Nursing Home Roundtable (LTC Advisory)

To: Nursing Home NHA’s, DON’s and other stakeholders

From: Jo Tansey, Section Manager Nursing Facilities

Attached is the agenda for the meeting September 3, 2019. Please join us in person or by phone. 

Phone # 1-712-775-8968 Code- 339028

Agenda

New Colorado Health Facility Interactive (CoHFI) System Testers Needed

To: HFEMSD Portal Users

From: Greg Schlosser, Branch Chief, Training and Technical Assistance Branch

We have some exciting news! Last year we shared with you that we are working on replacing the system you have been using to submit your license applications (Licensing), occurrence reports (Occurrences), and plans of correction (Survey Tracking). 

We are in the final stages of testing and would like to invite you to participate in the final testing and get a preview of the new system. We are looking for participants who can offer 30 minutes a day during the week of September 23rd or possibly October 7th. 

Testing participants should be individuals who are already familiar with our current system and know how to either submit an occurrence report, license application, or plan of correction. If you would like to volunteer please fill out this short survey(https://www.surveymonkey.com/r/CKNGJHZ) and we may reach out to you. After testing is complete and we have fixed as many bugs in the system as possible we plan to go live this fall. We will be offering and recording training webinars leading up to the release so you know how to navigate and use the new system. 

HCBS Settings Final Rule – Rights Modification Workgroup

To: Provider Directors

From: HFEMSD

The Department of Health Care Policy and Financing (HCPF) sent an Informational Memo to Home and Community-Based Services (HCBS) stakeholders, including providers, to announce that HCPF will host a workgroup to develop proposed materials regarding the rights modification process. HCPF also invited stakeholders to participate, including providers. Please review the attached Informational Memo. 

For further information, please see contact information provided in the Operational Memo

Johnson and Johnson’s "Landmark" Opioid Settlement, or Just Another Chapter in the Story of Corporate Management’s Impunity?

Introduction: our Chronic Narcotics Problem

Narcotic addiction has plagued human societies for hundreds of years.

[Print, 1880, opium den, London]

So as I have written before, after seeing too many dire results of narcotic addiction during my training and early career,
I was dismayed how narcotics were pushed as the treatment of choice for
chronic pain in the 1990s, with the predictable result that the US was once again
engulfed in an epidemic of narcotic abuse.  In the last few years, the narcotics (now called “opioids”) epidemic has frequently been in the headlines.  A few days ago, a judge decided that one large pharmaceutical/ biotechnology/ device company bears some blame for the problem

The Johnson and Johnson “Landmark” Settlement

On August 26, 2019, the New York Times reported a “landmark,” per the headline, settlement:

A judge in Oklahoma on Monday ruled that Johnson & Johnson had intentionally played down the dangers and oversold the benefits of opioids, and ordered it to pay the state $572 million in the first trial of a drug manufacturer for the destruction wrought by prescription painkillers.

The judge wrote

that Johnson & Johnson had promulgated ‘false, misleading, and dangerous marketing campaigns’ that had ’caused exponentially increasing rates of addiction, overdose deaths’ and babies born exposed to opioids.

It seems like a big story, big enough for another NYT article to fret over how the settlement might damage Johnson and Johnson’s sterling reputation.  

For Johnson & Johnson, which has said it plans to appeal, the decision represents another blow to its reputation as the trusted brand of parents, doctors and nurses.

Wall Street Journal editorialists fretted even more,

the ruling could have far larger, and more dangerous, consequences by opening a vast new arena for product-liability suits.

And warned the opioid epidemic will not

be eased by bankrupting America’s pharmaceutical companies

Maybe threats to this upstanding company inspired US President Trump, while running the most conflicted and corrupt administration ever (look here), to promote another fine Johnson and Johnson product.  On August 23, 2019, the Atlantic reported,

President Donald Trump said on Wednesday that the government will purchase ‘a lot of the drug esketamine, a derivative of ketamine.

