This Week: The House and Senate were out for Presidents’ Day recess... The Senate to vote on FDA Commissioner nominee Califf after 5:30 today... Medicare Advantage rates announced.

  1. Congress

House of Representatives


  1. Administration
  1. State Activities
  1. Regulations Open for Comment
  1. Reports
  1. Congress

House of Representatives

House Budget Committee Delays Budget Markup

In an effort to prevent birth defects in the Hispanic population, a bipartisan group of 42 House lawmakers is asking the U.S. Food and Drug Administration (FDA) to speed up its decision on whether to permit folic acid to be added to tortillas. “Preventable neural tube defects (NTDs) continue to occur in the United States, particularly among families in the Hispanic community,” lawmakers said in a letter Feb. 23 to Stephen Ostroff, acting director of FDA. “Public health experts hypothesize that these higher rates are linked to the fact that corn masa flour, the staple grain in the diet of most individuals of Hispanic descent, is still not fortified with folic acid.”

A Citizens Petition filed in April 2012 called for corn masa fortification and the lawmakers said they had been informed the FDA would respond last month — FDA instead requested an additional three months to answer. FDA has concerns about whether folic acid would remain chemically stable in corn masa flour during the manufacturing process, like it is in wheat flour.

House Lawmakers Call for FDA Approval of Corn Masa Fortification

In an effort to prevent birth defects in the Hispanic population, a bipartisan group of 42 House lawmakers is asking the U.S. Food and Drug Administration (FDA) to speed up its decision on whether to permit folic acid to be added to tortillas. “Preventable neural tube defects (NTDs) continue to occur in the United States, particularly among families in the Hispanic community,” lawmakers said in a letter Feb. 23 to Stephen Ostroff, acting director of FDA. “Public health experts hypothesize that these higher rates are linked to the fact that corn masa flour, the staple grain in the diet of most individuals of Hispanic descent, is still not fortified with folic acid.”

A Citizens Petition filed in April 2012 called for corn masa fortification and the lawmakers said they had been informed the FDA would respond last month — FDA instead requested an additional three months to answer. FDA has concerns about whether folic acid would remain chemically stable in corn masa flour during the manufacturing process, like it is in wheat flour.

Since the FDA authorized fortification of wheat and other types of flour in 1996, the rate of neural tube defects has been reduced by 27 percent, according to the Centers for Disease Control and Prevention (CDC). The lawmakers argue that it is critical for childbearing women in the Hispanic American community to have the same access to this intervention for preventing birth defects in the United States.


Senate Finance Committee Focuses on Lock-In Bill Addressing Opioid Epidemic

On Feb. 23, the Senate Finance Committee held a hearing to examine the opioid abuse epidemic and its effect on Medicare and the child welfare system. Committee Chair Orrin Hatch (R-UT) said he wants to pass opioid-abuse deterrent legislation, but community pharmacists oppose the bill’s central provision, and Democrats want additional emergency funding to deal with the opioid crisis.

The hearing focused on a bill, the Stopping Medication Abuse and Protecting Seniors Act (S. 1913), by Sen. Patrick Toomey (R-PA), that would lock at-risk Medicare beneficiaries into a single prescriber and a single pharmacy for opioid prescriptions. It would also encourage insurers, Part D plans and physicians to help beneficiaries get substance-abuse treatment.

“Nearly all Medicaid programs and private payers have such a prescription drug review and restriction, or ‘lock-in,’ program. I look forward to hearing more today about the success of these programs in Medicaid and how the Toomey-Portman bill would have a similar impact in Medicare,” Hatch said in his opening statement.

The National Governors Association (NGA) and Pew Charitable Trusts have also said that the lock-in policy has worked well in Medicaid and commercial plans and should be taken up by Medicare. NGA recommended requiring prescribers to register with their state Prescription Drug Monitoring Program — this includes databases in each state that monitor prescribing and dispensing of controlled substances.

