Overdose Prevention And Patient Safety Act
Mr. Speaker, pursuant to House Resolution 949, I call up the bill (H.R. 6082) to amend the Public Health Service Act to protect the confidentiality of substance use disorder patient records, and ask for its immediate consideration in the…
Mr. Speaker, pursuant to House Resolution 949, I call up the bill (H.R. 6082) to amend the Public Health Service Act to protect the confidentiality of substance use disorder patient records, and ask for its immediate consideration in the House.
Mr. Speaker, I ask unanimous consent that all Members may have 5 legislative days within which to revise and extend their remarks and insert extraneous material on H.R. 6082.
Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, over the course of the past several months, the Energy and Commerce's Subcommittee on Health held four legislative hearings on bills to address the opioid epidemic and reported 57 bills to the full committee. Of those 57 bills, only one received its own discrete hearing. That bill was H.R. 6082, the Overdose Prevention and Patient Safety Act, introduced by Representatives Mullin and Blumenauer.
As a physician, I believe it is vital that doctors have all of the appropriate information to determine the proper course of treatment for a patient, ensuring patient safety and privacy, as required by Federal regulation known as HIPAA. The Overdose Prevention and Patient Safety Act maintains the original intent of the 1970s statute behind 42 CFR part 2 by protecting patients and improving care coordination.
In fact, the bill increases protections for those seeking treatment by more severely penalizing those who illegally share patient data than under the current statute. Current part 2 law does not protect individuals from discrimination based on their treatment records and, to this date, there have been no criminal actions undertaken to enforce part 2.
This bill has a wide range of support from national and State organizations. Since the bill was introduced, the Energy and Commerce Committee has heard from over 100 organizations in its support.
Arguably, the most notable support for this legislation comes from the Substance Abuse and Mental Health Services Administration in the Department of Health and Human Services. Dr. Elinore McCance-Katz, the Assistant Secretary for Mental Health and Substance Use, wrote to Mr. Mullin in March, stating that SAMHSA ``is encouraged to see Congress examine the benefits of aligning part 2 with HIPAA. Patient privacy is, of course, critical but so too is patient access to safe, effective, and coordinated treatment.''
I agree with Dr. McCance-Katz that in order to ensure patient safety, physicians must have secure access to patient records, including substance use disorder information. When this information is not provided to healthcare professionals, they may end up prescribing medications that have dangerous drug interactions or may lead a patient who is in recovery to be inappropriately prescribed an opioid and fall back into addiction.
One particular complication driven by 42 CFR part 2 directly impacts the care for pregnant women and their infants. For women who are pregnant, part 2 does not allow redisclosure of substance use disorder medical documentation to the women's OB/GYN doctor, primary care physician, or health home without their written consent. This leads to fragmented care, which opens up the mother and her baby to potential harm.
Centerstone, one of the Nation's largest not-for-profit healthcare organizations, notes that ``mothers who continue to use during pregnancy and who do not wish to sign secondary releases to allow their care providers to treat them comprehensively put their unborn children at risk for addiction.''
Centerstone watches these women and their infants suffer right before their eyes, but, because of part 2, Centerstone cannot share the information to ensure that the mother and baby are getting proper care.
As an OB/GYN physician myself, I cannot imagine having this information withheld. Such a situation would leave me with the inability to treat the whole patient and ensure that the mother is healthy and her baby is not on a path for addiction.
In another situation, a patient was referred to a treatment center following an emergency room visit for an overdose. The patient was not able to give written consent to his providers due to acute intoxication. Due to a lack of written consent and 42 CFR part 2, the treatment facility could not communicate to the ER and learn about the patient's condition or confirm that the patient had, indeed, enrolled in a drug treatment center, further delaying critical care coordination.
There is clear evidence that part 2 is a massive roadblock to providing safe, quality, and coordinated care to individuals suffering from substance use disorder.
The issue of the stigma associated with substance use disorder has been a constant in all of the discussions that we have had, both in our offices and in our hearings. In April, we heard from numerous individuals who were parents of children who died from opioid overdoses. Some noted that their children were afraid to seek help from their families or from healthcare professionals because they were embarrassed or they felt stigmatized.
We should enable physicians to fully care for these patients suffering from substance use disorder as if they had any other disease. The Overdose Prevention and Patient Safety Act will do just that.
