CDC begins shipping coronavirus tests to state and local health departments

Coronavirus tests developed by the Centers for Disease Control and Prevention (CDC) shipped Wednesday to U.S. and international laboratories, including those at state and local public health departments.
Health providers and health departments previously sent samples for testing to the CDC in Atlanta, Ga.
The distribution of the tests will enable departments to identify new cases with increased speed — the test can provide results in four hours.

“Our goal is early detection of new cases and to prevent further spread of the coronavirus,” said CDC Director Robert R. Redfield.
“Distribution of these diagnostic tests to state laboratories, U.S. government partners and more broadly to the global public health community will accelerate efforts to confront this evolving global public health challenge,” he continued.
About 400 test kits will be distributed domestically and internationally. Each kit can test about 700-800 patient samples. More kits will be produced and shipped in the future, the CDC said.
The number of coronavirus cases reached 12 this week after a positive diagnosis in Wisconsin.
More than 28,000 cases have been confirmed worldwide, mostly in China. About 216 cases have been confirmed in other countries.
https://thehill.com/policy/healthcare/481944-cdc-begins-shipping-coronavirus-tests-to-state-and-local-health-departments

Ex-HHS chief threatens to vote ‘no’ on surprise medical billing measure

Rep. Donna Shalala (D-Fla.), a former secretary of Health and Human Services, said Friday she plans to vote against a bipartisan measure to protect patients from surprise medical bills unless it is changed.
The comments from Shalala are a sign of the divisions within both parties over the legislation.
Shalala said she is worried the bill from House Education and Labor Committee Chairman Bobby Scott (D-Va.) and ranking member Virginia Foxx (R-N.C.) would harm hospitals in her district.

The bill is slated for a vote in committee next week, and Shalala indicated other lawmakers have concerns as well.
Protecting patients from getting massive bills when they go to the emergency room and one of the doctors is outside their insurance network is seen as a rare area of bipartisan action this year. But the effort has been slowed by an array of competing proposals and intense lobbying from doctors and hospitals, who worry it would lead to damaging cuts to their payments.
Shalala said that she instead supports a rival proposal, more favorable to doctors and hospitals, that House Ways and Means Committee Chairman Richard Neal (D-Mass.) and ranking member Kevin Brady (R-Texas) also unveiled on Friday.
Shalala said she will seek to amend the bill next week but hasn’t worked out the details of her amendment given that she was only just shown the legislation.
“I have problems with it because it’s not balanced,” Shalala said of the Education and Labor proposal. “What I mean by that is the insurance companies are the big winners, the hospitals in my district and their employees get hurt and they’re the largest employers in my district. I can’t support a bill that will hurt the hospital workers in my district.”

Asked to respond, a spokesperson for Scott said, “There is broad consensus around the approach the Committee proposed today both within the Committee, as well as with our colleagues in the House Energy and Commerce Committee, and Senate [Health, Education, Labor and Pensions] Committee.”
The main dispute is over how much the insurer will pay the doctor or hospital once the patient is taken out of the middle.
The Energy and Commerce and Education and Labor bills would both set the payment rate based on the median payment for that service in the geographic area, with the option of going to arbitration for some high-cost bills.
In contrast, the Ways and Means bill gives the decision on payment to an outside arbiter, an approach more favored by doctors and hospitals but that has drawn criticism from the AFL-CIO and the consumer group Families USA as doing less to lower health care costs.
Neal defended his bill on Friday by pointing to the importance of not angering hospitals. “We think that it’s a good foundation,” Neal said. “We think that it’s patients first. Everybody’s got big hospitals [in their districts].”
House Energy and Commerce Committee Chairman Frank Pallone Jr. (D-N.J.) said Friday he thinks he can work with Ways and Means, but wants to make sure the final bill saves taxpayers money and does not raise premiums.
https://thehill.com/policy/healthcare/482042-ex-hhs-secretary-shalala-threatens-to-vote-no-on-surprise-billing-measure

Coronavirus hits trade fairs, conferences

Over two dozen large trade fairs and industry conferences in China and overseas have been postponed or hit by travel curbs and concerns about the spread of a coronavirus, potentially disrupting billions of dollars worth of deals.

