Author Archives: Jeffrey Lynne

About Jeffrey Lynne

Jeffrey C. Lynne is a South Florida native, representing individuals and business entities relating to licensing, accreditation, regulatory compliance, business structure, marketing, real estate, zoning and litigation pertaining to substance abuse treatment facilities and sober living residences. Mr. Lynne has been recognized across the region as a leader in progressive public dialogue about the role that substance abuse treatment has within our communities and the fundamental need and right to provide safe and affordable housing for those who are both in treatment for addiction and alcoholism as well as those who are established in their recovery.

Lawsuits Continue Against Insurance Companies for Refusing to Pay for Mental Health Care

Happy Thanksgiving to all of our readers.

Before the holiday break, I wanted to quickly give everyone a brief update on some interesting recently filed federal lawsuits against insurance providers relating to behavioral health.  We all have a lot to be thankful and grateful for as it relates to the plaintiffs and their lawyers who are fighting the “David v. Goliath” battle against many health insurance companies who continue to deny reimbursements for critical mental health care including behavioral health and Substance Use Disorders.

  1. Utah

In the pending case of K.H.B. v. UnitedHealthcare Insurance Co.,  in the U.S. District Court for the District of Utah, UnitedHealthcare is seeking to convince a Utah federal judge to reject most of a proposed class action brought by plaintiffs accusing it of improperly denying health insurance claims for wilderness therapy, a form of therapy said to be able to treat young people with substance abuse and mental health issues.  UnitedHealthcare moved to dismiss three out of four claims in an Employee Retirement Income Security Act suit that claims the company should have paid for the trip to a wilderness program attended by the plaintiff identified only as K.H.B.

Plaintiff K.H.B. alleged UnitedHealthcare is illegally disregarding the 2008 “Mental Health Parity and Addiction Equity Act”, a law that requires health care plans to provide about the same coverage for mental health and substance abuse claims that they provide for medical and surgical claims.  United responded that the pleadings “fell short on the claim for an alleged violation of that statute.”

According to K.H.B.’s amended complaint in August, he suffers from a wide range of mental illnesses, and sought help at a wilderness program after trying to commit suicide for the second time.

While he was insured by a UnitedHealthcare ERISA-governed health plan that covered mental health services, coverage for outdoor and wilderness behavioral programs are denied by UnitedHealthcare, even when the programs are required to treat mental issues, the amended complaint had alleged. He has said that he personally had to pay up almost $38,000 for his time spent at the program. And while K.H.B. has argued that outdoor and wilderness behavioral programs offer a cost-effective method for treating young people with mental health issues, UnitedHealthcare said that there hasn’t been a consensus reached in the scientific community as to whether such programs are effective.
 
[NOTE: Any waiver or reduction in the published costs of services could rise to an allegation of a state’s Patient Brokering laws, or potentially the new federal “Eliminating Kickbacks in Recovery Act” (EKRA) which makes any form of kickback within the addiction treatment space a federal crime.]
 

  1. Massachusetts

Also recently filed is the case of Steve C., et al., v. Blue Cross Blue Shield of Massachusetts Inc., in the U.S. District Court for the District of Massachusetts.  The suit’s plaintiffs are identified by the aliases Steve C. and Kelly W., along with daughter Jane Doe. The suit alleges that claims for Jane’s treatment for depression, anxiety and obsessive-compulsive disorder at a Utah inpatient facility were denied by the insurer despite being medically necessary.

The policies provided by Blue Cross of Massachusetts include coverage for inpatient intermediate residential treatment of mental health and substance use disorders, but the insurer improperly denied claims for such treatment, the suit alleges.  “However, BCBSMA interprets the language of the class policies in a way that improperly limits that coverage to only what it characterizes as ‘acute residential treatment’ to the exclusion of sub-acute residential treatment that is medically necessary,” the suit alleges.

After Jane was admitted to the inpatient facility on Feb. 26, 2016, Steve and Kelly submitted claims to their insurer, Blue Cross of Massachusetts. The insurer agreed to pay for the first 16 days of Jane’s treatment, but it said any treatment provided after March 14, 2016, would not be covered because it was not medically necessary, the complaint said.

After Steve and Kelly appealed Blue Cross’ decision, the company responded in October 2016 that it had made a mistake and would not be covering any of the treatment costs, citing the insurance plan provisions that it said excluded any intermediate inpatient treatment, even when it is medically necessary, the suit claims.

Steve and Kelly initiated a second appeal in March 2017, quoting the language of the insurance policy indicating that intermediate treatment was covered for mental health and substance abuse treatment, and that Blue Cross’ application of the “acute” limitations violated the policy and the Parity Act.

Blue Cross never responded to the second appeal, the complaint alleges, and never paid for any part of Jane’s treatment at the Utah facility. Jane received inpatient treatment for more than 10 months, and the suit said she experienced great progress and has become more functional.

Jane’s parents paid in excess of $185,000 for treatment that the suit claims should have been covered by Blue Cross because it was medically necessary.

The suit seeks restitution for the out-of-pocket expenses incurred by the proposed class members and an injunction preventing Blue Cross of Massachusetts from continued violation of its own insurance policies and of the Mental Health Parity and Addiction Equity Act, and a reprocessing of the class’ residential treatment claims.

  1. California

And then there is the case of Smith et al. v. United Healthcare Insurance Co. et al., in the U.S. District Court for the Northern District of California. In this case, a proposed class of employees who received psychotherapy through their employers’ health care plans sued United Healthcare Insurance Co. and United Behavioral Health in California federal court, accusing them of flouting the Employee Retirement Income Security Act (“ERISA”) by imposing unfair reimbursement limits on psychotherapy services.  The lawsuit targets a policy allowing United to pay therapists less when they have their master’s degrees and even lesser when they are certified psychologists. When United pays less to these therapists, customers foot larger portions of the bill, the workers state.

“Through these penalties, United is devaluing psychotherapy and is ultimately limiting access to an essential health benefit that plays a critical role in addressing pervasive public health issues, such as mental health and substance abuse disorders,” said the lead plaintiff’s counsel.

