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MichBIO_-_HIPAA__Industry-Provider_Interactions__and_Related_Compliance_Matters_1_2017.PPT
1.
© 2017 Foley
Hoag LLP. All Rights Reserved. HIPAA, Industry-Provider Interactions, and Related Compliance Matters MichBIO Bioscience Regulatory Compliance Workshop January 17, 2017 Colin J. Zick Co-Chair, Health Care and Data Privacy and Security Practices Foley Hoag LLP (617) 832-1275 czick@foleyhoag.com
2.
MichBIO - HIPAA
| 2© 2017 Foley Hoag LLP. All Rights Reserved. It’s Good to Be Back….
3.
MichBIO - HIPAA
| 3© 2017 Foley Hoag LLP. All Rights Reserved. Overview: Privacy, Security and Industry-Provider Interactions Data privacy and security issues are driven by more and more data. Industry – provider interactions have grown and evolved, despite scrutiny and regulation. These areas pose distinct and significant challenges for biotechs.
4.
MichBIO - HIPAA
| 4© 2017 Foley Hoag LLP. All Rights Reserved. 4 an Effective Compliance Plan The OIG Compliance Guidance lists seven elements of an effective compliance plan: 1)implementing written policies and procedures; 2)designating a compliance officer and compliance committee; 3)conducting effective training and education; 4)developing effective lines of communication; 5)conducting internal monitoring and auditing; 6)enforcing standards through well-publicized disciplinary guidelines; and 7)responding promptly to detected problems and undertaking corrective action.
5.
MichBIO - HIPAA
| 5© 2017 Foley Hoag LLP. All Rights Reserved. All That Data! Therapies, diagnostics, and connected devices now gather huge amounts of data That data can be more valuable than the “thing” that is treated, diagnosing, or connecting, provided you have the legal ability to use that data, by: –Direct consent –Operation of law –Aggregation/anonymization
6.
MichBIO - HIPAA
| 6© 2017 Foley Hoag LLP. All Rights Reserved. 2016: A Busy (and Dangerous) Year for Data and Data Security The flip side: breaches and cyber attacks continue to occur at a high frequency. A high percentage of the known breaches/attacks could have been prevented. While some attacks are very high tech, low tech attacks are very popular and often successful. Perpetrators know this and exploit human and systemic weaknesses.
7.
MichBIO - HIPAA
| 7© 2017 Foley Hoag LLP. All Rights Reserved. The Worst Case…. Dick Cheney’s Heart In 2008, a team of security researchers proved they could gain access through a pacemaker’s wireless control system Vice President Cheney had an implanted pacemaker This led to the communications capabilities of his pacemaker being disabled “Disconnection” is not a viable business model
8.
MichBIO - HIPAA
| 8© 2017 Foley Hoag LLP. All Rights Reserved. What is Protected By Law? “Personal Information” “Personal Information”: Individual’s name + one or more of the following: – Social Security number – Financial account number – Credit card number – Driver’s license number – Biometric indicators (fingerprints, DNA, voice print) Personal facts – Financial – Health – Family Medical records and health information
9.
MichBIO - HIPAA
| 9© 2017 Foley Hoag LLP. All Rights Reserved. HIPAA Overview What is HIPAA? –“Health Insurance Portability and Accountability Act of 1996” –A federal statute with related regulations and guidance What does HIPAA do? –The statute covers a lot of different subjects. The focus of this session is the part of HIPAA that deals with confidentiality of Protected Health Information (“PHI”), which is referred to as “administrative simplification” –PHI is any “individually identifiable health information” that is transmitted by a “covered entity” in connection with specified electronic transactions (which makes it “ePHI”)
10.
MichBIO - HIPAA
| 10© 2017 Foley Hoag LLP. All Rights Reserved. Does HIPAA Apply to Biotech Companies? What kinds of businesses are HIPAA “covered entities”? –Health care providers –Health plans –Health care clearinghouses Biotechs may be considered a HIPAA “covered entity” –Could also be HIPAA “business associate” working with various types of health care providers, who themselves are HIPAA “covered entities”.
11.
