Health Policy Legislative Update – 8/8/2015


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

Three House Bills Approved on July 29, 2015 by House Energy and Commerce Committee 

Thank goodness, this was not endorsing selling fetal tissue to the highest bidder.

1) H.R. 2820, Stem Cell Therapeutic and Research Reauthorization Act of 2015 authored by Reps. Chris Smith (R-NJ) and Doris Matsui (D-CA), introduced June 18, 2015, would amend the Stem Cell Therapeutic and Research Act of 2005 to reauthorize the National Cord Blood Inventory program and the C.W. Bill Young Cell Transplantation Program through 2020. These programs help match patients in need of a transplant with unrelated bone marrow and cord blood donors.

Full text:

Infant Drug Addiction Program
2) H.R. 1462, the Protecting Our Infants Act of 2015, authored by Reps. Katherine Clark (D-MA) and Steve Stivers (R-OH), aims to combat the rise in prenatal opioid abuse and neonatal abstinence syndrome. This bill requires the Agency for Healthcare Research and Quality to report on prenatal opioid abuse and neonatal abstinence syndrome (symptoms of withdrawal in a newborn). The report must include :

(1) an assessment of existing research on neonatal abstinence syndrome;

(2) an evaluation of the causes, and barriers to treatment, of opioid use disorders among women of reproductive age;

(3) an evaluation of treatment for pregnant women with opioid use disorders and infants with neonatal abstinence syndrome; and

(4) recommendations on preventing, identifying, and treating opioid dependency in women and neonatal abstinence syndrome.

Full text:

Renewing Prescription Drug Monitoring Programs
3) H.R. 1725, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015, authored by Reps. Ed Whitfield (R-KY) and Joseph Kennedy (D-MA), would reauthorize the NASPER program to support state prescription drug monitoring programs in order to ensure that appropriate law enforcement, regulatory, and state professional licensing authorities have access to prescription history information for the purposes of investigating drug diversion and prescribing and dispensing practices of errant prescribers or pharmacists. The bill also would authorize the Drug Enforcement Administration (DEA) or a state Medicaid program or state health department receiving nonidentifiable information from a controlled substance monitoring database to make such information available to other entities for research purposes.

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A Small Step Toward Transparency in Medicare

H.R. 876, the Notice of Observation Treatment and Implication for Care Eligibility Act (NOTICE Act) passed the Senate on July 29, 2015. This bill amends the Medicare program to require a hospital or critical access hospital with an agreement with the Secretary of Health and Human Services to give each individual who receives observation services as an outpatient for more than 24 hours an adequate oral and written notification within 36 hours after beginning to receive them which:

(1)    explains the individual’s status as an outpatient and not as an inpatient and the reasons why;

(2)    explains the implications of that status on services furnished (including those furnished as an inpatient), in particular the implications for cost-sharing requirements and subsequent coverage eligibility for services furnished by a skilled nursing facility;

(3)    includes appropriate additional information;

(4)    is written and formatted using plain language and made available in appropriate languages; and

(5)    is signed by the individual or a person acting on the individual’s behalf (representative) to acknowledge receipt of the notification, or if the individual or representative refuses to sign, the written notification is signed by the hospital staff who presented it.

Full text:

A Minor Electronic Health Records Temporary Victory

The Electronic Health Fairness Act of 2015, S. 1347, passed the Senate on Aug 5, 2015 and goes to the House for consideration. The bill prohibits any Medicare patient encounter of an eligible professional occurring at an ambulatory surgical center from being treated as such an encounter in determining whether an eligible professional qualifies as a meaningful electronic health record (EHR) user. This will be in effect for three years, giving HHS time to certify EHR technology for the ambulatory surgical center setting.

Full text:

Proposal for Medicare to Return to Paying for Annual Mammograms

This is an attempt to roll back the new guideline that mammograms need only be done once every two years.

On July 29, 2015, H.R. 3339, the Protecting Access to Lifesaving Screenings Act (PALS Act) was introduced by Rep Renee Ellmers (R-NC) and referred to the House Energy and Commerce and Ways and Means Committees. The bill would restore Medicare coverage for screening mammography without copayment to pre-2009 recommendations, i.e., once a year versus the current once every two years.

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A Step Toward Direct Payment for Medicare Beneficiaries

On July 14, 2015, S. 1757, the Accelerating Innovation in Medicine Act of 2015 or the AIM Act of 2015 was introduced by Sen. Robert Portman (R-OH) with bipartisan co-sponsors and referred to the Senate Finance Committee. The bill would amend Medicare to allow for the establishment of a list of medical devices voluntarily excluded from Medicare coverage, and therefore, allows the patient to pay out of pocket for the device.