The lawsuit seeks to enjoin United from imposing its reimbursement reduction policy, which allows the insurer to pay 25 percent less to psychologists and 35 percent less to master’s-level therapists.

The suit also looks to require United to pay for or reprocess all claims that it denied under that policy.

Why Isn’t Housing Deemed “Medically Necessary” in SUD Treatment?

I shock friends and colleagues from time to time by telling them that, “Did you hear…. from now on, insurance is no longer going to cover the cost of a hospital stay associated with any medical procedure, and that the costs of room and board while in post-surgical recovery all must come out of pocket.”

The look of incredulity and anger on their faces is priceless.

I entertain the discussion for a while and let it play out, enjoying listening to all of the justifications why that is abhorrent public policy (and equally bad health care).

Only afterwards, I take the time to tell them that, while I was joking, that it really isn’t a joke when it comes to mental health, behavioral health, and addiction treatment; that after detoxification (and for the lucky few, inpatient residential treatment), that the vast majority of people entering the drug and alcohol treatment space will be forcibly placed by their insurance carriers into an outpatient program but will not cover the necessary costs of a properly trained and supervised recovery residence.

At this point in my experience in this space, I am no longer surprised when they start to try to make a distinction.

However, in a news report that was admittedly surprising to me, HHS Secretary Alex Azar said in prepared remarks (as reported by ModernHealthcare.com) that Medicaid may soon allow hospitals and health systems to directly pay for housing, healthy food or other solutions for the “whole person.”

What?!?!

“What if we gave organizations more flexibility so they could pay a beneficiary’s rent if they were in unstable housing, or make sure that a diabetic had access to, and could afford, nutritious food,” Azar said in a speech supported by the Hatch Foundation for Civility and Solutions and Intermountain Healthcare.

Azar said the Center for Medicare and Medicaid Innovation is looking “to move beyond existing efforts to partner with social services groups and try to manage social determinants of health as they see appropriate…. If that sounds like an exciting idea … I want you to stay tuned to what CMMI is up to.”

“We believe we could spend less money on healthcare—and, most important, help Americans live healthier lives—if we did a better job of aligning federal health investments with our investments in non-healthcare needs,” he said.  According to ModernHealthcare.com, Azar didn’t elaborate on when the model would be launched, but the program could help Medicaid enrollees who need housing.

Granted, the discussion related mostly to seniors, medically-necessary improvements to homes, and home health care visits:

“These interventions can keep seniors out of the hospital, which we are increasingly realizing is not just a cost saver but actually an important way to protect their health, too,” Azar said. “If seniors do end up going to the hospital, making sure they can get out as soon as possible with the appropriate rehab services is crucial to good outcomes and low cost as well. If a senior can be accommodated at home rather than an inpatient rehab facility or a [skilled nursing facility], they should be.”

Azar was focusing on the agency’s approach to social determinants a day after it was announced that CMS would begin allowing states to cover a broader range of mental health services under Medicaid.

Specifically, CMS would consider Medicaid demonstration waivers (referred to as a §1115 waiver) covering short-term stays for acute care provided in psychiatric hospitals or residential treatment centers in return for states expanding access to community-based mental health services (these proposals would waive the so-called institutions for mental diseases (IMD) exclusion, a section of the Medicaid law (within the Social Security Act) that prohibits the use of federal Medicaid funding for most inpatient psychiatric services).

“It is the responsibility of state and federal governments together, alongside communities and families, to right this wrong,” Azar said. “More treatment options are needed, and that includes more inpatient and residential options that can help stabilize Americans with serious mental illness.”

However, Azar is speaking to psychiatric illness, not Substance Use Disorders, which appear to remain the “ugly stepchild” of health care, generally.

Back in 2014, the State of Illinois asked the Centers for Medicare and Medicaid Services (CMS) for permission to spend $60 million in Medicaid funding to help vulnerable enrollees find and maintain stable housing, joining New York and counties in Minnesota and California in efforts to try to add housing to the list of healthcare services offered to chronically ill Medicaid patients.

Under the waiver, Illinois wanted to offer managed-care plans incentive payments for enrollees specifically with mental illness or substance abuse disorders to successfully find temporary or permanent stable housing.

New York unsuccessfully sought $75 million from the CMS to develop housing capacity for high-cost Medicaid enrollees. The state ended up removing the request from its pending Medicaid waiver. But New York continues to seek $75 million to help chronically homeless, mentally ill or otherwise vulnerable adults live independently. Assistance—including counseling, employment aid, legal and budget help and case management—would be directed at those with high Medicaid costs.

At the present time, CMS determined that waivers cannot be used to pay outright for housing. Instead, these state programs can pay for assistance in finding housing, providing home modifications, and educating beneficiaries about tenant rights.

However, CMS has paid rent for Medicaid beneficiaries in the past through grant programs. The “Money Follows the Person” (MFP) demonstration project that was launched in 2008 transitioned Medicaid enrollees from an institutional setting back into the community. 43 states including California, Texas, New Jersey, Ohio, New York, Georgia and the District of Columbia participated in the grant program. Florida opted out.

By the end of 2016, there were 9,995 participants. In 2008, 289 people participated in the demonstration, according to federal data.

Though that grant program expired on September 30, 2016, the authorizing legislation required that the Secretary of HHS provide for a national evaluation of the MFP demonstration and submit a final report to the president and Congress that presents the findings and conclusions of this evaluation.  That report can be found here.

The report concluded:

MFP also provides strong evidence of success at improving the quality of life of participants. After transitioning to the community, participants experience increases across all seven quality-of-life domains measured, and the improvements are largely sustained two years post-transition. The changes in the quality of life that occur when participants move to the community are remarkable and important indicators that this demonstration has had positive impacts on participants’ lives. Estimating the value of the quality-of-life improvements reported by MFP participants would be extremely difficult, and any dollar value placed on these improvements would not adequately reflect what it means for people with significant disabilities when they can live in and contribute to their local communities.