In order of scheduled or likely dates:
* Taipei International Book Exhibition, Feb. 4-9 – Billed as Taiwan’s largest annual literary event, the exhibition has been postponed to May 7-12.
* League of Legends Pro League, due to start Feb. 5: The e-sports league owned by gaming giant Tencent Holdings said it would postpone the start of its second week until further notice.
* Singapore Airshow, Feb 11-16: The aviation leadership summit scheduled on the eve of the event was canceled. The show itself will go ahead as planned, but on a smaller scale with more than 70 exhibitors pulling out and the number of public tickets halved.
* China Commodity Markets Insight Forum 2020, Feb 19-20: The forum held by S&P Global Platts was delayed until further notice.
* National Association of Travel Agents Singapore (NATAS) travel fair 2020, Feb 21-23: Moved to May because exhibitors were concerned about turnout at the fair.
* US chipmaker Nvidia pulled out of the Feb. 24-27 Mobile World Congress telecoms conference in Barcelona, becoming the third exhibitor after Swedish equipment maker Ericsson and South Korea’s LG Electronics.
* China Iron Ore 2020, Feb. 25-27: The event held by Fastmarkets in Beijing has been postponed to June 30–July 2.

* East China Import and Export Commodity Fair, March 1-4：Due to be held in Shanghai, the fair usually attracts traders of garments and household goods. It was postponed until further notice.
* Malaysia’s biggest palm oil conference, the Palm and Lauric Oils Price Outlook Conference and Exhibition, or POC2020, originally scheduled for March 2-4, will be rescheduled to June 22-24.
* Marine Money China, March 3-4: Originally slated to be held in Shanghai, organizers of the meeting for shipping financiers have said that it has been delayed, likely until November.
* Food & Hotel Asia in Singapore, March 3-6: Organizers of the biennial trade show have postponed its first leg to July. The event attracted more than 80,000 attendees when it was last held in 2018.
* National People’s Congress, likely to have started March 5: China is considering delaying the annual meeting of its top legislative body, five people familiar with the matter told Reuters.
* 6th China LNG & Gas International Exhibition and Summit, Shanghai, March 4-6: Organizers said the event has been postponed until a later date this year. They are in the process of confirming the new date.
* Asian Ferroalloys, March 16-18: The conference by Fastmarkets, due to be held in Shanghai, has been postponed with no new date given.
* Art Basel Hong Kong show, March 19-21: The high-profile annual show has been canceled.
* SEMICON/FPD China 2020, March 18-30: The annual trade conference for the global chip industry in China was postponed until further notice.

* China Development Forum, usually late March: Hosted by a foundation under the State Council, the conference was postponed until further notice.
* Canton Fair, spring season from April 15: The venue of China’s oldest and biggest trade fair said it has suspended exhibitions until further notice.
https://www.reuters.com/article/us-china-health-events-factbox/coronavirus-hits-trade-fairs-conferences-idUSKBN2001CM?il=0

China’s Hubei to cut costs for small firms to ease coronavirus burden

China’s Hubei province, the epicenter of a coronavirus outbreak, will offer subsidies and cut costs for small and medium-sized firms to help them cope with the impact of the epidemic, the local government said on Sunday.
It said it would pay 30% of electricity costs for small and medium-sized firms involved in medical supplies, and cut the prices of water and natural gas for other smaller enterprises.
It will also move to cut rent, environmental inspection fees and financing costs for small and medium-sized firms and grant tax exemptions if they have been hit hard by the coronavirus.
https://www.reuters.com/article/us-china-health-hubei/chinas-hubei-to-cut-costs-for-small-firms-to-ease-coronavirus-burden-idUSKBN2030CZ

FDA Laboratory analysis of metformin products

FDA continues to investigate the presence of the N-Nitrosodimethylamine (NDMA) impurity in metformin approved for sale in the U.S. Metformin is a prescription drug used to control high blood sugar in patients with type 2 diabetes. FDA has identified low levels of NDMA in some samples of metformin drug products but has not identified NDMA in metformin active pharmaceutical ingredient (API). To date, no sample of metformin that FDA has tested exceeds the acceptable daily intake for NDMA.
FDA is posting its laboratory results in the table below showing NDMA levels in metformin products it tested. Some metformin drug products tested showed no detectable levels of NDMA, while others showed low levels of NDMA. The methods FDA used in the laboratory testing will be posted in the near future. FDA is also collaborating with international regulators to share testing results for metformin.
For reference, consuming up to the acceptable daily intake limit, 0.096 micrograms (96 nanograms), of NDMA per day is considered reasonably safe for human ingestion based on lifetime exposure. NDMA may increase the risk of cancer if people are exposed to it above the acceptable level and over a long period of time, but a person taking a drug that contains NDMA at-or-below the acceptable daily intake limit every day for 70 years is not expected to have an increased risk of cancer.
To date, FDA has not recommended metformin recalls in the U.S.

