Life Science Compliance Update

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December 10, 2013

Physician Payments Sunshine Act: Listing of Policy and Medicine Resources for Open Payments

Under the Physician Payments Sunshine Act Final Rule (Open Payments), beginning August 1, 2013 applicable manufacturers and group purchasing organizations will be required to report all payments and transfers of value to physicians and teaching hospitals to the Centers for Medicare and Medicaid Services (CMS).

Policy and Medicine has been writing about the Physician Payments Sunshine Act for a long time. Below is a summary of our articles about the Act since CMS announced the final rule. This will serve as an ongoing reference for articles related to the Sunshine Act.


Physician Payment Sunshine Act Final Rule: Quick Reference Guide

In light of the significant complexity the rule presents to many stakeholders, we decided to provide a condensed chart or quick reference guide for readers to
know many of the key details for reporting.

Physician Payment Sunshine Act: Final Rule Top 50 Things to Know

A brief overview of key areas of Sunshine compliance

Physician Payment Sunshine Act: Sunshine Alerts and Analysis

A listing of client alerts and other analysis from law firms and industry regarding the final regulations. 

Physician Payment Sunshine Act Final Rule: Nature of Payment

A review of the nature of payment categories and how they apply towards company reporting.

Physician Payment Sunshine Act Final Rule: Reporting Requirements

An analysis of the Reporting Requirements under the sunshine act final rule. 

Physician Payment Sunshine Act Final Rule: 45 Day Review Period and Penalties

Physician Payment Sunshine Act Final Rule: 45 Day Review Period and Penalties. Applicable manufacturers, applicable group purchasing organizations, covered recipients, and physician owners or investors must have an opportunity to review and submit corrections to the information submitted for a period of not less than 45-days before CMS makes the information available to the public. In no case may this 45-day period for review and submission of corrections prevent the information from being made available to the public. 

Physician Payment Sunshine Act: Reporting Physician Ownership

Several key pieces of information regarding physician ownership/investing and the Physician Payment Sunshine Act.

Questions and Answers 

Physician Payment Sunshine Act: Open Payment - Questions and Answers by Topic Category

A complete list of up to date Questions and Answers for Open Payments compiled by topic category in an easy to access format.

According to CMS they have received over 500 Q&A that they are hoping to answer.

Physician Payment Sunshine Act: CMS Post Round 1 of FAQ's

Physician Payment Sunshine Act: CMS Updates FAQ's –Textbooks, Imaging, Biologics and Employee Recruitment

Physician Payment Sunshine Act: CMS Posts Round 3 of Q&A Exempts Accredited Speaker Expenses and Educational Materials, Clarify Meals and Journal Reprints

Physician Payment Sunshine Act: CMS Posts Round 4 of FAQs: CME Exemption for Only the Five Accreditation Systems Listed, Promotional Speaking Listed as Honorarium or Services other than Consulting

Physician Payment Sunshine Act: CMS Posts Round 5 of FAQ's Adds Newsletters and Taxes Reportable

Physician Payment Sunshine Act: CMS Open Payments - Posts Round 6 of Frequently Asked Questions

Physician Payment Sunshine Act: Open Payments Webinar CMS Avoids Hard Deadlines

Instead of hard dates as stated in the final rule, CMS discussed their timeline during the webinar in terms of soft date targets, which include early 2014 submission, mid 2014 collection, and late 2014 publication of the data.


Physician Payment Sunshine Act: CME Coalition's Sunshine Act Compliance Guide for CME Providers and Supporters

The CME Coalition released a comprehensive guidebook to provide clear rules for participation in Sunshine-exempt Continuing Medical Education (CME) activities.

Physician Payment Sunshine Act: AMA House of Delegates Voice Concern over Accuracy and Potential Inclusion of CME Meals

Physician Payment Sunshine Act: Pfizer Grants Opts for Supporting Only Programs Accredited by the Five Bodies and No Meals

Pfizer, Inc. announced a change to its continuing education (CE) and continuing medical education (CME) policies in response to the Physician Payment Sunshine Act, which went into effect August 1st.

Physician Payment Sunshine Act: Congressman Calls for Meals Exemption for Accredited CME

The language regarding meals at Continuing Medical Education (CME) events continues to create confusion, and Congressman Robert E. Andrews (D-1st District, New Jersey) is asking the Center for Medicare and Medicaid Services to do something about it in a letter dated November 5, 2013.

Physician Payment Sunshine Act: 74 Physician Organizations Request HHS to Exempt Journal Reprints and Textbooks from Open Payments Reporting

33 physician organizations and 41 state medical societies sent a joint letter on October 28th to Department of Health and Human Services Secretary Kathleen Sibelius requesting that HHS reverse its policy (under Sunshine Act regulations) that states that journal reprints and medical textbooks are considered "transfers of value" and reportable.