This reads like it was taken verbatim from The American Journal of Community Psychology’s 2013 study on “The Role of Recovery Residences in Promoting Long-Term Addiction Recovery Outcomes.”

However, it was not, and the need for more-than-adequate sober living accommodations for people in recovery from addiction should be at the top of the list when it comes to health care public policy.

As I said before, we would never make a heart surgery patient go find a hotel to recover in and we would never let insurance carriers refuse to pay for such accommodations.

Let’s hope that HHS Secretary Azar is picking up the mantle from his predecessor and continuing to move addiction treatment health care into the full medical health care continuum, rather than to accept society’s generalized and simplistic view that addicts choose to be addicts, and we should not spend valuable resources on saving their lives.

“We can support both inpatient and outpatient investments at the same time,” Azar said. “Both tools are necessary and both are too hard to access today.”

Federal Government Seeks to Commentary Relating to Anti-Kickback Laws

According to an article published by FierceHealthCare.com, there continues to be a groundswell of opposition from hospital trade groups to the continued application of the federal anti-kickback laws to the extent they “stand in the way of growing participation in value-based models.”

Comments and opposition to existing payment structures came from major hospital groups and other industry stakeholders in response to the Department of Health and Human Service Office of Inspector General’s request for information on ways to reform the Stark and anti-kickback laws.

In its letter to OIG, the Federation of American Hospitals (FAH) said value-based payments are “hindered by the existing fraud and abuse regime.” To address this, OIG should build an overarching waiver to anti-kickback laws for advanced payment models run by the Centers for Medicare & Medicaid Services.

Provider groups, including the American Hospital Association, have long argued that the Stark and anti-kickback laws pose a major barrier to care coordination, a crucial piece of these new payment arrangements.

“Provided that the compensation to be received is fair market value, does not take into account the volume or value of referrals and is commercially reasonable, the arrangement should be deserving of safe harbor protection,” the group said.

Another hospital trade industry group, America’s Essential Hospitals (AEH), also wrote in favor of the OIG consider narrowing its use of anti-kickback and civil monetary penalty statutes.

Anti-kickback provisions, AEH said, are overly broad and could apply to any payment that has an impact on referrals, even if ultimately it leads to better care or otherwise benefits patients. At the same time, existing anti-kickback safe harbors are very narrow, the group said.

Narrowing the use of these statutes would offer providers greater certainty in the work they’re doing and would allow for clarification of regulatory requirements, AEH said.

“Regulatory uncertainty has put essential hospitals in an untenable position,” AEH said. “The very activities our members undertake to support new delivery system and payment models—actives the Centers for Medicare & Medicaid Services and Congress have encouraged—increase their exposure under the AKS and CMP law.”

The Association of American Medical Colleges (AAMC), which represents academic medical centers, noted in its commentary to OIG that “the Stark and anti-kickback laws are relics of a healthcare system that hadn’t yet conceived of value-based models.”

According to their argument, because alternative payment models are tightly regulated, it’s unlikely that patients would receive poor care, AAMC said.

“It is critical that CMS, the OIG, and other associated agencies coordinate their efforts to allow waivers of the physician self-referral law, the civil monetary penalties and anti-kickback laws, as appropriate to support the clinical and financial integration needed for the success of these new delivery and payment models,” AAMC said.

At the same time, and just last week, President Trump signed the “Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act” or the “SUPPORT for Patients and Communities Act”, H.R.6 — 115th Congress (2017-2018), which we reported about back on October 4th.

Included within that legislation was a section sponsored by Senators Marco Rubio and Amy Klobuchar entitled the “Eliminating Kickbacks in Recovery Act” (EKRA) which essentially makes the federal Anti-Kickback Statute applicable to private health care plans. As adopted, the new law:

  • Makes it illegal to provide, or receive, financial kickbacks for referring patients to recovery homes and clinical treatment facilities. These kickbacks are already illegal under Federal health care plans, like Medicare, but there is no federal law to prohibit them in private health insurance plans;
  • Fine anyone found guilty up to $200,000 or 10 years of prison, or both; and
  • Establish exceptions to enable legitimate cases of patient referral.

Those “exceptions” would be generated by HHS through adoption and publication in the Code of Federal Regulations (CFR).

We have reported in the past that it seems fundamentally unfair that healthcare providers involved in federally funded programs could seek guidance from OIG as to their behavior, while private pay providers could not. This was specifically true for providers in the SUD treatment space, who could only seek such input from their regulating agencies, such as the Department of Children and Families (DCF) in Florida. But since only the Florida Patient Brokering Act applied to such behavior, which is a state (not federal) criminal law, DCF was not authorized to comment upon such behavior.

With the adoption of EKRA and the anticipated development of regulations adopting “safe harbors,” SUD treatment providers should have clarity on what behaviors would trigger federal penalties. That law, however, does not cause state laws, such as Florida’s Patient Brokering Act, to be superseded. Those laws will remain on the books and will be prosecuted separately, without interpretation of the new federal law having any impact.

Florida DCF Releases Final Draft of Changes to Chapter 65D-30

The Florida Department of Children and Families (DCF) released today its Notice of Hearing relating to further proposed revisions made to Chapter 65D-30 of the Florida Administrative Code. These rules govern the licensure, management, regulation, as well as service delivery of care relating to Substance Use Disorders.

A copy of the revisions made to the initial rule change proposed in January 2018 is attached.

The hearing on the proposed changes is taking place at DCF’s office in Tallahassee on November 7, 2018, 10:00 a.m. – 12:00 p.m.  There will not be live-streamed videoconferencing across the state as had been offered in January 2018.  Considering the very large turnout at those prior gatherings, this comes across as somewhat of a surprise, and disappointing that input is somewhat limited.