The National Community Pharmacists Association (NCPA) opposes the bill’s central provision. Pharmacists argue that the Centers for Medicare and Medicaid Services (CMS) should be the sole entity administering lock-in programs, not Part D sponsors. CMS oversight is better because a lot of drug plan sponsors contract with retail pharmacy chains, which creates a conflict of interest. And, unlike Toomey’s bill, Medicaid lock-in programs allow beneficiaries to choose in-network prescribers and pharmacies. The legislation would also allow plans to change prescribers or pharmacies if it is decided that either entity contributes to abuse or diversion.

In his opening statement, Hatch lauded the Comprehensive Addiction and Recovery Act (CARA), which he voted for in the Senate Judiciary Committee. The bill, by Sen. Sheldon Whitehouse (D-RI), would authorize the Attorney General to award grants to address the opioid abuse and heroin use crisis.

Australia Makes Effort to Quell U.S. Drug Companies’ Concerns Over TPP

Former and current Australian trade ministers Andrew Robb and Steven Ciobo sought to reassure U.S. pharmaceutical companies on Feb. 20 that a key provision of the Trans-Pacific Partnership (TPP) trade agreement would provide at least eight years — and potentially as many as 12 to 17 years — of market protection in Australia for the new class of medicines known as biologics.

Rob and Ciobo were in the United States on a business development mission and met with U.S. Trade Representative Michael Froman and chief U.S. negotiator for the TPP Barbara Weisel. U.S. pharmaceutical companies wanted 12 years of data protection for biologics in the TPP agreement, arguing they need that time to recoup the cost of developing the complex medicines. The monopoly on the data bars the U.S. Food and Drug Administration (FDA) from sharing the data with other manufacturers for 12 years. However, the agreement settled upon last October allows TPP countries to give either eight years of data protection or five years of protection along with measures that give at least three more years of market safeguards for the medicines.

Senator Hatch (R-UT) is skeptical whether the “five-plus” option (which Australia and most other TPP countries are expected to choose) really gives more than five years of protection. Froman is asking TPP countries to help explain to Congress how the two options both give strong levels of intellectual property protection. Australia’s track record in approving biosimilars shows the original manufacturer has a much longer monopoly, according to Robb. However, U.S. pharmaceutical companies are still concerned that the TPP agreement is not establishing a strong enough international standard for biologics protection, despite Robb and Ciobo’s comments.

  1. Administration

CMS Updates Phone Instructions for Eligible Professionals in FAQ #2639

The Centers for Medicare and Medicaid Services (CMS) recently updated an FAQ that provides information on hospital-based eligible professionals’ eligibility to receive incentive payments from the Medicare and Medicaid EHR Incentive Programs. FAQ #2639 includes new instructions for EPs — highlighted in bold text below — who would like to contact the EHR information center about their hospital-based status.

FAQ #2639Are physicians who practice in hospital-based ambulatory clinics eligible to receive Medicare or Medicaid electronic health record (EHR) incentive payments?

A hospital-based eligible professional (EP) is defined as an EP who furnishes 90 percent or more of his/her services in either the inpatient or emergency department of a hospital. Hospital-based EPs do not qualify for Medicare or Medicaid EHR incentive payments.

If you are a new EP and need to determine your hospital-based status, contact the EHR information center at (888) 734-6433. Choose option 1 for the EHR Incentive Programs, then choose option 4 in the interactive voice response system (IVR). You will need your National Provider Identifier (NPI) and the last five digits of your Tax Identification Number (TIN). If you are an existing EP, review and resubmit your registration on the Registration and Attestation website to determine your hospital-based status.

CMS Releases Medicare Fee-For-Service Provider and Supplier Lists

On Feb. 22, the Centers for Medicare and Medicaid Services (CMS) — as part of its efforts to improve care delivery, data sharing and transparency — released data sets regarding the availability and use of services provided to Medicare beneficiaries by ground ambulance suppliers and home health agencies, as well as a list of Medicare fee-for-service (FFS) providers and suppliers currently approved to bill Medicare.

The Affordable Care Act (ACA) provided tools to improve CMS’s screening of providers and suppliers for potential fraud when they enroll. A Government Accountability Office (GAO) report recently found areas where CMS could improve its Provider Enrollment Chain and Ownership System (PECOS), which verifies provider and supplier practice locations and physician licensure statuses.