Though ketamine is known as a recreational hallucinogen, Trump asserted that a new nasal-spray derivative would be of great benefit to veterans with depression. As he left the White House for a veterans’ conference in Kentucky, he told reporters that he had instructed the Department of Veterans Affairs to make a large purchase—overriding a recent decision by the doctors who manage the hospitals’ formulary of which drugs are to be prescribed.

‘There’s a product that’s made right now that just came out by Johnson & Johnson which has a tremendously positive—pretty short-term, but nevertheless positive—effect,’ Trump said. But that statement is contrary to the evidence. A review by the Food and Drug Administration of what limited studies have been done with esketamine found mixed results, leaving many scientists unsure if the drug is indeed effective and safe. Just last week, the agency published a report that said the drug was not reliably better than placebo.

Should the Wall Street Journal (and perhaps President Trump) really be so worried? Was this settlement really so dire?

The March of Legal Settlements Continues

In fact, this particular settlement did not seem very harsh.  Per the first NYT article,

The amount fell far short of the $17 billion judgment that Oklahoma had sought to pay for addiction treatment, drug courts and other services it said it would need over the next 20 years to repair the damage done by the opioid epidemic.

The amount of the settlement would be unlikely in and of itself to give corporate leadership pause, given that the company’s revenues exceeded $81 billion last year (look here).

While the judge found that Johnson and Johnson caused a “public nuisance,” this seems unlikely to inspire much shame in corporate leaders, who took no overt responsibility for the narcotic epidemic:

In a statement about the Oklahoma case, Michael Ullmann, the general counsel and executive vice president of Johnson & Johnson, referring to the company’s pharmaceutical subsidiary, said that ‘Janssen did not cause the opioid crisis in Oklahoma, and neither the facts nor the law support this outcome.’

‘We recognize the opioid crisis is a tremendously complex public health issue,’ he said, ‘and we have deep sympathy for everyone affected.’

And like many other legal settlements which we have discussed in the past, this one caused no one at Johnson and Johnson who approved, directed, or implemented the deceptive marketing and other bad behavior to suffer any negative consequences. 

Ignoring Another Corporation’s Dismal Record

Furthermore, the settlement, like most others we have discussed, ignored Johnson and Johnson’s extensive track record of misbehavior.

The second NYT article did allow that the company has withstood

a series of damaging setbacks to its brand, including a spate of lawsuits over whether its talcum powder led to ovarian cancer, and high-profile cases over other potentially flawed products, like pelvic mesh and the anti-stroke drug Xarelto, which has caused excessive bleeding.

‘Johnson & Johnson is a corporation under duress on a number of fronts,’ said Stephen Hahn-Griffiths, an executive at Reputation Institute, which tracks public perception of companies through regular surveys.

However, that barely scratched the surface of Johnson and Johnson’s record.  In a 2018 post we discussed accusations that Johnson and Johnson tried to cover up the adverse effects of its baby powder.  However, we also discussed a settlement the company made of allegations it gave kickbacks to patients to facilitate its over-pricing of Tracleer, a drug for pulmonary artery hyptertension.  These were just the latest in a long string of misadventures by the company, as we have
been documenting over years.  (Our collected posts on Johnson &
Johnson are here
An updated version of their legal record from 2010 to 2016 is at the end of
this post.)

Perusing the list suggests that this giant company is a poster child for bad behavior by health
care organizations.  It has faced a multitude of allegations leading to
settlements, and sometimes findings of guilt.  The charges included many
instances of deceptive and unethical marketing, some that promoted
drugs or devices for use in situations in which they may have had harms
outweighing their benefit, some that involved concealing knowledge of
their risks, and some of selling adulterated drugs or defective
products. 

What is striking is that the company and its management have not faced more consequences for this sorry track record.

