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Open Payments Website Reopened, Dispute Period Extended and One-third of Records Withheld

Aug. 18, 2014 – The Centers for Medicare & Medicaid Services (CMS) recently announced that it had reopened its Open ... read more

Medical Groups Ask CMS to Make Changes to Sunshine Act Implementation

Doctors Recommend Fixes to CME Exemption Elimination, Educational Materials Provision Aug. 6, 2014 – More than 100 medical associations and ... read more

Doctors and Industry: When Sharing Sunshine Data, Context Matters

July 29, 2014 – Industry groups and physician organizations have banded together to petition the Centers for Medicare & Medicaid ... read more

Doctor Tells Congress That Communication Is Hampered by FDA, CMS Practices

July 28, 2014 – FDA and Centers for Medicare & Medicaid Services (CMS) policies are barriers to ongoing evidence development ... read more

FDA Plans to Study Effect of DTC Ads on Adolescents

July 24, 2014 – A better understanding of how adolescents weigh risks and benefits in direct-to-consumer (DTC) ads is needed ... read more

Bruce Grant Urges Pharma Communicators to Recognize Their Role in Health Advances

July 23, 2014 – Although the pharmaceuticals industry has come under fire in recent years, it is important to remember ... read more

FDA Social Media Draft Guidances Answer Some Questions, Raise Others

July 21, 2014 – Although the FDA has attempted to provide some clarity on its position regarding certain social media ... read more

Kamp to Washington Post: Companies Should Be Able to Speak Truthfully About Drugs

July 14, 2014 – Drug companies should be allowed to share truthful information about the off-label uses of their drugs, ... read more

CMS Proposes Eliminating CME Sunshine Act Exemption

July 7, 2014 – About 240 pages into the 600-page physician fee schedule proposed rule, which is due to be ... read more

FDA Device Document Revises Mobile Medical Apps Guidance

July 1, 2014 – The FDA’s recently issued draft guidance on medical device data systems (MDDS) not only lessens the ... read more

New FDA Social Media Guidances Address Space-limited Media, Correcting Online Misinformation

June 23, 2014 – Although the two social media draft guidance documents the FDA’s Office of Prescription Drug Promotion (OPDP) ... read more

AMA House of Delegates: Revise Sunshine Act Rules on Textbook/Reprints and TOV Amount

June 12, 2014 – The American Medical Association’s (AMA’s) House of Delegates is attempting to bring some common sense to ... read more

As Sunshine Act Phase One Implemenation Ends, Compliance Concerns Grow

June 9, 2014 – In a recent Pharmalot blog post on The Wall Street Journal site, Ed Silverman writes that ... read more

House Committee Seeks Patient Input on Availability of Treatments

June 3, 2014 – The House Energy and Commerce Committee is seeking public comments from patients, providers and other stakeholders ... read more

FDA To Study Viewers’ Responses to DTC Ad Risk Information

May 29, 2014 – The FDA announced May 28 in the Federal Register that it plans to conduct an eye ... read more

FTC Calls for Data Broker Legislation To Protect Consumers

May 29, 2014 – The Federal Trade Commission (FTC) released a report May 27 in which it asks Congress to ... read more

OPDP Enforcement Letters Address Omission of Risk Information

May 23, 2014 – The FDA’s Office of Prescription Drug Promotion (OPDP) has issued just three Untitled Letters to date ... read more

New Yorker Article Weighs Sales Rep Free Speech Arguments in Off-label Context

May 22, 2014 – Both sides of the argument over whether sales representatives’ speech about off-label drug uses are protected ... read more

WLF: FDA’s Revised Reprint Draft Guidance Violates Injunction and First Amendment

May 19, 2014 – In May 15 comments to the FDA regarding its draft guidance on reprint practices for articles ... read more

FTC Cites Privacy Concerns Related to Mobile Health Apps

May 9, 2014 – Mobile health and fitness applications are on the Federal Trade Commission’s privacy-protection radar following a study ... read more

CHC Comment to FDA: Less Is More in DTC TV Ads

May 2, 2014 – The Coalition for Healthcare Communication believes that “shorter, simpler disclosures are most likely to lead to ... read more

FDA Willing to “Re-examine” Off-label Policies in Light of First Amendment Rulings

April 28, 2014 – The FDA is not taking lightly industry’s concerns that its existing off-label policies are not in ... read more

CHC Press Release: Comment on Social Media Draft Guidance

April 9, 2014 — The Coalition for Healthcare Communication issued the following press release today regarding the CHC Social Media ... read more

Some States Impose Reporting Requirements That Add to Sunshine Burden

April 7, 2014 – Although the Physician Payment Sunshine Act preempts state laws that require reporting of similar information required ... read more

Kamp to WSJ: FDA Could Do a Better Job of Defending Off-label Limits

March 31, 2014 – The FDA’s recent draft guidance on disseminating reprints, textbooks and clinical practice guidelines (CPGs) discussing off-label ... read more

OPDP Issues First Untitled Letter for Branded Facebook Page

March 14, 2014 – The FDA’s Office of Prescription Drug Promotion (OPDP) on Feb. 24 issued its first enforcement letter ... read more

Cuts in Speaker Payments Should Be Placed in Proper Context

March 10, 2014 – The need for industry to educate the public on why company interaction with physicians is both ... read more

FDA Issues Updated Draft Guidance on Distributing Scientific and Medical Info on Unapproved New Uses

March 3, 2014 – The FDA announced today the availability of a new draft guidance (2014-04560) on distributing scientific and ... read more

New Tax Reform Legislation Includes Limit on Ad Tax Deductions

Feb. 27, 2014 – As expected, tax reform legislation introduced yesterday by Senate Ways and Means Committee Chairman Dave Camp ... read more