NDMA ESTIMATED RISK

FDA has determined that the levels of NDMA in metformin products range from not detectable to low levels, similar to the levels you would expect to be exposed to if you ate foods like grilled or smoked meats.

Company	Product	Lots Tested	NDMA level (micrograms-mcg/tablet)
Heritage	Rx Metformin 1000mg IR*	4521603A	not detected
Ingenus Pharmaceuticals	Rx Metformin 1000mg ER**	19088003	not detected
Actavis	Rx Metformin 1000mg ER	1358454A, 1358453A, 1358452A	0.01-0.02
Actavis	Rx Metformin 500mg ER	1358450A, 1358451A, 1358449A	0.01
Sun Pharma	Rx Metformin 1000mg ER	GKU0762, GKU0763, GKU0764	not detected
Sun Pharma	Rx Metformin 500mg ER	GKU06060	not detected
Westminster Pharmaceuticals	Rx Metformin 1000mg IR	D107031	not detected
Heritage	Rx Metformin 1000mg IR	4521611A	not detected
Aurobindo	Rx Metformin 1000mg IR	MTSC19039-A	not detected
Major Pharmaceuticals	Rx Metformin 1000mg IR	M02599D	not detected

*Immediate release
** Extended release

Related Information

• FDA Updates and Press Announcements on NDMA in Metformin
• Information about Nitrosamine Impurities in Medications

https://www.fda.gov/drugs/drug-safety-and-availability/laboratory-tests-metformin

Novel Coronavirus Vaccine Development Still on Track

Early steps in the development of a vaccine for the novel coronavirus have gone as planned, the head of the National Institute of Allergy and Infectious Diseases (NIAID) said on Friday.
“There have been no glitches so far,” said NIAID Director Anthony Fauci, MD, discussing a messenger RNA platform for producing viral antigens being developed by the National Institutes of Health in partnership with biotech company Moderna.

Fauci said during a press briefing with members of President Trump’s Coronavirus Task Force that immunogenicity had been established in mouse models, supplies of the drug were being developed, and barring any unexpected glitches “we will be in people in a phase I trial within the next 2.5 months.”
The Task Force offered assurance that things were largely status quo in the U.S., where the virus — known as 2019-nCoV — is still a low-level threat and is being contained with aggressive measures, including 14-day quarantines for some 800 passengers that have been evacuated from the Wuhan area.
The official U.S. case count stands at 12, though reports have surfaced that 11 Americans are among dozens diagnosed with the virus aboard a cruise ship off the coast of Japan.
CDC Director Robert Redfield, MD, said the agency had already screened 17,000 passengers coming in from flights from China, including an estimated 4,000 today. Worldwide, 31,530 cases have been reported, along with 638 deaths, the vast majority in Hubei province in China.
During the briefing, FDA Commissioner Stephen Hahn, MD, said that so far the medical supply chain — which relies heavily on drugs and other goods produced in China — had been unaffected by the outbreak, but that could change.

“FDA is closely monitoring the situation,” said Hahn. “At this moment, we have received no reports from manufacturers about disruptions to the medical product supply chain. Obviously the situation is fluid, and we’ll do everything we can to continue to monitor this and act accordingly.”
In the U.S., the CDC has already started sending out coronavirus diagnostic kits to certified laboratories across the country and Fauci suggested that point-of-care antibody tests would be an important next step in order to perform broad sero-surveillance screening and better determine the scope of the outbreak.
The World Health Organization reported on Friday that among 17,000 cases of the novel coronavirus, 82% were mild, 15% severe, and 3% critical.
New data also emerged detailing the risk for hospital-acquired with the novel coronavirus and the demands on intensive care units (ICUs) at the epicenter of the outbreak.
The single-center series in JAMA included 138 consecutive patients hospitalized at Zhongnan Hospital of Wuhan University with confirmed cases of the novel coronavirus from Jan. 1 to Jan. 28.