However, DCF is offering interested persons to “attend” via conference call: Dial 1(888)670-3525; Code: 800 740 0450 #

Questions or concerns should be addressed to: Jodi Abramowitz at (850)717-4470 or Jodi.abramowitz@myflfamilies.com

A few comments on items that we gleaned from the changes:

  • Definition of “Best Practices” – DCF requires licensed service providers to implement “best practices” and had defined those previously to be the standards adopted by ASAM. The definition is now much more broad and not as specific, seemingly requiring a provider to select which “validation tool” it believes to be “best practices” and to implement same.  We were hoping that the State would require specific standards so that insurance carriers would then not be dictating health care in this space, but that discussion seems to have gone in a different direction.
  • Change of Ownership/Transfer of Licensure – While state statute prevents a transfer of ownership/licensure in the SUD treatment space (unlike medical health care), the proposed revisions to the rules now make it clear that the plain language of the statute controls – that a “transfer” occurs when 51% or more of ownership is sold/transferred/acquired. Anything less would likely continue to only require submittal of notice to DCF of the identification of the new owners/investors and a Level 2 background check (which has been the consistent interpretation of DCF for many years, until recently).
  • Medical Consultant – the term “Medical Consultant” has been created, we believe, to distinguish the term from a “Medical Director”, the latter of which is only required for inpatient treatment services.
  • Clinical Supervisor – the term had been proposed by DCF back in January but has been since proposed for exclusion from the new rules.
  • Licenses for Each Location – it is not clear from the revisions whether DCF is now eliminating the requirement that an existing licensed service provider must submit a complete license application to provide the same services at a second location. Specific language was struck from the rules revision requiring a separate license “for each facility that is maintained on separate premises even if operated under the same management.” We will seek further clarification as to this point, as well as the intended concept of “overlay services.”
  • License Fees – not proposed for significant change (DCF license fees are significantly less than AHCA licensed facilities).
  • Calculation of “Days” – The ways that the number of days from which an event must occur (such as a license renewal application) has been changed from “calendar days” to “business days.” This is a significant and impactful change, when it comes to license review by the Department, but also benefits in a way treatment providers. Renewals were required to be submitted no less than 60 days prior to expiration. That has now been proposed to be changed to “business” days, which is approximately 12 weeks.  On the flip side, the Department is now proposing that it have 30 business days to review a new application to determine initial completeness. So, what would have been a month would now be 6 weeks or more.
  • Medical Directors & Number of Facilities – DCF has endeavored to try to create a methodology for determining the maximum number of individuals a Medical Director may serve (noting that a “medical director” is only still required for addiction receiving facilities; detoxifications; intensive inpatient treatment; residential treatment; and methadone medication-assisted treatment). This methodology, found within proposed Rule 65D-30.004 (Common Licensing Standards), subsection (6), breaks down the maximum number of patients that can be under a single Medical Director’s supervision, based upon license type.  However, a Medical Director is still not required for outpatient services.
  • Critical Incident Reporting – it appears that DCF has attempted to incorporate into rule the IRAS critical incident reporting tool, CFOP 215-6, for ease of reference. It should be noted that a mandatory reporting incident now includes: “Events regarding individuals receiving services or providers that have led to or may lead to media reports.”
  • Delivery of Clinical Services – The proposed changes to the rules appear to continue to require that all clinical services now be provided by either the Qualified Professional or by persons with specific degrees or recognized certifications.  “Mental health counseling interns” have been added.  It currently remains unclear whether non-clinical staff may still provide therapy and counseling.

This information is intended simply to make the reader aware of the proposed changes, and the date for the DCF hearing. It is not intended to be an analysis of the proposed changes or to be a substitute for clinical, compliance and/or legal counsel to determine the impact any of these proposed changes may have upon ownership, management, operations and service delivery.

The proposed rule changes are not final and still must go through a process for final adoption. Therefore, any comments any reader may have regarding the proposed rules should be directed to Jodi Abramowitz at DCF prior to the hearing on November 7, 2018.

If you have received this post from someone else and are not a subscriber to our newsletter, please make sure to sign up at SoberLawNews.com, where you can also find other articles, editorials, and commentary of interest.

IMPORTANT NOTE:

Consistent with the prior rule proposal back from January, DCF is continuing to propose the elimination of Residential Treatment Level 5.

“Day or Night Treatment with Community Housing” had been proposed for elimination but has been kept in the October 2018 proposed rules.

Click here to find out more

ASAM and CARF Announce New Certification Program for Treatment Centers

The American Society of Addiction Medicine (ASAM) and CARF International (CARF) announced yesterday, October 15, 2018, the pilot launch of a national certification program for addiction treatment programs that they believe will demonstrate the ability to deliver services consistent with established national guidelines for levels of care.

“The importance of certification to the future of addiction medicine cannot be overstated,” said Kelly J. Clark, MD, MBA, DFAPA, DFASAM, president of ASAM. “ASAM has led the national movement to standardize and deliver evidence-based care for the disease of addiction. Certification is the critical next step to implement consistent standards across the nation, build transparency and consumer confidence around the services patients receive at a particular program, ensure provider fidelity to The ASAM Criteria, and address an urgent national public health need.”

The certification program is intended to provide an independent, comprehensive assessment of an individual treatment program’s fidelity to a specific level of care as outlined in The ASAM Criteria. ASAM and CARF have clearly defined roles in the development and operation of the program to deliver accuracy and ensure independence throughout the certification process.

[Editor’s Note: While Florida law requires treatment programs to become accredited through a nationally-recognized body, a vast majority of programs flock to obtain that accreditation from the Joint Commission, rather than CARF. It is believed within the treatment industry that Joint Commission standards are less stringent than CARF.]

“CARF is pleased to partner with ASAM to deliver a certification program that will benefit patients and their families, health professionals, and insurers, with the necessary clarity to identify discrete levels of care for persons with substance use disorders,” said Brian J. Boon, PhD, president/CEO of CARF.

The ASAM Criteria is the nation’s most widely used and comprehensive set of guidelines for placement, continued stay, and transfer/discharge of patients with addiction and co-occurring conditions.

[Editor’s Note: There are many practitioners who do not believe the ASAM Criteria to be the “gold standard” when it comes to addiction medicine and care.]