FDA Is Considering Shorter List of Risks in DTC TV Ad Major Statement

Feb. 17, 2014 – In recognition that the stream of risks currently disclosed on direct-to-consumer (DTC) television ads may be ... read more

OPDP Enforcement Letters Target Common Issues in Last Half of 2013

Feb. 4, 2014 — Many of the 14 enforcement letters issued by the FDA’s Office of Prescription Drug Promotion (OPDP) ... read more

Caronia Decision One Year Later: Off-label Change May Be Slow, But It’s Brewing

Jan. 27, 2014 – Although FDA officials have treated the U.S. Court of Appeals for the Second Circuit decision in ... read more

Coalition Seeks Input on FDA Online Promotion Guidance

Jan. 23, 2014 – The Coalition for Healthcare Communication would like to receive feedback from its members regarding the FDA ... read more

FDA Draft Guidance Addresses Postmarket Submission of Online Promotional Material

Jan. 14, 2014 – The determining factor regarding whether a firm submits online prescription drug promotional material to the agency ... read more

Kamp on Off-label Discussion at the CMS/FDA Summit

Jan. 3, 2014 – From Coalition for Healthcare Communication Executive Director John Kamp: Several weeks ago I was privileged to ... read more

Coalition Calls on Senators to Reject Tax on Advertising

Dec. 16, 2013 – Today the Coalition for Healthcare Communication sent a letter to U.S. Senators and Members of the ... read more

House Members Speak Out Against Inclusion of Textbooks, Reprints in Sunshine Act Reporting

Nov. 26, 2013 – On Nov. 22, 23 members of the U.S. House of Representatives sent a letter to the ... read more

OPDP Sends Warning Letter Based on Statements Made on Fast Money TV Show

Nov. 11, 2013 – The FDA Office of Prescription Drug Promotion’s (OPDP’s) recent enforcement actions – four Untitled Letters and ... read more

Physician Organizations, Medical Societies Implore HHS to Reverse Policy on Reprints and Textbooks

Oct. 28, 2013 – On Monday, 33 physician organizations and 41 national and state medical societies sent a letter to ... read more

MIWG Asks FDA to Clarify Position Regarding Manufacturer Dissemination of New Use Information

Sept. 16, 2013 – The Medical Information Working Group (MIWG), a coalition of medical product manufacturers seeking to improve the ... read more

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Sunshine Act Final Rule Resets Clock on Annual Reporting of Payments to Physicians

Many Questions Still Unresolved

Feb. 4, 2013 – Although the final rule to implement the Sunshine provisions of the Affordable Care Act clarified several areas in question in the proposed rule, unresolved issues remain and the burden placed on industry to keep records and report on funds provided to physicians and teaching hospitals is significant, according to John Kamp, Executive Director, Coalition for Healthcare Communication.

The Sunshine final rule states that manufacturers must start collecting required data on Aug. 1 of this year and report it to the Centers for Medicare & Medicaid Services (CMS) by March 31, 2014.

“There are plusses and minuses to the final rule,” Kamp said. “It ends the uncertainty we’ve lived under since the proposed rule was issued in December 2011 and removes some of the meaningless requirements to report every bagel and cup of coffee offered at general meetings, but it also states that many routine products and services provided to physicians as part of reasonable and beneficial collaborative relationships are reportable,” he noted.

In the “pro” column for the final rule, which was released by the U.S. Department of Health & Human Services (HHS) on Feb. 1 and will be published Feb. 8 in the Federal Register, Kamp lists the following:

  1. Many

    rules are explicit, clear, understandable, standardized, and actionable.

  2. The national Website reports will contain a section where buy viagra canada clients can explain the purpose and context of the payments, thus enabling the public to understand their value.
  3. Clients and doctors have new, clear systems for reporting, reviewing and resolving disputes before the reports are public.
  4. Certified continuing medical education (CME) that follows national accreditation rules explicitly is exempted both for speaker fees and the value of attendance.
  5. The value of mass media supported by advertisers appears to be exempt.
  6. New meal reporting rules exempt coffee, snacks and buffets at widely attended events.

However, there are a corresponding number of items in the “con” column:

  1. The system is extremely burdensome to administer. (CMS conservatively estimates that it will cost $269 million the first year and $180 million per year thereafter.)
  2. Many politicians, reporters and others still are likely to consider every payment indicia of a conflict of interest and will criticize industry and doctors for simply collaborating.
  3. The rules appear to require reporting of all promotional education, even mandated education under REMS.
  4. Indirect payments by agencies and publishers to known physician recipients all must be reported.
  5. The value of all formal meals and entertainment at educational and other unpaid events offered to identifiable doctors must be reported.
  6. Disputes between doctors and clients must be resolved in a very short time span or they will be reported on the registry as unresolved.

It is the government’s position that while it understands that industry/provider collaboration “contributes to the design and delivery of life-saving drugs and devices … payments from manufacturers to physicians and teaching hospitals can also introduce conflicts of interest that may influence research, education, and clinical decision-making in ways that compromise clinical integrity and patient care, and may lead to increased health care costs,” the rule’s executive summary notes. 

However, even though the rule states that “financial ties alone do not signify an inappropriate relationship,” industry has reason to be concerned that these ties will be viewed negatively, Kamp explained.

“With these rules in place, the press and some politicians must stop treating reported payments as indicators of some sort of scandal,” he said. “Collaboration between industry, physicians and academicians has led

to great medical breakthroughs in the past, so driving a wedge between these parties will hurt, not help patients. Transparency is good, but it must be clear to the public that a physician who collaborates with industry is not doing anything wrong.”

CMS will be accepting public comment on the final rule for 45 days.viagra 100 mg