Full text:

Full text of identical House bill:

Less Expensive Prescription Drugs

On July 16, 2015, S. 1790, the Safe and Affordable Prescription Drugs Act of 2015 was introduced by Sen. David Vitter (R-LA) and referred to the Senate Health, Education, Labor, and Pensions Committee. The bill would amend the Food, Drug, and Cosmetic Act to allow importation of a prescription drug that:

  • is purchased from an approved pharmacy;
  • is dispensed by a pharmacist licensed to practice pharmacy and dispense prescription drugs in the country in which the pharmacy is located;
  • is purchased for personal use by the individual, not for resale, in quantities that do not exceed a 90-day supply;
  • is filled using a valid prescription issued by a physician licensed to practice in a State in the United States; and
  • has the same active ingredient or ingredients, route of administration, dosage form, and strength as a prescription drug approved by the HHS Secretary.

Additionally, the drug does not include :

  • a controlled substance;
  • a biological product;
  • an infused drug (including a peritoneal dialysis solution);
  • an intravenously injected drug;
  • a drug that is inhaled during surgery;
  • a parenteral drug;
  • a drug manufactured through 1 or more biotechnology processes, including a therapeutic DNA plasmid product; a therapeutic synthetic peptide product of not more than 40 amino acids; a monoclonal antibody product for in vivo use; and a therapeutic recombinant DNA-derived product;
  • a drug required to be refrigerated at any time during manufacturing, packing, processing, or holding; or
  • a photoreactive drug.

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Medicare Freedom to Contract Bill

On July 23, 2015, S. 1849, the Medicare Patient Empowerment Act of 2015 was introduced by Sen. Lisa Murkowski (R-AK) and referred to the Senate Finance Committee. The bill would allow a Medicare payment option for patients and eligible practitioners to freely contract, without penalty for Medicare fee-for-service items and services. The bill requires a Medicare beneficiary to agree in writing in such a contract to: (1) pay the eligible professional for a Medicare-covered item or service; and (2) submit (in lieu of the eligible professional) a claim for Medicare payment. Allows a beneficiary to negotiate, as a term of the contract, for the eligible professional to file such claims on the beneficiary’s behalf. The bill would preempt state laws from limiting the amount of charges for physician and practitioner services for which Medicare payment is made.

Full text:

Full text of identical House bill introduced by Rep. Tom Price, MD March 26, 2015:

More Infantilization of Young Adults

On July 23, 2015, H.R. 3184, the Youth Parity Act, was introduced by Rep. Brenda Lawrence (D-MI) and referred to the House Ways and Means Committee. The bill would amend the Internal Revenue Code to permit medical expenses of dependents who have not attained age 26 permitted to be paid from health savings accounts. Currently the relevant age is 19 years.

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Medicare Smart Card: Anti-fraud or More Efficient Government Intrusion?

On July 27, 2015, H.R. 3220, the Medicare Common Access Card Act of 2015 was introduced by Rep. Peter Roskam (R-IL) and referred to the House Energy and Commerce and House Ways and Means Committees. The bill would establish a Medicare smart card pilot program that utilizes a smart card as a Medicare identification card for Medicare beneficiaries. Such a card shall contain appropriate security features and protect personal privacy. Such technology would (1) increase the quality of care furnished to Medicare beneficiaries; (2) improve the accuracy and efficiency in the billing for Medicare items and services; (3) reduce the potential for identity theft and other unlawful use of Medicare beneficiary identifying information; and (4) reduce waste, fraud, and abuse in the Medicare program.

Full text:

An identical bill, S. 1871 was introduced by Sen. Mark Kirk (R-IL) on July 27, 2015.

Bill to Exclude Medicare Coverage for Advanced Care Planning

This is purely a bill to make a statement.  This will not stop back-door rationing.

On July 28, 2015, H.R. 3251 was introduced by Rep. Steve Ling (R-IA) and referred to the House Energy and Commerce and Ways and Means Committees. The bill would exclude Medicare coverage of advance care planning services.

Full text:

Another Universal Health Care Proposal – This Time State-Based

On July 28, 2015, H.R. 3241, the State-based Universal Health Care Act of 2015, was introduced by Rep. Jim McDermott (D-WA) and referred to the House Committee on Armed Services, House Committee on Education and the Workforce, Energy and Commerce, and Ways and Means Committees. The bill would amend the Affordable Care Act to authorize the establishment of, and provide support for, State-based universal health care systems.

The State plan:

(A) will provide health benefits coverage to State residents that is at least as comprehensive as the health benefits coverage that such residents would have received under the specified Federal health program for which such residents would have been eligible, absent such waiver;

(B) will provide coverage and cost sharing protections against excessive out-of-pocket spending to State residents that are at least as affordable as the coverage and cost sharing protections under the specified Federal health program for which such residents would have been eligible, absent such waiver;

(C) will provide coverage to substantially all residents of the State, including substantially all those otherwise covered under the Federal health care or subsidy programs (except Indian Health Service);

(D) will be publicly administered by an agency of the State; and

(E) will not increase the Federal deficit.

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