Applicable Manufacturers Must Submit Their Reports of Payments or Other Transfers of Value to APRNs Engaged in Independent Practice in Connecticut by July 1, 2017

May 22, 2017

In 2015, Connecticut enacted legislation requiring applicable manufacturers that provide payments or other transfers of value to advanced practice registered nurses ("APRNs") engaged in independent practice to submit annual reports to the Connecticut Commissioner of Consumer Protection. The law requires that the first report be submitted no later than July 1, 2017, and annually thereafter, and should include payments or other transfers of value provided to APRNs during the preceding calendar year.

The Department of Consumer Protection Drug Control Division will accept reports in the format found on its website. Reports should be submitted via email to DCP.DrugManufacturers@ct.gov in either Excel or CSV format. The email should contain "APRN Payment Report" in the subject line. There is no minimum threshold for reporting, and the type of compensation provided is not required. Each APRN should have a single line entry on the report indicating the "Total Value of Payment to APRN." The Department of Public Health has published a list of APRNs engaged in independent practice on its website. Applicable manufacturers should use this list when determining whether information on payments or other transfers of value made to APRNs must be reported.


The Open Payments Data Correction Period Begins May 16, 2017, and Will End on May 30, 2017

May 16, 2017

According to the Sunshine Act and its implementing regulations, applicable manufacturers, applicable group purchasing organizations ("GPOs"), covered recipients, and physician owners or investors must have an opportunity to review and submit corrections to Open Payments data submitted pursuant to the Sunshine Act. This review and correction period must occur at least 45 days before the Centers for Medicare and Medicaid Services ("CMS") makes the submitted data available to the public.

The review and dispute period concluded on May 15, 2017. The correction period, which lasts for 15 days, began May 16, 2017 and will end on May 30, 2017. During the correction period, applicable manufacturers and applicable GPOs have the opportunity to acknowledge and resolve disputes initiated by physicians and teaching hospitals. CMS has emphasized that it is up to applicable manufacturers and applicable GPOs to work directly with physicians or teaching hospitals to resolve any disputes; CMS will not mediate any disputes.

When a dispute is resolved by making changes to a disputed record, the record must be resubmitted and re-attested. Once this has been completed, the review and dispute status in Open Payments will automatically be updated to "resolved." If it is determined that no changes need to be made to disputed records, the status in Open Payments will be updated to "resolved, no change." If the dispute is not resolved by the end of the 15 day review period, CMS will publicly report the original information disclosed by the applicable manufacturer or GPO and mark it as "disputed." CMS has posted step-by-step instructions on the data correction process in the Resources section of the Open Payments website.


Reminder: The Open Payments Review and Dispute Period for Physicians and Teaching Hospitals Will End on May 15, 2017

May 03, 2017

According to the Physician Payments Sunshine Act and its implementing regulations, applicable manufacturers, applicable group purchasing organizations ("GPOs"), covered recipients, and physician owners or investors must have an opportunity to review and submit corrections to reported data before it becomes publicly accessible. This review and correction period must occur at least 45 days before the Centers for Medicare and Medicaid Services ("CMS") makes the submitted data available to the public.

CMS has issued a reminder that the review and dispute period for the 2016 reporting year will end on May 15, 2017. Physicians and teaching hospitals may review and, if necessary, dispute payments before the information is made public on June 30, 2017.

If physicians and teaching hospitals wish to participate in the dispute, review, and correction process, they must be registered with CMS. Physicians and teaching hospitals who registered last year do not need to register again in the CMS Enterprise Portal or the Open Payments system. Updated information may be required, however, depending on how long the account has been inactive.


The Massachusetts Department of Public Health Has Posted on Its Website an Updated List of Covered Recipients

May 01, 2017

The Massachusetts Pharmaceutical and Medical Device Manufacturer Conduct Law [Mass. Gen. Laws Ch. 111N] ("Law") and its implementing regulations require each pharmaceutical and medical device manufacturer that employs or contracts with a pharmaceutical or medical device manufacturer agent to disclose annually to the Department of Public Health ("Department") the "value, nature, purpose and particular recipient of any fee, payment, subsidy or other economic benefit with a value of at least $50, which the company provides, directly or through its agents" to any covered recipient in connection with the company's sales and marketing activities. The implementing regulations define a "covered recipient" to include "a person authorized to prescribe, dispense, or purchase prescription drugs or medical devices in Massachusetts, including a hospital, nursing home, pharmacist, health benefit plan administrator, or a health care practitioner."

When completing disclosure reports, manufacturers are required to disclose information regarding each covered recipient. In an effort to help manufacturers comply with the disclosure requirements, the Department has posted on its website an updated list of covered recipients for the 2016 calendar year. The annual disclosure report is due by July 1st of each year for expenditures incurred during the preceding calendar year. As July 1st falls on a Saturday this year, a representative with the Department has confirmed that the deadline to submit reports is Monday, July 3, 2017, for the period covering January 1 through December 31, 2016. Disclosure reports must be sent in a CSV file as an email attachment to the following address: pharmameddata@massmail.state.ma.us.


Manufacturers and Wholesalers That Sell or Market Products in Nevada Must Submit Certification and Compliance Forms to the Nevada Board of Pharmacy by June 1, 2017

April 26, 2017

Nevada law requires each manufacturer and wholesaler that employs a person to sell or market a drug, medicine, chemical, device, or appliance in the state to:

  1. Adopt a written marketing code of conduct that establishes standards for the marketing and sale of its products;
  2. Adopt a training program to provide regular training to appropriate employees on the marketing code of conduct, including its sales and marketing staff;
  3. Conduct annual audits to monitor compliance with its marketing code of conduct;
  4. Adopt policies and procedures for investigating instances of non-compliance; and
  5. Identify a compliance officer responsible for developing, operating, and monitoring the company's marketing code of conduct.

Further, Nevada requires these manufacturers and wholesalers to submit the following information to the Nevada Board of Pharmacy by June 1st of their initial year of filing using the "Compliance Packet for Manufacturers and Wholesalers of Drugs, Medicines, Chemicals, Devices, or Appliances":

  1. A copy of the company's marketing code of conduct;
  2. A description of the training program used by the company to train the appropriate employees on the marketing code of conduct;
  3. A description of the investigation policies the company utilizes to investigate noncompliance;
  4. The name and address of the company's compliance officer responsible for developing, operating, and monitoring the company's marketing code of conduct, including the compliance officer's signature; and
  5. Certification that the company has conducted its annual audit and is in compliance with its marketing code of conduct.

The annual audit certification period is from May 1, 2016, through April 30, 2017. Certifications signed and dated before May 1, 2017, will be considered non-compliant for the certification period. Both the Compliance Packet and the Annual Audit Certification Form are available on the Nevada Board of Pharmacy's website. The appropriate documentation must be submitted by June 1, 2017. A company may submit its forms via electronic mail, mail, or personal delivery.


The District of Columbia Department of Health Has Released the "Pharmaceutical Marketing Expenditures in the District of Columbia, 2015" Report

April 25, 2017

Pursuant to the District of Columbia’s prescription drug marketing cost reporting law [D.C. CODE § 48-833.01], manufacturers and labelers of prescription drugs that employ, direct, or utilize marketing representatives in D.C. are required to submit an annual report disclosing certain prescription drug marketing costs. The report must be submitted to the D.C. Department of Health (“Department”) by July 1st of each year for those expenses incurred during the previous calendar year.

The Department recently released the "Pharmaceutical Marketing Expenditures in the District of Columbia, 2015" Report ("Report"). This year's Report analyzed expenditures from 140 pharmaceutical manufacturers reporting to D.C.'s AccessRx, and 438 pharmaceutical and medical device manufacturers reporting to Open Payments. According to the Report, the 140 pharmaceutical manufacturers reported expending $96.1 million in 2015 for advertising, gift, and aggregate expenses in D.C. Of the 2015 total, companies spent $24.4 million for gift expenses, $5.6 million for advertising expenses, and $66.2 million for aggregate expenses.


Massachusetts Department of Public Health Has Confirmed That Pharmaceutical and Medical Device Manufacturers Must Submit Annual Disclosure by Monday, July 3, 2017

April 18, 2017

The Massachusetts Pharmaceutical and Medical Device Manufacturer Conduct Law [Mass. Gen. Laws Ch. 111N] (“Law”) and its implementing regulations require each pharmaceutical and medical device manufacturer that employs or contracts with a pharmaceutical or medical device manufacturer agent to annually disclose to the Department of Public Health (“Department”) the “value, nature, purpose and particular recipient of any fee, payment, subsidy or other economic benefit with a value of at least $50, which the company provides, directly or through its agents” to any covered recipient in connection with the company’s sales and marketing activities. The annual disclosure report is due by July 1st of each year for expenditures incurred during the preceding calendar year.

As July 1st falls on a Saturday this year, a representative with the Department has confirmed that the deadline to submit reports is Monday, July 3, 2017, for the period covering January 1 through December 31, 2016. Disclosure reports must be sent in a CSV file as an email attachment to the following address: pharmameddata@massmail.state.ma.us.

Manufacturers with no disclosures to report should send an email to the above email address with the subject line containing the manufacturer's name and user ID, and state in the body of the email there are no disclosures to report.

In addition to submitting annual disclosure reports, each manufacturer must adopt the marketing code of conduct issued by the Department and establish a program to routinely train appropriate employees on the code of conduct. Specifically, manufacturers must establish policies and procedures for conducting investigations into instances of non-compliance, taking corrective action, and reporting instances of non-compliance to the appropriate state authority.


The District of Columbia Department of Health Has Posted on Its Website the 2016 Prescription Drug Marketing Cost Reporting Form

April 13, 2017

Pursuant to the District of Columbia’s prescription drug marketing cost reporting law [D.C. CODE § 48-833.01-.09], manufacturers and labelers of prescription drugs dispensed in D.C. that employ, direct, or utilize marketing representatives in D.C. are required to submit an annual report disclosing certain prescription drug marketing costs. The report must be submitted to the D.C. Department of Health (“Department”) by July 1st of each year for those expenses incurred during the previous calendar year.

