This Week: Repealing Obamacare becomes problematic in the Senate... More focus on drug prices and reimbursement... FDA asks, should we regulate “natural” and if so, how?

1. Congress

House of Representatives

Senate

2. Administration

3. State Activities

4. Regulations Open for Comment

5. Reports

1. Congress

House

Energy and Commerce Health Subcommittee Chair Not Seeking Reelection

House Energy and Commerce Health Subcommittee Chair Rep. Joe Pitts (R-PA) announced Nov. 6 that he will not be seeking reelection in 2016. Pitts has been the Chair of the Health subcommittee since 2011. He played a major role in the passage of major health care bills, including the “Doc Fix,” or SGR reform, “Track and Trace,” or Drug Supply Chain security and the 21st Century Cures bill.

Two Bills Introduced to Prevent Tax Inversions in Response to Pfizer-Allergan Talks

On Nov. 9, Rep. Mark Pocan (D-WI) introduced two bills that would prevent corporations from using tax inversions to reduce their tax bills:

  1. The “Corporate Fair Share Tax Act” would restrict corporate earnings stripping or, the moving of profits abroad by loading up a U.S. subsidiary with tax-deductible debt, by limiting the available deduction. The legislation limits the deductions a corporation may claim to a level at which the U.S. entity’s share of interest on debt is proportionate to the U.S. entity’s share of earnings. The Treasury Department estimates this would raise revenue by $48.6 billion over the next 10 years.
  2. The “Putting America First Corporate Tax Act” changes Section 952 of the tax code to eliminate deferral of taxation on foreign profits — the Congressional Budget Office estimates that ending this loophole would raise revenue by $114 billion over the next 10 years.

There has been renewed congressional scrutiny on the practice of moving a company’s tax headquarters abroad through a merger, brought about by Pfizer Inc.’s pursuit of a merger with Allergan PLC.

House Judiciary Subcommittee to Hold Third Hearing on Competition in Health Care with Focus on PBMs

On Nov. 17, the House Judiciary Subcommittee on Regulatory Reform, Commercial and Antitrust Law will hold its third hearing in a series on the state of competition in health care. The hearing is entitled “The State of Competition in the Pharmacy Benefit Manager (PBMs) and Pharmacy Marketplaces” and will examine the state of competition and any related competitive issues.

Witnesses:

Ms. Amy Bricker, R.Ph. 
Vice President of Retail Contracting & Strategy 
Express Scripts 
Mr. David A. Balto, Esq. 
Law Offices of David Balto

Ms. Natalie A. Pons, Esq. 
Senior Vice President and Assistant General Counsel 
CVS Health

Mr. Bradley J. Arthur, R.Ph. 
Owner 
Black Rock Pharmacy

To see a press release about the hearing, click here.

Senate

Repealing Obamacare Hits Snags in Senate

The House-passed reconciliation bill containing repeal of many provisions of the Affordable Care Act (ACA) has run into trouble in the Senate. On Nov. 10, the Senate Parliamentarian ruled that the law’s individual and employer mandates that were included in the House bill do not meet reconciliation standards. The Parliamentarian said those provisions were merely incidental and did not meet the budgetary standards needed for reconciliation protection. Reconciliation legislation needs only a majority to pass in the Senate, not the usual 60 votes. Overruling that decision would require 60 votes and would be blocked by Democrats. In addition, some Republican Senators do not think the House bill goes far enough in repealing the Affordable Care Act.

The remainder of the House bill would defund Planned Parenthood for one year and repeal the “Cadillac” tax — a tax on insurers, the medical device tax and the Independent Payment Advisory Board, and cut the Prevention and Public Health Fund. It now looks like the Senate will not take up this legislation — or some version of it — until after Thanksgiving.

Regardless of what passes, the President is not likely to sign the bill into law. Some are looking to the upcoming tax extender package as a possible vehicle for repealing some provisions of Obamacare. Extenders are expected to be acted upon at the end of the year.

