Subscribe   RSS Contact Us

WLF to CMS: Deem Medical Textbooks Educational Materials or Face Potential First Amendment Challenge

May 16, 2013 – The Centers for Medicare & Medicaid Services (CMS) is likely “to find itself the target of ... read more

Kamp in MMM: Off-label Is on the Table

May 14, 2013 — In a Medical Marketing and Media (MMM) column posted May 1, Coalition for Healthcare Communication Executive ... read more

Next OPDP Webinar Will Address Five Months of Enforcement Actions

May 14, 2013 — The FDA’s Office of Prescription Drug Promotion (OPDP) will be holding an Enforcement Webinar May 16, ... read more

Many Physicians Are Both Unaware and Wary of Sunshine Act Requirements, Survey Says

May 6, 2013 — With Sunshine Act reporting slated to begin in less than three months, it is sobering to ... read more

Senate Commerce Committee Growing Impatient with Self-regulatory Measures

April 29, 2013 – Although the Digital Advertising Alliance (DAA) has made great strides to protect consumers’ privacy online – ... read more

Coalition: Educational Materials Should Be Excluded from Sunshine Reporting

April 22, 2013 – In April 18 comments to the Centers for Medicare & Medicaid Services (CMS) the Coalition for ... read more

White Paper Examines FDA Enforcement in Digital, Social Media Realm

April 4, 2013 – A new White Paper, “FDA Communications Oversight in a Digital Era,” issued April 2 by Eye ... read more

Policy and Medicine: News Outlets Accentuate the Negative in Describing Industry-Physician Relationships

April 4, 2013 — Headlines run by news outlets regarding the status of industry-physician relationships rarely focus on the benefits ... read more

Kamp Commentary: Supreme Court Decision Could End “Pay for Delay,” Hurt Patent Protection

April 1, 2013 – By John Kamp, Executive Director, Coalition for Healthcare Communication While not directly about communication and marketing, ... read more

Promotion Down, But Prospects Up for New Drugs

March 22, 2013 – Although spending on drug promotion has declined in recent years,  2013 could be a pivotal year ... read more

“Cyberspace Is Not Without Boundaries,” FTC States in Digital Advertising Guidelines

March 19, 2013 – Although the FDA has not yet issued its long-awaited social media guidance for the biopharma industry, ... read more

NDHI Releases Statement Outlining Four Principles for Industry/Provider Collaborations

March 11, 2013 – Healthcare industry collaborations with physicians and researchers have “been at the heart of most of the ... read more

Study Cites Benefits of Pharma’s Promotional Efforts

March 4, 2013 – A recent study released by the National Bureau of Economic Research (NBER) states that although consumer-directed ... read more

CMS Launches "OpenPayments" Site as Part of Sunshine Implementation

Feb. 25, 2013 – The Centers for Medicare & Medicaid (CMS) launched its “OPENPAYMENTS” Website last week, which will be ... read more

Sunshine Act Final Rule: Coalition for Healthcare Communication Summary

On Feb. 1, the Centers for Medicare & Medicaid Services (CMS) issued a final rule implementing the Sunshine Act provisions ... read more

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 ... read more

Coalition’s Policy Update: Keep Fiscal Challenges, Privacy Regulation on Radar

Jan. 15, 2013 – If 2012 – with its high number of new drug approvals, senior staff stability within the ... read more

OPDP Untitled Letters on PR Materials Surprise Industry

Nov. 27, 2012 – An Oct. 31 enforcement letter from the FDA’s Office of Prescription Drug Promotion (OPDP) to Cornerstone ... read more

DAA’s Self-regulatory Ad Program to Protect Consumers Online Is Praised by White House, DOC and FTC

 Feb. 23, 2012 – At a White House meeting held today to unveil the blueprint for the Obama Administration’s “Consumer ... read more

Sorrell v. IMS: What Marketing Professionals Need to Know

By John Kamp, Executive Director, Coalition for Healthcare Communication July 18, 2011 — For those who have not read the ... read more

Previous Next

Supreme Court Upholds Major Provisions of the Affordable Care Act, Including PhRMA-backed Provisions

By John Kamp, Executive Director, Coalition for Healthcare Communication

June 28, 2012 – In a 5-4 decision, the U.S. Supreme Court today upheld the mandate in the Affordable Care Act (ACA) that nearly all individuals purchase health insurance

or face penalties. However, the Court restricted the federal government from withdrawing all Medicaid funds to states that do not comply with the Act’s new coverage requirements.

With the exception of the Medicaid provisions, virtually all major provisions of the ACA stand, including the drug discount and other provisions supported by PhRMA, the pathway for approval of follow-on biologics, the Sunshine Act (which creates the national registry of payments to physicians), and the extension of care and medicine to as many as 30 million additional U.S. citizens.

This decision, much discussed by news pundits, may conclude this particular case, but it will not end the debate over health care in this country during the Presidential election and beyond.

For the medical agency and publishing industries, the decision means that efforts to prepare for the implementation of the ACA provisions will continue, but that close attention must be paid to possible legislative changes and the adoption of new rules to implement its most relevant provisions.

Meanwhile, the most significant facts facing the biopharmaceutical and device industries will be the continued pressure by the government and all payers to reduce prices, as well as continued criticism by some policy makers of company

relationships with industry and of professional communication and consumer marketing.

Stay tuned.

User Comments 2

  1. According to an informal poll by Med Page Today, over half of the the medical professionals that responded believe the Supreme Court did the right thing.

    jkamp on Jul 2, 2012 @ 3:53PM
  2. At the End of the Day, Medicine is Vital
    By Jack Angel, Education Foundation Executive Director,
    Coalition for Healthcare Communication

    Although many are deeply disappointed with the recent U.S. Supreme Court decision on the Affordable Care Act (ACA), especially those hoping that the Sunshine Act would be the baby thrown out with the bathwater, all is not lost. I believe that a very strong case has been made with regulators regarding the glaring unintended consequences the Sunshine Act may bring. Those concerned about such consequences should be comforted by the fact that, generally, the rulemaking process tends to soften the original drafts to eliminate the more draconian measures. I believe that this will be the case with the Sunshine Act.

    At the risk of committing a bit of heresy here and stepping back from the fray, there are some positives to consider. For openers, I don’t think there is one American who doesn’t believe that our healthcare system is in distress and that changes are in order. If you are blessed with some form of healthcare coverage, it is not hard to accept the status quo. But if you are one of those 30 million or 40 million Americans who is just one diagnosis away from financial disaster, it becomes quite a different picture. So the issue will continue to be debated and I would submit that what comes out the other end will not be a mirror image of what it looks like now.

    In the meantime, the pharmaceutical industry has made a calculation that the addition of millions more covered patients will offset the concessions they have made to help render the ACA affordable. Many, including me, feel that this calculation may be very conservative. So the health of the industry, as demonstrated by market reaction to the Supreme Court decision, and logically the health of those of us who serve the industry, should be reasonably stable for the near future.

    Close vigilance and behind-the-scenes planning continues at the Coalition. And our PhRMA colleagues are moving more deliberately than we have seen in the past to educate our government, the media, and world leaders about medicines and the important contributions they make every second of every day. We all need to keep this in mind as we go about our day-to-day activities. Medicine is an indispensible element of our nation’s health.

    Jack Angel on Jul 2, 2012 @ 4:35PM