Legislative Update – 12/1/2015


Marilyn Singleton, MD, JD summarizes recent healthcare-related legislative activity on Capitol Hill.

Reconciliation Placed on the Senate’s Calendar

H.R. 3762, the Restoring Americans’ Healthcare Freedom Reconciliation Act of 2015, authored by Rep. Tom Price, MD (R-GA) would (1) repeal the Affordable Care Act’s individual mandate to purchase health insurance; (2) repeal the employer mandate to provide health insurance; (3) repeal the medical device excise tax; (4) repeal the “Cadillac” tax on premium health care plans; (5) prohibit Medicaid reimbursements for Planned Parenthood services for one year; (6) increase the Community Health Center Fund by $235 million/year for two years.

The bill passed in the House in October 2015 by a vote of 240 to189. The budget reconciliation process was established by Congress on a bipartisan basis in 1974 as a special set of rules that the majority party in Congress could use to fast track their annual budget priorities. Budget reconciliation is the one chance each year that the majority party gets to bypass the Senate filibuster to get a bill to the President’s desk without needing a single vote from the minority party. A senate vote will require only a simple majority of 51 votes for passage, not the 60-vote supermajority that has become standard for Senate business.

It appears that the Senate will act on this repeal bill beginning Wednesday with a final vote planned for Thursday.  The Senate will also bolster the House bill by including a wind-down of Medicaid Expansion and end to exchange subsidies.

Full text: https://www.govtrack.us/congress/bills/114/hr3762/text.
Bills Signed into Law by the President

On November 25, 2015, S. 799, the Protecting Our Infants Act of 2015, authored by Mitch McConnell (R-KY) was enacted. This law will require the Secretary of Health and Human Services to conduct a review to identify possible gaps in the research, prevention, and treatment of prenatal opioid abuse and infants born experiencing withdrawal. Companion legislation, H.R. 1462, authored by Reps. Katherine Clark (D-MD) and Steve Stivers (R-OH), was approved by voice vote in early September. S. 799 had also passed by voice vote.

Full text: https://www.govtrack.us/congress/bills/114/s799/text.

On November 25, 2015, H.R. 639, Improving Regulatory Transparency for New Medical Therapies Act was enacted. The bill was approved by unanimous consent of the House. This law, authored by Joseph Pitts (R-PA) amends the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to delay the effective date of approval of a drug, biological product, or animal drug for which the Food and Drug Administration (FDA) recommends controls under the Controlled Substances Act until the Department of Justice (DOJ) issues a final interim rule for the drug. The law amends the Controlled Substances Act to require the Department of Justice (DOJ) to issue a final interim rule (immediately effective) for a drug product recommended for controls by the FDA not later than 90 days after DOJ receives a recommendation for controls or the FDA approves the drug.

The law’s advocates explained that it will put companies manufacturing drug products that contain controlled substances in the U.S. on an equal playing field with foreign manufacturers who are not subject to similar export restrictions. Accordingly this should help keep manufacturing jobs from going overseas.

Full text: https://www.govtrack.us/congress/bills/114/hr639/text.


Bill Heading for the President’s Desk

On Nov. 19, 2015, S. 599, the Improving Access to Emergency Psychiatric Care Act, authored by Benjamin Cardin (D-MD) was passed by the House and Senate. This bill amends the Patient Protection and Affordable Care Act to revise the length of the emergency psychiatric demonstration project under title XIX (Medicaid) of the Social Security Act that is currently limited to three years. States may extend beyond 2019 and new states can join the demonstration projects if they can show that Medicaid spending will not be increased.

Full text: https://www.govtrack.us/congress/bills/114/s599/text.


The Energy and Commerce Committee on November 18, 2015 approved the following bills for consideration by the House.

H.R. 3716, the Ensuring Terminated Providers Are Removed from Medicaid and CHIP Act, authored by Rep. Larry Buchson, M.D. (R-IN), addresses issues raised in a recent report from the Health and Human Services Office of the Inspector General that found health care providers terminated from Medicaid in one state were still participating in Medicaid and CHIP programs in other states. The bill mandates that states no later than 14 business days after program termination the State must submit to HHS the terminated provider’s name, his/her practice specialty, the reason for termination, a copy of the notice of termination sent to the provider, and their Social Security number, date of birth, national provider number, federal taxpayer ID, and State license number.