“Three decades ago, a group of committed administrators, addiction clinicians, physicians, researchers, and scientists set out to define one national set of criteria for providing outcome-oriented, results-based care for the treatment of addiction – what is known today as The ASAM Criteria,” said Paul H. Earley, MD, DFASAM, ASAM president-elect and one of the authors of The ASAM Criteria.  “With [yesterday’s] certification announcement, ASAM advances the specialty of addiction medicine in another significant way by giving addiction treatment programs a way to validate their ability to provide care consistent with ASAM’s nationally recognized best practices.”

ASAM and CARF anticipate piloting the certification in early 2019, adding verification in a second phase, and making the program broadly available later in the year.  The ASAM level of care certification will initially offer certification standards based on Level 3 of the ASAM Criteria, specifically levels 3.1, 3.5, and 3.7, covering residential treatment programs.  Certifications for other levels of care may be developed at a later date.

ASAM and CARF collaborated on the development of proprietary ratable certification elements and scoring methodology, which include certain pass/fail elements that ASAM has determined are essential to an applicant’s certification.

Importantly, CARF will evaluate programs for certification. To obtain certification, programs will need to demonstrate to CARF that they have the capacity to deliver services at the level of care defined by The ASAM Criteria, as represented by satisfaction of the applicable ratable elements in accordance with the scoring methodology. Programs will submit applications to CARF directly and CARF will independently perform the certification process, including reviewing individual provider applications and conducting site visits.

“CARF possesses the necessary infrastructure, credibility, and expertise to offer certification as a valid proxy of the ASAM levels of care delivered by providers of residential substance use disorder services,” stated Michael Johnson, MA, CAP, managing director for Behavioral Health at CARF.

Each certification will be valid for up to three years, at which time the program may reapply.The American Society of Addiction Medicine (ASAM) and CARF International (CARF) announced yesterday, October 15, 2018, the pilot launch of a national certification program for addiction treatment programs that they believe will demonstrate the ability to deliver services consistent with established national guidelines for levels of care.

“The importance of certification to the future of addiction medicine cannot be overstated,” said Kelly J. Clark, MD, MBA, DFAPA, DFASAM, president of ASAM. “ASAM has led the national movement to standardize and deliver evidence-based care for the disease of addiction. Certification is the critical next step to implement consistent standards across the nation, build transparency and consumer confidence around the services patients receive at a particular program, ensure provider fidelity to The ASAM Criteria, and address an urgent national public health need.”

The certification program is intended to provide an independent, comprehensive assessment of an individual treatment program’s fidelity to a specific level of care as outlined in The ASAM Criteria. ASAM and CARF have clearly defined roles in the development and operation of the program to deliver accuracy and ensure independence throughout the certification process.

[Editor’s Note: While Florida law requires treatment programs to become accredited through a nationally-recognized body, a vast majority of programs flock to obtain that accreditation from the Joint Commission, rather than CARF. It is believed within the treatment industry that Joint Commission standards are less stringent than CARF.]

“CARF is pleased to partner with ASAM to deliver a certification program that will benefit patients and their families, health professionals, and insurers, with the necessary clarity to identify discrete levels of care for persons with substance use disorders,” said Brian J. Boon, PhD, president/CEO of CARF.

The ASAM Criteria is the nation’s most widely used and comprehensive set of guidelines for placement, continued stay, and transfer/discharge of patients with addiction and co-occurring conditions.

[Editor’s Note: There are many practitioners who do not believe the ASAM Criteria to be the “gold standard” when it comes to addiction medicine and care.]

“Three decades ago, a group of committed administrators, addiction clinicians, physicians, researchers, and scientists set out to define one national set of criteria for providing outcome-oriented, results-based care for the treatment of addiction – what is known today as The ASAM Criteria,” said Paul H. Earley, MD, DFASAM, ASAM president-elect and one of the authors of The ASAM Criteria.  “With [yesterday’s] certification announcement, ASAM advances the specialty of addiction medicine in another significant way by giving addiction treatment programs a way to validate their ability to provide care consistent with ASAM’s nationally recognized best practices.”

ASAM and CARF anticipate piloting the certification in early 2019, adding verification in a second phase, and making the program broadly available later in the year.  The ASAM level of care certification will initially offer certification standards based on Level 3 of the ASAM Criteria, specifically levels 3.1, 3.5, and 3.7, covering residential treatment programs.  Certifications for other levels of care may be developed at a later date.

ASAM and CARF collaborated on the development of proprietary ratable certification elements and scoring methodology, which include certain pass/fail elements that ASAM has determined are essential to an applicant’s certification.

Importantly, CARF will evaluate programs for certification. To obtain certification, programs will need to demonstrate to CARF that they have the capacity to deliver services at the level of care defined by The ASAM Criteria, as represented by satisfaction of the applicable ratable elements in accordance with the scoring methodology. Programs will submit applications to CARF directly and CARF will independently perform the certification process, including reviewing individual provider applications and conducting site visits.

“CARF possesses the necessary infrastructure, credibility, and expertise to offer certification as a valid proxy of the ASAM levels of care delivered by providers of residential substance use disorder services,” stated Michael Johnson, MA, CAP, managing director for Behavioral Health at CARF.

Each certification will be valid for up to three years, at which time the program may reapply.

Bipartisan Opioid Legislation Heads to President’s Desk

We have been holding off reporting on a rare bipartisan effort from Congress to continue to address the national opioid epidemic, only because like most Americans, we have become cynical that anything works in that institution of government anymore.

However, yesterday, October 3, 2018, the Senate approved the compromise version of the House bill which means that the legislation is now headed to President Trump’s desk for signature.

Called the “Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act” or the “SUPPORT for Patients and Communities Act”, H.R.6 — 115th Congress (2017-2018), this bill makes several changes to state Medicaid programs to address opioid and substance use disorders.

The summary, provided by Congress, provides that the bill:

  • modifies provisions related to coverage for juvenile inmates and former foster care youth;
  • establishes a demonstration project to increase provider treatment capacity for substance use disorders;
  • requires the establishment of drug management programs for at-risk beneficiaries;
  • establishes drug review and utilization requirements;
  • extends the enhanced federal matching rate for expenditures regarding substance use disorder health home services; and
  • temporarily requires coverage of medication-assisted treatment.

