VA OIG Releases Report on Opioid Prescribing Habits
Conclusion
“Veterans receiving opioid prescriptions from VA-referred clinical settings may be at greater risk for overdose and other harm because medication information is not being consistently shared,” said Michael J. Missal, Inspector General, U.S. Department of Veterans Affairs. “That has to change. Healthcare providers serving veterans should be following consistent guidelines for prescribing opioids and sharing information that ensures quality care for high-risk veterans.”
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Source: Policy and Medicine - August 24, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
AMA and ACCME Announce Simplification of Credit and Accreditation Systems
On August 1, 2017, the American Medical Association (AMA) and the Accreditation Council for Continuing Medical Education (ACCME) announced that they have adopted a final proposal to simplify and align their expectations for accredited continuing medical education (CME) activities certified for AMA PRA Category 1 Credit.
The final proposal follows a call for comment on the proposed simplification in April 2017, when the vast majority of those who responded endorsed the proposal and agreed that it would give them sufficient opportunity to innovate and evolve their CME programs. The proposal was then adopted by both the AMA ...
Source: Policy and Medicine - August 23, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
CMS Announces Part D Premiums Are Going Down
On July 31, 2017, the Centers for Medicare and Medicaid Services (CMS) announced that Medicare Part D premiums will drop in 2018. The announcement states that the Part D national average monthly bid amount for 2018 will be $57.93, the 2018 Part D base beneficiary premium will be $35.02, and the de minimis amount will be $2.
This decrease is the first drop in five years, in part because of the bids submitted by drug plans for basic coverage in Part D and because rebates and other price concessions are projected to grow faster than drug costs. The decline comes amid reports of surging spending in Medicare on specialty drugs...
Source: Policy and Medicine - August 22, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
AMIA Supports ONC Draft Framework
The American Medical Informatics Association (AMIA) responded to a request for information (RFI) issued by the Office of the National Coordinator for Health IT (ONC) outlining a draft framework to measure the use of interoperability standards in health IT products. The national association of health informatics professionals supported ONC’s draft framework, recommending a measurement approach that focuses on the clinician and patient experience. AMIA underscored the need to have the benefits of any measurement outweigh the costs, and urged federal officials to provide sufficient support to develop and implement automated...
Source: Policy and Medicine - August 21, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
CMS Issues Proposed Rule on EHR Reporting Requirements
A recent Centers for Medicare & Medicaid Services (CMS) proposed rule would ease EHR reporting requirements over the next two years. The proposed regulation, which covers the 2018 Medicare payments for hospital inpatient services, relaxes data reporting requirements for Clinical Quality Measures (CQMs) that are part of the EHR Incentive program. In 2017, eligible hospitals demonstrating meaningful use for the first time would need to submit two self-selected quarters of CQM data and report at least six selected CQMs, down from eight. CMS offered similar flexibility when it released its Hospital Outpatient Prospective P...
Source: Policy and Medicine - August 18, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Ohio “Drug Price Relief Act” Ballot Update
We have previously written about the ballot proposition that is scheduled to be on the ballot in Ohio this November as Issue #2.
– An analysis by former Ohio Budget Director Greg Browning has found that a key claim by proponents of the so-called Ohio Drug Price Relief Act is “simply false and without merit.”
Backers of the November ballot issue have repeatedly asserted that passing the initiative would save Ohio at least $400 million per year. But Browning, who served as Ohio Budget Director from 1991-98, says that in making that claim, proponents appear to have “ignored the signific...
Source: Policy and Medicine - August 17, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
CMS Issues Proposed Rule on Physician Fee Schedule
Last month, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that includes proposals to update payment policies, payment rates, and quality provisions for services furnished under the Medicare Physician Fee Schedule (PFS) on or after January 1, 2018. The calendar year (CY) 2018 PFS proposed rule is one of several proposed rules that reflect a broader Administration-wide strategy to create a healthcare system that results in better accessibility, quality, affordability, empowerment, and innovation.
The wide-ranging proposed rule addresses reimbursement to off-campus departments under section 60...
Source: Policy and Medicine - August 16, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
President Trump Declares Opioid Crisis a National Emergency
Working off of the recent recommendations in the interim report issued by the President’s Commission on Combating Drug Addiction and the Opioid Crisis, President Donald Trump has issued a directive to his administration to use all “appropriate emergency and other authorities to respond to the crisis caused by the opioid epidemic.”