Physician Payment Sunshine Act Final Rule: Research

Under the Physician Payment Sunshine Act Final Rule, certain research payments or other transfers of value made to a covered recipient by an applicable manufacturer under a product research or development agreement may be delayed from publication on the website.

Reporting Requirements

Deadlines Resources and Responsibilities

A user-friendly resource for other stakeholders regarding important information and dates that the Centers for Medicare & Medicaid Services (CMS) is providing through their Open Payments webpage. CMS has provided several easy to follow charts with important dates and brief descriptions that will provide a useful reference to all stakeholders.

CMS Posts Reporting Templates for 2013

CMS released their physician payment sunshine reporting templates for 2013. The templates apply for reports August 1, 2013 -December 31, 2013.

State Reporting


Review of Individual State Reporting Requirements

Several states, including Vermont and Massachusetts, have additional reporting requirements above and beyond the Sunshine Act. We compiled a list of these disclosure states. 

List of Teaching Hospitals

Physician Payment Sunshine Act: CMS Releases List of Teaching Hospitals for 2013 Reporting Period

CMS final list of teaching hospitals to be used for Physician Payment Sunshine Reporting for August 1 – December 31st 2013. The list includes 1,162 hospitals from all 50 States.

Physician Payment Sunshine Act: CMS Updates Teaching Hospital List for 2014 and No Changes to File Specifications

As required in the final rule for 2014 Open Payments data collection (from January 1, 2014 through December 31, 2014), the 2014 Teaching Hospital List was released on October 1 by the Centers for Medicare & Medicaid Services (CMS).

Open Payment Resources

Physician Payment Sunshine Act: CMS Releases User Guide for Industry

The Centers for Medicare & Medicaid Services (CMS) published a "User Guide for Industry" regarding its Open Payments program—also known as the Physician Payments Sunshine Act. Interestingly, the subtitle of the guide is, "Creating Public Transparency Into Industry-Physician Financial Relationships."  

Physician Payment Sunshine Act: CMS Teleconference Offers Future Clarification and Links to New Patient-Physician Brochures

The Centers for Medicare & Medicaid Services (CMS) held a conference call regarding the implementation of its Open Payments program (a.k.a. the Physician Payments Sunshine Act). CMS officials went through a slide show outlining some updates and summaries of the final Sunshine Rule, they also provided links to new physician and patient brochures. 

Physician Payment Sunshine Act: CMS Releases Fact Sheets

Payments website to include fact sheets for applicable manufacturers, applicable group purchasing organizations (GPOs), teaching hospitals and physicians who will be affected by the Open Payments, commonly known as Sunshine, final rule. 

Physician Payment Sunshine Act: OPEN PAYMENTS - Policy Updates on Payments and the Physician Resource Toolkit

Notice of August 8, 2013 MLN Connects National Provider Call discussing the OPEN PAYMENTS (Physician Payment Sunshine Act) requirement that manufacturers of pharmaceuticals or medical devices publicly report payments made to physicians and teaching hospitals.

Physician Payment Sunshine Act: HHS OIG Reports the NPPES Database as Largely Inaccurate

The Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS) issued a report titled Improvements Needed to Ensure Provider Enumeration and Medicare Enrollment Data Are Accurate, Complete, and Consistent. The report cites multiple failings in the reliability of the data contained in the National Plan and Provider Enumeration System (NPPES) and the Provider Enrollment, Chain and Ownership System (PECOS).

This report is of particular interest to those stakeholders who are currently gearing up for implementation and compliance with the Physician Payments Sunshine Act a government surveillance and monitoring program targeting manufacturers' payments to physicians and teaching hospitals. One of the main requirements under the reporting provisions is that manufacturers and GPOs report a physician's name, address, NPI number, and other identifying information all based on information in the NPPS database.

Physician Payment Sunshine Act: CMS Teleconference Offers Future Clarification and Links to New Patient-Physician Brochures

The Centers for Medicare & Medicaid Services (CMS) held a conference call regarding the implementation of its Open Payments program, outlining some updates and summaries of the final Sunshine Rule.

Requests for Comments

Physician Payment Sunshine Act: CMS Requests Comments on Open Payments System due September 20, 2013

CMS Requests Comments on Open Payments System implementation. The notice was included within another notice for request for comments for the Nationwide Consumer Assessment of Healthcare Providers and Systems.

Physician Payment Sunshine Act: CMS-OMB Posts New Request for Comments

In an effort to further refine the Physician Payment Sunshine Act reporting requirements, CMS has issued a request for comments from stakeholders.


Cost and Impact

Physician Payment Sunshine Final Rule: Cost and Impact of Regulation

The cost and impact of the Physician Payment Sunshine Act. We focused on the costs CMS has estimated the Sunshine Act will have on affected stakeholders—doctors, hospitals, and manufacturers—as well as the regulatory impact analysis CMS conducted in issuing the regulation. 

Physician Payment Sunshine Act: Radiologists Concerned With Potential Mischaracterizations of Relationships With Industry

Radiologists need to care because the Sunshine reports may not paint an accurate picture. For example, a manufacturer may report a $50,000 grant in the travel or the research category, leading to misperception issues.