Senator Writes Letters Asking Stores to Pull Certain Dietary Supplements

On Nov. 9, Sen. Claire McCaskill (D-MO) wrote letters to 10 retailers asking them to voluntarily pull from sale dietary supplements containing picamilon — a substance that does not meet the definition of a dietary ingredient. The letters come after the Oregon Attorney General filed a complaint against General Nutrition Corporation (GNC) for selling products containing picamilon. Sen. McCaskill has been pressing the U.S. Food and Drug Administration (FDA) to take action on the substance, which is classified as a drug in other countries but is not approved by the FDA.

Senator Hatch Concerned with CMS Spending on Advertising

On Nov. 10, Senate Finance Committee Chairman Orrin Hatch (R-UT) wrote a letter to the Centers for Medicare and Medicaid Services (CMS) expressing his concern about the agency’s advertising practices related to open enrollment, citing the potential for “wasteful government spending.” The U.S. Department of Health and Human Services says it will spend $35 million for advertising in the states using Healthcare.gov for the 2016 open enrollment period. Hatch asked CMS to provide him with the total amount of spending on advertising and public relations from fiscal year 2011 to the present. He requested a response by no later than Nov. 25.

Senate Finance Committee Announces Hearing on Physician Owned Distributorships

On Nov. 17, the Senate Finance Committee will hold a hearing entitled “Physician Owned Distributors: Are They Harmful to Patients and Payers?” The hearing will focus on whether physician owned distributorships (PODs) — entities in which physicians earn revenue from the sale of medical devices they prescribe — should be allowed.

Witnesses

Dr. Scott Lederhaus 
President of Association for Medical Ethics 
Monarch Beach, CA

Dr. John Steinmann 
Board Advisor for American Association of Surgical Distributors 
Redlands, CA

Ms. Suzie Draper 
Vice President of Business Ethics and Compliance for Intermountain Healthcare 
Salt Lake City, UT

Mr. Kevin Reynolds 
Son of a Patient of a Surgeon Affiliated with a Physician Owned Distributor 
Ventura, CA

To see a related press release, click here.

Senators Write Letter Applauding CDC Opioid Guidelines

On Nov. 10, eight senators wrote a letter to the Centers for Disease Control and Prevention (CDC) to praise the agency for its newly released Draft Guidelines for Opioid Prescribing. The guidelines would recommend nondrug therapy as the preferred treatment for chronic, noncancer pain, prescribe the lowest dose and least number of pills considered effective for the patient, and regularly review the risks to the patient from the prescription drugs they are taking. The senators note that the U.S. makes up only 4.6 percent of the world’s population, but consumes around 80 percent of its opioids.

To see a related press release, click here.

2. Administration

FDA Requests Information Concerning Direct-to-Consumer Tests

On Nov. 2, the U.S. Food and Drug Administration (FDA) sent three manufacturers of direct-to-consumer tests requests for information. FDA is suggesting that the products may meet the definition of medical devices and lack FDA clearance. The three manufacturers are DNA-Cardiocheck Inc., Interleukin Genetics, Inc., and DNA4Life. This comes as policymakers are debating whether FDA or CMS should oversee laboratory-developed tests.

USP Tells FDA to Scrap Proposed Biosimilar Naming Plan and Suggests Alternative

The U.S. Pharmacopeial Convention (USP) told the U.S. Food and Drug Administration (FDA) to get rid of its proposed biosimilar naming plan and suggested an alternative: add a suffix to the USP labeling requirements that would be used to identify and track products back to manufacturers. USP said that FDA’s plan to convey the regulatory status of a product could weaken established scientific principles and the understanding of drug and biologic substances, and could harm patients. USP sets standards for the identity, strength, quality and purity of medicines, food ingredients and dietary supplements manufactured, distributed and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries.

FDA published draft guidance proposing to attach non-meaningful, four-letter suffixes to biosimilars’ nonproprietary names in order to prevent unintentional substitution of products that haven’t been deemed interchangeable. USP contends that the FDA proposal would cause confusion and put patients at risk due to medication errors and the disruption of pharmacy systems. It could also create obstacles to global trade by creating requirements that other countries view to be an unfair restraint of trade.