The first step in addressing a problem is admitting that it exists. I would like to pose a question to those who are arguing against this legislation:
If we continue to silo the substance use disorder treatment information of a select group of patients rather than integrating it into our medical records and comprehensive care models, how can we ensure that these patients are, in fact, receiving quality care? How can we really treat substance use disorder like all other complex health conditions?
H.R. 6082 ensures adequate patient data protection in accordance with Federal law, with HIPAA. There are provisions in the language that ensure that the data may only be used for purposes of treatment, payment, or healthcare operations. Substance use disorder data cannot be used in criminal, civil, or administrative investigations, actions, or proceedings without patient consent or a court order.
Additionally, the legislation explicitly prohibits discrimination against an individual on the basis of their patient needs. Currently, part 2 includes no antidiscrimination protections and no protections for individuals if there is a data breach or improper disclosure.
Think about that for a minute, Mr. Speaker. This was a 1970s-era law. There were not data breaches back in the 1970s. 42 CFR part 2 was never intended to protect a patient in the instance of a data breach.
Should any entity or individual share patient data under H.R. 6082, they, in fact, will be severely penalized.
There is a reason why SAMHSA and most of the healthcare stakeholder community is asking for this change. Clearly, there is an issue here that must be addressed. This opioid crisis is devastating our country. Passing the Overdose Prevention and Patient Safety Act will enable greater coordination among healthcare providers in providing quality, effective care for individuals across the country who are battling substance use disorder.
My thanks to Mr. Mullin on the Energy and Commerce Committee and to Mr. Blumenauer for introducing this legislation that is of utmost importance.
I urge strong support for the bill, and I reserve the balance of my time.
Mr. Speaker, I yield 3 minutes to the gentleman from Oklahoma (Mr. Mullin), the principal sponsor of the bill and a valuable member of the Energy and Commerce Committee.
Mr. Speaker, I yield 5 minutes to the gentleman from Oregon (Mr. Walden), the chairman of the full committee.
Mr. Speaker, I yield myself 2 minutes for the purpose of response before I yield to Dr. Bucshon.
Mr. Speaker, the tragic story that was just related to us really only reinforces the need to change the statute behind 42 CFR part 2. There are some important facts missing from the description of the situation that occurred.
It appears evident that at least one or both of the parties involved, the judge, and/or the methadone maintenance program, violated existing regulations under both part 2 and HIPAA.
Under part 2, patient records may only be disclosed without patient consent if the disclosure is authorized by an appropriate order of a court of competent jurisdiction. There must be a showing of good cause in which the court must weigh the public interest and need for disclosure against the injury to the patient, the physician-patient relationship, and treatment services. Further, the court must impose appropriate safeguards against unauthorized disclosure.
It is not clear from the description provided in the letter how the judge found out about the patient's participation in a methadone maintenance program. If the information to the judge was provided without an appropriate court order, then the methadone maintenance program likely violated the requirements under part 2 to safeguard the patient's records from such disclosure. If the information was provided as a result of a court order, then it is possible that the judge violated his or her ethical obligations to appropriately weigh the need for the information and safeguard the information once received.
Under HIPAA, there is still an obligation for the parties seeking information to confirm that reasonable efforts have been made to ensure that the individual has been given notice of the request for personal health information and the opportunity to object or that reasonable efforts have been made to secure a qualified protective order. Compliance with either of these requirements appears to have been lacking in the situation described in the letter.
All of this suggests that part 2 currently is insufficient to protect patients in these situations. The legislation before us today does not decrease the protections against the use of the records in criminal proceedings that already exist under part 2, but HIPAA makes the protections stronger.
I yield 3 minutes to the gentleman from Indiana (Mr. Bucshon), a valuable member of our committee and our subcommittee that has heard the testimony on this legislation.
Mr. Speaker, I yield 3 minutes to the gentleman from Illinois (Mr. Shimkus), a valuable member of the Energy and Commerce Committee.
(Mr. SHIMKUS asked and was given permission to revise and extend his remarks.)
Mr. Speaker, I yield an additional 30 seconds to the gentleman from Illinois.
Mr. Speaker, I yield myself 3 minutes.
Mr. Speaker, I would like to point out that there are over 100 groups in support of the Partnership to Amend 42 CFR part 2. A letter from that partnership says, in part:
We are pleased that the bill aligns part 2 with HIPAA's
consent requirements for the purposes of treatment, payment
and operations, which will allow for the appropriate sharing
of substance use disorder records, among covered entities, to
ensure persons with opioid use disorder and other substance
use disorders receive the integrated care that they need.
