Marilyn Singleton, MD, JD summarizes recent healthcare-related legislative activity on Capitol Hill.
If Anyone Has Not Yet Heard About This
The partial ObamaCare repeal passed via reconciliation, the Restoring Americans’ Healthcare Freedom Reconciliation Act of 2015, H.R. 3762, was vetoed by President Obama. The House attempted to override the veto on February 2, 2016 but failed. (Yeas and Nays: (2/3 required): 241 – 186.
Another Replacement for the Affordable Care Act
On February 9, 2016, S. 2519, the Empowering Patients First Act was introduced by Sen. John McCain (R-AZ) and referred to the Senate Finance Committee. It is the Senate companion bill to Rep. Tom Price’s HR 2300 introduced last year. The bill repeals the Patient Protection and Affordable Care Act and the health care provisions of the Health Care and Education and Reconciliation Act of 2010, effective as of their enactment. This bill replaces those provisions with amendments to the Internal Revenue Code, the Public Health Service Act, and the Employee Retirement Income Security Act of 1974 (ERISA) to address health care coverage.
(1) provides for refundable tax credits for health insurance coverage and health savings account (HSA) contributions.
(2) raises the annual HSA contribution limit, expands eligibility for tax-deductible HSA contributions, and allows HSAs to be used to pay periodic or capitated primary care fees.
(3) places limits on the amount of an employer’s contribution to health coverage that can be excluded from the employee’s taxable income.
(4) mandates that the Department of Health and Human Services (HHS) provide a grant to each state for high-risk pools or reinsurance pools to subsidize health insurance for high-risk populations and individuals.
(5) excludes abortion coverage from funds authorized, tax credits, and tax deductions under this Act, with exceptions.
(6) provides for the establishment and governance of independent health pools, entities that form risk pools to offer health insurance coverage to their members.
(7) provides for the establishment and governance of association health plans, which are group health plans sponsored by business associations that meet certain ERISA certification requirements.
- Health insurers offering individual coverage may deny coverage to an individual, outside of open enrollment periods. Preexisting conditions may be excluded from coverage under certain conditions.
- Individual health insurance coverage is governed by the laws of a state designated by the health insurance issuer.
- HHS must issue clinical practice guidelines. The bill specifies how these guidelines may be used in a health care lawsuit.
- HHS may not use comparative effectiveness research or patient-centered outcomes research to deny coverage of an item or service under a federal health care program.
- This bill amends title XVIII (Medicare) of the Social Security Act to permit Medicare beneficiaries to contract with a physician or practitioner for covered health care and submit a claim for payment under Medicare.
- Health care professionals are exempted from federal and state antitrust laws in connection with negotiations with a health plan to provide health care items or services.
Bill to Replace Medicaid and CHIP with Block Grants to States
On January 11, 2016, H.R. 4362, the State Health Flexibility Act of 2016 was introduced by Rep. Todd Rokita (R-IN) and referred to the House Appropriations and Education and the Workforce Committees, and 6 other committees. The bill would amend the Social Security Act to replace the Medicaid program and the Children’s Health Insurance program with a block grant to the States. The purpose of the bill is to provide Federal financial assistance to the States, in the form of a single grant, to allow the States maximum flexibility in providing, and financing the provision of, health-care-related items and services to indigent individuals. The grant funds would be distributed quarterly and must be used in the year disbursed or the succeeding year, but states would be allowed to set aside some “rainy day” funds.
The funds could not be used for abortion unless (1) the pregnancy is the result of an act of rape or incest; or (2) where a woman suffers from a physical disorder, physical injury, or physical illness that would, as certified by a physician, place the woman in danger of death unless an abortion is performed, including a life-endangering physical condition arising from the pregnancy itself.