The Biosimilars Forum — made up of brand-name and generic drug manufacturers — noted that if FDA attaches suffixes to the nonproprietary names, the suffixes should be meaningful (based on a given company’s name) instead of non-meaningful. The group thinks that the final rule should create a level playing field for biosimilars and reference biologics, and that sponsors should have the flexibility to transition into the new naming system.

Companies Amgen and Sandoz Biosimilars Case Likely to Go to Supreme Court

Industry attorneys have predicted either Amgen or Sandoz will appeal to the Supreme Court the Federal Circuit’s decision concerning the biosimilar pathway’s patent and marketing requirements. The two primary issues in this case are 1) whether the “patent dance” is mandatory and 2) when a biosimilar applicant can provide notification of commercial marketing. The appeals court denied requests for a full hearing when a three-judge panel ruled that the law’s patent exchange provisions are optional and the 180-day notice for commercial marketing can be issued only after the drug gets approval. Attorneys note that it is unlikely that this decision will be the last in the case, as the Federal Circuit was severely divided on the matter.

There are three separate court cases addressing similar issues that could be affected if the Supreme Court becomes involved — two cases were brought by Amgen against Apotex and Hospira and another by Janssen against Celltrion and Hospira.

FDA Approves First Product Marketing Orders Under the Tobacco Control Act of 2009

On Nov. 10, the U.S. Food and Drug Administration (FDA) announced that for the first time it has authorized the marketing of new tobacco products through the premarket tobacco application (PMTA) pathway. The authorization is for Swedish Match North America to sell eight snus smokeless products — this is the first time FDA has granted approvals under the Tobacco Control Act of 2009, which gave it authority to regulate the industry. The FDA review found that the snus products will likely provide less toxic options if smokeless tobacco users use them exclusively.

However, the tobacco company is not allowed to imply that their products are FDA approved, and must submit a separate application to market their products as less harmful than others.

Insurer Announces Outcome-based Pricing for Cholesterol Drugs Ahead of HHS Drug Pricing Forum

On Nov. 9, Harvard Pilgrim announced an outcomes-based pricing contract with Amgen for cholesterol drugs in return for preferential treatment of Amgen’s drug. Various stakeholders as well as the U.S. Department of Health and Human Services (HHS) have mentioned outcomes-based payment models as a topic to discuss at the upcoming drug forum on Nov. 20.

Amgen agreed to discount cholesterol drugs for Harvard Pilgrim when the drugs do not reduce LDL levels by as much as was observed during clinical trials. Amgen will further discount the drug if more patients use it than expected.

NAIC Passes New Model Law on Plan Network Access and Adequacy

On Nov. 4 the National Association of Insurance Commissioners’ (NAIC) Health Insurance Committee passed a new model law entitled “Health Benefit Plan Network Access and Adequacy Model Act.” For the first time since 1966, the model law will update existing requirements and includes new guidelines on telehealth, mental health, in-network protocols, provider directory requirements and the “good faith” nondiscrimination provision of the Affordable Care Act (ACA). It makes the states responsible for having regulatory control over the information insurers include in plans as well. The full membership of the NAIC will vote on Nov. 22 on adopting the model law and on whether to keep all the proposed revisions in each respective state.

Consumer representatives to the NAIC sent a letter to the Health Insurance Committee applauding the model law while requesting more changes before it becomes final. While the changes weren’t made, NAIC noted that states still have the ability to create additional rules for insurers — it is up to the states to decide if they want to make the changes.

The U.S. Department of Health and Human Services (HHS) has expressed interest in the model law and will likely put some of its guidance into federal regulations if it passes. HHS is currently working on its own nondiscrimination rulemaking.