MichBIO - HIPAA
| 11© 2017 Foley Hoag LLP. All Rights Reserved. Is HIPAA Relevant If You Are Not a “Covered Entity”? Even if HIPAA does not literally apply, it is a widely- accepted standard for health information and its management. Courts will look to HIPAA for guidance in determining what is appropriate under the laws of the states in which you do business. Therefore, even if you are not a “covered entity,” you need to know, understand and apply HIPAA’s standards for privacy and security of health information.
12.
MichBIO - HIPAA
| 12© 2017 Foley Hoag LLP. All Rights Reserved. Disclosure and Use Under HIPAA With notice (treatment, payment and health care operations) With authorization (marketing, research) Subject to objection (family, friends, clergy) By HIPAA “override” (public health, law enforcement, certain research)
13.
MichBIO - HIPAA
| 13© 2017 Foley Hoag LLP. All Rights Reserved. Keys to Protecting Personal Information Awareness Physical Security Electronic Security Data Retention/Destruction
14.
MichBIO - HIPAA
| 14© 2017 Foley Hoag LLP. All Rights Reserved. Security Risks – Wikileaks Type Email Hacks How did Team Clinton fail? – Inappropriate IT vetting of phishing scam – Podesta failed to use two factor authentication – Poor virtual situational awareness
15.
MichBIO - HIPAA
| 15© 2017 Foley Hoag LLP. All Rights Reserved. Information Security Risks Spoofing and Identity Theft –A major issue, and not just for credit card companies, but for any entity that has an individual’s: • Name • Address • Email address • Social Security number • Financial Account number(s) • Credit Card number(s) • Drivers’ License number Confidential Information Breaches and Leaks – Impact on customers and customer relations – Negative PR for “brand”
16.
MichBIO - HIPAA
| 16© 2017 Foley Hoag LLP. All Rights Reserved. Contracts and Data Use Contracts are key to data use: –Consents and authorizations –Terms of use and privacy policies –Notices of privacy practices –Licenses –HIPAA business associate agreements
17.
MichBIO - HIPAA
| 17© 2017 Foley Hoag LLP. All Rights Reserved. Industry-Provider Interactions Basic principles: Avoid fraud, abuse, kickbacks What are the relevant laws? –Federal and state anti-kickback statutes –Federal and state false claims acts –Federal Stark anti-self-referral law and state analogues –Federal and state Sunshine Acts/physician transparency laws –Federal exclusion sanctions
18.
MichBIO - HIPAA
| 18© 2017 Foley Hoag LLP. All Rights Reserved. Privileged and Confidential: Attorney-Client Materials 18 Relevant Marketing Codes Governing Industry – Provider Interactions OIG Compliance Guidance: Compliance Program Guidance for Pharmaceutical Manufacturers, issued by the Department of Health and Human Services Office of Inspector General, 68 Fed. Reg. 23731 (May 5, 2003) Trade Association Codes: –PhRMA Code on Interactions with Healthcare Professionals –AdvaMed Code of Ethics on Interactions with Healthcare Professionals –International Federation of Pharmaceutical Manufacturers & Associations Code of Pharmaceutical Marketing Practices –Association of the British Pharmaceutical Industry Code of Practice
19.
MichBIO - HIPAA
| 19© 2017 Foley Hoag LLP. All Rights Reserved. Federal Anti-Kickback Statute Federal anti-kickback statute (AKS) makes it a criminal offense to knowingly and willfully offer, pay, solicit or receive any remuneration to induce referrals of items or services reimbursed by federal health care programs. –Payments, credits or other forms of remuneration provided to Medicare/Medicaid beneficiaries can implicate the federal anti-kickback statute, 42 U.S.C. § 1320a-7b(b). –However, if no federal programs currently reimburse the product/service and you do not believe that any federal programs will pay for the product/service for an extended period of time, then the federal anti-kickback statute is probably not applicable.
20.
