H.R. 6 – Support for Patients and Communities Act
Background: On September 17, 2018, the Senate passed an amendment in the form of a substitute to H.R. 6 by a vote of 99-1. The House of Representatives passed H.R. 6 on September 28, 2018, by a vote of 393-8.
Floor Situation: The Senate will likely consider H.R. 6 soon.
Executive Summary: The House and Senate have advanced bipartisan legislation to address the opioid problem. The final bill authorizes critical funding to assist states, expands patient access to addiction treatment, and improves the detection of illegal drug imports, such as fentanyl.
NOTABLE BILL PROVISIONS
Section 2003 — Every Prescription Conveyed Securely
The bill combines House and Senate-passed language to require providers to electronically prescribe controlled substances that are Schedule II, III, IV, or V for enrollees in Medicare Part D and Medicare Advantage prescription drug plans. The purpose is to improve coordination and prevent fraud and diversion. The CBO estimates this provision would result in 10-year savings of $250 million.
Section 3002 — Evidence-based Opioid Analgesic Prescribing Guidelines and Report
H.R. 6 contains a House-passed provision to require the FDA to develop evidence-based prescribing guidelines for indication-specific treatment of acute pain. The FDA would be required to provide a statement of purpose for the new guidelines and ensure they are not intended to impede access for patients or health care providers.
Section 3012 – Notification, Non-distribution, and Recall of Controlled Substances
The bill modifies a House-passed provision authorizing the FDA to order manufacturers, importers, distributors, or pharmacists to cease distribution of a controlled substance if it is determined that there is reasonable probability that the controlled substance would cause serious adverse health consequences or death. The entity subject to the order is entitled to an informal hearing and if it is determined that adequate evidence exists, the FDA can require a recall of the controlled substance, as long as recalling the controlled substance does not present a greater risk to public health.
Section 3013 — Single Source Pattern of Imported Illegal Drugs
The bill includes a House-passed provision that would allow the secretary of HHS to issue an order determining all drugs intended for import from a person who has been prohibited from importing drugs as a result of a pattern of importing or offering to import illicit substances to be adulterated or misbranded. Unless the person can provide evidence to the contrary, the secretary is authorized to issue these orders.
Section 3201 — Allowing for More Flexibility With Respect to Medication-Assisted Treatment for Opioid Use Disorders
The bill combines House and Senate-passed language to allow more qualified health care providers to prescribe or administer medication-assisted treatment. For waivered practitioners who are board certified or administering MAT in a qualified practice setting, the bill allows these providers to treat up to 100 patients at a time. In addition, permanent prescribing authority is given to physician assistants and nurse practitioners.
CBO estimates these provisions to increase mandatory spending by $395 million for fiscal years 2019-2028.
Section 4001 — Promoting Value in Medicaid Managed Care
The final language creates an incentive for states to adopt a medical loss ratio requirement of 85 percent for their Medicaid managed care organizations. It does this by allowing these states to retain more of the remittances they collect from MCOs from fiscal year 2021 through 2023. CBO estimates this provision would reduce mandatory spending by $2.7 billion over the 10-year budget window.
Section 4002 — Requiring Reporting by Group Health Plans of Prescription Drug Coverage Information for Purposes of Identifying Primary Payer Situations under the Medicare Program
The bill would require group health plans, starting in 2020, to report on their enrollees’ prescription drug coverage to HHS and Part D plan sponsors, adding to the mandatory reporting requirements already in place for plans offered by employers and unions. The purpose is to improve benefits coordination under Medicare Part D. CBO estimates this provision would reduce mandatory spending by $45 million over the 10-year budget window.
Section 4003 — Additional Religious Exemption from Health Coverage Responsibility Requirement
Beginning in 2019, the section amends the Affordable Care Act by expanding religious exemptions from the individual mandate to include people whose acceptance of medical health services does not align with their religious beliefs. The ACA religious conscious exemption only applies to certain religions. The expansion would apply to members of religious groups who annually report they have not accessed medical health services during the previous tax year and have instead only relied on alternative, religious methods of healing.
This bipartisan provision was passed by the House by unanimous consent. The CBO estimates the provision would reduce mandatory spending by $26 million over the budget window.
Section 5042 — Medicaid Providers Are Required to Note Experiences in Record Systems to Help In-Need Patients
For the purpose of prevention, the final language includes a provision to require Medicaid providers to refer to prescription drug monitoring programs before prescribing in-need patients with Schedule II controlled substances. In addition, the bill would require Medicaid programs to report to CMS on PDMP data and information.
Section 5052 — State Option to Provide Medicaid Coverage for Certain Individuals with Substance Use Disorders Who Are Patients in Certain Institutions for Mental Diseases
The bill gives states the option to provide Medicaid beneficiaries ages 21 to 65 “substance use disorder” care in institutions for mental diseases. The federal government will reimburse states for up to 30 days of care during a one year period. The House-passed version would have only applied to reimbursement to states for services provided to people with opioid or cocaine use disorders in IMDs.
The provision would apply to fiscal years 2019 to 2023. CBO estimates this provision would increase mandatory spending by $1.0 billion over the 10-year budget window.
Sections 7051-7053 — Jessie’s Law
The final package includes Senate-passed language that allows patient medical records to include opioid abuse information in electronic health records as requested by the patient. The provision would allow authorized medical professionals to access consenting patients’ medical history for the purpose of improving patient treatment and preventing the prescribing of opioids to patients with known substance use disorders.
The provision does not align 42 CFR Part 2 with the HIPAA privacy rule, which would allow HIPAA covered entities the authority to access patient medical records. Privacy protection provisions of 42 CFR Part 2 apply to people seeking care for substance use disorders and outline the circumstances in which a patient’s medical treatment can be disclosed.
Section 7161 and 7162 — Preventing Overdoses of Controlled Substances; Prescription Drug Monitoring Program
These sections combine Senate and House-passed language for the purpose of providing all states access to CDC grants to improve state-run prescription drug monitoring programs. PDMPs collect public health data and carry out other evidence-based prevention projects to increase education and awareness efforts pertaining to opioids.
The provision incorporates NASPER grants into the CDC. NASPER currently is authorized to administer grants through Substance Abuse and Mental Health Services Administration to create and enhance PDMPs, ensuring states have the ability to share data with other authorized users. However, NASPER has not been funded since 2010 and CDC has been providing most state PDMP funding since then.
The authorization for the grant funding appropriation does not increase mandatory spending and totals $496 million for each fiscal year 2019 to 2023.
A statement of administration policy is not available for the bill at this time. President Trump has spoken in support of passing legislation to address the opioid problem.
The Congressional Budget Office estimates the bill would result in an on-budget deficit decrease of $52 million over the 10-year budget window.
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