Among these patients (median age 56, men 54.3%), 26.1% ended up in the ICU, and hospital-acquired infection was presumed to be the source of infection in 41.3% (40 healthcare workers and 17 hospitalized patients), reported Zhiyong Peng, MD, of the Zhongnan Hospital of Wuhan University, and colleagues.
Most (88.9%) were treated with antiviral therapy, at least 64.4% received antibacterials, and a little less than half received glucocorticoid therapy (44.9%). Complications leading to ICU transfer included acute respiratory distress syndrome, arrhythmia, and shock. Patients landing in the ICU tended to be older (median 66 vs 51 years), have dyspnea (63.9% vs 19.6%) or anorexia (66.7% vs 30.4%), and a higher proportion had underlying comorbidities (72.2% vs 37.3%).
The study noted that all patients showed “bilateral patchy shadows or ground glass opacity in the lungs” on CT scans.
In all, six of the 138 patients died (4.3%). Median duration of hospital stay among the 47 discharged patients was 10 days. The remaining 85 patients were still hospitalized as of Feb. 3.

Study authors reported no conflicts of interest.

• Primary Source

  JAMA

  Source Reference: Wang D, et al “Clinical characteristics of 138 hospitalized patients with 2019 novel coronavirus-infected pneumonia in Wuhan, China” JAMA 2020; DOI: 10.1001/jama.2020.1585.

https://www.medpagetoday.com/infectiousdisease/publichealth/84784

Many State Medicaid Programs Flop for Lung Cancer Screening

When it comes to screening Medicaid patients for lung cancer, states need to do a better job, a report found.
“Lung cancer screening using low-dose computed tomography is recognized by the U.S. Preventive Services Task Force (USPSTF) with a Grade B rating, and therefore is a covered health benefit for Medicare and commercial insurance beneficiaries; it is not mandated for Medicaid,” noted the report commissioned by the LUNGevity Foundation, a Chicago-based group aimed at improving lung cancer survival rates. “Unfortunately, almost one-third of states do not cover lung cancer screening.”

When compared by region, screening rates were better for Northeastern states; 91% covered the screening, compared with Southern states, where only 50% covered it, according to the report, which was written by the consulting firm ADVI using publicly sourced data. A total of 66% of Midwestern states covered it, as did 61% of Western states.
Byron Crowe, MD, associate medical director at Solera Health, a Denver digital health company that creates programs to address chronic disease and social determinants of health, said it was “very exciting” to see that 66% of state Medicaid plans were covering the screening even thought they weren’t obliged to. “We’re optimistic about the other 33%” also deciding to cover it eventually, said Crowe, who spoke during a phone interview with a public relations person present. “We think coverage of these preventive services is a huge benefit to patients and should be something states embrace.” Crowe noted that more and more states have begun covering diabetes prevention programs, “and we’re hopeful more states will adopt coverage for other Grade A and B recommendations that aren’t now covered.”
The report also examined rates of coverage for lung cancer biomarker testing. “Last year, Medicare issued a National Coverage Decision (NCD) validating the clinical utility of NGS [next generation sequencing] panels for somatic mutation analysis in advanced malignancies (including lung cancer) and establishing coverage and payment for FDA-approved panels,” the authors noted. “Many, although not all, commercial insurers cover these panels as a medical benefit in lung cancer. Medicaid, however, is not bound by either Medicare NCDs or a commercial payer policy.” Overall, “we found that the vast majority of states did not have an explicit coverage policy for comprehensive biomarker testing, but that about 40% did provide coverage (as evidenced by paid claims) as a medical benefit.”
Finally, the authors looked at how many states covered the routine costs of clinical trials — procedures and services needed during the trial, excluding the drugs themselves — for experimental treatments for lung cancer and other diseases. They found that 24% of state Medicaid plans provided this coverage.
The report also graded individual states on five factors, giving them one point for each:

• Medicaid program covers lung cancer screening
• Medicaid fee-for-service program covers comprehensive biomarker testing
• Is a Medicaid expansion state
• Lung cancer incidence is less than the national average; currently lung cancer represents 13% of all cancers diagnosed nationwide
• State’s 5-year lung cancer survival rate is higher than the national average of 21.7%

The four states receiving an “A” grade — with 5 points — were Maryland, Minnesota, Oregon, and Washington; those with “F” grades — 0 or 1 point — included Alabama, Arkansas, Georgia, Idaho, Kansas, Kentucky, Louisiana, Mississippi, Missouri, Nebraska, North Carolina, Oklahoma, South Carolina, and Tennessee.
“We recognize there is a lot of work to do,” the authors wrote, adding that their report “establishes a baseline to measure improvements (or lack thereof) in how lung cancer care is delivered, and to identify pain points and opportunities in the system that we can address to improve patient access to better care, including precision medicine treatments.”
https://www.medpagetoday.com/hematologyoncology/lungcancer/84779