The bill also alters Medicare requirements to address opioid use. Specifically, the bill:

  • exempts substance use disorder telehealth services from specified requirements;
  • requires the initial examination for new enrollees to include an opioid use disorder screening;
  • modifies provisions regarding electronic prescriptions and post-surgical pain management;
  • requires prescription drug plan sponsors to establish drug management programs for at-risk beneficiaries; and
  • requires coverage for services provided by certified opioid treatment programs.

The bill also addresses other opioid-related issues. Specifically, the bill:

  • establishes and expands programs to support increased detection and monitoring of fentanyl and other synthetic opioids; and
  • increases the maximum number of patients that health care practitioners may initially treat with medication-assisted treatment (i.e., under a buprenorphine waiver).

Additionally, the bill temporarily eliminates the enhanced federal matching rate for Medicaid expenditures regarding specified medical services provided by certain managed care organizations.

The bill is meant to address several aspects of the opioid crisis — which involves overdose deaths from prescription painkillers and heroin — through medical research, expanding access to treatment, giving more tools to law enforcement, but only allocates roughly $8.5 billion in funding authorized in appropriations bills passed earlier this year.  Some lawmakers suggested $100 billion was the necessary number.

The bill’s passage comes a year after President Trump declared the opioid crisis a national emergency. The Senate’s vote was the last step before the President signs the measure into law.

Public-health advocates laud the bill’s increased attention to treatment, which they say is the key component to overcoming addiction. The legislation would create a grant program for comprehensive recovery centers that include housing and job training, as well as mental and physical health care. It would increase access to medication-assisted treatment that helps people with substance abuse disorders safely wean themselves.

Another major aspect of the bill is the change to a decades-old arcane rule that prohibited Medicaid from covering patients with substance abuse disorders who were receiving treatment in a mental health facility with more than 16 beds. The bill lifts that rule to allow for 30 days of residential treatment coverage.

The legislation passed Wednesday, which spans more than 650 pages, aims to tackle the crisis by going after different angles that have made it more difficult for healthcare workers to respond. It allows hospitals to take in more patients with addiction to receive government funding, allows more medical providers to prescribe addiction treatment, helps the postal service intercept fentanyl from being sent through the mail, and encourages the development of a non-addictive treatment to pain. Lawmakers stressed that they saw the bill as only the beginning.

Many say that this amount of money simply isn’t enough, as the epidemic, by some reports (released by the National Institute of Drug Abuse) kills more than 115 people a day die from opioid overdose and 21 percent to 29 percent of patients prescribed opioids for chronic pain misuse them.  According to the CDC, overdoses killed more than 50,000 people in 2017 alone. As a result, Sen. Elizabeth Warren, D-Mass., and Rep. Elijah Cummings, D-Md., had introduced measures that would have provided $100 billion toward the effort over a decade, which was modeled after the bill Congress passed to fight the HIV epidemic during the 1990s.

There are other critics of the bill as well, for not doing enough.  “This legislation edges us closer to treating addiction as the devastating disease it is, but it neglects to provide the long-term investment we’ve seen in responses to other major public health crises,” said Lindsey Vuolo, Associate Director of Health Law and Policy at Center on Addiction in an interview with The Washington Post. “We won’t be able to make meaningful progress against the tide of addiction unless we make significant changes to incorporate addiction treatment into the existing health care system.”

One provision negotiated by leaders allows hospitals to receive Medicaid payments when they take in more patients who have a mental illness or addiction. Previously, hospitals were allowed to take in no more than 16, leading to long wait lines for care. The bill also allows patients to stay as long as 30 days, rather than the 15-day limit currently in place.

The opioid legislation also allows more healthcare providers to give medication to patients that helps them stave off the painful symptoms of withdrawal. It seeks to reduce the prevalence of illicit fentanyl, a highly potent drug, by having the postal service scan packages coming from overseas. It also requires prescription painkillers to be sold in blister packs so that the amount patients receive is limited and so that patients can tell how many they have had.

The Food and Drug Administration would be required to update information on nonaddictive treatments for chronic pain and addiction. In January, the FDA released its strategic policy roadmap, which included bolstering efforts to prevent and treat opioid addiction.

The issue has bled into other areas of health and the economy. People who use drugs are unable to pass drug tests to secure jobs, and the spread of HIV and hepatitis C has increased in communities where sharing infected needles is common. Patients with severe pain have said they do not have an alternative allowing them to find relief, and patients who seek treatment for addiction often make several attempts and cycle through the criminal justice system. Drug users report that they have been revived with the drug naloxone during an overdose but then did not receive treatment for addiction, causing them to return to drug use and overdose again at a later time.

“I hope Congress doesn’t think they can put this behind them because they passed these bills,” said Patrick Kennedy, a former Democratic congressman of Rhode Island and a mental health advocate. “It takes an urgency like we had during HIV-AIDS. That will call to mind what it takes to address a crisis, it takes political will.”

Excepts for this story have been taken from:

https://www.congress.gov/bill/115th-congress/house-bill/6/text?q=%7B%22search%22%3A%5B%22SUPPORT+for+Patients+and+Communities+Act%22%5D%7D&r=1#toc-H90D3579192CE4F958A3FD339DFA0DC82
https://www.washingtonexaminer.com/policy/healthcare/senate-sends-opioid-package-to-trumps-desk
https://www.washingtonexaminer.com/policy/healthcare/congress-reaches-final-deal-on-opioid-package
https://thehill.com/policy/healthcare/409751-senate-sends-bipartisan-package-to-fight-opioid-epidemic-to-trumps-desk
https://www.usatoday.com/story/news/politics/2018/10/03/opioids-senate-passes-legislation-battle-nations-opioid-crisis/1515372002/
https://www.washingtonpost.com/politics/2018/10/03/senate-is-poised-send-sweeping-opioids-legislation-president-trump/?utm_term=.0782cd996f4d

Surgeon General Releases Spotlight on Opioids

This morning, the US Dept. of Health and Human Services (HHS) announced an update to original 2016 release of the comprehensive “Facing Addiction in America: The Surgeon General’s Report on Alcohol, Drugs and Health” by publishing a shorter and updated “Spotlight on Opioids” which HHS says “calls for a cultural shift in the way Americans talk about the opioid crisis and recommends actions that can prevent and treat opioid misuse and promote recovery.”