Although the company has paid multiple fines and made numerous monetary
settlements over the years, none have been big enough to affect its
immense revenues.  Furthermore, ultimately the monies used to pay them
came from all Johnson & Johnson employees in the form of smaller
paychecks; customers, patients and the public at large in the form of
higher prices; and only to some extent by investors in the form of
slightly lower profits.  Meanwhile, it appears that the company’s top
managers made an immense amount of money, possibly in part as rewards for the
revenues produced by the misadeventures.

Former Johnson & Johnson CEO William Weldon, upon his
retirement in 2014, was to receive a retirement package estimated to be
worth from $143 to $197 million (look here).  In 2010, his total compensation was $29 million (look here).   According to the 2012 Johnson and Johnson proxy statement,
his 2011 total compensation was greater than $26 million. As far as I
can tell, Mr Weldon never suffered any negative consequences for his
company’s sorry record, and retired a very rich man. (look here).

Current CEO Alex Gorsky received  $25 million total compensation in 2014 (look here).  More recently, the New York Times reported
his 2017 total pay was $22.8 million, making him the seventh highest
paid health care executive that year. 

While management made so much money, very rarely has anyone who was involved in authorizing, directing, or implementing bad behavior had to suffer any negative consequences, therefore
appearing to enjoy impunity.

So what was to deter management from embarking on further misadventures,
as long as the results might be enlarging their personal
wealth? 

And why should we expect that this settlement will lead to any meaningful solution to the ongoing narcotics (opioid) epidemic?

Summary: Meaningless Settlements and the Impunity of Top Management

Nothing changes.  We have seen many legal settlements by health care organizations of charges of  fraud, bribery, and kickbacks
Often such behaviors appeared to risk patient harms.  However, the companies
involved usually paid tiny fines that relative to their revenues.  Rarely did they have to admit responsibility, and almost never did a
settlement cause company managers and leaders to 
suffer any negative consequences for enabling, authorizing, directing or
implementing the bad behavior.

Thus it seems that US health care is
rigged to benefit top insiders and their cronies, and is part of a
larger rigged system.  We have previously discussed how market fundamentalism (or
neoliberalism) led to deregulation, which enabled deception, fraud,
bribery, and intimidation to become standard business
practices, concentrating corporate power while top managers got rich. Other employees, patients, customers, vendors and suppliers, and the public at large
lost out.   In health care, these changes led to an increasingly
costly system which produced increasingly bad results. 

We have called for true health care
reform to derig the system. Unfortunately, despite our hopes,
perceptions of a rigged
system may not always inspire honest reform. Instead, they can facilitate the rise of demagogues and would be dictators.  Donald Trump cried out that only he could
fix our problems and drain our swamps, but the waters are now rising (look here) while he has enjoyed his own impunity (look here).  

The “landmark” settlement by Johnson and Johnson should remind us of the reforms we have not achieved.  However, to have a chance of truly reforming health care, we need to accomplish wholesale government reform. We need to excise
the deception, crime and corruption at the heart of our government and
restore government by the people, of the people, and for the people. 

Appendix – A Look at Some of Johnson and Johnson’s Legal Record 2010-2016

Derived from our previous blog posts – 

 2010
– Convictions in two different states for misleading marketing of Risperdal
– A guilty plea for misbranding Topamax

2011
– Guilty pleas to bribery in Europe by DePuy subsidiary
– A guilty plea for marketing Risperdal for unapproved uses  (see this link for all of the above)
– A guilty plea to misbranding Natrecor by subsidiary Scios (see post here)

2012 
 
– Testimony in a trial of allegations of
unethical marketing of the drug Risperdal (risperidone) by the Janssen
subsidiary revealed a systemic, deceptive stealth marketing campaign
that fostered suppression of research whose results were unfavorable to
the company, ghostwriting, the use of key opinion leaders as marketers
in the guise of academics and professionals, and intimidation of
whistleblowers. After these revelations, the company abruptly settled
the case (see post here).
–  fined $1.1 billion by a judge in Arkansas for
deceiving patients and physicians again about Risperdal (look here).
–  announced it would pay $181
million to resolve claims of deceptive advertising again about Risperdal
(see this post).