The Department of Health recently posted on its website the 2016 Prescription Drug Marketing Costs reporting form. Applicable manufacturers and labelers must use the form to report their marketing expenses for the 2016 calendar year. Companies must submit their 2016 reports by July 1, 2017, along with a $5,000 filing fee.

Some of the notable changes for this year's form include changes to the accepted values for Recipient Credentials. "APRN" has been replaced with "APN/NP", "RN" has been replaced with "RN/LPN", and "OD" (optometrist) has been added. Additionally, the Secondary Purpose value of "Speaker Fee or Payment" has been removed. Also, the accompanying "Guide for Pharmaceutical Manufacturers and Labelers Published by the District of Columbia Department of Health Calendar Year 2016" ("Guide") provides information to help companies reduce "double counting" of payments that have been reported to Open Payments.


D.C.'s Temporary Legislation That Amends the Pharmaceutical Detailer Licensure Exemption is Effective Today, April 7, 2017

April 07, 2017

Pursuant to the District of Columbia Pharmaceutical Detailers Amendment Act of 2008 ("Act"), pharmaceutical manufacturer and labeler representatives that are engaged in the practice of pharmaceutical detailing in the District of Columbia must obtain a pharmaceutical detailer license. The District's Municipal Regulations define pharmaceutical detailing as “the practice by a representative of a pharmaceutical manufacturer or labeler of communicating in person with a licensed health professional, or an employee or representative of a licensed health professional, located in the District of Columbia, for the purpose of selling, providing information about, or in any way promoting a pharmaceutical product." The Act was amended in 2015 to provide licensure exemption for individuals "engaged in the practice of pharmaceutical detailing for less than 30 consecutive days per calendar year."

The Mayor of D.C. ("Mayor") approved the Pharmaceutical Detailing Licensure Exemption Temporary Amendment Act of 2016 ("Temporary Act") on February 10, 2017. The Temporary Act strikes the phrase "30 consecutive days per calendar year" from the current law, and inserts the phrase "30 days per calendar year" in its place. The Temporary Amendment is effective today, April 7, 2017, and will expire on November 18, 2017.

The Pharmaceutical Detailing Licensure Exemption Emergency Act of 2016 ("Emergency Act"), which was approved by the Mayor on January 6, 2017, expired on April 6, 2017. The Emergency Act also removed the phrase "30 consecutive days per calendar year" from the current law, and inserted the phrase "30 days per calendar year" in its place.


Drug Manufacturers Must Submit Annual Disclosure Reports to the Minnesota Board of Pharmacy by May 1, 2017

April 03, 2017

Minnesota requires drug manufacturers to report annually to the Minnesota Board of Pharmacy ("Board") all “payments, honoraria, reimbursement or other compensation” permitted under the gift prohibition statute and provided to practitioners during the previous calendar year. The report must identify the value and nature of payment totaling $100 or more, and the practitioner receiving the payment. Reportable practitioners in Minnesota include physician assistants, nurse practitioners, veterinarians and dental therapists.

The annual disclosure report is due by May 1st of each year for expenditures incurred during the preceding calendar year.


CMS Has Announced That the Review and Dispute Period for Physicians and Teaching Hospitals Will Begin on Saturday, April 1, 2017, and Will End on May 15, 2017

March 31, 2017

According to the Physician Payments Sunshine Act and its implementing regulations, applicable manufacturers, applicable group purchasing organizations ("GPOs"), covered recipients, and physician owners or investors must have an opportunity to review and submit corrections to reported data before it becomes publicly accessible. This review and correction period must occur at least 45 days before the Centers for Medicare and Medicaid Services ("CMS") makes the submitted data available to the public.

CMS has announced that the review and dispute period for the 2016 reporting year will begin Saturday, April 1, 2017, and will last until May 15, 2017. During this period, physicians and teaching hospitals may review and, if necessary, dispute payments before the information is made public on June 30, 2017.

According to CMS, "the opportunity for physicians and teaching hospitals to dispute any data associated with them expires at the end of the calendar year in which the record is published." If physicians and teaching hospitals wish to participate in the dispute, review, and correction process, they must be registered with CMS. Physicians and teaching hospitals who registered last year do not need to register again in the CMS Enterprise Portal or the Open Payments system. Updated information may be required, however, depending on how long the account has been inactive.


Reminder: Applicable Manufacturers and GPOs Have Until March 31, 2017, to Submit Their 2016 Sunshine Act Data in CMS' Open Payments System

March 27, 2017

According to the Sunshine Act, applicable manufacturers of covered drugs, devices, biological products, and medical supplies must report annually certain information regarding payments and other transfers of value to physicians and teaching hospitals. An additional provision requires applicable manufacturers and applicable group purchasing organizations ("GPOs") to report all ownership and investment interests held by physicians or members of their families. Applicable manufacturers and GPOs have until March 31, 2017, to submit their 2016 Sunshine Act data in the Centers for Medicare and Medicaid Services' ("CMS") Open Payments system. Prior to submitting their data, applicable manufacturers and GPOs must register or recertify their registrations in the Open Payments system.

For helpful information related to registering in Open Payments and submitting data for the 2016 program year, please see the updated CMS Open Payments Quick Reference Guides, which are located on the Resources page of the Open Payments website.


The Centers for Medicare and Medicaid Services Will Hold Its Next Q&A Session on Wednesday, April 12, 2017

March 14, 2017

The Centers for Medicare and Medicaid Services ("CMS") has announced that it will conduct its next live Question and Answer session on Wednesday, April 12, 2017, from 1:00 p.m. - 2:00 p.m. EST. The session will begin with a short presentation. The Open Payments Team will then respond to questions. System users with questions about the Data Correction Period are encouraged to attend.

To ask a question, session attendees must register online at least 15 minutes prior to the start of the webinar at https://meetings-cms.webex.com. Registered attendees will receive a separate email with instructions for joining the call and asking questions.


The Vermont Attorney General's Office Has Posted the 2016 Expenditure and Sample Disclosure Forms for Reporting Under the Prescribed Products Gift Ban and Disclosure Law

February 22, 2017

The Vermont Attorney General’s Office (“AG Office”) recently posted on its website the 2016 Expenditure Disclosure and Sample Disclosure Forms to aid reporting entities in complying with the requirements of Vermont's Prescribed Products Gift Ban and Disclosure Law (“Law”). Manufacturers of prescription drugs, biological products, and medical devices must submit the 2016 Expenditure Disclosure Form by April 3, 2017, and must disclose the value, nature, purpose, and recipient of any allowable expenditure made or permitted gift given between January 1 and December 31, 2016.

Additionally, manufacturers of prescription drugs, biological products, and medical devices must submit the 2016 Sample Disclosure Form by April 3, 2017, and must include the product, recipient, number of units, dosage, and other information for all samples provided to health care providers. The samples report should cover samples distributed between January 1 and December 31, 2016.

To make the required disclosures, manufacturers may either: (1) manually enter their data on a form available on the AG Office's website (http://agoprescribedproducts.atg.state.vt.us/login); or (2) enter the data on the 2016 Expenditures Excel spreadsheet and/or the 2016 Samples Excel spreadsheet provided on the AG Office's website and submit to the following email address: ago.prescribedproducts@vermont.gov.

A representative with the AG's Office has stated that the Access database is no longer being utilized for reporting. Additionally, as April 1st falls on a Saturday this year, the AG's Office has confirmed that the deadline to submit reports for calendar year 2016 is Monday, April 3, 2017.


D.C. Has Enacted Both Temporary and Emergency Legislation to Amend the Pharmaceutical Detailer Licensure Exemption

February 15, 2017

Pursuant to the District of Columbia Pharmaceutical Detailers Amendment Act of 2008 ("Act"), pharmaceutical manufacturer and labeler representatives that are engaged in the practice of pharmaceutical detailing in the District of Columbia must obtain a pharmaceutical detailer license. The District's Municipal Regulations define pharmaceutical detailing as “the practice by a representative of a pharmaceutical manufacturer or labeler of communicating in person with a licensed health professional, or an employee or representative of a licensed health professional, located in the District of Columbia, for the purpose of selling, providing information about, or in any way promoting a pharmaceutical product." The Act was amended in 2015 to provide licensure exemption for individuals "engaged in the practice of pharmaceutical detailing for less than 30 consecutive days per calendar year."

In December 2016, the D.C. Council ("Council") enacted the Pharmaceutical Detailing Licensure Exemption Emergency Declaration Resolution of 2016 ("Emergency Resolution"). According to the Emergency Resolution, since the enactment of the amended Act in 2015, there has been some ambiguity in how to interpret and implement the "30 consecutive days" to determine whether an individual needs to obtain a pharmaceutical detailer license. As such, the Council resolved that removing the term "consecutive" would eliminate any ambiguity from the exemption.

On January 6, 2017, the Mayor of D.C. ("Mayor") approved the Pharmaceutical Detailing Licensure Exemption Emergency Act of 2016 ("Emergency Act"). The Emergency Act strikes the phrase "30 consecutive days per calendar year" from the current law, and insert the phrase "30 days per calendar year" in its place. Additionally, the Mayor approved the Pharmaceutical Detailing Licensure Exemption Temporary Amendment Act of 2016 ("Temporary Act") on February 10, 2017, which amends the current law in the same way.

Although both the Emergency Act and the Temporary Act amend the current law in the same way, the Temporary Act will remain in effect for a longer period of time than the Emergency Act (220 days for the Temporary Act and 90 days for the Emergency Act). The Temporary Act will provide sufficient time for the Council to enact permanent legislation. It is not uncommon for the Council to concurrently introduce temporary and emergency legislation.


Senators Grassley and Blumenthal Have Reintroduced Legislation to Require Applicable Manufacturers to Report Payments Made to PAs and APRNs

February 13, 2017

Senator Charles Grassley and Senator Richard Blumenthal have reintroduced legislation that would amend the Sunshine Act by requiring applicable manufacturers to report payments made to physician assistants and advanced practice registered nurses. Pursuant to the Sunshine Act, applicable manufacturers of covered drugs, devices, biological products, and medical supplies are required to report annually certain information regarding payments and other transfers of value to physicians and teaching hospitals. Senate Bill 308 ("S. 308"), cited as the "Provider Payment Sunshine Act," would amend the Sunshine Act to require applicable manufacturers to also report payments made to physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives.