CMS Restarts Medicare Recovery Auditors Contracting Process

On Nov. 6, the Centers for Medicare and Medicaid Services (CMS) restarted the contracting process for Medicare Recovery Auditors (RACs). CMS has maintained that when providers appeal payment denials, RACs will not be paid until after those appeals are denied at the second level, even though a similar provision thwarted CMS’s last attempt to set up RAC contracts.

This summer, CMS said it planned to update the Recovery Auditors’ Statement of Work and release new Requests for Proposals. On Nov. 6 it announced the new Requests for Proposals, including updated Statements of Work on the Federal Business Opportunities website. On the same day, CMS also released a timeline of RAC “program enhancements.” One enhancement to be incorporated into the new contracts is that RACs “will not receive their contingency fee until after the second level of appeal is exhausted,” the document says.

The Statement of Work also says that RACs are expected to support CMS in cases that make it to the Administrative Law Judge (ALJ) level of appeals. RACs previously complained they wanted to be involved in more appeals because their presence at a hearing increases the probability that appeals are decided in CMS’s favor. Under the new work statement, RACs would also need to wait 30 days after notifying providers of the results of a review before forwarding the claim to a Medicare Administrative Contractor for a pay adjustment so that providers can request a discussion period. CMS also states that it has the authority to settle appeals without RAC approval or input.

Because of a backlog in claims getting to the ALJ level, CMS recently settled about 300,000 claims and paid more than 1,900 hospitals about $1.3 billion for inpatient claims denied on the basis of medical necessity that were under appeal. CMS paid 68 percent of the claims under appeal as part of the settlement.

For more information, click here.

CMS Announces Medicare Premiums and Deductibles for 2016

On Nov. 10, the Centers for Medicare and Medicaid Services (CMS) announced the 2016 premiums and deductibles for Medicare Part A and Part B programs. About 30 percent of Medicare Part B beneficiaries will avoid a huge rate spike due to the Bipartisan Budget Act signed into law recently. Now those beneficiaries will pay a monthly premium of $121.80 instead of over $150 — and most beneficiaries will continue to pay the same monthly premium as last year, which is $104.90.

CMS Grants Special Innovation Projects

On Nov. 12, the Centers for Medicare and Medicaid Services (CMS) announced that it awarded 16 two-year Special Innovation Projects (SIPs) to 10 regional Quality Innovation Network-Quality Improvement Organizations (QIN-QIOs). The projects will address sepsis in long-term care, colorectal cancer screening (CRC) and readmission reduction in rural hospitals, among other things.

MedPAC Discusses Proposed Part D Policy Option Package

At a Medicare Payment Advisory Commission (MedPAC) meeting earlier this month, commissioners began consideration of a package of potential Part D reforms that would give plans higher incentives to control drug spending, give increased flexibility to manage costs and give out-of-pocket protections for enrollees. The commission is also considering changes to Medicare’s reinsurance policies. MedPAC Chair Jay Crosson laid out potential policy options at the meeting, and noted that some could hurt beneficiaries while others could hurt plans. The proposed policy option package is as follows:

  • Reduce Medicare’s reinsurance from 80 percent to 20 percent
  • Limit beneficiaries’ out-of-pocket costs beyond the cap: one proposal would be for the non-Low Income Subsidy (LIS) beneficiaries and would set a fixed-dollar copayment. For LIS beneficiaries, the proposal would provide a nominal copayment only for brand-name drugs for individuals over the out-of-pocket limit
  • Give plans increased flexibility by removing two drug classes — immunosuppressants and antidepressants — from the six protected classes
  • Ease the procedural processes around getting approval for midyear formulary changes for high-priced drugs
  • Introduce an additional tier, for example a non-preferred generic tier, for Low Income Subsidy (LIS) beneficiaries’ drugs — and also allow the plans to use preferred pharmacy networks with different copayments for LIS beneficiaries

MedPAC will continue discussions on these ideas in March and will vote on final recommendations in April.