The first data file CMS released is called the Public Provider Enrollment file and includes information on providers and suppliers, nationwide, who are approved to bill Medicare. The data is taken directly from PECOS and is updated quarterly. The second is an extension of the Enrollment Moratoria Authority. CMS recently extended the temporary enrollment moratoria on new ground ambulance suppliers and home health agency sub-units and branch locations in the Medicare, Medicaid and Children’s Health Insurance Programs (CHIP) for an additional six months in seven geographic locations. These provisions were authorized by the ACA to reduce fraud, waste and abuse while ensuring that patient access to care is not interrupted.

The Moratoria Provider Services and Utilization Data Tool was created using ground ambulance and home health agency paid claims data that resides in CMS systems for Medicare fee-for-service beneficiaries. The data provides the number of Medicare providers and suppliers servicing a geographic region, identifies moratoria regions at the state and county levels and identifies the number of people with Medicare benefits who use a specific health service in that region. The tool can help CMS to determine which geographic and health service areas might be considered for a moratorium on new provider and supplier enrollments.

The enrollment moratoria extension, along with these new provider and supplier data tools, shows that the potential for fraud, waste and abuse continues to exist in these areas, according to CMS.

The data can be found here.

Insurance Industry Asks CMS for “Good Faith” Compliance For Cost-Sharing Reduction Reconciliation

The insurance industry has asked the Centers for Medicare and Medicaid Services (CMS) to apply a “good faith” compliance standard to plans that are getting ready to reconcile two years’ worth of cost-sharing reduction (CSR) payments beginning April 1. Industry wants CMS to streamline the process and avoid requiring plans to submit unnecessary data. The request was made in response to CMS’s draft manual for reconciliation of advance payment of CSR reductions that was published on Jan. 15.

Cost-sharing reductions must be available to enrollees who earn between 100 percent and 250 percent of the federal poverty level and who enroll in a silver plan through the marketplace, or to Native Americans who are enrolled in any metal level plan through the marketplace. The payments are used to lower out-of-pocket costs, thus increasing the actuarial value of the plan. Qualified health plan (QHP) issuers must notify the Secretary of Health and Human Services (HHS) of CSRs provided on behalf of eligible enrollees. Additionally, “periodic timely” payments equal to the value of those reductions are required to be sent to issuers. CSR payments can be made in advance and reconciled with actual claims.

The initial submission will include data for plan years 2014 and 2015, but the information for each year will be filed separately. The submission window will open April 1 and close April 30. CMS chose to delay the process in order to improve accuracy of the payments. It also said it would allow issuers to switch from a simplified reconciliation methodology to the standard one at any time before sending in data.

In its comments on the draft manual, America’s Health Insurance Plans (AHIP) asked CMS to adopt a compliance standard for the reconciliation process so that issuers who make a good faith effort to abide by the requirements do not get penalized. The group asked that CMS include the good faith standard in the final manual and in the final Notice of Benefit and Payment Parameters for 2017.

Industry is also concerned about the short timeline and asks that CMS streamline the process so that only minimal data elements are required. It is likely that CMS will not have a final draft ready until March 15.

CMS Administrator Slavitt Introduces 2016 Priorities

On Feb. 23, Acting CMS Administrator Andy Slavitt introduced the agency’s three main priorities for 2016: 1) continuing to build a market attractive to consumers and health plans; 2) ensuring market rules are fair and promote rate stability; and 3) using the marketplace as a stepping stone to what he calls a “fully retail” health care system. Speaking at a National Association of Health Underwriters conference, Slavitt also announced that CMS will release more changes to special enrollment periods later in the week and stakeholders will have the opportunity to provide their input.

At the conference, Slavitt noted that CMS and insurers are on the same page. He said CMS thinks “it is critical … to enforce the integrity of the Special Enrollment eligibility process so that it serves those consumers who are eligible for them, not those who want to wait to buy insurance until they’re sick.” He noted that Special Enrollment Periods (SEPs) are important for consumers who lose employer-sponsored coverage or have another qualifying event. CMS will reduce the number of SEPs available and overhaul the process to ensure that they meet their intended purpose.

