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CMS Open Payments review
Physicians have until May 15, 2016, to review and dispute reports regarding their financial interactions with drug and medical device manufacturers as reported under the Open Payments (Sunshine Act) program. Under the Sunshine Act, drug and medical device manufacturers are required to report their financial interactions with licensed physicians, including consulting fees, travel reimbursements, research grants, and other gifts. The U.S. Centers for Medicare & Medicaid Services (CMS) will publish the 2015 payment data and updates to the 2013 and 2014 data on June 30, 2016.

Physician quality reporting
A study published in Health Affairs (March) examines physician payment systems in the United States. Researchers surveyed 394 physician practices and found that physicians and staff averaged 15.1 hours per physician per week processing quality metrics—an equivalent of 785.2 hours per physician per year—at an average cost of $40,069 per physician per year. However, they noted that time and money spent reporting was lower for specialists compared to primary care physicians; primary care physicians averaged 3.9 hours per week dealing with quality measures, compared with 1.1 hours for orthopaedists. The researchers agree that much is to be gained from quality measurement, but write that "the current system is unnecessarily costly, and greater effort is needed to standardize measures and make them easier to report."

Value-based payment program
According to CMS data, 13,813 physician groups participated in the agency's value-based payment modifier (VBM) program, but only 128 group practices will see reimbursement increases, while 8,208 will remain unchanged and 5,477 will be penalized. CMS is gradually phasing in the VBM program; it only applied to group practices of 100 or more eligible professionals during 2015, and to groups of 10 or more in 2016. In 2017, it will apply to all physicians and physician groups.

FDA 510(k) process
A study published in The Journal of Bone & Joint Surgery (March 16) finds that medical devices cleared by the U.S. Food and Drug Administration (FDA) 510(k) Premarket Notification process are 11.5 times more likely to be recalled than devices cleared under the more stringent Premarket Approval (PMA) process. The researchers reviewed information from the public FDA database on orthopaedic and nonorthopaedic devices that received market approval between 1992 and 2012. They found that during the study period the proportion of nonorthopaedic devices cleared via 510(k) decreased from 91 percent to 53 percent, and the proportion of orthopaedic devices decreased from 94 percent to 88 percent. Overall, the percentage of recalled devices was 17.8 percent for 510(k)-cleared devices and 1.6 percent for PMA-approved devices. When stratified on the basis of recall class, the odds ratios were 3.5 for class-I devices, 13.2 for class-II devices, and 8.5 for class-III devices.

Opioid trend
Data from a study published in The Journal of the American Medical Association (online) suggest an increasing trend in opioid prescribing for undergoing common surgical procedures. The research team analyzed insurance claims for 155,297 adults who underwent at least one of four common outpatient surgeries—carpal tunnel release, knee arthroscopy, laparoscopic cholecystectomy, or inguinal hernia repair. Patients were excluded if they had filled any opioid prescription in the 6 months prior to surgery. The research team found that, from 2004 through 2012, the proportion of patients filling prescriptions for any opioid and for hydrocodone/acetaminophen and oxycodone/acetaminophen increased over time for all surgical procedures. Overall, 80.0 percent filled a prescription for any opioid within 7 days of surgery, and 86.4 percent of those prescriptions were for hydrocodone/acetaminophen or oxycodone/acetaminophen. The proportion of patients filling a prescription for hydrocodone/acetaminophen or oxycodone/acetaminophen varied across surgical procedures from 59.7 percent (carpal tunnel release) to 75.5 percent (inguinal hernia repair).

Opioid prescribing guideline
The U.S. Centers for Disease Control and Prevention (CDC) has issued new recommendations for prescribing opioid medications. The guideline aims to improve patient safety by offering recommendations on the use of opioids in treating pain lasting longer than 3 months, excluding cancer, palliative, and end-of-life care. The guideline includes recommendations on:

• When to initiate or continue opioids for chronic pain
• Opioid selection, dosage, duration, follow-up, and discontinuation
• Assessing risk and addressing harms of opioid use

Among other things, the guideline states that clinicians should consider opioid therapy only if expected benefits for both pain and function are anticipated to outweigh risks to the patient, and recommends that clinicians establish treatment goals with patients, including realistic goals for pain and function, along with a plan for discontinuing opioid therapy if the benefits do not outweigh the risks.