MichBIO - HIPAA
| 20© 2017 Foley Hoag LLP. All Rights Reserved. 20 Anti-Kickback Statute (cont.) Remuneration includes anything of value and can take many forms besides cash, such as free rent, expensive hotel stays and meals, and excessive compensation for medical directorships or consultancies. In some industries, it is acceptable to reward those who refer business to you. However, in the Federal health care programs, paying for referrals is a crime. The statute covers the payers of kickbacks—those who offer or pay remuneration— as well as the recipients of kickbacks—those who solicit or receive remuneration. Each party’s intent is a key element of their liability under the AKS. Generally, the difficulty in determining potential liability lies in distinguishing between: – remuneration intended to induce referrals; and – remuneration paid to the referral source in return for legitimate services and in appropriate amounts
21.
MichBIO - HIPAA
| 21© 2017 Foley Hoag LLP. All Rights Reserved. 21 21 Anti-Kickback Statute (cont.) Criminal penalties and administrative sanctions for violating the AKS include fines, jail terms, and exclusion from participation in the Federal health care programs. – Under the civil monetary penalty provisions, physicians who pay or accept kickbacks also face penalties of up to $50,000 per kickback plus three times the amount of the remuneration. Safe harbors protect certain payment and business practices that could otherwise implicate the AKS from criminal and civil prosecution. – To be protected by a safe harbor, an arrangement must fit squarely in the safe harbor and satisfy all of its requirements. – Some safe harbors address personal services and rental agreements, investments in ambulatory surgical centers, and payments to bona fide employees.
22.
MichBIO - HIPAA
| 22© 2017 Foley Hoag LLP. All Rights Reserved. Privileged and Confidential: Attorney-Client Materials 22 Stark Law: What Is It and What Services Are Covered By It? Stark prohibits certain physician referrals to entities they have an interest in: Clinical laboratories Physical therapy Occupational therapy Certain radiology services Radiation therapy services and supplies Durable medical equipment and supplies Parental and enteral nutrients, equipment, and supplies Prosthetics, orthotics, and prosthetic devices and supplies Home health services Outpatient prescription drugs Inpatient and outpatient hospital services
23.
MichBIO - HIPAA
| 23© 2017 Foley Hoag LLP. All Rights Reserved. The Federal Sunshine Act Enacted as Section 6002 of the Patient Protection and Affordable Care Act (“ACA”) on March 23, 2010. Creates significant new legal obligations for drug and device manufacturers. Requires every “applicable manufacturer” to file an annual disclosure report with the federal government. (Requires actual sales….) This annual report must detail the manufacturers’ financial relationships with physicians and teaching hospitals (“covered recipients”) over the previous year. Known as the “Sunshine Act” provisions, since they were originally proposed in 2007 as the “Physician Payments Sunshine Act” (sponsored by Senators Charles Grassley and Herb Kohl). Unlikely to be repealed…. Several states have similar reporting laws or outright prohibitions.
24.
MichBIO - HIPAA
| 24© 2017 Foley Hoag LLP. All Rights Reserved. Sunshine Act Basics Disclosure –Requires manufacturers to disclose almost all payments and “transfers of value” made to physicians or teaching hospitals. –Requires manufacturers to disclose specific payments made to physicians and teaching hospitals, rather than simply disclosing aggregate payments. –Disclosures will be made public in a online, searchable database. Penalties – Imposes significant financial penalties on manufacturers for noncompliance.
25.
MichBIO - HIPAA
| 25© 2017 Foley Hoag LLP. All Rights Reserved. Sunshine Act Penalties Manufacturers can face two types of noncompliance penalties – one for unknowing failures to report, and one for knowing failures to report. Unknowing Failures to Report –Subject to a penalty of between $1,000 and $10,000 for each unreported payment, transfer, or ownership interest. –Total penalties for unknowing omissions are capped at $150,000 annually. Knowing Failures to Report –Subject to significantly steeper penalties: between $10,000 to $100,000 per each unreported payment, transfer, or ownership interest. –Total penalties for unknowing omissions are capped at $1,000,000 annually.
26.
MichBIO - HIPAA
| 26© 2017 Foley Hoag LLP. All Rights Reserved. Colin Zick Partner and Co-Chair, Health Care and Privacy & Data Security Practice Groups Foley Hoag LLP czick@foleyhoag.com 617.832.1275
Notas del editor
Internet of Devices Me – telemedicine in the 1990s
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