Slavitt also reiterated CMS’s commitment to making sure risk adjustment continues to work as intended and improves based on recent data and accounts for new trends that emerge (i.e., higher-cost drugs). In preparation for a public risk adjustment conference on March 31, CMS is going to release its newest risk adjustment white paper, which will outline topics it is looking at. He added that the conference will bring together market participants, actuaries and stakeholders to review the methodology in order to build in changes based on the first years of experience. He also added that CMS will send out early estimates of health plan specific risk adjustment calculations to better inform care management approaches, network strategy and prices.

Finally, Slavitt pointed to the HHS announcement that it will pay up to $7.7 billion in reinsurance payments for 2015 — the reinsurance program paid out $7.9 billion for 2014.

To see Acting Administrator Slavitt’s full speech, click here.

To see specifics on the new special enrollment confirmation process, click here.

CMS Issues Federal Funding Methodology for Basic Health Program, Years 2017 and 2018

On Feb. 26, the Centers for Medicare and Medicaid Services (CMS) issued a final notice establishing the methodology for determining federal funding for the Basic Health Program (BHP) in years 2017 and 2018. The BHP gives states the option to establish a health benefits coverage program for low-income individuals as an alternative to Health Insurance Marketplace coverage under the Affordable Care Act (ACA). This notice is substantially the same as the notice for program year 2016.

Click here to see the final notice.

  1. State Activities

Iowa: CMS Approves State Medicaid Managed Care

On Feb. 23, the Centers for Medicare and Medicaid Services (CMS) approved an April 1, 2016, start date for Iowa’s transition to Medicaid managed care. Iowa Gov. Terry Branstad had asked that the waiver take effect Jan. 1, but CMS indicated that some key requirements had not yet been met by the state. The largest concerns were with adequate provider networks. CMS identified 16 action items and asked that Iowa demonstrate progress in those areas. Although the state preferred a start date of March 1, CMS said an April 1 date gives additional time for Iowa to make progress toward a smooth transition, including completing provider contracts and training case managers. The managed care proposal has garnered significant opposition in the state along with national attention.

Nevada: OIG Report Finds Nevada Misallocated Funds to Establishment Grants

report from the Office of Inspector General (OIG) found Nevada’s health insurance exchange illegally used $893,464 in establishment grant money for costs that should have gone to the Medicaid program over three years. Nevada redirected the funds back to the marketplace, but exchange officials and the OIG continue to be at odds over whether CMS guidance allowed the original allocation.

The Silver State Health Insurance Exchange’s executive director, in his response to the report, maintained the original funding decision was appropriate and the methodology was approved by CMS. However, OIG found that Nevada lacks the internal controls necessary to ensure costs are properly allocated.

The report provided four recommendations for the exchange: 1) refund $893,464 to CMS or work with CMS to resolve the amounts misallocated to the establishment grants; 2) work with CMS on a new cost allocation methodology to ensure that costs claimed after the audit period are allocated correctly; 3) develop a written policy that explains how to perform cost allocations and emphasizes the necessity to use updated data when available; and 4) strengthen staff oversight to ensure the application of updated data to properly allocate costs.

Although it did not concur with the first recommendation, the Nevada Exchange resolved the issue by transferring the requested funds to the exchange. The Exchange agreed with all other recommendations and will move toward implementing them. Acting CMS Administrator Andy Slavitt wrote in a November 2015 letter that Nevada last updated its cost allocation procedure in April 2015 based on real data, therefore complying with federal guidance.

Several other states — including Arkansas, Oregon, Maryland, Massachusetts and Washington state — are being watched by CMS and OIG regarding their use of establishment grants.