Full text: https://www.govtrack.us/congress/bills/114/hr3716/text.

H.R. 3821, the Medicaid Directory of Caregivers Act, authored by Rep. Chris Collins (R-NY), would require state Medicaid programs that operate fee-for-service and/or primary care case management programs include a directory of physicians who served Medicaid patients in the prior 12 months on the Medicaid program’s website. The information must include the name, specialty, address, telephone number, whether the provider is accepting new patients, and their languages spoken.

Full text: https://www.govtrack.us/congress/bills/114/hr3821/text.

H.R. 2446, To amend title XIX of the Social Security Act to require the use of electronic visit verification for personal services furnished under the Medicaid program, authored Rep. Brett Guthrie (R-KY), requires states to have in place an electronic verification of visits conducted as part of personal care services or else have their federal medical assistance percentage reduced by specified amounts up to 1 percent by 2022.

Full text: https://www.govtrack.us/congress/bills/114/hr2446/text.

H.R. 3014, the Medical Controlled Substances Transportation Act, authored by Rep. Pete Sessions (R-TX), would amend the Controlled Substances Act to allow registered physicians to transport and administer controlled substances to patients at other practice settings and disaster areas if the physician is registered to dispense, or conduct research with, controlled substances listed on schedules II, III, IV, or V, and the physician enters into a specific agreement with the Drug Enforcement Administration (DEA). The agreement must require a physician to provide advance notification to the DEA, limit the duration of transport to 72 hours, and maintain records of the controlled substances dispensed. A “disaster area” is the area covered by a President’s major disaster declaration.

Full text: https://www.govtrack.us/congress/bills/114/hr3014/text.


New Bills

A Short-term Blanket Exemption for Meaningful Use of EHRs

Of course, the real way to have relief from the hardship of electronic medical records is to eliminate the mandate for their use.

On November 5, 2015, H.R. 3940, the Meaningful Use Hardship Relief Act of 2015. was introduced by Rep. Tom Price, MD (R-GA) and referred to the House Energy and Commerce and Ways and Means Committees. The bill would authorize a blanket exception to the meaningful use significant hardship exception for the 2015 reporting period due to the delay in timely publication of the Stage 2 meaningful use rule.

Full text: https://www.govtrack.us/congress/bills/114/hr3940/text.

Bill Restoring Favorable Tax Treatment of Over-the-Counter Medications

On September 17, 2015, H.R. 1270, the Restoring Access to Medication Act of 2015, sponsored by Lynn Jenkins (R-KS) was sent it to the House as a whole for consideration. The bill (and its sister bill in the Senate sponsored by Sen. Pat Roberts (R-KS)) would repeal provisions of the Internal Revenue Code, as added by the Patient Protection and Affordable Care Act, that limit payments for medications from health savings accounts, medical savings accounts, and health flexible spending arrangements to only prescription drugs or insulin (thus allowing distributions from such accounts for over-the-counter drugs). .

Full text (House): https://www.govtrack.us/congress/bills/114/hr1270/text.

Full text (Senate): https://www.govtrack.us/congress/bills/114/s709/text.

Tax Deduction for Physical Fitness

On October 29, 2015, S. 2218, the Personal Health Investment Today Act of 2015 or the PHIT Act of 2015 was introduced by Sen. John Thune (R-SD) and referred to the Senate Finance Committee. The bill would allow some amounts paid for physical activity, fitness, and exercise to be treated as money paid for medical care. Qualifying sports and fitness expenses includes (1) membership at a fitness facility, (2) for participation or instruction in physical exercise or physical activity, or (3) for equipment used in a program (including a self-directed program) of physical exercise or physical activity. A fitness facility must only be for physical fitness — not sailing, golfing, hunting or riding. Equipment must be used exclusively for fitness, exercise, sport, or other physical activity. Instructional videos, books, and similar materials are included.

The expenses are limited to 1,000 for individual and $2,000 for joint or head of household tax return.

Full text: https://www.govtrack.us/congress/bills/114/s2218/text.