2013
–  settled case by shareholders alleging that management made
misleading statements and withheld material information about
manufacturing problems (see this post)
–  Janssen subsidiary pleaded guilty to a charge of misbranding
Risperdal, and settled for a total of $2.2 billion allegations that it
promoted the drug for elderly demented patients and adolescents without
an indication, and despite evidence of its harms (see this post).
 –  DePuy subsidiary agreed to settle with multiple plaintiffs for
$2.5 billion allegations that it sold defective mental-on-metal
artificial hip, and hid evidence of its harms .
–  Janssen subsidiary was found by two juries to have concealed
harms of its drug Topamax (see this post for this and above case).
–  Ethicon subsidiary’s Advanced Surgical Products and two of its
executives agreed to settle charges by US FDA that is sold mislabeled
products used to sterilize equipment such as endoscopes (see this post).
– fined by European Commission for anticompetitive practices, that
is, collusion with Novartis to delay marketing generic version of
Fentanyl (see this post).

2014 
– DePuy subsidiary settled Oregan state charges
that it marketed the ASR XL metal-on-metal hip joint prosthesis without
disclosing its high failure rate (see this post).

2015
–  found by jury to have concealed harms of Risperdal.
–  Ethicon subsidiary found by jury to have concealed harms of its vaginal mesh device.
–  McNeil subsidiary pleaded guilty to marketing adulterated Tylenol. (see this post for three items above.)

2016
– subsidiary Aclarent settled allegations that it
sold its Stratus device for unapproved uses.  Two former executives of
that subsidiary also were found guilty of distributing misbranded and
adulterated devices (see this post

 

VERY SMALL QUANTITY GENERATOR HEALTHCARE FACILITY HAZARDOUS WASTE SELF-CERTIFICATION CHECKLIST

The Colorado Department of Public Health and Environment, Hazardous Materials and Waste Management Division (the Division) sent a letter and an email on August 28th, providing notice that all very small quantity generator (VSQG) healthcare facilities in Colorado, including VSQG hospitals, long term care facilities, and ambulatory service facilities, are required to complete the annual hazardous waste self-certification checklist by September 30, 2019.

There are a few new items to note. 

1. The Colorado Department of Public Health and Environment, Hazardous Materials and Waste Management Division (the Division), has created a 10-minute tutorial video to assist facilities in understanding how to fill out the self-certification checklist. The link for this video will be available on the self-certification webpage at https://www.colorado.gov/pacific/cdphe/hmselfcert

2. The Division has also created a 45-minute hazardous waste disposal training video specific to VSQG healthcare facilities in Colorado for each facility to use to train staff on the basics of Colorado’s Hazardous Waste Regulations, 6 CCR 1007-3 (the Regulations), and how they apply to healthcare. This video, in combination with supporting documentation, is recommended for initial training as well as refresher training for staff involved in the management of hazardous waste at your facility. The link for this video will be available on the self-certification webpage at https://www.colorado.gov/pacific/cdphe/hmselfcert, as well as the hazardous waste healthcare webpage at https://www.colorado.gov/pacific/cdphe/medical-and-pharmaceutical-waste-guidance

3. To access the self-certification checklist, go to our website at https://www.colorado.gov/pacific/cdphe/hmselfcert. Choose the link titled “VSQG Healthcare Facility Checklist”. The checklist also contains a link to a short video explaining each question or section. 

If you have questions about hazardous waste management or the self-certification checklist, please contact our Customer Technical Assistance Hotline at 303-692-3322.