No funding for illegal aliens except in emergencies. That is, health care services are (A) necessary for the treatment of an emergency medical condition (i.e., patient’s health is in serious jeopardy or has serious impairment of bodily organ or function; and (B) health-care-related items and services that such State would provide payment for if to an indigent individual. The illegal alien must be indigent and otherwise eligible for services; the services cannot be related to an organ transplant
If an audit finds that a state improperly spent funds, the funds must be repaid with a 10 percent penalty.
Finally, the bill would repeal the Affordable Care Act and the Health Care and Education and Reconciliation Act of 2010 and the federal requirements of Medicaid and CHIP.
The CDC Issues Opiate Prescribing Clinical Practice Guidelines
The ultimate strategy may include payment incentives (or disincentives, as the case may be).
On March 15, 2016, the Centers for Disease Control and Prevention issued opiate prescribing guidelines for primary care physicians with the goal of:
- Determining when to initiate or continue opioids for chronic pain outside of active cancer treatment, palliative care, and end-of-life care
- Opioid selection, dosage, duration, follow-up, and discontinuation
- Assessing risk and addressing harms of opioid use
Of note, the CDC will “work with federal partners and payers to evaluate strategies such as payment reform and health care delivery models that could improve patient health and safety. For example, strategies might include strengthened coverage for nonpharmacologic treatments, appropriate urine drug testing, and medication-assisted treatment; reimbursable time for patient counseling; and payment models that improve access to interdisciplinary, coordinated care.”
The CDC has provided a checklist for prescribing opioids for chronic pain (http://stacks.cdc.gov/view/cdc/38025) as well as a website (http://www.cdc.gov/drugoverdose/prescribingresources.html) with additional tools to guide clinicians in implementing the recommendations.
The Opiate War is a Bipartisan Effort
On March 10, 2016, S. 524, the Comprehensive Addiction Recovery Act (CARA) was easily passed by the Senate a vote of 94 to 1 and goes to the House next for consideration. The single “no” vote came from Sen. Ben Sasse (R-Neb.), saying he wasn’t sure battling opioid addiction was best addressed by the federal government. As an indication to the seriousness (or political capital) of the ongoing opioid epidemic the bill was introduced on February 12, 2016 by Sen. Sheldon Whitehouse (D-RI) and Sen. Rob Portman (R-OH) and made it to a vote in only a month.
According to the Hill, no Member of Congress appears to have expressed outright opposition to this bill. It sits at the intersection of criminal justice reform and mental health legislation, two of the three policy areas which House Speaker Paul Ryan (R-WI) suggested could pass both the Republican Congress and Democratic president this year.
The legislation would:
(1) Expand the availability of naloxone to law enforcement agencies and other first responders
(2) Improve prescription drug monitoring programs to help states monitor and track prescription drug diversion
(3) Shift resources towards identifying and treating incarcerated people who are suffering from addiction, rather than just punishment
(4) Prohibit the Department of Education from including questions about the conviction of an applicant for the possession or sale of illegal drugs on the Free Application for Federal Student Aid (FAFSA) financial aid form.
On February 29, 2016, S. 2605, the Medicaid Coverage for Addiction Recovery Expansion Act was introduced by Sen. Richard Durbin (D-IL) and referred to the Senate Finance Committee. The bill would amend the Medicaid law to give states the option to provide medical assistance for residential addiction treatment facility services for not more than 2 consecutive periods of 30 consecutive days. The provision of medical assistance for residential addiction treatment facility services to an individual shall not prohibit Federal financial participation for medical assistance for items or services that are provided to the individual in or away from the residential addiction treatment facility during any 30-day period in which the individual is receiving residential addiction treatment facility services.
The bill also would establish HHS programs to award grants to States for the purpose of expanding the infrastructure and treatment capabilities of eligible youth addiction treatment facilities that provide addiction treatment services to Medicaid or CHIP beneficiaries who have not attained the age of 21 and are in communities with high numbers of medically underserved populations of at-risk youth. At least 15 percent of the grant money must be awarded to facilities in rural areas.