The press release is below.  [Editor’s Note: I have highlighted specific sections in the HHS press release which I believe require the most immediate attention as well as long-term strategic planning and funding.]

The Spotlight – the Surgeon General’s newest update on opioid addiction – also provides the latest data on prevalence of substance misuse, opioid misuse, opioid use disorder and overdoses.
The Surgeon General today also released a digital postcard, highlighting tangible actions that all Americans can take to raise awareness, prevent opioid misuse and reduce overdose deaths.
“Addiction is a brain disease that touches families across America – even my own,” said U.S. Surgeon General Jerome M. Adams. “We need to work together to put an end to stigma.”
According to preliminary data from the Centers for Disease Control and Prevention, overdose deaths in 2017 increased by almost 10 percent – claiming the lives of more than 70,000 Americans.. Nearly 48,000 of those were opioid overdose deaths, with the sharpest increase occurring among deaths related to illicitly made fentanyl and fentanyl analogs (synthetic opioids).
Despite the fact that effective treatment for opioid use disorder exists, only about one in four people with this disorder receive any type of specialty treatment. Yet for a variety of reasons, including stigma, inability to access or afford care, or refusal to stop misusing opioids, a treatment gap remains.
In addition, the existing healthcare workforce is understaffed, often lacks the necessary training, and has been slow to implement Medicated-Assisted Treatment [Note: MAT remains controversial amongst seasoned addiction treatment professionals and modern thinking about opioid treatment] as well as prevention, early identification, and otherevidenced-based recommendations.
“Now is the time to work together and apply what we know to end the opioid crisis,” said Dr. Elinore McCance-Katz, Assistant Secretary for Mental Health and Substance Use. “Medication-assisted treatment combined with psychosocial therapies and community-based recovery supports is the gold standard for treating opioid addiction.”
The federal government has been working with key stakeholders to address this problem and is seeing real progress. This week, HHS disbursed more than $1 billion in opioid-specific funding for states, which includes State Opioid Response grant programs administered by SAMHSA [Note: the private sector should get equal access to these funds but they appear earmarked for distribution to government-based social service agencies and non-government non-profit organizations] to support a comprehensive array of prevention, treatment, and recovery services. Additional funding from the Health Resources and Services Administration (HRSA) went to community health centers to increase access to substance abuse disorder and mental health services, to increase  the number of professionals and paraprofessionals who are trained to deliver integrated behavioral health and primary care services as part of health care teams in HRSA-supported health centers as well as to rural grantees to increase services and develop plans to implement evidence-based opioid use disorder prevention, treatment and recovery interventions.  There are signs that efforts to stem the opioid crisis are having success, with the use of medication-assisted treatment growing significantly and the number of Americans initiating heroin use dropping significantly from 2016 to 2017.
“Addressing the opioid crisis with all the resources possible and the best science we have is a top priority for President Trump and for everyone at HHS,” said HHS Secretary Alex Azar. “Surgeon General Adams has been a leader in raising awareness about the nature of addiction and the effectiveness of medication-assisted treatment, complementing the support HHS provides for access to treatment and recovery services.”
“Today’s announcement is another step forward in our efforts to educate the American public about steps they can take to prevent addiction,” said Assistant Secretary for Health Brett P. Giroir, M.D, who also serves as the HHS Senior Advisor for Opioid Policy. “We are making progress. Just last week we released the 2017 National Survey on Drug Use and Health (NSDUH) data, which showed significantly more people received treatment for their substance use disorder in 2017 than in 2016. This was especially true for those with heroin-related opioid use disorders.”
The science shows us that no area of the United States is exempt from the opioid crisis. Yet, only 53 percent of the public consider opioid addiction a major concern. As a result, the Surgeon General is calling on all individuals to do the following:

  • Talk about opioid misuse. Have a conversation about preventing drug misuse and overdose.
  • Be safe. Only take opioid medications as prescribed, make sure to store medication in a secure place, and dispose of unused medication properly.
  • Understand pain and talk with your healthcare provider. Treatments other than opioids can be effective in managing pain.
  • Understand that addiction is a chronic disease. With the right treatment and supports, people do recover.
  • Be prepared. Get and learn how to use naloxone, an opioid overdose reversing drug.

For the full document and to view the digital postcard, visit http://addiction.surgeongeneral.gov/.

Primary Care Physicians Have Little Training on Handling Addiction

According to the Centers for Disease Control and Prevention, addiction — whether to tobacco, alcohol or other drugs — is a disease that contributes to 632,000 deaths in the United States annually.

But comprehensive addiction training is rare in American medical education. A report by the National Center on Addiction and Substance Abuse at Columbia University called out “the failure of the medical profession at every level — in medical school, residency training, continuing education and in practice” to adequately address addiction.

Dr. Timothy Brennan, who directs an addiction medicine fellowship at Mount Sinai Health System, said that combating the crisis with this provider work force is “like trying to fight World War II with only the Coast Guard.”

From: “Most Doctors Are Ill-Equipped to Deal With the Opioid Epidemic. Few Medical Schools Teach Addiction,” NY Times, 9/10/18.

https://www.nytimes.com/2018/09/10/health/addiction-medical-schools-treatment.html

DCF Rebukes Florida Legislature on Community Housing Sober Living

In an abrupt, stunning, and unforeseen policy shift, outgoing Department of Children and Families Secretary Mike Carroll signed an Administrative Order yesterday declaring that the residential component of a “Day or Night Treatment with Community Housing” license (commonly referred to as “PHP” or “Partial Hospitalization”) does NOT have to obtain certification from the Florida Association of Recovery Residences (“FARR”).

