessarily comply with the ACA’s consumer protection rules.
While the HRA money can be used mostly for buying plans that meet Affordable Care Act requirements, employers under the rule can establish a special type of “excepted benefit” HRA for employees to use in buying cheaper short-term plans that don’t comply with ACA rules such as pre-existing condition protections. These special accounts are capped at $1,800 a year.
The ACA requires that companies with more than 50 full-time workers provide their employees with health insurance. Employers can satisfy the requirement if they provide adequate HRA contributions for employees to buy individual coverage.
A wide range of groups expressed fears about negative effects on the individual market if employers offloaded their sicker, more costly workers from their employer group plans to the individual market.
There also were broad concerns about whether workers accustomed to their employer group plan would understand how to use an HRA to shop around and buy an individual health plan.
But the agencies said the coverage expansion and cost-saving benefits of the rule outweighed the risks of adverse selection and consumer confusion. They said the final rule included adequate safeguards against employer moves that could disrupt the individual market.
“The policy creates an exciting new opportunity for employers—especially small employers that might not offer coverage today—to provide employees tax-preferred funds to help buy coverage on the individual health insurance market,” CMS Administrator Seema Verma said in a written statement. “Making this option available to employers will significantly increase coverage across America and reduce the number of uninsured.”
Conservative groups including Americans for Prosperity and the Council for Affordable Health Coverage praised the rule, saying it will give employers and employees greater flexibility and control, and increase market competition.
Other observers said that while the rule could expand and strengthen the ACA individual markets, its impact is hard to predict, partly because no one knows how many employers will use HRA accounts to pay for workers’ coverage in the individual market.
“If the administration’s estimates are right, this would result in a huge influx into the ACA-regulated individual insurance market,” said Larry Levitt, senior vice president for health reform at the Kaiser Family Foundation. “But these new accounts could shift employer-provided health insurance to a defined-contribution approach, leaving workers at greater risk for premium increases over time.”
One of the most closely watched issues was whether the administration would allow HRA funds to purchase short-term plans that don’t comply with the ACA; those plans now can last up to a year and be renewed three times in many states.
In the final rule issued Thursday, the agencies decided that an “individual coverage” HRA can only be used to buy ACA-compliant plans. But this type of HRA will only be available to workers who are not offered a traditional group plan, according to Matthew Fiedler, an economist at the Brookings Institution’s Center for Health Policy.
Employers providing a traditional group plan can offer workers an “excepted benefit” HRA, capped at $1,800 a year, that they can use to buy a short-term plan but not an ACA-compliant plan.
The agencies said they chose not to allow integration of standard HRAs with short-term plans due to concerns about an adverse-selection impact on the ACA markets.
They also said nothing in the rule prevents states from regulating or even prohibiting short-term plans, which some states like California and New York have done.
More broadly, the agencies acknowledged that allowing the use of HRAs could result in “some market segmentation and health factor discrimination.” But they said “the risk can be sufficiently mitigated” through the rule’s various provisions to limit adverse selection.
The agencies modestly strengthened some of those guardrail provisions in response to public comments.
The final rule retained the proposed rule’s provision that employers cannot offer the same class of employees the choice of either a traditional group plan or an HRA-funded individual-market plan.
To protect against employers isolating less healthy workers into separate classes and shipping them off to the individual market, the final rule added a minimum class size based on employer size. It also barred employers from creating a class of employees younger than age 25, whom employers might want to keep in their group plan because they’re healthier.
But the agencies declined to include specific enforcement guidance to determine whether employers are targeting individual coverage HRAs to high-cost employees.
They noted that they may provide additional guidance if they become aware of arrangements that are inconsistent with the safeguards against adverse selection contained in the final rule.
The agencies also acknowledged the likelihood that employees will find the new HRA benefit system confusing, and that they may not understand the coverage limitations of short-term plans. The final rule requires individual coverage HRAs to provide notice to eligible participants explaining how it works.

Drugmakers Sue Trump Administration to Halt Prices-in-Ads Rules

Some of the U.S.’s biggest pharmaceutical companies sued the Trump administration to try and block a rule that would force them to put the price of their drugs in television advertisements.
In the lawsuit filed in federal court Friday, Merck & Co., Eli Lilly & Co., Amgen Inc. and an advertising trade association claim that the Department of Health and Human Services doesn’t have the legal power to compel drugmakers to include prices in their ads, and that doing so would also mislead patients.
Many drugmakers, including Lilly and Amgen, have created websites to disclose prices, but argued that including them in ads could result in patients being scared off from getting treatment. The Trump administration has said that forcing drugmakers to disclose prices for drugs, which have risen sharply in recent years, could push down list prices.
“Not only does the rule raise serious freedom of speech concerns, it mandates an approach that fails to account for differences among insurance, treatments, and patients themselves, by requiring disclosure of list price,” Amgen said in a statement accompanying the lawsuit.
A court battle over the rule could hamper part of the administration’s blueprint to drive down drug prices with regulation. Congress so far has failed to pass any major legislation, despite drug prices being an issue on which Republicans and Democrats can find common ground.
The Department of Health and Human Services didn’t immediately respond to a request for comment.
The case is Merck v. U.S. Department of Health and Human Services, 19-cv-1738, U.S. District Court, District of Columbia (Washington).

Witness calls Johnson & Johnson ‘kingpin in our opioid crisis’

A key witnesses for the state ripped into Johnson & Johnson on Thursday, accusing the company of engaging in aggressive and disturbing opioid marketing practices.
“I believe Johnson & Johnson was a major cause of our opioid crisis,” New York City psychiatrist Andrew Kolodny testified Thursday afternoon. “I believe it’s fair to characterize them as the kingpin in our opioid crisis.”
Kolodny’s testimony came on Day 13 of a trial in Cleveland County District Court in which Johnson & Johnson and its subsidiaries have been accused of creating a public nuisance through false or misleading marketing of opioid painkillers. The state alleges the companies overstated the benefits of opioids while understating their risks, leading to thousands of addictions and overdose deaths.
Kolodny elaborated on his kingpin remark, citing evidence that Noramco – one of Johnson & Johnson’s former subsidiaries – continued to expand the United States’supply of opioid prescription drugs by supplying Johnson & Johnson and other drug manufacturers with increasing amounts of raw materials and the active ingredient for opioids even after addiction rates and overdose deaths had begun to soar.

bluebird bio (BLUE) EHA ‘Solid Win’, But Zynteglo’s Launch in EU Delayed – Cowen

Cowen analyst Yaron Werber reiterated an Outperform rating

Milestone 2019 Jefferies Global Healthcare Conference Slideshow