  1. Regulations Open for Comment

Food and Drug Administration (FDA) Issues Final Rule to Phase Out Trans Fats

FDA issued a final rule June 16 that gives the food manufacturers three years to phase out partially hydrogenated oils (PHOs), which are still used in a wide variety of food products from microwave popcorn to cake frosting. The decision finalizes an agency determination that PHOs, the primary dietary source of artificial trans fat in processed foods, are not “generally recognized as safe” or GRAS for use in human food. Since 2006, manufacturers have been required to include trans fat content information on the Nutrition Facts label of foods. Between 2003 and 2012, the FDA estimates that consumer trans fat consumption decreased about 78 percent and that the labeling rule and industry reformulation of foods were key factors in informing healthier consumer choices and reducing trans fat in foods. Comments on the final rule are due by June 18, 2018.

More information on FDA’s decision can be found in the agency’s press release.

HHS Posts Guidance for State Innovation Waivers

On Dec. 11, the Department of Health and Human Services (HHS) posted guidance for states interested in seeking a State Innovation Waiver under Section 1332 of the Affordable Care Act (ACA). State Innovation Waivers allow states to receive federal funding to implement alternative models of health care coverage that provide affordable coverage to their residents. The notice clarifies that the minimum length of public notice and comment periods for waiver applications is 30 days.

To see the guidance, click here.

CMS Issues Proposed Rule Expanding Access to Medicare Claims Data

The Centers for Medicare and Medicaid Services (CMS) issued a proposed rule entitled “Medicare Program: Expanding Uses of Medicare Data by Qualified Entities.” The rule would expand access to Medicare information by permitting certain organizations to buy and share claims data. Created under Obamacare, Medicare’s qualified entity program allows providers, employers and others access to Medicare data to analyze the performance of providers and suppliers. The rule aims to help qualified entities make business decisions that reduce costs and improve quality of care. These changes were mandated in the Medicare Access and CHIP Reauthorization Act and CMS thinks the expansion of data sharing will stir more interest in the program. If the proposal is finalized, CMS estimates the number of qualified entities will go from 13 to 20. Comments will be accepted on the proposed rule until 5 p.m. on March 29, 2016.

CMS Releases Proposed Updates to Medicare Advantage and Part D Programs

On Feb. 19, the Centers for Medicare and Medicaid Services (CMS) released proposed updates to the Medicare Advantage (MA) and Part D programs for next year. The updates target high drug costs and the opioid abuse epidemic. CMS’s call letter encourages plans to notify patients about drugs that are added to formularies in the middle of the year, such as generics or other newly approved drugs, which could provide better value than existing options. It also aims to add a link from the Medicare Plan Finder website to the Medicare Drug Spending Dashboard by 2017. CMS is proposing for Part D plans to implement edits to prevent opioid overutilization at the point of sale, and says it will not approve benefit designs that hinder access to medication-assisted treatment through overly restrictive utilization management strategies or high cost-sharing. About one-third of enrollees are in Part D plans with quality rankings of at least four stars, compared to 27 percent in 2009. Comments must be submitted by March 4 and the proposal will be finalized April 4.

CMS Releases Proposed Rule for Provider Enrollment Process

On Feb. 25, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule to implement additional provider enrollment provisions of the Affordable Care Act (ACA) to help make sure that entities and individuals who pose risks to the Medicare program are kept out of it or removed for extended periods. This rule is part of CMS’s effort to prevent questionable providers and suppliers from entering the Medicare program.

If finalized, the regulations would allow CMS to remove or prevent enrollment of those who try to circumvent enrollment requirements through name and identity changes or through inter-provider relationships. It will also address vulnerabilities such as when providers and suppliers avoid paying their Medicare debts by reenrolling as a different entity.