This requirement would not apply to PAs and APRNs who are employees of the applicable manufacturer that is required to submit information under the Sunshine Act. This amendment would apply to "information required to be submitted under [the Sunshine Act]…each calendar year beginning with 2019."

In support of S. 308, Senator Grassley stated that the “goal of sunshine for payments to doctors is to help the public. It makes sense to apply the sunshine to anyone who prescribes medicine. This bill is meant to continue the transparency that brings accountability in this part of the health care system.” Senator Blumenthal added that it is "absolutely essential that companies disclose gifts and payments made to any health care provider who prescribes medications – not just doctors.” He continued in saying that S. 308 will "rein in bad behavior by increasing transparency and accountability across the healthcare industry. Increased access to information is in the public’s best interest, and this legislation will ensure healthcare consumers receive safe, efficient, and cost-effective practices.”

Senators Grassley and Blumenthal introduced similar legislation in 2015.


The Centers for Medicare and Medicaid Services Will Hold Its Next Q&A Session on Wednesday, February 8, 2017

February 06, 2017

The Centers for Medicare and Medicaid Services ("CMS") has announced that it will conduct its next Question and Answer session on Wednesday, February 8, 2017, from 1:00 p.m. - 2:00 p.m. EST. During the session, the Open Payments Team will present an overview of system enhancements, and will respond to questions regarding the 2016 Open Payments program year. The dial in information for the session is 1-844-396-8222, and the meeting ID is 909 001 849.


Federal Drug Sample Disclosure Reports for Calendar Year 2016 are Due Monday, April 3, 2017

February 02, 2017

According to the Patient Protection and Affordable Care Act ("Act"), manufacturers and authorized distributors of record ("ADRs") are required to disclose to the Secretary of the Department of Health and Human Services ("Secretary") certain information related to drug samples on or before April 1st of each year. The Act states that manufacturers and ADRs who make distributions of samples of applicable drugs by mail, common carrier, or by other means, must submit the following information to the Secretary:

The identity and quantity of drug samples requested;

The identity and quantity of drug samples distributed;

The name, address, professional designation, and signature of any person who makes or signs for the request; and

Any other category of information determined appropriate by the Secretary.

As April 1st falls on a Saturday this year, a representative from the Secretary's office has confirmed that the deadline to submit reports for calendar year 2016 is Monday, April 3, 2017.


CMS Announces That Applicable Manufacturers and GPOs May Begin Data Submission for Payments or Transfers of Value That Occurred in the 2016 Calendar Year

February 01, 2017

The Centers for Medicare and Medicaid Services ("CMS") has announced that the Open Payments system is now available. Applicable manufacturers and group purchasing organizations ("GPOs") may begin submitting data in the system for payments or transfers of value made between January 1 and December 31, 2016. Additionally, applicable manufacturers and GPOs may register or recertify their registration from the previous year, and may submit corrected data from previous program years. The data submission period will continue through March 31, 2017. All applicable manufacturers and GPOs with reportable payments, other transfers of value, or ownership or investment interests must register or recertify their registration.


The Minnesota Board of Pharmacy Has Posted the Payments to Practitioners Reporting Form for the 2016 Calendar Year

January 27, 2017

Minnesota requires drug manufacturers to report annually to the Minnesota Board of Pharmacy ("Board") all “payments, honoraria, reimbursement or other compensation” permitted under the gift prohibition statute and provided to practitioners during the previous calendar year. The report must identify the value and nature of payment totaling $100 or more, and the practitioner receiving the payment. Reportable practitioners in Minnesota include physician assistants, nurse practitioners, veterinarians, and dental therapists.

The annual disclosure report is due by May 1st of each year for expenditures incurred during the preceding calendar year. Drug manufacturers should use this form when submitting their reports to the Board.


The Centers for Medicare and Medicaid Services Has Updated the Open Payments Dataset to Reflect Changes Made to the Data Since June 30, 2016

January 18, 2017

The Centers for Medicare and Medicaid Services ("CMS") has updated the Open Payments dataset, reflecting changes made to the data since the last publication on June 30, 2016. The updated dataset includes:

Changes made to records;

Changes to delay in publication flags;

Changes to disputed records; and

Record deletions.

The updated dataset is available on the Open Payments website at https://openpaymentsdata.cms.gov.


CMS' Open Payments System Will Be Unavailable for Maintenance Beginning Today January 16, 2017, through January 31, 2017

January 16, 2017

The Centers for Medicare and Medicaid Services' ("CMS") Open Payments system will be unavailable for maintenance beginning today, January 16, 2017, through January 31, 2017. The system outage is due to preparation for the Data Submission Period, which is scheduled to begin on February 1, 2017, and continue through March 31, 2017. During the outage, access to Open Payments data, the data search tool, and the Enterprise Portal registration will remain available.


D.C. Has Enacted Emergency Legislation to Amend the Pharmaceutical Detailer Licensure Exemption

January 10, 2017

Pursuant to the District of Columbia Pharmaceutical Detailers Amendment Act of 2008 ("Act"), pharmaceutical manufacturer and labeler representatives that are engaged in the practice of pharmaceutical detailing in the District of Columbia must obtain a pharmaceutical detailer license. The District's Municipal Regulations define pharmaceutical detailing as “the practice by a representative of a pharmaceutical manufacturer or labeler of communicating in person with a licensed health professional, or an employee or representative of a licensed health professional, located in the District of Columbia, for the purpose of selling, providing information about, or in any way promoting a pharmaceutical product." The Act was amended in 2015 to provide licensure exemption for individuals "engaged in the practice of pharmaceutical detailing for less than 30 consecutive days per calendar year."

In December 2016, the D.C. Council ("Council") enacted the Pharmaceutical Detailing Licensure Exemption Emergency Declaration Resolution of 2016 ("Emergency Resolution"). According to the Emergency Resolution, since the enactment of the amended Act in 2015, there has been some ambiguity in how to interpret and implement the "30 consecutive days" to determine whether an individual needs to obtain a pharmaceutical detailer license. As such, the Council resolved that removing the term "consecutive" would eliminate any ambiguity from the exemption.

On January 6, 2017, the Mayor of D.C. approved the Pharmaceutical Detailing Licensure Exemption Emergency Act of 2016 ("Emergency Act"). The Emergency Act strikes the phrase "30 consecutive days per calendar year" from the current law, and insert the phrase "30 days per calendar year" in its place. The Emergency Act will remain in effect for 90 days.


Miami-Dade County, Florida Lobbyists Must Renew Their Annual Lobbyist Registrations by January 15, 2017

December 28, 2016

The Code of Miami-Dade County, Florida (“Code”) requires any individual who seeks to encourage the actions, decisions, or recommendations of the County Commission, County Manager, County Personnel, or any County board or committee to register as a lobbyist with the Miami-Dade Board of County Commissioners. Pursuant to the Code, lobbyists operating in the County must register with the Clerk of the Board of County Commissioners (“Clerk”) within five business days of being retained as a lobbyist or before engaging in any lobbying activities, whichever occurs first. Each new lobbyist must create an account and register on the Clerk's website. Lobbyist registrations must be renewed annually.

Miami-Dade County lobbyist registrations will expire on December 31, 2016. Lobbyists may submit their 2017 Annual Lobbyist Registration Form ("Registration Form") and a registration fee of $490 to the Clerk via the Lobbyist Online Registration and Information System, or may file using a paper form prior to January 15, 2017.

Please note that the lobbyist’s principal, or the company that employs the lobbyist to engage in lobbying, must file a separate Lobbyist Activity Authorization Form before any lobbying activity takes place. This form, however, does not have to be resubmitted with the annual registration.


The Centers for Medicare and Medicaid Services Announces That It Will Publish a Refresh of Open Payments Data in January 2017

December 16, 2016

The Centers for Medicare and Medicaid Services ("CMS") has announced that it will publish a refresh of the Open Payments data in January 2017. The refresh will include updates to payments or transfers of value that were made during Program Years 2013 – 2015, including the following:

Payments or transfers of value that were previously excluded from Open Payments due to delay in publication rules (the delay in publication indicator must have been removed by November 15, 2016);

Changes to undisputed records made by November 15, 2016;

Changes to disputed records made by December 31, 2016; and

Record deletions made by December 31, 2016.

CMS also announced that the Open Payments system will be unavailable due to maintenance starting January 16, 2017, through January 31, 2017. CMS' Enterprise Identity Management System (EIDM) registration will continue to be available for reporting entities, physicians, and teaching hospitals during that time period.


Connecticut's Department of Public Health Publishes List of APRNs Engaged in Independent Practice to Assist Manufacturers Required to Submit Reports on Payments Made to These Practitioners

November 28, 2016

In 2015, Connecticut enacted legislation requiring applicable manufacturers that provide payments or other transfers of value to Advanced Practice Registered Nurses ("APRNs") engaged in independent practice to submit annual reports to the Connecticut Commissioner of Consumer Protection. As written, the law requires that the first report be submitted no later than July 1, 2017, and annually thereafter, and should include payments or other transfers of value provided to APRNs during the preceding calendar year.

Connecticut's law also requires the Commissioner of Public Health to publish annually on the Department of Public Health's ("Department") website a list of APRNs who are authorized to engage in independent practice. The Department recently published this list on its website. Applicable manufacturers should use this list when determining whether information on payments or other transfers of value made to APRNs must be reported. The list can be found at http://www.ct.gov.

The Department of Consumer Protection has indicated that its Drug Control Division will accept reports in the format found on the Centers for Medicare and Medicaid Services' Open Payments website titled "2013-2015 CSV Sample File: General Payments [CSV]." Reports should be submitted via email to DCP.DrugManufacturers@ct.gov. Questions regarding the reporting form should be submitted to the same email address.