Some of the immediate actions the Trump administration could take to address the opioid crisis include: (1) approve state waivers to remove the Medicaid Institutions for Mental Diseases (IMD) exclusion, which prohibits the use of federal Medicaid funds for care provided to most patients in...
Source: Policy and Medicine - August 15, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Sunshine Act Takes Effect in South Korea
In early 2017, South Korea joined the global transparency movement and enacted a “Sunshine Act” similar to others found around the world. The law requires pharmaceutical and medical device companies operating in South Korea to prepare an aggregated expenditure report if they have provided economic benefits to healthcare professionals and others employed at medical institutions during a fiscal year.
Interestingly, while the scope of the Korean Sunshine Act is broader than the United States law, it does not require companies to submit the aggregated report and any supporting documents to the government unless it is dete...
Source: Policy and Medicine - August 14, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
MACRA Categories and Codes in CMS Proposed Fee Schedule
In the 2018 proposed Medicare Fee Schedule rule, CMS reviews MACRA patient relationship categories and codes, their development and timelines, and provides details for the initial claims-based reporting of the relationship categories and codes to CMS.
Background
Section 101(f) of MACRA added a new subsection (r) to section 1848 of the Act entitled Collaborating with the Physician, Practitioner, and Other Stakeholder Communities to Improve Resource Use Measurement. Section 1848(r)(2) requires the development of care episode and patient condition groups plus group classification codes. To satisfy the purpose of patient and...
Source: Policy and Medicine - August 11, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Deep Dive Into Proposed MACRA Rule
As we recently reported, CMS published their proposed rule to update the MACRA Quality Payment Program (QPP). The QPP is a part of a fundamental shift from fee-for-service to a more value-based health care system. Below, we offer a more in-depth look at the proposed rule.
Some Major Points
MACRA eliminated the sustainable growth rate formula and replaced it with a 0.5% rate increase through 2019. Physicians are encouraged to pick one of two Quality Payment Programs: 1) the Merit-based Incentive Payment System (MIPS) or 2) Alternative Payment Models (APMs). MIPS folds together CMS legal programs of Meaningful Use, ...
Source: Policy and Medicine - August 10, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
EU Court Issues Over-Reaching Ruling on Vaccines
In June 2017, the Court of Justice of the European Union ruled that courts may consider vaccines to be the cause of an illness, even if there is no scientific evidence confirming a link. The Court said that if the development of a disease is timely to the person’s receiving a vaccine, it may serve as enough proof – provided that the person was previously healthy with a lack of history of the disease in their family and if a significant number of disease cases are reported among people receiving a particular vaccine.
The ruling stemmed from the case of a French man known as J.W., who was vaccinated against hepatitis B ...
Source: Policy and Medicine - August 9, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
FDA Issues Two Proposed Studies on Disclosures for Advertising
Last month, the FDA issued two proposed studies on disclosures for advertising: one for general advertising and another for oncology advertising. Both studies have comment periods that end on August 18, 2017.
For both proposals, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality,...
Source: Policy and Medicine - August 8, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
McCaskill Opioid Investigation Expanding
United States Senator Claire McCaskill recently announced that she is expanding her wide-ranging investigation into the causes of the current opioid epidemic by requesting information and documents from four additional pharmaceutical manufacturers and three opioid distributors.
Her requests focus on the distribution of opioids and the efforts leading companies have made to monitor, report, and investigate the diversion of drugs for illicit use. Drug diversion occurs when pharmaceutical products meant for legal use by individuals are transferred to others for illicit use, including through the black market. ...
Source: Policy and Medicine - August 7, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
AbbVie Found Liable for Misrepresentation in AndroGel Case
In July 2017, a Chicago jury found AbbVie Inc. guilty of fraudulently misrepresenting the risks of its testosterone replacement drug AndroGel. The federal jury ordered the company to pay $150 million in punitive damages.
Allegations
The verdict comes in a case where Jesse Mitchell blamed the drug for a heart attack he had in 2012 after four years of taking AndroGel. Mitchell, who used AndroGel from 2008 to 2012, alleged that AbbVie knew or should have known the drug could cause cardiovascular disease, strokes and other serious injuries, but failed to adequately warn consumers and doctors. He was 49 at the time of his hea...
Source: Policy and Medicine - August 7, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