PDPM Implementation Webinars for MDS

To: Federally Certified Skilled Nursing Facilities Administrators, Directors of Nursing, MDS Coordinators, Billing and Coding Personnel, Licensed Nursing Facilities Administrators 

From: The Health Facilities Education and Quality (HFEQ) Branch of the Health Facilities and Emergency Medical Services Division (HFEMSD)

The Patient-Driven Payment Model (PDPM) is coming for all MDS 3.0 submissions with an Assessment Reference Date (ARD, A2300) on or after October 1, 2019. This will have implications for submission to the Federal database (OBRA and optional Interim Payment Assessments) for Medicare reimbursements. There will be additional considerations for State reimbursements via Medicaid for using the Optional State Assessments (OSA).

Explanatory webinars are planned to introduce these changes. Participants will identify State contacts for questions and further information.

Each webinar will have course materials available before the sessions. It is important to register via Train.org, and to allow Train to send email notifications to receive the call-in times and URL. Multiple participants are welcome per phone line.

PDPM Practice Webinars (ID 1086630) This series of 5 one-hour weekly webinars will compare and contrast the current Prospective Payment System (PPS) with upcoming PDPM concepts and requirements.

– Intro – Adjustments and additions to the Item Set will be discussed. The new Interrupted Stay policy will be explained. A framework for the calculation of PDPM payments using the new HIPPS codes will be introduced. The webinar will be a prerequisite to further PDPM Practice Webinars because of terminology.
– Case 1 – Admit with Infection 
– Case 2 – Admit for Procedure Aftercare 
– Case 3 – Acute Infection becomes Pneumonia 
– Case 4 – Complex Surgical Aftercare

Using the Optional State Assessment (OSA) for Medicaid Nursing Home Residents in Colorado (ID 1086621)

This will be a joint webinar between the Colorado Departments of Public Health and Environment (CDPHE) and Health Care Policy and Financing (HCPF) to clarify the use of OSA for nursing homes. Medicaid requirements and timelines will be explained, and practical examples of MDS 3.0 items will be reviewed. There will be time for Q&A. To see additional session details and register for session materials for one of these offerings:

1. Go to http://www.train.org/ 
2. Log in to your existing CO.TRAIN account, or new users click “Create an Account”.
3. Once you’ve logged in, or created an account, Search (top right) for the appropriate Course ID. (See above for desired training)
4. Click link for desired course. Note open session options.
5. Click the “Register” button for the session you wish to attend.
6. Remember to register separately for each desired course.

Detailed Instructions for Using Train.org (if needed)

Questions?: Please email betty.metz@state.co.us

https://www.colorado.gov/pacific/cdphe/mds-training-and-resources

Join NHSN Colorado Group Monthly Webinar on 8/14/2019

Please join us at our next monthly webinar on Wednesday, August 14, 2019.
Go
to https://zoom.us/meeting/register/0f4853b4057656868c34be5db4a05ad8,
to register for the webinar. The monthly webinar is held on the second Wednesday
of every month from 1p.m. – 1:30 p.m. (MST).

The Colorado Department of
Public Health and Environment is hosting a monthly NHSN Colorado user group
webinar to provide updates and training related to NSHN. The purpose of the
monthly webinar is to provide updates and training on various topics to the
licensed facilities in Colorado who report in NHSN. Immediately following the
webinar, CDPHE staff will be available to assist new users in NHSN set-up,
enrollment and other facility specific questions.

Agenda:

Announcement
– Demonstration of Custom Reports
– Q & A

For
questions, please contact Lynda Saignaphone at 303-692-2923, lynda.saignaphone@state.co.us.

Reminder – Assisted Living Advisory Committee meeting on Thursday, August 22, 2019

To: Assisted Living Residence Providers and Stakeholders 

From: Dee Reda, Community Services Section Manager

The next Assisted Living Advisory Committee meeting is on Thursday, August 22, 2019 from 1:30 p.m. – 3:30 p.m. in Building A, Sabin/Cleere Room.

For meeting agendas, handouts, etc. please go to: https://drive.google.com/drive/folders/0ByqZDBabyNVSR3pNejg2X2J0V2c?usp=sharing%20. Click on the folder labeled “2019 Meetings” and find the corresponding meeting date. We recommend that you return to this site on the day of the meeting to check for additional or revised meeting materials. 