Additionally, as we do not want patients with substance use
disorders to be made vulnerable as a result of seeking
treatment for addiction, this legislation strengthens
protections and limits the number of institutions that have
access to their records.
I am not going to read all of the names on the list, but some of the notable ones are the National Alliance on Mental Illness, Mental Health America, Hazelden Betty Ford Foundation, National Governors Association, Healthcare Leadership Council, American Hospital Association, American Society of Addiction Medicine, Centerstone, New Jersey Hospitals, and National Association of Addiction Treatment Providers.
Mr. Speaker, I include in the Record the entire list of all of the groups in favor of the Partnership to Amend 42 CFR.
Partnership To Amend 42 CFR Part 2--A Coalition of Over 40 Health Care Stakeholders Committed To Aligning 42 CFR Part 2 (Part 2) With HIPAA To Allow Appropriate Access to Patient Information That Is Essential for
Providing Whole-Person Care
June 15, 2018.
Hon. Markwayne Mullin,
House of Representatives,
Washington, DC.
Hon. Earl Blumenauer,
House of Representatives,
Washington, DC.
Dear Representatives Mullin and Blumenauer: The undersigned
members of the Partnership to Amend 42 CFR Part 2
(Partnership) and additional stakeholder organizations
applaud your leadership on the issue of substance use
disorder privacy records. We strongly support the Overdose
Prevention and Patient Safety (OPPS) Act, H.R. 6082, which
will align 42 CFR Part 2 (Part 2) with the Health Insurance
Portability and Accountability Act (HIPAA) for the purposes
of health care treatment, payment, and operations (TPO). The
Partnership is pleased that the OPPS Act was voted out of the
Committee on Energy and Commerce with a bipartisan vote.
The Partnership is a coalition of more than 40
organizations representing stakeholders across the health
care spectrum committed to aligning Part 2 with HIPAA to
allow appropriate access to patient information that is
essential for providing whole-person care.
We are pleased that the bill aligns Part 2 with HIPAA's
consent requirements for the purposes of TPO, which will
allow for the appropriate sharing of substance use disorder
records, among covered entities, to ensure persons with
opioid use disorder and other substance use disorders receive
the integrated care they need. Additionally, as we do not
want patients with substance use disorders to be made
vulnerable as a result of seeking treatment for addiction,
this legislation strengthens protections and limits the
number of institutions that have access to patient records.
Thank you both for your leadership on this issue and we
look forward to working with you on helping to address the
opioid crisis by passing this important bipartisan
legislation on the floor of the U.S. House of
Representatives.
Sincerely,
Partnership to Amend 42 CFR Part 2 Members
Academy of Managed Care Pharmacy; American Association on
Health and Disability; American Health Information Management
Association; American Hospital Association; American
Psychiatric Association; American Society of Addiction
Medicine; American Society of Anesthesiologists; America's
Essential Hospitals; America's Health Insurance Plans; AMGA;
Association for Ambulatory Behavioral Healthcare; Association
for Behavioral Health and Wellness; Association for Community
Affiliated Plans; BlueCross BlueShield Association; Catholic
Health Association of the U.S.; Centerstone; Confidentiality
Coalition; Employee Assistance Professionals Association;
Global Alliance for Behavioral Health and Social Justice;
Hazelden Betty Ford Foundation.
Health IT Now; Healthcare Leadership Council; The Joint
Commission; InfoMC; Medicaid Health Plans of America; Mental
Health America; National Alliance on Mental Illness; National
Association for Behavioral Healthcare; National Association
of ACOs; National Association of Counties (NACo); National
Association of State Mental Health Program Directors
(NASMHPD); Netsmart; OCHIN; Otsuka; Pharmaceutical Care
Management Association; Premier Healthcare Alliance.
Additional Stakeholder Organizations
ACO Health Partners; Aetna; AMITA Health; Anthem, Inc.;
Ascension Health; Avera Health; Banner Health; Baptist
Healthcare System; Beacon Health Options; Bon Secours Health
System, Inc.; CareSource; Catholic Health Initiatives;
Centene Corporation; Change Healthcare; Cigna; College of
Healthcare Information Management Executives (CHIME).