3. State Activities

New Jersey: New Jersey Adopts a Biosimilar Substitution Measure

New Jersey Gov. Chris Christie (R) signed A. 2477 into law on Nov. 9 — an interchangeable biosimilar substitution measure that requires pharmacists to tell prescribers after they make a switch rather than send a notification before the change. This measure mirrors an agreement between the Biotechnology Industry Organization (BIO) and the Generic Pharmaceutical Association (GPhA) to compromise language on biosimilar substitution that states could use as a template for laws.

Under the New Jersey law, pharmacists must tell the prescriber the name of the product and manufacturer of the interchangeable biosimilar within five business days of substitution — however, the pharmacist cannot make the substitution if the physician has expressly written that there may not be one. The New Jersey State Board of Pharmacy must also have a link on its website with a current list of all biological products the U.S. Food and Drug Administration (FDA) has approved as interchangeable. Until the FDA determines whether a specific biosimilar is interchangeable with its reference biologic, the substitution policy is up to the individual states.

Ten other states — California, Washington, Utah, Texas, Tennessee, North Carolina, Louisiana, Illinois, Georgia and Colorado — have passed biosimilar substitution laws that contain the compromise language. Eight states had already adopted substitution laws before the compromise occurred — Massachusetts, Delaware, Indiana and Idaho (2014); Virginia, Florida, North Dakota and Oregon (2013).

4. Regulations Open for Comment

Centers for Medicare and Medicaid Services (CMS) Issues Proposed Rule to Begin Data Collection for New Fee Schedule for Medicare Clinical Diagnostic Laboratory Tests

CMS released a proposed rule Sept. 25 that initiates the agency’s next step in implementing the Protecting Access to Medicare Act of 2014 (PAMA), a bill that requires clinical laboratories to report on private insurance payment amounts and volumes for lab tests. Under the proposed rule, certain laboratories would be required to report private payor rate and volume data if they receive at least $50,000 in Medicare revenues from laboratory services and more than 50 percent of their Medicare revenues from laboratory and physician services. Laboratories would collect private payor data from July 1, 2015, through Dec. 31, 2015, and report it to CMS by March 31, 2016. CMS will post the new Medicare rates by Nov. 1, 2016; these rates will be effective on Jan. 1, 2017. Tests that meet the criteria for being considered new advanced diagnostic laboratory tests (ADLTs) will be paid at actual list charge for a minimum of three quarters. ADLTs are tests offered under Medicare Part B and are furnished by only one laboratory and that either include a unique algorithm and are at a minimum an analysis of RNA or DNA, or are cleared or approved by the U.S. Food and Drug Administration (FDA). Under PAMA, the Medicare payment amount for any test cannot be reduced by more than 10 percent compared to the prior year’s amount during the first three years of implementation (2017-2019) and cannot be reduced by more than 15 percent in the following three years (2020-2022).

Medicare’s current fee schedule for lab tests was first adopted in 1984 and has remained relatively unchanged except to establish payments for new tests or implement across-the-board statutory payment updates. Medicare pays approximately $8 billion a year for clinical diagnostic laboratory tests. The new system will be updated every three years for clinical diagnostic laboratory tests (CDLTs) and every year for ADLTs to reflect market rates paid by private payors. One hot-button issue in the proposed rule is the definition of “applicable laboratory.” PAMA defined an applicable laboratory as one that receives a majority of its Medicare revenues under the MCLFS or the Medicare Physician Fee Schedule (MPFS). In a fact sheet summarizing the proposed rule, CMS said it does not expect any hospital laboratory to meet the definition of “applicable laboratory” and that more than 50 percent of independent laboratories and more than 90 percent of physician offices would likely be excluded based on the $50,000 threshold. The proposed rule was published in the Federal Register on Oct. 2. CMS will solicit comments until Nov. 24, 2015.