Physician Payment Sunshine Act: Open Payments May Cause Physicians to Change Company Interactions – Concerns about Accuracy Persist

Many physicians factor consulting relationships, continuing medical education and speaking engagements into their annual revenue projections. Concerns about the impact of Open Payments may cause doctors to change some of their outside activities. However, although a vast majority of patients will likely not seek out the CMS website to investigate their doctor's financial relationships with drug and device companies, physicians may want to proactively educate patients about Open Payments. Physicians may also want to be prepared to explain their relationships to various companies and emphasize that the relationships do not influence their treatment decisions.


Physician Payment Sunshine Act: Opportunities and Challenges for Global Implementation

In a recent client alert from the law firm Debevoise & Plimptom, LLP, several attorneys discussed the potential international implications that can affect physicians and manufacturers in light of the finalized Physician Payment Sunshine Act regulations.

Physician Payment Sunshine: Pan European Physician Payment Rules Begin January 1, 2015

Pharmaceutical manufacturers operating in Europe must disclose payments made to physicians starting in 2016 in an effort to boost transparency and make patients aware of possible conflicts of interest.

French Sunshine Act: France Issues Final Decree - Reporting Retroactive to January 1, 2012

The decree implementing French Law No. 2011-2012 on the Strengthening of Health Protection for Medicinal and Health Products (the decree), was issued on May 21, 2013.  Its aim is to specify the scope of disclosure obligations, which affect all agreements concluded between health care professionals (HCPs) and companies, as well as every benefit in kind or in cash exceeding €10. They
adopted a retroactive reporting requirement to January 1, 2012.


Physician Payment Sunshine Act: Fraud and Abuse Implications of Sunshine

A recent article written by Kelly M. Cleary, a lawyer from Akin Gump Strauss Hauer & Feld, discussed some of the potential federal and state healthcare fraud issues that may be implicated by the Sunshine Act.

Tools and Systems

Physician Payment Sunshine Act: CMS Launches Open Payment Apps for Physicians and Manufacturers, and Contest to Develop Future Apps

The Centers for Medicare and Medicaid Services (CMS) released their Open
Payments Apps for Physicians and Manufacturers/GPO's to help keep records for Physician Payment Sunshine Act reporting.

The Open Payment Mobile for Physicians, provided free by CMS (IPhone and Android) is intended to help both physicians and members from industry keep track of, store, and view financial payments and other transfers of value as required by the Physician Payment Sunshine Act and its implementing regulations.

Physician Payment Sunshine Act: AMA Reminds Members to Update Their Disclosures

The American Medical Association reminds physicians to update their disclosures.

Physician Payment Sunshine Act: 62% of Companies are Capturing Aggregate Spend Information

The Center for Business Intelligence (CBI) recently reported that only 62% of companies in a recent survey are capturing aggregate spend
information as it relates to Physician Payment Sunshine Act and similar state laws.
 30% are only operational as it relates to states, but working on
and planning to comply with federal regulations. Interestingly, the survey also
showed that only 54% of sales personnel get signatures for non-HCPs (e.g.,
support staff) when providing a meal in an office or hospital setting.

Physician Payment Sunshine Act: Compliance Recommendations for Physician Practices

Health IT company RxVantage hosted a webinar with Randy Vogenberg, managing principal at consulting firm Bentelligence, to address some common questions posed by physicians and share best practices, The thirty minute presentation offers several tips.

Physician Payment Sunshine Act: New England Journal of Medicine Articles on Requirements and Potential Effects

With less than two months for applicable manufacturers and group purchasing organizations to begin collecting the required payment information and data required under the National Physician Payment Transparency Program (NPPTP) of the Centers for Medicare and Medicaid Services (CMS), stakeholders are increasingly beginning to discuss the requirements and potential effects. In fact, the New England Journal of Medicine (NEJM) devoted several articles in a recent issue.

Physician Payment Sunshine Act: Four Tips for Manufacturers, Physicians and Hospitals

A recent article from Med City News highlighted 4 Tips for applicable manufacturers and 4 tips for physicians regarding compliance with the finalized rules implementing the Physician Payments Sunshine Act.

Physician Payment Sunshine Act: CMS to Host Education for Company Registration and Data Submission

According to a release from the Centers for Medicare & Medicaid Services (CMS), in response to stakeholder requests, on November 19, from 1:00 p.m. to 3:00 p.m. EST, CMS presented the first two sessions in a series of technology-focused webinars designed to introduce features of the Open Payments system currently in development. The webinars focus on two major Open Payments components: registration and data submission.

Physician Payment Sunshine Act: Open Payments Technology Vendor Mired in Healthcare.Gov

The same troubled contractor that is responsible for building—the health insurance exchange website that has been plagued with significant technical issues over the last three weeks—was also hired to create the Open Payments database and website.

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