Connecticut's Department of Consumer Protection Has Updated Its Website to Provide Guidance on Reporting Payments or Other Transfers of Value to APRNs Engaged in Independent Practice

November 15, 2016

In 2015, Connecticut enacted legislation requiring applicable manufacturers that provide payments or other transfers of value to Advanced Practice Registered Nurses ("APRNs") engaged in independent practice to submit annual reports to the Connecticut Commissioner of Consumer Protection. As written, the law requires that the first report be submitted no later than July 1, 2017, and annually thereafter, and should include payments or other transfers of value provided to APRNs during the preceding calendar year.

The Department of Consumer Protection ("Department") recently posted information on its website regarding report submissions. According to the Department, the Drug Control Division will accept reports in the format found on the Centers for Medicare and Medicaid Services' Open Payments website titled "2013-2015 CSV Sample File: General Payments [CSV]." Reports should be submitted via email to DCP.DrugManufacturers@ct.gov. Questions concerning the reporting form should be submitted to the same email address.

Connecticut's law also requires the Commissioner of Public Health to publish annually on the Department of Public Health's website a list of APRNs who are authorized to engage in independent practice. Applicable manufacturers should refer to this list when determining whether they must report information on payments or other transfers of value made to an APRN. This list has not yet been published. Applicable manufacturers may, however, generate a list of Connecticut-licensed APRNs on the state's eLicense website, and filter this list to view those APRNs engaged in independent practice. This list is updated in real time with information provided by APRNs. A representative with the Department of Public Health indicated that a separate list with only APRNs engaged in independent practice may be published in the future.


Registered Lobbyists in Louisiana Must Submit Their October Lobbyist Expenditure Reports to the Board of Ethics by November 28, 2016

November 08, 2016

The Louisiana Executive Branch Lobbying Law ("Law") requires any pharmaceutical sales representative who interacts with members of the Medicaid Pharmaceutical and Therapeutics Committee for the purpose of inclusion of a product on the pharmacopoeia or formulary to register with the Louisiana Board of Ethics ("Board") as a lobbyist. Lobbyists must register with the Board no more than five days after becoming employed as a lobbyist or engaging in the first action requiring registration as a lobbyist, whichever occurs first.

In addition to the registration requirement, the Law requires that each registered lobbyist file a monthly Lobbyist Expenditure Report ("Report") with the Board. The Report must list all expenditures that the lobbyist incurred during the previous calendar month for the purposes of lobbying. Lobbyists must file their October 2016 Report with the Board on or before Monday, November 28, 2016. The Report must include expenditures incurred for the purposes of lobbying between October 1 and October 31, 2016.

Reports must be submitted online at http://ethics.la.gov/Lobbyist/.

The Board may impose a late fee of $50 per day against any person who fails to submit a timely Report. In addition, the Board may assess a penalty of up to $10,000 against any person whose Report is filed 11 or more days after the November 28th deadline.


The Centers for Medicare and Medicaid Services Has Posted Updated Quick Reference Guides on Its Open Payments Website

October 28, 2016

Pursuant to the Sunshine Act, applicable manufacturers and group purchasing organizations ("GPOs") of covered drugs, devices, biological products, and medical supplies are required to register and report annually certain information regarding payments and other transfers of value made to physicians and teaching hospitals. The Centers for Medicare and Medicaid Services ("CMS") has posted updates to its quick reference guides on its Open Payments website to assist with Sunshine Act registration and data submission for the 2016 calendar year. CMS posted the following updated guides:

•Applicable Manufacturer and Applicable GPO Registration and Re-certification – Quick Reference Guide (Dated September 2016); and

•Reporting Entities: User Roles, Nominations, Approving/Rejecting Self-Nominations – Quick Reference Guide (Dated September 2016).

These resources are available on the Open Payments website in the "User Registration" section.


The Center for Medicare and Medicaid Services Has Posted Updated Data Submission Resources for 2016 on Its Open Payments Website to Assist with Sunshine Act Reporting

October 04, 2016

The Centers for Medicare and Medicaid Services (“CMS”) has posted updated data submission resources on its Open Payments website to assist reporting entities with 2016 data submission as required by the Sunshine Act. Pursuant to the Sunshine Act, applicable manufacturers of covered drugs, devices, biological products, and medical supplies are required to report annually certain information regarding payments and other transfers of value to physicians and teaching hospitals.

CMS recently posted the following data submission resources to assist reporting entities with 2016 data submission:

•2016 Data Submission Data Mapping Document; and

•Open Payments Change Summary: 2016 Data Submission Data Mapping Document (Dated September 2016).

These resources are available on the CMS Open Payments website in the “Data Submission and Attestation” section.


The Centers for Medicare and Medicaid Services Has Released the Adjusted 2017 Open Payments Reporting Threshold for Payments or Other Transfers of Value

October 03, 2016

The Centers for Medicare and Medicaid Services (“CMS”) recently announced that it has adjusted the reporting threshold for payments or other transfers of value pursuant to the Sunshine Act. According to the Sunshine Act, applicable manufacturers are not required to report transfers of anything valued at less than $10, unless the aggregate amount “transferred to, requested by, or designated on behalf of the covered recipient by the applicable manufacturer during the calendar year exceeds $100.” The Sunshine Act further states that “[f]or calendar years after 2012, the dollar amounts specified [above] shall be increased by the same percentage as the percentage increase in the consumer price index for all urban consumers . . . for the 12-month period ending with June of the previous year.”

As such, CMS recently adjusted the reporting threshold based on the consumer price index. For the 2017 reporting period (January 1 – December 31, 2017), applicable manufacturers are not required to report transfers of anything valued at less than $10.32 ($10.22 for 2016), unless the aggregate amount transferred to, requested by, or designated on behalf of a covered recipient exceeds $103.22 ($102.19 for 2016) in the calendar year.


CMS Has Posted on Its Open Payments Website the 2017 List of Teaching Hospitals

September 30, 2016

The Centers for Medicare and Medicaid Services ("CMS") posted on its Open Payments website the 2017 Teaching Hospital List ("List"). the final regulations implementing the Sunshine Act define a "teaching hospital" as "any institution that received a payment under 1886(d)(5)(B), 1886(h), or 1886(s) of the Act during the last calendar year for which such information is available." In order to assist applicable manufacturers in identifying teaching hospitals, CMS stated that it will publish a list of the relevant teaching hospitals "at least 90 days before the beginning of the reporting year...."

The 2017 List includes the same information categories as the 2016 Teaching Hospital List (i.e. taxpayer identification number ("TIN"), teaching hospital name, PECOS legal business name, NPPES business address, etc."). Applicable manufacturers and applicable group purchasing organizations should use the List for the January 1 through December 31, 2017, data collection period.


Porzio AggregateSpendID Version 5.2 System Release

September 26, 2016

MedPro Systems (MedPro) and Porzio Life Sciences (PorzioLS) are pleased to announce the availability of Version 5.2 of Porzio AggregateSpendID ("Version 5.2"). The enhancements included in the Version 5.2 release are available to customers as of September 26, 2016 and feature updates to customer Dashboards, Manage Spend functionality, Compliance Reports and Settings.

If you have any questions, please contact the Customer Service Help Desk via the "Contact Us" link.


The Last Day to Submit Comments to the Centers for Medicare and Medicaid Services Regarding Aspects of the Open Payments Program is Tuesday, September 6, 2016

September 02, 2016

The Centers for Medicare and Medicaid Services ("CMS") recently published in the Federal Register its proposed Physician Fee Schedule for 2017. As part of the proposal, CMS briefly discussed the Sunshine Act and the implementing rule regarding the Open Payments Program. According to CMS, it has identified areas in the rule "that might benefit from revision." As such, CMS is soliciting comments from stakeholders to inform future rulemaking. The last day to submit comments is Tuesday, September 6, 2016.

CMS is interested in receiving comments on the following:

1. Whether the nature of payments categories is inclusive enough to facilitate reporting of all payments or transfers of value to covered physicians and teaching hospital and is requesting feedback on proposed new categorizations;

2. Feedback on how many years applicable manufacturers and group purchasing organizations ("GPOs") should remain obligated to monitor and report on past reporting program years;

3. Feedback on how many years of Open Payments data is relevant to determine how many years to continue to publish and refresh annually;

4. Feedback on the requirement that manufacturers and GPOs register each year regardless of whether the entity will be reporting any payments or transfers of value and also seeking comments about requiring manufacturers and GPOs to identify reasons they are not reporting payments;

5. Comments on a requirement that manufacturers and GPOs pre-vet payment information with covered recipients and physician owners or investors before reporting to the Open Payments system, specifically feedback on pre-vetting based on threshold values or random samplings of covered recipients;

6. Feedback on the current definition of a covered recipient teaching hospital and requesting alternative feasible definitions;

7. To help teaching hospitals in verifying payments and to avoid payment disputes, feedback on adding a new non-public data element to assist in reviewing and affirming payment records;

8. Feedback on the benefit of reporting data to CMS early or ongoing throughout the year in an effort to increase data validity and minimize disputes;

9. Feedback on changing reporting requirements to insure that the industry can properly represent changes due to mergers. acquisitions and other structural corporate changes;

10. Feedback on operationally feasible definitions regarding ownership or investment interests, specifically regarding the terms "value or interest" and "dollar amount invested";

11. Ideas on how to define physician-owned distributors and what portion of the reported data should be shared on the website;

12. Ways to streamline or make the reporting process more efficient; and

13. With respect to all solicitations, an estimate of the time and cost burden associated with reporting to comply with the Paperwork Reduction Act.

Comments are due by 5:00 PM on September 6th. Comments may be submitted by following submission instructions at http://www.regulations.gov/.


The Miami-Dade County (Florida) Commission on Ethics and Public Trust Will Hold Its Next Training Session for Lobbyists on Friday, September 16, 2016

August 25, 2016

On Friday, September 16, 2016, the Miami-Dade County Commission on Ethics and Public Trust (“Commission”) will hold its next ethics training course for lobbyists. According to Miami-Dade County's Conflict of Interest and Code of Ethics Ordinance ("Ordinance"), the ethics course must include a review of the Ordinance, as well as Florida's Sunshine Law and Public Records Law.

Pursuant to the Ordinance, within 60 days after registering as a lobbyist, each lobbyist is required to submit to the Clerk of the Board of County Commissioners ("Clerk") a certificate of completion of an ethics course offered by the Commission. The Commission has scheduled an ethics course for September 16, 2016, from 9:00 a.m. to 1:00 p.m.