Excellus BlueCross BlueShield; Franciscan Sisters of
Christian Charity Sponsored Ministries, Inc.; Greater New
York Hospital Association; Henry Ford Health System; Howe
Home Designers; Johns Hopkins Medicine; Kern Health
Systems; Leidos; Lycoming County; Magellan Health;
Marshfield Clinic Health System; Mental Health America of
Indiana; Mosaic Life Care; NAMI; NAMI DC; NAMI Delaware.
NAMI Greene County Tennessee; NAMI Helena; NAMI of Howard
County, MD; NAMI Jefferson County, Washington; NAMI Kaufman
County; NAMI Kershaw County; NAMI Lewistown; NAMI Lexington;
NAMI of the Pee Dee (South Carolina); NAMI Piedmont Tri-
County; NAMI Sarasota County; NAMI South Suburbs of Chicago;
NAMI Sussex, Inc.; NAMI Temple Area; NAMI Utah; NAMI Valley
of the Sun.
National Alliance on Mental Illness (NAMI) Texas; National
Association of Addiction Treatment Providers; New Directions
Behavioral Health; OPEN MINDS; Optum; PerformCare; Providence
St. Joseph Health; SCAN Health Plan; SSM Health; Texas Health
Resources; The Center for Health Affairs/Northeast Ohio
Hospital Opioid Consortium; The MetroHealth System; Trinity
Health; University of Tennessee Medical Center; Valley Health
System; Vizient; Wayne Meriwether.
Mr. Speaker, I reserve the balance of my time.
Mr. Speaker, I yield myself the balance of my time.
Mr. Speaker, by continuing to segregate substance use disorder records means that we are willing to allow some patients to receive care that is potentially lower quality at a higher cost.
Treating patient substance use disorder in isolation from their medical and mental health conditions--which predominated care in the 1970s--is not the standard for good practice today. There is now overwhelming evidence that patients' substance use disorders cannot be treated in isolation from other healthcare conditions. In the 1970s when part 2 was written, this was not widely accepted, and treatment for addiction was largely separate from treatment for other illnesses.
Mr. Speaker, further, I would say that the problem here is we need to treat addiction just like any other medical illness and improve our outreach to patients who meet the criteria for treatment. Maintaining a decades old, ineffective confidentiality law simply is not going to do that.
I urge my colleagues to support the bill. It is a good bill supported by Mr. Mullin and Mr. Blumenauer.
Mr. Speaker, I yield back the balance of my time.
Mr. Speaker, I reserve a point of order against the motion.
Mr. Speaker, I withdraw my point of order.
Mr. Speaker, I claim the time in opposition to the motion.
Mr. Speaker, I urge a ``no'' vote on the motion to recommit as it will destroy the intent of the bill.
Eliminating the sharing of records for the purposes of treatment, payment, and healthcare operations completely negates the entire purpose of this initiative.
Aligning 42 CFR part 2 with HIPAA for purposes of treatment, payment, and healthcare operations is the entire purpose of the legislation.
Opponents of this bill have offered no evidence or findings to back up their claim that HIPAA is inadequate to protect sensitive data contained in substance use disorder treatment records.
HIPAA is currently functioning well in protecting sensitive patient information in a number of areas.
Real integration of behavioral health and primary care simply cannot happen until we align 42 CFR part 2 with HIPAA.
The opposition of H.R. 6082 is not based on protecting privacy. It is based on very specific distrust of the healthcare community to properly provide care to people with substance use disorder--the very people whom we are asking to help us with this.
Yet, the ranking member is strongly in favor of numerous bills that seek to expand access to evidence-based medication-assisted treatment, telehealth and integration with mainstream medicine--the very things that demand alignment with HIPAA. So the thinking, Mr. Speaker, to be kind, is incongruous.
Prohibiting the sharing of addiction medical records for treatment, payment, and healthcare operations makes it impossible to prescribe the latest substance use treatment medications safely.
Like most pharmaceuticals, buprenorphine and methadone have drug interactions and interact with other medicines. Adverse events from drug interactions can lead to emergency hospital visits, serious injuries, or death.
We must amend part 2 so we can safely prescribe medication-assisted treatment for patients. Put simply, standard clinical practices like medication reconciliation are not feasible under the current Federal law. For that reason, I urge my colleagues to vote ``no'' on the motion to recommit. Vote ``yes'' on the underlying motion.
Mr. Speaker, I yield back the balance of my time.