Major provisions of the proposed rule include:

  • Disclosure of Affiliations: Would require health care providers and suppliers to report affiliations with entities and individuals that: (1) currently have uncollected debt to Medicare, Medicaid or CHIP; (2) have been or are subject to a payment suspension under a federal health care program or subject to an Office of Inspector General (OIG) exclusion; or (3) have had their Medicare, Medicaid or CHIP enrollment denied or revoked. CMS could deny or revoke the provider’s or supplier’s Medicare, Medicaid or CHIP enrollment if CMS determines that the affiliation poses an undue risk of fraud, waste or abuse.
  • Different Name, Numerical Identifier or Business Identity: CMS could deny or revoke a provider’s or supplier’s Medicare enrollment if CMS determines that the provider or supplier is currently revoked under a different name, numerical identifier or business identity.
  • Abusive Ordering/Certifying: Would allow CMS to revoke a physician’s or eligible professional’s Medicare enrollment if he or she has a pattern or practice of ordering, certifying, referring or prescribing Medicare Part A or B services, items or drugs that is abusive, represents a threat to the health and safety of Medicare beneficiaries or otherwise fails to meet Medicare requirements.
  • Increasing Medicare Program Re-enrollment Bars: Would improve protection of the Medicare Trust Funds and program beneficiaries by: 1) raising the existing maximum re-enrollment bar from three years to 10 years; 2) allowing CMS to add three more years to the provider’s or supplier’s re-enrollment bar if the provider attempts to re-enroll in Medicare under a different name, numerical identifier or business identity; and 3) imposing a maximum 20-year re-enrollment bar if the provider or supplier is being revoked from Medicare for the second time.
  • Other Public Program Termination: Would permit CMS to deny or revoke a provider’s or supplier’s Medicare enrollment if: (1) the provider or supplier is currently terminated from participation in a particular Medicaid program or any other federal health care program under any of its current or former names, numerical identifiers or business identities; or (2) the provider’s or supplier’s license is revoked in a state other than that in which the provider or supplier is enrolled or enrolling.
  • Expansion of Ordering/Certifying Requirements: Would permit CMS to require that physicians and eligible professionals who order, certify, refer or prescribe any Part A or B service, item or drug must be enrolled in or validly opted out of Medicare.

For more information, click here.

  1. Reports

GAO Report on Health Care Fraud Schemes and the Use of Smart Cards

On Feb. 22, the U.S. Government Accountability Office (GAO) published a health care fraud report entitled “Information on Most Common Schemes and the Likely Effect of Smart Cards.” GAO was asked to identify and categorize schemes found in health care fraud cases. The report provides descriptions of 1) the prevalence of health care fraud schemes among cases resolved in 2010 and 2) the extent to which the schemes could have been affected by smart card technology. GAO reviewed reports on health care fraud and smart card technology and reviewed 739 fraud cases resolved in 2010.

The 739 fraud cases showed the following:

  • 68 percent included more than one scheme, with 61 percent including two to four, and 7 percent with five or more.
  • The most common schemes were related to fraudulent billing — such as billing for services not provided (43 percent) and billing for unnecessary services (25 percent).
  • Other schemes included falsifying records to support the fraud (25 percent), paying kickbacks to participants (21 percent) and fraudulently obtaining controlled substances or misbranding drugs (21 percent).
  • Providers were complicit in 62 percent of cases and beneficiaries were complicit in 14 percent.

GAO found that smart cards could have affected around 22 percent (165 cases) of cases reviewed that had schemes involving the lack of verification of the beneficiary or provider at point of care. The majority of cases (78 percent) would not have been affected by smart card use because beneficiaries or providers were complicit, or for other reasons. GAO did not make any recommendations.

OIG Report Provides Detail on Disaster

On Feb. 23, the Office of Inspector General (OIG) issued a report entitled “ Case Study of CMS Management of the Federal Marketplace.” The report gives detailed insight into the Obama administration’s missteps in trying to develop — including organizational disorder and a lack of clear leadership.

The case study contains new information about issues that CMS faced prior to the launch of the website in fall 2013, and how warnings were ignored by or not effectively communicated to essential staff. Given the technical complexity required, the development of faced a high risk of failure. OIG found that HHS and CMS made many missteps in development and implementation including poor leadership, delays in decision making, lack of clarity in project tasks and the inability of CMS to recognize the magnitude of problems as the project fell apart.

Early on there was no official below the CMS administrator responsible for and there was high staff turnover. After the launch, initial repair efforts were thwarted by lack of coordination and organization. In its investigation, OIG conducted interviews with 86 officials, contractors and others involved in developing the website.