The ethics training course for lobbyists will be held at the following location:

Miami-Dade County Commission on Ethics and Public Trust COE Conference Room 19 West Flagler Street, Suite 820 Miami, FL 33130

The fee for attending the ethics course is $100. Interested individuals should download the registration form at http://ethics.miamidade.gov/training.asp and submit the completed form with a check for $100 made payable to the Miami-Dade Ethics Commission at the address provided above. Individuals also have the option of faxing the completed form with their credit card information to (305) 579-0273.


Applicable Manufacturers Required to Report Payments to APRNs Engaged in Independent Practice in Connecticut May Generate a List of These Practitioners on the State's eLicense Website

August 05, 2016

Effective July 1, 2014, advanced practice registered nurses ("APRNs") in Connecticut who have practiced and prescribed in collaboration with a licensed physician for at least three years are permitted to independently (1) diagnose and treat alterations in health status, and (2) prescribe, dispense, and administer medical therapeutic and corrective measures and dispense professional samples. Please note that those APRNs who do not qualify to practice independently are required to practice and prescribe, dispense, and administer medication in collaboration with a physician licensed to practice medicine in the state.

Connecticut has also enacted legislation requiring applicable manufacturers that provide payments or other transfers of value to APRNs engaged in independent practice to submit annual reports to the Connecticut Commissioner of Consumer Protection. The first report is due no later than July 1, 2017, and should include payments or other transfers of value provided to APRNs from January 1 – December 31, 2016. The Commissioner of Public Health is required to publish annually on the Department of Public Health's ("Department") website a list of APRNs who are authorized to engage in independent practice. Applicable manufacturers must refer to this list when determining whether it must report information on payments or other transfers of value made to an APRN.

The Department has not yet published a list of APRNs engaged in independent practice. Applicable manufacturers may, however, generate a list of Connecticut-licensed APRNs on the state's eLicense website, and filter this list to view those APRNs engaged in independent practice. This list is updated in real time with information provided by APRNs. A representative with the Department indicated that the Department may publish a separate list with only APRNs engaged in independent practice in the future. Please see the PCD for updated versions of this list.


The Centers for Medicare and Medicaid Services Will Host Its Special Open Door Forum Today Starting at 1:30 P.M. (Updated Start Time)

August 02, 2016

The Centers for Medicare and Medicaid Services ("CMS") recently published in the Federal Register its proposed Physician Fee Schedule for 2017. As part of the proposal, CMS briefly discussed the Sunshine Act and the implementing rule regarding the Open Payments Program. According to CMS, it has identified areas in the rule "that might benefit from revision." As such, CMS is soliciting comments from stakeholders to inform future rulemaking.

In addition to accepting comments as noted in the submission instructions at http://www.regulations.gov/, CMS will host a Special Open Door Forum to receive input from stakeholders. The Forum will be held today, August 2nd, and will now begin at 1:30 p.m. EST; CMS updated the start time for the Forum yesterday. The Participant dial-in information for the Forum is (800) 837-1935, and the Conference ID is 44678813.


Pharmaceutical and Medical Device Manufacturers Must Renew Registration to the Massachusetts Department of Public Health by August 31, 2016

August 01, 2016

The Massachusetts Pharmaceutical and Medical Device Manufacturer Conduct Law [Mass. Gen. Laws Ch. 111N] ("Law") and its implementing regulations require each pharmaceutical and medical device manufacturer that employs or contracts with a pharmaceutical or medical device manufacturer agent to renew their registration each year with the Massachusetts Department of Public Health ("Department"). The 2016 registration period is open from July 5 until August 31.

Manufacturers are required to annually renew their registration with the Department, and certify that they have conducted annual audits to monitor compliance with the code of conduct. In addition, manufacturers will be required to pay a $2,000 renewal fee.

The Department provides two methods by which manufacturers may renew their registrations. The first method allows manufacturers to renew their registrations by utilizing the Department's online renewal system during the registration renewal period. This method requires a manufacturer to have a unique renewal ID as provided by the Department in order to renew its registration online. Manufacturers using the online system will be permitted to pay the $2,000 fee via credit card or electronic check.

The second method allows manufacturers to renew their registrations by using a paper Registration Renewal Compliance Filing Form. Notably, payment in the form of a check or a money order must accompany paper renewal submissions. Manufacturers renewing their registration in this manner should mail their forms and payments to the following address:

Pharmaceutical Code of Conduct Program MA Division of Health Care Quality 99 Chauncy Street, 11th floor Boston, MA 02111


The Centers for Medicare and Medicaid Services Will Hold a Special Open Door Forum to Obtain Comments From Stakeholders on Aspects of the Open Payments Program

July 21, 2016

The Centers for Medicare and Medicaid Services ("CMS") recently published in the Federal Register its proposed Physician Fee Schedule for 2017. As part of the proposal, CMS briefly discussed the Sunshine Act and the implementing rule regarding the Open Payments Program. According to CMS, it has identified areas in the rule "that might benefit from revision." As such, CMS is soliciting comments from stakeholders to inform future rulemaking.

In addition to accepting comments as noted in the submission instructions at http://www.regulations.gov/, CMS has announced that it will host a Special Open Door Forum to receive input from stakeholders. The Forum will be held on Tuesday, August 2, 2016, from 1:00 p.m. to 3:30 p.m. EST. The Participant dial-in information for the Forum is (800) 837-1935, and the Conference ID is 44678813.


The Centers for Medicare and Medicaid Services is Soliciting Comments From Stakeholders Regarding Aspects of the Open Payments Program

July 14, 2016

The Centers for Medicare and Medicaid Services ("CMS") recently published in the Federal Register its proposed Physician Fee Schedule for 2017. As part of the proposal, CMS briefly discussed the Sunshine Act and the implementing rule regarding the Open Payments Program. According to CMS, it has identified areas in the rule "that might benefit from revision." As such, CMS is soliciting comments from stakeholders to inform future rulemaking. CMS is interested in receiving comments on the following:

1. Whether the nature of payments categories is inclusive enough to facilitate reporting of all payments or transfers of value to covered physicians and teaching hospital and is requesting feedback on proposed new categorizations;

2 .Feedback on how many years applicable manufacturers and group purchasing organizations ("GPOs") should remain obligated to monitor and report on past reporting program years;

3. Feedback on how many years of Open Payments data is relevant to determine how many years to continue to publish and refresh annually;

4. Feedback on the requirement that manufacturers and GPOs register each year regardless of whether the entity will be reporting any payments or transfers of value and also seeking comments about requiring manufacturers and GPOs to identify reasons they are not reporting payments;

5. Comments on a requirement that manufacturers and GPOs pre-vet payment information with covered recipients and physician owners or investors before reporting to the Open Payments system, specifically feedback on pre-vetting based on threshold values or random samplings of covered recipients;

6. Feedback on the current definition of a covered recipient teaching hospital and requesting alternative feasible definitions;

7. To help teaching hospitals in verifying payments and to avoid payment disputes, feedback on adding a new non-public data element to assist in reviewing and affirming payment records;

8. Feedback on the benefit of reporting data to CMS early or ongoing throughout the year in an effort to increase data validity and minimize disputes;

9. Feedback on changing reporting requirements to insure that the industry can properly represent changes due to mergers. acquisitions and other structural corporate changes;

10. Feedback on operationally feasible definitions regarding ownership or investment interests, specifically regarding the terms "value or interest" and "dollar amount invested";

11. Ideas on how to define physician-owned distributors and what portion of the reported data should be shared on the website;

12. Ways to streamline or make the reporting process more efficient; and

13. With respect to all solicitations, an estimate of the time and cost burden associated with reporting to comply with the Paperwork Reduction Act.

Comments are due by 5:00 PM on September 6, 2016. Comments may be submitted by following submission instructions at http://www.regulations.gov/.


Today, June 30, 2016, CMS Published the 2015 Open Payments Data

June 30, 2016

According to the Sunshine Act, applicable manufacturers of covered drugs, devices, biological products, and medical supplies must report annually certain information regarding payments and other transfers of value to physicians and teaching hospitals. An additional provision requires applicable manufacturers and group purchasing organizations ("GPOs") to report all ownership and investment interests held by physicians or members of their families. The Sunshine Act requires that the Centers for Medicare and Medicaid Services ("CMS") makes the reported data available to the public on an Internet website that is searchable, clear, and understandable.

Today, CMS published the 2015 Open Payments data submitted and attested to by manufacturers and GPOs earlier this year. According to an email blast from CMS, manufacturers reported "$7.52 billion in payments and ownership and investment interests to physicians and teaching hospitals." This amount is comprised of "11.90 million total records attributable to 618,931 physicians and 1,116 teaching hospitals." Today's publication also includes newly submitted and updated payment records for 2013 and 2014.

Payments in the three major reporting categories are: •$2.60 billion in general (i.e., non-research related) payments; •$3.89 billion in research payments; and •$1.03 billion of ownership or investment interests held by physicians or their immediate family members.

According to CMS, it has published 28.22 million records since the Open Payments program began in 2014. These records account for $16.77 billion in payments and ownership and investment interests. To view and search Open Payments data, click on the following link: https://openpaymentsdata.cms.gov/.


The Centers for Medicare and Medicaid Services Will Publish the 2015 Open Payments Data on 6/30/2016

June 28, 2016

According to the Sunshine Act, applicable manufacturers of covered drugs, devises, biological products, and medical supplies must report annually certain information regarding payments and other transfers of value to physicians and teaching hospitals. An additional provision requires applicable manufacturers and group purchasing organizations ("GPO'S") to report all ownership and investment interests held by physicians or members of their families. The Sunshine Act requires that the Centers for Medicare and Medicaid Services ("CMS") make the reported data available to the public on an internet website that is searchable, clear and understandable. On June 30, 2016, CMS is scheduled to publish the 2015 Open Payments data submitted and attested to by manufacturers and GPOs earlier this year.