To participate via Web using Zoom Meetings: 
Join from PC, Mac, Linux, iOS or Android: https://zoom.us/j/881545146 

Meeting ID: 881-545-146

Step #1: Go to https://zoom.us/j/881545146 
The Zoom meeting screen will appear entitled “Assisted Living Advisory Committee”
Step #2: For sound, choose Phone Call or Computer Audio.
Step #3: You will now be in the Virtual Meeting Room.

If you have never attended a Zoom meeting before:
Get a quick overview: https://support.zoom.us/hc/en-us/articles/204772869-Zoom-Rooms-User-Guide

To participate by telephone:
Step #1: Dial (for higher quality, dial a number based on your current location): US: +1 669 900 6833+ or 1 408 638 0968 or +1 646 876 9923
Step #2: When prompted, enter the Meeting ID: 881 545 146
Step #3: You will be on hold until a few moments before the meeting.

If you have any questions, please contact Michelle Topkoff at michelle.m.topkoff@state.co.us or call 303-692-2848 at least a business day in advance of the meeting. 

Meeting information

At the Colorado Department of Public Health and Environment, we work hard to protect and promote your health and the environment. If you’re planning a visit to our campus and want to ride your bike here, we won’t take a second look at your helmet head, and if the bus you’re taking is running a little late, we won’t worry. We want you to be your healthiest you, and we appreciate your efforts to reduce pollution.
If you’re coming to our campus: Our campus is located at 4300 Cherry Creek Drive South, Denver, 80246.
If you’re riding your bike: Our campus is located just south of the Cherry Creek bike trail. Bicycle parking is available at multiple locations on the main campus. Covered bicycle parking also is available at several locations, as well as on the ground floor of the parking structure on Birch Street, which is just east of the main campus 
If you’re riding the bus: RTD’s Trip Planner is a great way to find the fastest route.
If you’re driving: Visitor parking is conveniently located in front of all of our buildings. Please check in with security in Building A so you can get a visitor badge.
You might also want to know:
We care about your health, so our campus is tobacco-free.
We are located just east of Glendale’s City Set, where there are several restaurants.
Lactation Rooms are available on the first floors of buildings A and B. 

Chapter 7 Assisted Living Regulation Updates and Resources:

Updates on the Chapter 7 Assisted Living Regulations can be found on the Assisted Living News & Resources web page at http://67.231.102.44/HFEMSD/ALR/index.html.

It is our hope that this resource will provide you with up-to-date and relevant tools, training, and information, as we move forward with implementing the new regulations under 6CCR 1011-1, Chapter 7 Assisted Living Regulations. Current features of the newsletter include on “What’s New”, “Important Dates,” “Training,” “Blog,” “FAQs”, “Help” and “Advisory Committee”. Our goal is to provide you with a clear understanding of the new portions of the regulation as well as training to help you comply. 

HHA IDR Committee Meeting

This blog publishes information typically sent through the Health Facilities Web Portal to health care entities regulated by the Colorado Department of Public Health and Environment. Please note that the Web Portal is the official medium for business communication between the Department and licensed and Medicare/Medicaid certified health care entities. Health care entities should continue to monitor their portal accounts routinely.

Chapter 4 Hospital Rule Revision meeting information


Dear Stakeholder:

In keeping with the statutory requirement to routinely review and update our regulations, the department is beginning the stakeholder process this October for the regulatory review of 6 CCR 1011-1, Chapter 4 – General Hospitals, Chapter 10 – Rehabilitation Hospitals, Chapter 18 – Psychiatric Hospitals, and Chapter 19 – Hospital Units. These chapters cover a wide range of topics that impact hospitals, both general and specialty. 

The stakeholder meeting schedule and detailed information regarding the rule revision process can be accessed at this link https://drive.google.com/drive/folders/1yTm15HQ_6pOdnL_jn9Lj1mpUUB6r-5qV