Life Science Compliance Update

July 26, 2017

LSCU SPECIAL FEATURE: Into the Nexus - Anti-Kickback Statute ("AKS") versus Value-Driven Health Care

Lg-salesauction_hpslider

Part 2: The Tension Increases - Online Auctions Violate the AKS

We have noted in previous articles that there is an increasing tension between efforts to reduce healthcare costs and assuring those efforts are not improper inducements under the Anti-Kickback Statute’s (“AKS”). In a recent opinion by the Federal District Court in Connecticut, that tension ratcheted up several notches with the Court’s novel application of the AKS to certain e-commerce arrangements.


The decision in Medpricer.com, Inc. v. Becton, Dickinson & Co was originally decided in March 2017 and reaffirmed in April. Judge Michael Shea’s decision resolved a contract dispute between MedPricer, a company that provides an online portal for the auctioning of medical supplies and equipment, and Becton, Dickinson & Company (“BD”), a medical products provider.

To Read the Full Story, Subscribe, Download a Sample Issue, or Sign In
PM_LSCU_Box

July 24, 2017

LSCU SPECIAL FEATURE: Into the Nexus - Anti-Kickback Statute ("AKS") versus Value-Driven Health Care

TNG

Part 1: An Uncertain Future in a Dynamic Landscape

Fans of Star Trek will remember the scene from the 1994 movie “Generations” in which Captains James T. Kirk and Jean-Luc Picard meet each other in The Nexus: the old versus the new. As the need to reform the healthcare system becomes ever more urgent, a new Nexus has developed between the old legal and regulatory framework (i.e., the Anti-Kickback Statute) and new ways of incentivizing the system to reward improved patient outcomes (i.e., Value Driven Health Care).

Health care is changing, including the way in which payments, compensation, and value policies and procedures are being implemented. As one recent article notes, these “changes are moving healthcare from a fee-for-service reimbursement model to a fee-for-value payment and care delivery model [including the] passage of the Patient Protection and Affordable Care Act of 2010 (ACA)."

To Read the Full Story, Subscribe, Download a Sample Issue, or Sign In
PM_LSCU_Box

June 26, 2017

California Gift Ban Bill to be Heard Tomorrow

4f5f662d74f6391e620017cf-1331652142

On Tuesday, June 27, 2017, California Senate Bill 790 will be heard in the Assembly Committee on Health, with limited testimony allowed per side. We have previously written about the bill, noting that the bill passed the California Senate back in May 2017

The bill, if passed as written, would prohibit a manufacturer of a prescribed product from offering or giving a gift to a health care provider. The bill would further prohibit a manufacturer of a prescribed product or an entity on behalf of a manufacturer of a prescribed product from providing a fee, payment, subsidy, or other economic benefit to a health care provider in connection with the provider’s participation in research, except as specified.

Under existing Sunshine Act law, manufacturers are required to disclose to the Centers for Medicare and Medicaid Services (CMS) any payments or other transfers of value made to physicians or teaching hospitals.

The intent of the Legislature is that the prohibitions and requirements described above will operate in conjunction with the Sunshine Act. If the Sunshine Act is repealed or becomes inoperative, the intent of the Legislature to enact legislation similar to the Sunshine Act.

Specific Bill Language

The bill prohibits or limits the offering or giving of gifts to a health care provider by a drug manufacturer. It allows a drug manufacturer to provide meals for a health care provider, provided the meals do not exceed $250 per person per year in value. Further, drug company payments to health care providers for research and education must meet certain criteria.

Specifically, this bill:

1) Prohibits a pharmaceutical manufacturer from offering or giving a gift to a health care provider.

2) Defines gift as a payment, food, entertainment, travel, subscription, advance, service, or anything else of value provided at no cost or less than full market value to a health care provider.

3) Allows or exempts from the gift ban payments all of the following:

a) The payment is made to the sponsor of a significant educational, medical, scientific, or policymaking conference or seminar, as specified, including allowing some or all of the funding at the sponsor’s discretion to provide meals and other food for all conference participants;

b) Honoraria and payment of expenses of a health care professional who serves on the faculty of a bona fide educational, medical, scientific, or policymaking conference or seminar, if certain conditions are satisfied, as specified; 

c) In connection with a bona fide clinical trial or research project that constitutes a systematic investigation, is designed to develop or contribute to general knowledge, and reasonably can be considered to be of significant interest or value to scientists or health care professionals;

d) Reasonable expenses, necessary for technical training on the administration of a prescribed product, if outlined in an agreement between provider and manufacturer;

e) Public health initiatives, as specified;

f) Royalties and licensing fees in return for contractual rights, including joint ventures;

g) Bona fide marketing research conducted by a third party, as defined;

h) Expenses of an individual related to an interview for a bona fide employment opportunity with a manufacturer;

i) Meals for a health care provider that do not exceed $250 per person per year in value in addition to any meals provided under a) above;

j) Other reasonable fees, payments, subsidies, or other economic benefits at fair market value;

k) Samples of a prescribed product;

l) The provision of peer-reviewed academic, scientific, or clinical articles or journals and other items that serve a genuine educational function;

m) Scholarships for medical students, residents, and fellows to attend significant educational, scientific or policy making conferences of professional associations where the recipient is chosen by the association;

n) Rebates and discounts for products provided in the normal course of business;

o) Financial donations and free prescription drugs and other products to a free clinic;

p) Prescription drugs distributed free or at a discount as part of a patient assistance program;

q) Salary support for fellows through grants from manufacturers, under specified conditions;

r) Coffee or other snacks or refreshments at a booth at a conference or seminar;

s) Anything of value for which the health care provider reimburses the cost at fair market value; and,

t) Any payment made in compliance with the Political Reform Act of 1974 except a gift made under that act.

Previous Legislation

AB 2821 (Feuer) of 2008 would have established a gift limit of $250 per physician per year for each pharmaceutical company and required both the public disclosure of gifts of $50 or more and the payment of a disclosure fee to the Department of Health Care Services (DHCS). AB 2821 failed passage in the Assembly Health Committee.

SB 1765 (Sher), Chapter 927, Statutes of 2004, requires pharmaceutical companies to adopt and update CCPs for interactions with health care professionals. Requires pharmaceutical companies to establish explicitly in its CCP an annual dollar limit on gifts, promotional materials or other items or activities, with exceptions, in accordance with existing guidelines, as specified. Requires such companies to annually declare in writing that they are in compliance with their CCPs and with the limits on gifts established by the bill.

AB 1437 (Koretz), of 2004 would have prohibited inappropriate marketing by pharmaceutical companies by codifying the PhRMA code on Interactions with Healthcare Professionals. AB 1437 failed passage in the Assembly Health Committee.

AB 103 (Reyes) of 2003 would have required pharmaceutical manufacturers to disclose to the Department of Health Services (now DHCS) information about gifts made to any person authorized to prescribe, dispense, or purchase prescription drugs. AB 103 failed passage on the Assembly Floor.

Hearing Information

The hearing is set for 1:30 pm PST, and SB 790 is the second-to-last bill to be heard. The link to the hearing audio can be found here.

Newsletter


Preview | Powered by FeedBlitz

Search


 
Sponsors
July 2017
Sun Mon Tue Wed Thu Fri Sat
1
2 3 4 5 6 7 8
9 10 11 12 13 14 15
16 17 18 19 20 21 22
23 24 25 26 27 28 29
30 31