There are three ways that members of the public may access the Open Payments data located on the CMS website https://www.cms.gov/openpayments/index.html . The public can use the "search tool" to review identified data for physicians, teaching hospitals, or companies making payments by name, city, state, and specialty. The "data explorer tool" can be used to search and browse the datasets and views or each year's full data set can be downloaded.


Pharmaceutical and Medical Device Manufacturers Must Submit Annual Disclosure Reports to the Massachusetts Department of Public Health by July 1, 2016

June 20, 2016

The annual disclosure report is due by July 1st of each year for expenditures incurred during the preceding calendar year. This year’s disclosure report is due July 1, 2016, and covers the period from January 1 through December 31, 2015. Disclosure reports must be sent in a CSV file as an email attachment to the following address: pharmameddata@state.ma.us.

In addition to submitting annual disclosure reports, each manufacturer must adopt the marketing code of conduct issued by the Department and establish a program to routinely train appropriate employees on the code of conduct. Specifically, manufacturers must establish policies and procedures for conducting investigations into instances of non-compliance, taking corrective action, and reporting instances of non-compliance to the appropriate state authority.

Further, manufacturers are required to annually renew their registration with the Department, and certify that they have conducted annual audits to monitor compliance with the code of conduct. The Department provides two methods by which manufacturers may renew their registrations. The first method allows manufacturers to renew their registrations by utilizing the Department’s online renewal system during the registration renewal period. This method requires a manufacturer to have a unique renewal ID as provided by the Department in order to renew its registration online. Manufacturers using the online system will be permitted to pay the $2,000 fee via credit card or electronic check.

The second method allows manufacturers to renew their registrations by using a paper Registration Renewal Compliance Filing Form. Notably, payment in the form of a check or a money order must accompany paper renewal submissions. Companies renewing their registration in this manner should mail their forms and payments to the following address: Pharmaceutical Code of Conduct Program MA Division of Health Care Quality 99 Chauncy Street, 11th floor Boston, MA 02111

Please note that companies who have not previously registered with the Department may not use these forms. Initial registrants must complete and submit the Initial Registration Compliance Filing Form and the registration fee to the address indicated above.


Prescription Drug Manufacturers and Labelers That Market in the District of Columbia Must Submit Their Annual Prescription Drug Marketing Costs Report by July 1, 2016

June 09, 2016

According to D.C.’s law and implementing regulations, manufacturers and labelers must disclose the following:

•All costs associated with educational programs and informational programs, including: support for IME/CME programs; printing costs of patient education materials and disease management materials; design and production costs of patient education materials and disease management materials designed specifically for District users; payments for writing articles or publications; charitable grants; payments made for participation in market research surveys or assistance in developing marketing strategies.

•All costs associated with food, entertainment, and gifts valued at more than $25 provided to healthcare professionals, pharmacies, hospitals and other entities licensed to provide healthcare.

•All costs associated with trips and travel.

•All costs associated with product samples, except for samples that will be distributed free of charge to patients.

•All expenses associated with advertising, marketing, and direct promotion of prescription drugs through radio, television, magazines, newspapers, direct mail, and telephone communications as they pertain to District residents. For each advertising expense that is to be reported, companies must disclose the following information: activity date, type of activity, medium type and name, product marketed, target audience, and the cost of activity.

Additionally, the annual report must also include the total cost of, including all forms of payment, to all employees and contractors engaged in marketing activities, directly or indirectly, in the District or directed at residents in the District. Please note that in light of the federal Sunshine Act reporting requirements, applicable manufacturers and labelers are not required to report to D.C. payments and gifts made to physicians and teaching hospitals that are subject to disclosure under Sunshine. Physicians include doctors of medicine and osteopathy, doctors of dental surgery and medicine, doctors of podiatric medicine, doctors of optometry, and chiropractors. The reporting requirements for aggregate and advertising expenses remain unchanged.


The U.S. Senate Has Introduced Legislation That Would Exclude the Distribution of Peer-Reviewed Medical Journals and Textbooks From Sunshine Act Reporting

June 06, 2016

The United States Senate recently introduced Senate Bill 2978 ("S.B. 2978"), which would amend the Sunshine Act by excluding from the reporting requirement "peer-reviewed journals, journal reprints, journal supplements, and medical textbooks." Currently, the Centers for Medicare and Medicaid Services ("CMS") does not exclude these materials from reporting. According to the preamble of the final regulations implementing the Sunshine Act, educational materials (including medical textbooks) provided to covered recipient physicians for their own education, but that do not directly benefit patients, are subject to reporting. CMS notes in the preamble that although these items are important for physicians and may have “downstream benefits” for patients, they are not directly beneficial to patients and are not intended for patient use. Therefore, according to CMS, these items are reportable under the Sunshine Act.

S.B. 2978 would also add to the current list of exclusions an indirect payment or transfer of value to a covered recipient who is a physician "for speaking at, or preparing educational materials for, an educational event for physicians or other healthcare professionals that does not commercially promote a covered drug, device, biological, or medical supply," or "that serves the sole purpose of providing the covered recipient with medical education, such as by providing the covered recipient with the tuition required to attend an educational event or with materials provided to physicians at an educational event."

Please note that in 2015, the House of Representatives introduced two similar bills to exclude these materials from reporting. House Bill 293 ("H.R. 293") and House Bill 6 ("H.R. 6"). H.R. 293 is under consideration by the House Ways and Means Committee. H.R. 6, also known as the 21st Century Cures Act, was passed by the House of Representatives in July and is currently under consideration by the Senate.


The Massachusetts Department of Public Health Has Posted on Its Website an Updated List of Covered Recipients

June 02, 2016

The Massachusetts Pharmaceutical and Medical Device Manufacturer Conduct Law [Mass. Gen. Laws Ch. 111N] (“Law”) and its implementing regulations require each pharmaceutical and medical device manufacturer that employs or contracts with a pharmaceutical or medical device manufacturer agent to disclose annually to the Department of Public Health (“Department”) the “value, nature, purpose and particular recipient of any fee, payment, subsidy or other economic benefit with a value of at least $50, which the company provides, directly or through its agents” to any covered recipient in connection with the company’s sales and marketing activities. The implementing regulations define a “covered recipient” to include “a person authorized to prescribe, dispense, or purchase prescription drugs or medical devices in Massachusetts, including a hospital, nursing home, pharmacist, health benefit plan administrator, or a health care practitioner.”

When completing disclosure reports, manufacturers are required to disclose information regarding each covered recipient. In an effort to help manufacturers comply with the disclosure requirements, the Department has posted on its website an updated list of covered recipients for the 2015 calendar year. The annual disclosure report is due by July 1st of each year for expenditures incurred during the preceding calendar year.


Reminder: The Open Payments Data Correction Period Will End on May 30, 2016

May 16, 2016

According to the Sunshine Act and its implementing regulations, applicable manufacturers, applicable group purchasing organizations ("GPOs"), covered recipients, and physician owners or investors must have an opportunity to review and submit corrections to the data submitted pursuant to the Sunshine Act. This review and correction period must occur at least 45 days before the Centers for Medicare and Medicaid Services ("CMS") makes the submitted data available to the public. The review and dispute period concluded on May 15, 2016. The correction period began on, May 16, 2016, and concludes on May 30, 2016. During the correction period, applicable manufacturers and applicable GPOs will have the opportunity to "acknowledge and resolve" disputes initiated by physicians and teaching hospitals. CMS has emphasized that it is up to applicable manufacturers and applicable GPOs to work directly with physicians or teaching hospitals to resolve any disputes; CMS will not mediate any disputes. CMS has posted step-by-step instructions on the data correction process. This information is located on the Resources Page of the Open Payments website.


Rhode Island Introduces Legislation That Would Require Certain Manufacturers to Report Marketing and Advertising Costs Associated With Promotion of Their Drugs

May 03, 2016

The Rhode Island General Assembly recently introduced House Bill H 7839 ("H7839"), which would require the Executive Office of Health and Human Services ("EOHHS") to develop a list of critical prescription drugs where there is a substantial public interest in drug pricing. H7839 would require manufacturers of each drug placed on the critical prescription drug list to report to the EOHHS the costs related to each qualifying drug. Among other reportable costs, the report must disclose the "marketing and advertising costs for the drug, apportioned by marketing activities that are directed to consumers, marketing activities that are directed to prescribers, and the total cost of all marketing and advertising that is directed primarily to Rhode Island consumers and prescribers." H7839 would also require the EOHHS to promulgate regulations, that would further define the provisions of this section, which may include monetary penalties for failure to comply with the requirements. Additionally, the EOHHS would be required to submit an annual report on prescription drug prices and their role in overall health care spending in the state based on the data submitted. The report shall be posted on the EOHHS's website and would be filed with the speaker of the house of representatives and the president of the senate. If passed, this act shall take effect on January 1, 2017.


Version 5.1 Release

May 02, 2016

MedPro and PorzioLS are pleased to announce the availability of Version 5.1 of Porzio AggregateSpendID ("Version 5.1"). Version 5.1 features functionality and layout enhancements to the Alerts, Dashboard and DisputeID screens.


The District of Columbia Department of Health Has Released the "Pharmaceutical Marketing Expenditures in the District of Columbia, 2014" Report

April 22, 2016

Pursuant to the District of Columbia’s prescription drug marketing cost reporting law [D.C. CODE § 48-833.01], manufacturers and labelers of prescription drugs that employ, direct, or utilize marketing representatives in D.C. are required to submit an annual report disclosing certain prescription drug marketing costs. The report must be submitted to the D.C. Department of Health (“Department”) by July 1st of each year for those expenses incurred during the previous calendar year. The Department recently released the "Pharmaceutical Marketing Expenditures in the District of Columbia, 2014" Report ("Report"). This year's Report analyzed expenditures from 153 pharmaceutical manufacturers reporting to D.C.'s AccessRx, and 486 pharmaceutical and medical device manufacturers reporting to Open Payments. According to the Report, 153 pharmaceutical manufacturers reported expending $95.6 million in 2014 for advertising, gift, and aggregate expenses in D.C. This was a decrease from the 2013 total of $101.2 million. Of the 2014 total, companies spent $22.6 million for gift expenses, $7.9 million for advertising expenses, and $65.1 million for aggregate expenses. In addition to analyzing the reported data, the Report also discusses "pharmaceutical marketing as a whole and then analyzes subgroups – including physicians, nurses, teaching hospitals, and organizations." The Report also provides information on the "quality of company submissions and recommendations for the reporting and utility of data in future years."