Opioid abuse bill
The U.S. Senate has passed an opioid abuse bill with strong bipartisan support. If enacted, the Comprehensive Addiction and Recovery Act of 2016 would, among other things, authorize grants to expand educational efforts to prevent abuse of opioids, heroin, and other substances of abuse, understand addiction as a chronic disease, and promote treatment and recovery; support treatment alternatives to incarceration programs; and develop plans for integrated opioid abuse response initiatives. A similar bill is under consideration in the U.S. House of Representatives, and the Obama administration has indicated support for addressing opioid abuse.

Off-label drug marketing
The New York Times reports that the FDA has settled a lawsuit that some experts say could have implications for the marketing of drugs for off-label use. At issue is a case in which a pharmaceutical manufacturer sued the FDA for the right to promote a product to a broader range of patients. Last year, a federal district judge ruled that the agency could not prohibit the company from using truthful information to promote its drug—even for unapproved uses—because doing so would violate the company's right to free speech. A spokesperson for the FDA states that the settlement applies only to one specific case, and that the agency's position on off-label marketing remains unchanged. However, observers note that the settlement could encourage other companies to seek similar arrangements.

EHR incentive programs
In a letter to the acting principal deputy administrator of CMS, the American Hospital Association (AHA) urges the agency to do away with what it calls an "all-or-nothing approach" to meaningful use of electronic health records (EHRs). The AHA notes that under the existing system, "failure to meet any one of the requirements under the Medicare and Medicaid EHR Incentive Programs has meant a provider would not receive an incentive payment," and that current rules penalize such providers. The AHA states that such a system is "unfair to providers that make good faith efforts to comply, may actually comply with a large percentage of the requirements, expend significant resources and funds in doing so, but still fall short." CMS has responded that the agency lacks the legal authority to vary from its current approach, but the AHA letter addresses those issues and requests that CMS allow providers who attest to meeting 70 percent of the meaningful use requirements to be designated as meaningful users.

CJR penalties
An analysis conducted by Avalere Health finds that episodes of care at 60 percent of participant hospitals in the Comprehensive Care for Joint Replacement (CJR) model currently cost more than episodes at their regional peers—a factor that could subject those hospitals to penalties if they do not rein in total episodic costs. In addition, the company finds that 39 percent of total spending on hip and knee arthroplasty episodes is tied to postdischarge care, suggesting that hospitals may be penalized in part for healthcare spending after discharge.

Orthopaedic specialty hospitals
According to a study published in the Journal of Shoulder and Elbow Surgery (online), shoulder arthroplasty performed at an orthopaedic specialty hospital (OSH) may be associated with reduced length of stay (LOS) compared to the same procedure performed at a tertiary referral center (TRC). The authors conducted a matched cohort study of 136 primary shoulder arthroplasties performed at an OSH and 136 primary shoulder arthroplasties performed at a TRC. They found that average LOS was 1.31 days at the OSH and 1.85 days at the TRC. Of 136 OSH patients, 3 patients (2.2 percent) required transfer to a TRC. Overall readmission rates were similar across both institutions.

Team physicians
Lexology reports that as of Feb. 4, 2016, sports team physicians visiting Pennsylvania with teams from outside the state are now permitted to treat their players without violating Pennsylvania law. An amendment to the Pennsylvania Medical Practice Act exempts visiting sports team physicians from the state's licensure requirements, provided that the physician has an agreement with a sports team to treat team members and coaches traveling with the team for a specific sporting event in the state. In certain cases, the exemption also extends to physicians invited by a national sport governing body to provide services within the state at a national training center or an event or competition sanctioned by that governing body.

Concurrent surgeries
The Boston Globe reports that the chair of the U.S. Senate Finance Committee has asked 20 hospital systems to provide detailed records regarding the practice of concurrent surgery. A committee staffer refers to the request as a "fact-finding exercise." A spokesperson for the American Hospital Association states that the organization is aware of the letter and is working to "educate the committee staff about this very complex issue."

Telemedicine
Study data indicate that the use of telemedicine to treat patients at a Vermont Veterans Affairs hospital resulted in an average savings of 145 miles and 142 minutes per visit between 2005 and 2013, which translates to an average travel payment savings of $18,555 per year. The study, published in the journal Telemedicine and e-Health (March), also found that the volume of telemedicine services grew significantly over the study period—so much so that the travel savings increased to $63,804 by the final year. The authors note that the number of mental health telemedicine visits increased during the study period, but remained small relative to the number of face-to-face visits, and that a higher proportion of telemedicine visits involved new patients.