On February 23, 2016, S. 2567, the Preventing Overprescribing for Pain Act of 2016 was introduced by Sen. Kirsten Gillibrand (D-NY) and referred to the Senate Health, Education, Labor, and Pensions Committee. This bill requires the Centers for Disease Control and Prevention to issue guidelines for the safe prescribing of opioids for the treatment of acute pain.
On March 15, 2016, S. 2678, the Safe Treatments and Opportunities to Prevent Pain Act or the STOP Pain Act was introduced by Sen. Brian Schatz (D-HI) and referred to the Senate Health, Education, Labor, and Pensions Committee. The bill would direct the National Institutes of Health (NIH) to intensify research on the understanding of pain, the discovery and development of therapies for chronic pain, and the development of alternatives to opioids for effective pain treatments.
On February 24, 2016, S. 2578, the Reducing Unused Medications Act of 2016 was introduced by Sen. Elizabeth Warren (D-MA) and referred to the Senate Health, Education, Labor, and Pensions Committee. The bill would amend the Controlled Substances Act to allow partial filling of prescriptions for Schedule II drugs if:
(1) it is requested by the practitioner that wrote the prescription by making a notation on the face of the written prescription, written record of the emergency oral prescription, or in the electronic prescription record; or the patient;
(2) the pharmacist partially filling the prescription records the partial filling in the same manner as a filling of the prescription;
(3) the pharmacist partially filling the prescription updates the record each time the prescription is partially filled;
(4) the total quantity dispensed in all partial fillings does not exceed the total quantity prescribed; and
(5) the pharmacist notifies the practitioner that wrote the prescription of each partial fill.
The remaining portions of a partially filled prescription may be filled; and must be exhausted prior to, or on the same date that such prescription, if fully filled, would have been exhausted.
On March 15, 2016, S. 2687, the Plan of Safe Care Improvement Act was introduced by Sen. Robert Casey, Jr. (D-PA) and referred to the Senate Health, Education, Labor, and Pensions Committee. The bill would amend the federal Child Abuse Prevention and Treatment Act to develop policies and procedures that require:
(I) the development of a plan of safe care for an infant born and identified as being affected by illegal substance abuse or withdrawal symptoms or a Fetal Alcohol Spectrum Disorder; and
(II) the development and implementation by the State of monitoring systems regarding the plan of safe care to (1) ensure the safety and well-being of children; (2) address the health, including mental health, needs of the child and family involved; and (3) determine whether local entities are capable of providing referrals to and delivery of appropriate services for the child and family.
The bill requires the HHS Secretary to conduct monitoring of States to ensure that each State is meeting the requirements of the proposed law to improve outcomes among children who are most at risk for child abuse and neglect.
New Database for Terminated Medicaid and CHIP “Providers”
On March 2, 2016, H.R. 3716, the Ensuring Removal of Terminated Providers from Medicaid and CHIP Act was pass and referred to the Senate. The bill was introduced by Larry Bucshon (R-IN) on October 8, 2015.
This bill amends the Medicaid and Children’s Health Insurance Program (CHIP) to prohibit federal payment under Medicaid for nonemergency services furnished by providers whose participation in Medicaid, Medicare, or CHIP has been terminated.
Under current law, a state must exclude from Medicaid participation any provider that has been terminated under any state’s Medicaid program or under Medicare. The bill further requires a state to exclude from Medicaid participation any provider that has been terminated under CHIP and exclude from CHIP participation any provider that has been terminated under Medicaid or Medicare.
The state requires from Medicaid and CHIP providers specified identifying information, and accordingly must provide to the Secretary of Health and Human Services: (i) the name of such provider or person; (ii) the provider type of such provider or person; (iii) the specialty of such provider’s or person’s practice; (iv) the date of birth, Social Security number, national provider identifier, Federal taxpayer identification number, and the State license or certification number of such provider or person; (v) the reason for the termination; (vi) a copy of the notice of termination sent to the provider or person; (vii) the date on which such termination is effective, as specified in the notice; and (viii) any other information required by the Secretary.