Reminder: The Centers for Medicare and Medicaid Services and the Open Payments Team Will Conduct Its Next Q&A Session Tomorrow, April 19, 2016

April 18, 2016

The Centers for Medicare and Medicaid Services ("CMS") has announced that it will conduct its next informal Question and Answer session tomorrow, April 19, 2016, from 12:00 p.m. – 1:00 p.m. EST. The dial in information for the session is 1-844-396-8222, and the meeting ID is 640 008 040.

CMS has indicated that in order to ask a question, you must go online and register prior to the start of the webinar. After registering, you will receive an email with information on how to join the call and ask a question.

For additional information on Sunshine Act reporting, please visit the Federal Transparency section of the Porzio Compliance Digest.


CMS Has Announced That the Review and Dispute Period for Physicians and Teaching Hospitals Began on Friday, April 1, 2016

April 06, 2016

According to the Sunshine Act and its implementing regulations, applicable manufacturers, applicable group purchasing organizations ("GPOs"), covered recipients, and physician owners or investors must have an opportunity to review and submit corrections to reported data before it becomes publicly accessible. This review and correction period must occur at least 45 days before the Centers for Medicare and Medicaid Services ("CMS") makes the submitted data available to the public

On April 1, 2016, CMS announced that the review and dispute period for the 2015 reporting year will begin Friday, April 1, 2016, and will last 45 days. During this 45-day period, physicians and teaching hospitals may review and, if necessary, dispute payments before the information is made public on June 30, 2016.

According to CMS, "the opportunity for physicians and teaching hospitals to review and dispute the data submitted about them expires at the end of the year that the record is published." If physicians and teaching hospitals wish to participate in the dispute, review, and correction process, they must be registered with CMS. Physicians and teaching hospitals who registered last year do not need to register again in the CMS Enterprise Portal or the Open Payments system. Updated information may be required, however, depending on how long the account has been inactive.

For additional information on Sunshine Act reporting and the dispute and resolution process, please visit the Federal Transparency section of the Porzio Compliance Digest.


Drug Manufacturers Must Submit Annual Disclosure Reports to the Minnesota Board of Pharmacy by May 1, 2016

April 05, 2016

Minnesota requires drug manufacturers to report annually to the Minnesota Board of Pharmacy ("Board") all “payments, honoraria, reimbursement or other compensation” permitted under the gift prohibition statute and provided to practitioners during the previous calendar year. The report must identify the value and nature of payment totaling $100 or more, and the practitioner receiving the payment. Reportable practitioners in Minnesota include physician assistants, nurse practitioners, veterinarians and dental therapists.

The annual disclosure report is due by May 1st of each year for expenditures incurred during the preceding calendar year.

For more information on Minnesota's disclosure requirements and gift prohibition, please see Minnesota's Marketing Disclosure and Gift Limitation/Prohibition sections of the Transparency and Limitations Database.


Minnesota Introduces Legislation That Would Require Certain Manufacturers to Report Marketing and Advertising Costs Associated With Promotion of Their Drugs to Prescribers

March 23, 2016

The Minnesota Senate recently introduced Senate Bill 2947 ("S.F. 2947"). S.F. 2947 would require manufacturers of prescription drugs that have a wholesale acquisition price of $10,000 or more per year or per course of treatment made available in Minnesota to file reports on the costs for the production of each qualifying drug. Among other reportable costs, manufacturers must disclose "the total marketing and advertising costs for promotion of the drug directly or indirectly to prescribers."

S.F. 2947 would require manufacturers to submit their reports to the Commissioner of Health ("Commissioner") on or before August 1, 2017, and each August 1 thereafter. S.F. 2947 would also require the Commissioner to convene an advisory committee to develop a reporting form. The Commissioner will make the report available to the public on an agency website.

Please note that the Minnesota House of Representatives has introduced similar legislation.

For more information and to view a copy of S.F. 2947, please visit Minnesota's Marketing Disclosure section of the Transparency and Limitations database.


D.C. Department of Health Has Posted on Its Website the 2015 Prescription Drug Marketing Cost Reporting Form and a Description of Changes to the Reporting Requirement for 2015

March 22, 2016

Pursuant to the District of Columbia’s (“D.C.”) Prescription Drug Marketing Costs Law (D.C. CODE § 48-833.01-09), manufacturers and labelers of prescription drugs dispensed in D.C. that employ, direct, or utilize marketing representatives in D.C. must submit an annual report disclosing certain prescription drug marketing costs. The report must be submitted to the D.C. Department of Health (“Department”) by July 1st of each year for those expenses incurred during the previous year.

The Department recently posted on its website the 2015 Prescription Drug Marketing Costs reporting form, as well as a description of changes to the reporting requirement for 2015. According to a notice from the Department, D.C. has changed its gift reporting requirements in light of federal Sunshine Act reporting. Of note, the reporting categories of "Nature of Payment," "Form of Payment," and "Primary Purpose" have been updated to align with the federal Open Payments system. Additionally, and consistent with the Sunshine Act, the Department will not require applicable manufacturers to report gifts made to teaching hospitals and physicians (doctors of medicine or osteopathy, doctors of dental surgery or medicine, doctors of podiatric medicine, doctors of optometry, and chiropractors). Gifts made to recipients other than teaching hospitals and physicians, however, must be reported. Reporting requirements for aggregate and advertising expenses remain unchanged.

Applicable manufacturers and labelers must use the form to report their marketing expenses for the 2015 calendar year. Companies must submit their 2015 reports by July 1, 2016, along with a $5,000 filing fee.

For more information and to view a copy of the reporting form, please see D.C.’s Marketing Disclosure section in the Transparency and Limitations Database.


The Centers for Medicare and Medicaid Services and the Open Payments Team Will Conduct Its Next Q&A Session Tuesday, March 15, 2016

February 23, 2016

The Centers for Medicare and Medicaid Services ("CMS") has announced that it will conduct its next informal Question and Answer session on Tuesday, March 15, 2016, from 1:00 p.m. – 2:00 p.m. EST. The dial in information for the session is 1-844-396-8222, and the meeting ID is 642 811 200.

CMS has indicated that in order to ask a question, you must go online and register 15 minutes prior to the start of the webinar.


The Centers for Medicare and Medicaid Services and the Open Payments Team Will Conduct Its Next Q&A Session Tuesday, February 9, 2016

February 02, 2016

The Centers for Medicare and Medicaid Services ("CMS") has announced that it will conduct its next informal Question and Answer session on Tuesday, February 9, 2016, from 2:00 p.m. – 3:00 p.m. EST. The dial in information for the session is 1-844-396-8222, and the meeting ID is 649-555-812.

CMS has indicated that in order to ask a question, you must go online and register 15 minutes prior to the start of the webinar.

For additional information on Sunshine Act reporting, please visit the Federal Transparency section of the Porzio Compliance Digest.


CMS Has Announced That Applicable Manufacturers and GPOs May Begin Data Submission for Payments or Transfers of Value That Occurred in the 2015 Calendar Year

February 01, 2016

The Centers for Medicare and Medicaid Services ("CMS") has announced that applicable manufacturers and group purchasing organizations ("GPOs") may begin submitting Sunshine Act data in the Open Payments System for payments or transfers of value that occurred in the 2015 calendar year. According to the Sunshine Act, applicable manufacturers of covered drugs, devices, biological products, and medical supplies must report annually certain information regarding payments and other transfers of value to physicians and teaching hospitals. An additional provision requires applicable manufacturers and GPOs to report all ownership and investment interests held by physicians or members of their families.

Applicable manufacturers and GPOs have until March 31, 2016, to submit their 2015 data, as well as corrected 2013 and 2014 data. CMS intends to publish the 2015 payment data and any applicable updates to the 2013 and 2014 data in June 2016.

In addition to submitting their data, applicable manufacturers and GPOs are also able to register or recertify their registrations in the Open Payments system. Physicians and teaching hospitals may also register in the system at this time. The review and dispute period for physicians and teaching hospitals will begin in April 2016 following the close of data submission.

For more information on the 2015 program year, please see the 2015 Open Payments Program Overview and Enhancements – PowerPoint Tutorial, which is located on the Resources page of the Open Payments website. Additionally, CMS has updated its various Quick Reference Guides; the updated guides are also located on the Resources page.

For additional information on Sunshine Act reporting, please visit the Federal Transparency section of the Porzio Compliance Digest.


New Jersey Introduces Legislation That Would Require Certain Manufacturers to Report Marketing and Advertising Costs Associated With Promotion of Their Drugs

January 28, 2016

The New Jersey Assembly has introduced Assembly Bill 762 ("AB 762"). AB 762 would establish the Prescription Drug Review Commission ("Commission"), and would require the Commission to prepare a list of "critical prescription drugs made available in New Jersey for which there is a substantial public interest in understanding the development of pricing for the drugs." Additionally, AB 762 would require manufacturers of these drugs to report to the Commission certain costs associated with producing and marketing their respective drugs. Among other reportable costs, manufacturers must disclose "marketing and advertising costs for the drug, apportioned by marketing activities that are directed to consumers, marketing activities that are directed to prescribers, and the total cost of all marketing and advertising that is directed primarily to New Jersey consumers and prescribers."


Colorado Introduces Legislation That Would Require Certain Manufacturers to Report Marketing and Advertising Costs Associated With Promotion of Their Drugs to Prescribers

January 25, 2016

The Colorado House of Representatives recently introduced House Bill 16-1102 ("HB 16-1102"), which requires manufacturers of prescription drugs that have a wholesale acquisition price of $50,000 or more per year or per course of treatment made available in Colorado to file reports on the costs for the production of each qualifying drug. Among other reportable costs, manufacturers must disclose "the total marketing and advertising costs to promote the qualifying prescription drug directly or indirectly to prescribers."