Physician ratings
A survey of parents conducted by C.S. Mott Children's Hospital suggests that many lack trust in online physician ratings. The research team sent a survey to 1,407 nationally representative households and 54 percent responded. Overall, they found that 30 percent of respondents had looked at online physician ratings for themselves or a family member in the previous year. However, 69 percent stated that they believe at least some rating websites contain fake ratings, 64 percent believe that there were too few ratings to make a quality decision, and 54 percent opined that the physician may have influenced those who left the ratings. About 11 percent stated that they have posted a physician rating themselves.

Apology initiatives
An article on CNN.com discusses the issue of apologies and medical liability suits. The writer notes that 36 states have enacted so-called "I'm sorry" laws, which prevent apologies from being used as evidence against medical professionals in court. The writer also profiles a resolution program initiated at Stanford University and several other major healthcare institutions that encourages providers to "acknowledge and apologize" in place of a "deny and defend" approach following medical errors. Since implementation of the program in 2009, the Stanford resolution program has seen a 27 percent reduction in indemnity costs and a 24 percent reduction in money spent defending lawsuits.

Insurance terminology
A report from the Rice University Baker Institute for Public Policy finds that about 25 percent of Texans may lack confidence in understanding some of the most basic terminology about health insurance plans, such as "premium," "copayment," and "provider network." The researchers drew data from the Health Reform Monitoring Survey—a quarterly survey of adults ages 18 to 64 years—administered between September 2013 and September 2015.

ACA fraud
By failing to fully utilize its data hub to verify information provided by those attempting to enroll for coverage or income-based subsidies under the Affordable Care Act (ACA), CMS is missing out on opportunities to detect fraud and to improve overall management of the Health Insurance Marketplace, the U.S. Government Accountability Office (GAO) declared in a report. The GAO also said that CMS lacked an effective process for resolving inconsistencies in individual applications—such as those involving Social Security numbers or incarceration history. In undercover testing conducted by the GAO for 2014, the federal Marketplace approved subsidized coverage for 11 of 12 fictitious applications submitted online or by phone; applicants were able to maintain subsidized coverage throughout the year even though the GAO had sent fictitious documents or none at all to resolve application inconsistencies. The GAO concluded that until CMS performs a comprehensive fraud risk assessment of the ACA enrollment and eligibility process, the agency "is unlikely to know whether existing control activities are suitably designed and implemented to reduce fraud risk to an acceptable level."

ACA cost estimates
A report from the U.S. Congressional Budget Office (CBO) projects that health insurance subsidies are expected to cost the federal government about $660 billion in 2016, with $136 billion of that total driven by higher than expected enrollment in Medicaid. CBO projects the cost of healthcare subsidies to grow about 5.4 percent annually as more people enroll in Medicaid. Over 10 years, the total cost of health subsidies is expected to rise to $1.1 trillion. The agency projects that the Affordable Care Act will cost an additional $28 billion due to recent legislation that postponed the so-called "Cadillac tax" on high-cost insurance plans.

Medicare spending growth
The U.S. Department of Health and Human Services (HHS) has released a report on Medicare spending growth. The report notes a decreasing trend in Medicare spending growth, stating that Medicare spent $473.1 billion less on personal healthcare expenditures during the period 2009 to 2014, compared to projected rates of increase based on the period from 2000 to 2008. The agency projects that if trends continue through 2015, $648.6 billion will have been saved compared to the 2000 to 2008 time frame. The report states that overall national personal healthcare spending increased 4.3 percent per person during 2014.

HIPAA Phase 2
The HHS Office for Civil Rights (OCR) has begun Phase 2 of the Health Insurance Portability and Accountability Act (HIPAA) audit program. During this phase, OCR will review the policies and procedures adopted and employed by covered entities and their business associates to meet selected standards and implementation specifications of the Privacy, Security, and Breach Notification Rules. HHS states that the audits will primarily be desk audits, although some on-site audits will also be conducted. The 2016 audit process begins with an email sent to covered entities and business associates requesting that contact information be provided to OCR in a timely manner. The agency notes that communications from OCR may be incorrectly classified by email servers as spam, and recommends that covered entities check their junk or spam email folders for emails from OCR. Lack of response to the OCR email will not prevent an audit or compliance review.