To see the 92-page report, click here.

Avalere Report Reveals Need for Broader Coverage of Adult Vaccines

new report from Avalere backed by drugmaker GlaxoSmithKline found Medicare Part D plans (PDPs) offer less access to vaccines than most commercial plans subject to the Affordable Care Act (ACA) requirement that certain vaccines be covered at no cost. Avalere suggests policymakers consider changing Part D policies to lower barriers to vaccinations for seniors.

Avalere looked at 10 vaccines from the list of those recommended by the Centers for Disease Control and Prevention (CDC) committee on immunizations and found that no Part D plans covered any of those with no cost-sharing between 2011 and 2016. The report also found that 12 percent of enrollees in Medicare Advantage (MA) plans — 4 percent of overall Part D enrollees — had access to these vaccines in 2016 with no cost-sharing (up from less than 5 percent in 2011). Medicare Advantage plans are more likely than Part D plans to cover certain vaccines without cost-sharing and are more likely to charge cost-sharing with a fixed dollar copay rather than coinsurance.

“This difference illuminates how plans that bear responsibility for all parts of the Medicare benefit may adopt a more comprehensive approach to avoiding immune-preventable illnesses. Because PDPs do not have the same financial incentives, policymakers may want to consider other requirements if they want to improve access to vaccines among PDPs,” Avalere says.

Study Looks Into Independent Scope-of-Practice Laws for Nurse Practitioners

According to new research from the Health Care Cost Institute, five states — Hawaii, Colorado, Nevada, Vermont and Maryland — that implemented independent scope-of-practice (SOP) laws for nurse practitioners (NP) saw slightly lower prices for primary care but higher overall health care costs. The study focused on the five states between the years 2008 and 2012 and focused on privately insured patients using certain drugs — including those used to treat diabetes and high cholesterol. The report found that provider prices for primary care services fell by 1 to 4 percent in the states with independent SOP laws, but health care costs increased by the same amount.

The study’s authors hypothesized that the rise in health care spending may have happened because people had more access to services, but additional research is needed. Lead author Ulrike Meunch said the remaining question is what happens to the volume of health care services.

The report concluded that although independent SOP laws have no effect on medication adherence and a marginal impact on prices and costs, they could be important for other reasons. Evidence suggests the laws have increased the number of routine checkups and reduced emergency room admission rates, for example.

Twenty-one states and the District of Columbia allowed full practice authority for nurse practitioners as of last year.

Pressure on Rx Makers to Provide Cheap Naloxone

Medicaid health plans and the nation’s biggest physician lobby group have raised concerns about the increasing prices of the opioid overdose treatment naloxone. American Medical Association (AMA) President Steven Stack demanded the pharmaceutical industry cast profit interests aside and help solve the public health epidemic by ensuring the drug is cheap. Stack used Lexington, Kentucky, as an example: emergency medical crews paid $4.50 in 2010 for the same dose of naloxone that cost $38 in 2015; this translated from paying $2,200 a year to $46,000 a year for naloxone.

Many believe the drug price has been artificially inflated, but that could be more related to the general trend of higher drug prices than to issues uniquely related to naloxone.

The executive director at the National Association of Medicaid Directors, Matt Salo, said that both the price and use of the drug are going up and are a cause for concern. In March 2015 HHS launched an initiative to decrease opioid overdoses, overdose mortality and the frequency of opioid abuse disorder, and it targets three areas: opioid prescribing practices, expanded use and distribution of naloxone and expansion of medication-assisted treatment. In recent guidance to Medicaid programs, CMS said the opioid epidemic has a disproportionate impact on Medicaid beneficiaries because they are prescribed painkillers at twice the rate of non-Medicaid patients and are three to six times more at risk of a painkiller overdose.

Jeff Myers, president and CEO of Medicaid Health Plans of America, said states are trying to make naloxone more broadly available as prices increase, and this is putting Medicaid in a hard spot — especially as traditional strategies to control drug prices don’t work for an emergency, life-saving drug.