HHS shall include such termination notifications in a database or similar system, as specified by the bill.
Bill to Place Generic Drugs on Fast Track to FDA Approval
On March 1, 2016, S. 2615, the Increasing Competition in Pharmaceuticals Act was introduced by Sen. Susan Collins (R-ME) and referred to the Senate Health, Education, Labor, and Pensions Committee. The bill’s preamble notes that 88 percent of prescription drugs dispensed in the United States are generic drugs. Further, generic drugs account for only 28 percent of total prescription drug spending and were responsible for $1,680,000,000,000 in estimated savings over the period of 2005 to 2014.
Despite enactment of the Generic Drug User Fee Amendments of 2012 which was established to provide the Food and Drug Administration with industry funding to ensure a more consistent timeline for generic drug approvals, a significant backlog of abbreviated new drug applications for generic drugs remains. Sen. Collins believes that improving the review of abbreviated new drug applications and the approval of generic drugs would help to improve competition and lower prices for patients.
The bill would require the FDA to review of certain generic drugs not later than 150 calendar days after the date of the submission of an application. Nothing in bill affects any period of exclusivity under this Act or the protection of any patent.
The bill also mandates a study on the FDA’s risk evaluation and mitigation strategy (REMS) program and the effectiveness of expanded regulations under which the FDA may impose restrictions on distribution necessary to ensure a drug is safely used. The study would determine (1) if and how the REMS program has improved drug safety, as compared to the time before the REMS program became effective, and how the Food and Drug Administration tracks such improvements; (2) the burdens associated with REMS, including burdens on patients, health care providers, generic drug manufacturers, and brand drug manufacturers; (3) in the case of a REMS program for a drug containing a controlled substance, the coordination between the Food and Drug Administration and the Drug Enforcement Administration; and (4) the impact of additional risk mitigation strategies, including non-REMS restricted distribution systems, imposed by companies outside of what is required under the REMS program.
Bill to Have Medicare Coverage for CT Colonography
On February 25, 2016, H.R. 4632, the CT Colonography Screening for Colorectal Cancer Act of 2016 was introduced by Rep. Brad Wenstrup (R-OH) and referred to the House Energy and Commerce and Ways and Means Committees. This bill would require Medicare to cover computed tomography colonography as a colorectal cancer screening test. The test will be covered every 24 months for high risk persons and 119 months after a previous screening colonoscopy or within the 59 months after a previous screening flexible sigmoidoscopy or a previous screening computed tomography colonography. This conforms to the frequency limits for other colorectal cancer screening tests.
Although malpractice reform is a worthy goal, it is troubling to have more federal laws governing actions that are traditionally the purview of the states.
On February 23, 2016, H.R. 4589, the Excellence in Medicare Act was introduced by Rep. Tom MacArthur (R-NJ) and referred to the House Energy and Commerce, and Ways and Means Committees. This bill sets forth federal malpractice rules for any health care lawsuit (not solely those involving federal funds). Such rules include a 3-year statute of limitation from the date of injury or one year from the date of discovery of injury unless there is proof of fraud, intentional concealment, or foreign body. There would be unlimited economic damages but a $250,000 cap on non-economic damages. Each party to the lawsuit would be responsible for only their share of the injury. The bill also limits attorneys’ contingency fees.
Punitive damages may, if otherwise permitted by applicable State or Federal law, be awarded against any person in a health care lawsuit only if it is proven by clear and convincing evidence that such person acted with malicious intent to injure the claimant, or that such person deliberately failed to avoid unnecessary injury that such person knew the claimant was substantially certain to suffer.
This law would not preempt state law that specifies a particular monetary amount of compensatory or punitive damages (or the total amount of damages) that may be awarded in a health care lawsuit, or state defenses.