No Mandatory Minimum Wage for Home-care Workers

On October 29, 2015, S. 2221, the Ensuring Access to Affordable and Quality Home Care for Seniors and People with Disabilities Act was introduced by Sen. Pat Roberts (R-KS) and referred to the Senate Health, Education, Labor, and Pensions Committee. This bill would amend the Fair Labor Standards Act of 1938 with respect to the exemption from minimum wage and maximum hour requirements of domestic service employment to provide companionship services for individuals who because of age or infirmity are unable to care for themselves. The exemption would now extend to third-party employment, i.e., the worker is employed by an employer or agency other than the family or household. “Companionship services” exclude services with require trained medical personnel.

Full text: https://www.govtrack.us/congress/bills/114/s2221/text.

Bill Addressing the Epidemic of Opioid Deaths

On November 5, 2015, S. 2256, the Co-Prescribing Saves Lives Act of 2015 was introduced by Sen. Timothy Kaine (D-VA) and referred to the Senate Health, Education, Labor, and Pensions Committee. This bill was prompted by the epidemic of opioid deaths and misuse. The bill would require guidelines for opioid use training health care providers in federal medical facilities. The training must address, at a minimum, best practices for appropriate and effective prescribing of pain medications, principles of pain management, the misuse potential of controlled substances, identification of potential substance use disorders and referral to further evaluation and treatment, and proper methods for disposing of controlled substances.

The bill would also require naloxone co-prescribing in federal medical facilities to patients at an “elevated risk” of overdose. Elevated risk of overdose may be based on the criteria provided in the Opioid Overdose Toolkit published by the Substance Abuse and Mental Health Services Administration (http://store.samhsa.gov/product/Opioid-Overdose-Prevention-Toolkit-Updated-2014/SMA14-4742); and may include patients on a first course opioid treatment, patients using extended-release and long-acting opioid analgesic, and patients with a respiratory disease or other co-morbidities.

Full text: https://www.govtrack.us/congress/bills/114/s2256/text.

Bill Proposing Federal Assisted Suicide

On October 22, 2015, S. 2204, the End of Suffering Act of 2015 was introduced by Sen. Barbara Boxer (D-CA) and referred to the Senate Health, Education, Labor, and Pensions Committee. This is framed as “a bill to respect the Constitutional entitlement to liberty by recognizing the right of an individual to have personal control over the medical assistance and treatment necessary to alleviate intolerable physical suffering.” The bill would require that there be no federal or state laws or regulations that restrict the right of an adult “who is suffering from an advanced illness with intolerable pain or a medically certified terminal illness, to receive medication or treatment from a physician for the relief of pain and other symptoms that limit activities of daily living.” “Advanced illness with intolerable pain” occurs when pain associated with one or more incurable and life-threatening conditions becomes intolerable enough that general health and functioning decline, treatment begins to lose its effect, and quality of life increasingly becomes the focus of care, a process that continues to the end of life.

Physicians who have obtained informed consent and treat such individuals are shielded from liability.

Secretary of Health and Human Services would develop a written informed consent form that shall document the patient’s informed decision and be signed and dated by the patient, and witnessed by at least two individuals. Informed consent means that the individual was fully informed by a physician of his or her medical diagnosis, prognosis, potential risks associated with taking the medication to be prescribed; and the feasible alternatives.

Full text: https://www.govtrack.us/congress/bills/114/s2204/text


New Regulation Regarding Bundled Payment for Hip and Knee Joint Replacements

On November 18, 2015, the Centers for Medicare & Medicaid Services (CMS) issued a final rule governing payment for hip and knee replacements for Medicare patients. The Comprehensive Care for Joint Replacement (CCJR) rule requires bundled payments for joint replacements to the lower extremities over a 90-day “episode of care” in 67 metropolitan areas.

An episode of care begins with hospital admission and ends 90 days after hospital discharge. The hospital will be assessed for quality of care. Based on the assessment the hospital would be given an additional payment or penalized.

CMS explanation of the rule available at:

http://www.hhs.gov/about/news/2015/11/16/cms-finalizes-bundled-payment-initiative-hip-and-knee-replacements.html and https://innovation.cms.gov/initiatives/cjr.

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