Registered Client Lobbyists in Connecticut Must File Their Quarterly Financial Reports with the Office of State Ethics by January 10, 2016

January 08, 2016

The Connecticut Code of Ethics (Ct. Gen. Stat., Title 1, Chapter 10) (“Code”) defines a “lobbyist” as any person who spends or receives $2,000 or more per calendar year to communicate with, or solicit someone to communicate with, any legislative or executive branch official in an effort to influence legislative or administrative action. According to an advisory opinion issued by the Connecticut Office of State Ethics (“Office”), a drug maker is “lobbying” as defined in the Code if it communicates with members of the Pharmaceutical and Therapeutics (“P&T”) Committee in an effort to have a drug placed on the state’s preferred-drug list. The Office explained that, under these circumstances, the drug maker is soliciting the members of the P&T Committee to communicate with the Commissioner of Social Services, an executive branch official, to influence administrative action and, therefore, must register as a lobbyist. The Code recognizes two types of lobbyists: client lobbyists and communicator lobbyists. A client lobbyist is the party that pays for lobbying services on its own behalf. A communicator lobbyist is the party that receives payment to do the actual lobbying. There are separate registration and reporting requirements for each type of lobbyist.


The Vermont AG’s Office Has Posted the 2015 Expenditure Disclosure, Sample Disclosure, and Compliance Officer Forms; the Compliance Officer Form is Due January 1, 2016

December 15, 2015

The Vermont Attorney General’s Office (“AG's Office”) recently posted on its website the 2015 Expenditure Disclosure, Sample Disclosure, and Compliance Officer Forms. The Expenditure Disclosure and Sample Disclosure forms aid reporting entities in complying with the requirements of Vermont's Prescribed Products Gift Ban and Disclosure Law (“Law”). Manufacturers of prescription drugs, biological products, and medical devices must submit the 2015 Expenditure Disclosure Form by April 1, 2016, and must disclose the value, nature, purpose, and recipient of any allowable expenditure made or permitted gift given between January 1 and December 31, 2015. Manufacturers of prescription drugs, biological products, and medical devices must also submit their 2015 Sample Disclosure Form by April 1, 2016, and must include the product, recipient, number of units, dosage, and other information for all samples provided to “health care providers.” The samples report should cover samples distributed between January 1 and December 31, 2015. Please note that the AG's Office has made minor changes to each section of the 2015 Samples Disclosure form. Please refer to the Transparency and Limitations Database to view the updated forms.


Today, October 29, 2015, The Centers for Medicare and Medicaid Services Will Conduct a Webinar to Discuss Changes to the Data Submission Process for the 2015 Calendar Year. CMS Will also Discuss Changes to the Data Collection Process from the 2016 Calendar Year

October 29, 2015

Today, October 29, 2015, the Centers for Medicare and Medicaid Services ("CMS") will conduct a webinar to discuss changes to the data submission process for the 2015 calendar year. CMS will also discuss changes to the data collection process from the 2016 calendar year. The target audience for this webinar is applicable manufacturers and group purchasing organizations, including physician-owned distributors. The webinar will be held today from 2:30 p.m. to 3:30 p.m. EST.


CMS Has Posted on Its Website Brochures for Patients and Physicians About “Open Payments,” the National Physician Payment Transparency Program

August 16, 2015

These brochures are available in the “Downloads” section on the OPEN PAYMENTS website at the following address: https://www.cms.gov/openpayments/index.html


The Open Payments Data Correction Period Began on May 21, 2015 and Will End Tomorrow, June 5, 2015

June 15, 2015

According to the Sunshine Act and its implementing regulations, applicable manufacturers, applicable group purchasing organizations ("GPOs"), covered recipients, and physician owners or investors must have an opportunity to review and submit corrections to the data submitted pursuant to the Sunshine Act. This review and correction period must occur at least 45 days before the Centers for Medicare and Medicaid Services ("CMS") makes the submitted data available to the public. The review and dispute period concluded on May 20, 2015. The correction period began May 21, 2015, and will end tomorrow, June 5, 2015. During the correction period, applicable manufacturers and applicable GPOs will have the opportunity to "acknowledge and resolve" disputes initiated by physicians and teaching hospitals. CMS has emphasized that it is up to applicable manufacturers and applicable GPOs to work directly with physicians or teaching hospitals to resolve any disputes; CMS will not mediate any disputes. CMS has posted step-by-step instructions on the data correction process. This information is located on the Resources Page of the Open Payments website.


Pharmaceutical and Medical Device Manufacturers that Employ or Contract with a Pharmaceutical or Medical Device Manufacturer Agent in Massachusetts Must Complete Their Registration Renewal Compliance Form and Submit Their $2,000 Registration Fee by August 31, 2015

June 11, 2015

In accordance with the Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct Law [Mass. Gen. Laws Ch. 111N] (“Law”) and its implementing regulations, each pharmaceutical and medical device manufacturer that employs or contracts with a pharmaceutical or medical device manufacturer agent must adopt the marketing code of conduct issued by the Department of Public Health (“Department”) and establish a program to routinely train appropriate employees on the code of conduct. Manufacturers must also establish policies and procedures for conducting investigations into instances of noncompliance, taking corrective action, and reporting instances of noncompliance to the appropriate state authority. The regulations also require manufacturers to annually renew their registration with the Department and certify that they have conducted annual audits to monitor compliance with the code of conduct. Manufacturers are also required to submit a $2,000 registration fee. The Department provides two methods by which manufacturers may renew their registrations. Manufacturers may utilize the Department’s online renewal system by August 31, 2015. To do so, a manufacturer must have a unique renewal ID provided by the Department. Manufacturers using the online system will be permitted to pay the $2,000 fee via credit card or electronic check. To submit renewal registrations, certifications, and payments online, please use the following link:https://onlineservices.hhs.state.ma.us/MyLicense%20Enterprise/


The 45-Day Review and Dispute Period for Physicians and Teaching Hospitals Closes Tomorrow, May 20, 2015

May 19, 2015

According to the Sunshine Act and its implementing regulations, applicable manufacturers, applicable group purchasing organizations ("GPOs"), covered recipients, and physician owners or investors must have an opportunity to review and submit corrections of reported data before it becomes publicly accessible. This review and correction period must occur at least 45 days before the Centers for Medicare and Medicaid Services ("CMS") makes the submitted data available to the public. The 45-day review and dispute period for the 2014 reporting year will close tomorrow, May 20, 2015. During this 45-day period, physicians and teaching hospitals may "review and, if necessary, dispute payments before the information is made public on June 30, 2015." Once the 45-day review and dispute period closes, companies will have 15 days to resolve and submit corrections. If disputed data is not resolved by the end of the 15-day period, it will be published on the public website and marked as disputed. According to CMS, physicians and teaching hospitals may continue to register and initiate disputes after the review and dispute period officially closes; however, resolutions will not be publicly displayed until the next reporting cycle.


Prescription Drug, Biological Product, and Medical Device Manufacturers Must Submit Their Disclosure Reports to the Vermont Attorney General's Office by April 1, 2015

March 30, 2015

Pursuant to Vermont's Prescribed Products Gift Ban and Disclosure Law, manufacturers of prescription drugs, biological products and medical devices are required to disclose to the Vermont Attorney General's Office ("AG's Office") the value, nature, purpose, and recipient of any allowable expenditure or permitted gift by April 1, 2015. The disclosure reports must include the reportable payments or expenditures made to "health care providers" during the time period from January 1 to December 31, 2014. Manufacturers of prescription drugs, biological products, and medical devices are also required to submit completed samples disclosure reports by April 1, 2015. The samples report must include the product, recipient, number of units, dosage and other information for all samples provided to “health care providers.” The samples report should cover samples distributed between January 1 and December 31, 2014. For more information on Vermont's Disclosure Law, please see Vermont's Marketing Disclosure Section in the Transparency and Limitations Database.


Applicable Manufacturers and GPOs Have Until March 31, 2015, to Submit Their 2014 Sunshine Act Data in CMS' Open Payments System

March 12, 2015

According to the Sunshine Act, applicable manufacturers of covered drugs, devices, biological products, and medical supplies must report annually certain information regarding payments and other transfers of value to physicians and teaching hospitals. An additional provision requires applicable manufacturers and applicable group purchasing organizations ("GPOs") to report all ownership and investment interests held by physicians or members of their families. Applicable manufacturers and GPOs have until March 31, 2015, to submit their 2014 Sunshine Act data in the Centers for Medicare and Medicaid Services' ("CMS") Open Payments system. Reporting entities must also submit corrected 2013 data by this date. CMS intends to publish the 2014 payment data and any applicable updates to the 2013 data in June 2015. Prior to submitting their data, applicable manufacturers and GPOs must register or recertify their registrations in the Open Payments system. For more information on the 2014 program year, please see the 2014 Open Payments Program Overview and Enhancements – Video Tutorial, which is located on the Resources page of the Open Payments website. Additionally, CMS has updated its various Quick Reference Guides; the updated guides are also located on the Resources page.


The Centers for Medicare and Medicaid Services and the Open Payments Team Will Conduct Its Next Q&A Session on January 15, 2015

January 07, 2015

The Centers for Medicare and Medicaid Services ("CMS") will conduct its next informal Question and Answer session on January 15, 2015, from 11:30 a.m. - 12:30 p.m. EST. . The dial in information for the session is 1-877-267-1577, and the meeting ID is 995-248-830. Attendees are encouraged to bring questions related to the December 19th data refresh and the upcoming Open Payments program year. CMS has indicated that it will conduct these Q&A sessions each month, and will announce upcoming calls at least a week in advance.


CMS Has Posted on Its Website Brochures for Patients and Physicians About “Open Payments,” the National Physician Payment Transparency Program

August 16, 2013

These brochures are available in the “Downloads” section on the OPEN PAYMENTS website at the following address: https://www.cms.gov/openpayments/index.html


The Centers for Medicare and Medicaid Services Posted on Its Website an Updated List of Frequently Asked Questions Regarding the National Physician Payment Transparency Program: Open Payments

August 08, 2013

These new FAQs are related to a wide variety of Open Payments topics, including loans for covered devices, clarification on when a distributer is considered an applicable manufacturer and how to classify a number of different forms of payments.


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