The Department released its “Order on Petition for Declaratory Statement” filed by Amethyst Recovery Center, LLC, stating:

“A provider licensed for day or night treatment with community housing is not required to comply with the voluntary certification requirements outlined in sections 397.487 and 397.4871, F.S., in order to operate the community housing portion of its license. The standards for this licensing component are found in Rule 65D-30.0081, F.A.C.”

In the matter of “Amethyst Recovery Center, LLC, Case No. 18-065CF, Rendition No. DCF-18-196-DS”, Secretary Carroll made the following conclusions:

  • “The definition of day or night treatment with community housing differs from the definition of recovery residence.”
    • MY RESPONSE: EVEN DCF ADMITS THERE IS NO DEFINITION OF “COMMUNITY HOUSING” BUT ANY PLAIN READING OF THE STATUTE DEFINING “RECOVERY RESIDENCE” CLEARLY CAPTURES ALL HOUSING ASSOCIATED WITH ALL OUTPATIENT TREATMENT.
  • “A recovery residence is not a licensable service component and is not monitored by the Department.”
    • MY RESPONSE: DCF HAS CONSISTENTLY STATED FOR YEARS THAT THE DEPARTMENT ONLY REGULATES CLINICAL SERVICES, NOT HOUSING. THAT IS WHY THE FLORIDA LEGISLATURE DIRECTED DCF TO IDENTIFY A “CREDENTIALING AGENCY” WHICH IS IN THIS CASE, IS FARR.
  • “To require day or night treatment with community housing licensed facilities to have the licensed community housing part also certified in order to maintain their license or make referrals within that one licensed component would not appear to be aligned with statute and would not appear to be the referrals that are intended to be restricted under section 397.4873(1), F.S.
    • MY RESPONSE: IT IS ABUNDANTLY CLEAR THAT THERE IS A FUNDAMENTAL DISCONNECT WITH TALLAHASSEE AND ALL THAT HAS TRANSPIRED WITH THE FINANCIAL ALLOCATION OF RESOURCES TO THE PALM BEACH STATE ATTORNEY’S OFFICE TO MAKE STATEWIDE FINDINGS AS TO WHETHER RESIDENCES WITHIN WHICH EXISTING PATIENTS AND PERSONS WHO HAVE COMPLETED TREATMENT REQUIRE OVERSIGHT, STANDARDS, AND REGULATIONS.
  • “[T]his requirement would also be duplicative as this component already has license standards outlined and monitored by the Department.”
    • MY RESPONSE: THERE ARE ABSOLUTELY NO STANDARDS FOR COMMUNITY HOUSING BUT FOR THE REQUIREMENT OF A FIRE INSPECTION AND PROOF OF LIABILITY INSURANCE; BOTH AHCA AND FARR AND ALL STATE AGENCIES RELATING TO ANY FORM OF HOUSING HAVE MORE STANDARDS RELATING TO HOUSING THAT DCF.
  • “Even if the community housing part of day or night treatment with community housing falls within the definition of a recovery residence, the community housing offered is an integral part of the Petitioner’s licensed company.”
    • MY RESPONSE: HOUSING BY ALL PROVIDERS IS AN INTEGRAL PART OF THEIR LICENSED COMPANY. INSURANCE SHOULD BE PAYING FOR HOUSING AT ALL LEVELS. PROVIDING ROOM AND BOARD ASSOCIATED WITH TREATMENT, PARTICULARLY SOCIALIZED RECOVERY HOUSING, IS A MEDICAL NECESSITY. AND THEREFORE, THE FLORIDA LEGISLATURE HAS DECIDED THAT ALL SUCH HOUSING REQUIRES A MODICUM OF STANDARDS. DCF DISAGREES.

While this topic is far from closed, there is great concern that DCF, FARR, and the Florida Legislature are operating on different planes and the efforts to adopt national and statewide housing standards for all residences in which treatment providers place their patients have been undermined – by the State of Florida.

Click here for “18-064CF_Amethyst Recovery Center, LLC – DS” Click here for “FARR Motion to Intervene – in re Amethyst” Click here for “Petition for Declaratory Statement – 18-064CF_In the Matter of_ Amethyst Recovery Center, LLC”

FDA Push for MAT Means More Money for Big Pharma

Medication-Assisted Treatment (MAT), coupled with psychosocial counseling, is widely acknowledged to be the current “gold standard” of care in treating opioid addiction.

Currently, just three drugs exist to treat opioid use disorder: buprenorphine, methadone, and naltrexone. Adherence to the drugs is typically low, and addiction treatment experts have long said MAT is vastly underutilized, calling for expanded access to existing options and the development of more drugs beyond the existing three.

How effective is MAT for addiction? Here’s the science.

On Monday August 6th, the Food and Drug Administration announced a new policy in the way it evaluates drugs to treat opioid addiction that the agency says will give it more flexibility to approve new treatments.

FDA Commissioner Scott Gottlieb, since his appointment, has been a strong proponent of MAT.

Now, the agency will also consider factors like whether a drug could reduce overdose rates or the transmission of infectious diseases.

“We must consider new ways to gauge success beyond simply whether a patient in recovery has stopped using opioids, such as reducing relapse overdoses and infectious disease transmission,” FDA Commissioner Scott Gottlieb said in a statement.

The announcement is the latest in a string of efforts to improve the federal government’s response to the growing opioid crisis, which also includes legislation on Capitol Hill that aims to ensure treatment is evidence-based and, separately, to ensure more federal programs will pay for methadone treatment.

According to STAT News, the topic has also led to some controversy in Washington. The White House recently name-checked  a single drug, Vivitrol, a form of naltrexone manufactured by Alkermes, in a strategy document — preferential treatment that addiction experts said could hamstring doctors who should be able to consider all available treatment options.

The Senate is also expected to make MAT a key element of its response to the opioid crisis, but it remains unclear whether it will consider legislation on the opioid crisis prior to November’s midterm elections.