Department of Health and Human Services (HHS) Proposes Updates to “the Common Rule”

HHS and 15 other agencies released a notice of proposed rulemaking Sept. 2 for the Common Rule, the existing regulatory framework to transparency and oversight for scientific research involving human subjects. The proposed changes are to address the substantial changes that have occurred within scientific research. Current regulations have been in place since 1991 and are followed by 18 federal agencies. Proposed updates to the rule include:

  • Strengthened informed consent provisions
  • Requirements for administrative or IRB review that would align better with the risks of the proposed research
  • New data security and information protection standards
  • Requirements for written consent for use of an individual’s biological samples, for example, blood or urine, for research with the option to consent to their future use for unspecified studies
  • Requirement, in most cases, to use a single institutional review board for multisite research studies
  • Application of rule to clinical trials, regardless of funding source, if they are conducted in a U.S. institution that receives funding from a Common Rule agency for research involving human participants.

In July 2011, HHS issued an Advance Notice of Proposed Rulemaking to seek the public’s input on updating the Common Rule. The proposed rule issued reflects input and requests comments for HHS to consider as it drafts the final rule. HHS will take public comment on the proposed rule until Dec. 7.

For a press release detailing changes to the rule visit hhs.gov.

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.

CMS Releases Proposed Rule on Basic Health Program; Federal Funding Methodology for Program Years 2017 and 2018

On Oct. 22, the Centers for Medicare and Medicaid Services (CMS) published a proposed rule related to federal funding methodology for the Basic Health Plan. The document provides the methodology and data sources necessary to determine federal payment amounts made in program years 2017 and 2018 to states that elect to establish a Basic Health Program under the Affordable Care Act to offer health benefits coverage to low-income individuals otherwise eligible to purchase coverage through Affordable Insurance Marketplaces. The Affordable Care Act provides states with an option to establish a Basic Health Program (BHP). Federal funding will be available for BHP based on the amount of PTC and cost-sharing reductions that BHP enrollees would have received had they been enrolled in qualified health plans (QHPs) through Marketplaces. These funds are paid to the states through trust funds dedicated to BHP, and the states then administer the payments to standard health plans within BHP. The proposed rule is open for comment. Comments must be received by 5 p.m. on Nov. 23, 2015.

CMS Releases a Request for Comment (RFC) on Proposed Medicaid Services “Received Through” Indian Health Service/Tribal Facility

On Oct. 27, the Centers for Medicare and Medicaid Services (CMS) released a Request for Comment (RFC) on a proposed change being considered regarding the circumstances in which 100 percent federal funding would be available for services given to Medicaid-eligible American Indian and Alaska Native (AI/AN) individuals through facilities of the Indian Health Service (IHS) or Tribes. This policy change would apply to all states and is intended to improve access to care for AI/AN Medicaid beneficiaries. The RFC describes the policy options under consideration and asks for feedback from states, Tribes, and various stakeholders. The comment period will be open until Nov. 17, 2015.

Additional information on Indian Health and Medicaid can be found here.

CMS Releases Proposed Rule with New Discharge Planning Requirements

The Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would require all hospitals develop a written discharge plan for all inpatient and many outpatients in an attempt to reduce readmissions. The proposed rule, “Medicare and Medicaid Programs; Revisions to Requirements for Discharge Planning for Hospitals, Critical Access Hospitals, and Home Health Agencies,” would require hospitals to develop a discharge plan based on the needs of each applicable patient within 24 hours of admission. The plan would include a medication reconciliation process. Hospitals would be required to establish a process for patients who are transferred to a different facility or who went home.

CMS noted that the requirements could help reduce readmissions by a third. Until now, hospitals have had the ability to decide which patients need a written discharge plan, and have increasingly used the plans to reduce readmission and avoid the Affordable Care Act’s (ACA) financial penalties. Comments will be accepted until no later than 5 p.m. on Jan. 4, 2016.

A press release can be found here.

CMS Issues Final Rule to Ensure Medicaid Services for Beneficiaries and Issues Request for Information on the Rule

On Oct. 29, the Centers for Medicare and Medicaid Services (CMS) issued a final rule that ensures Medicaid beneficiaries have sufficient access to covered Medicaid services. CMS said that the rule, entitled “Methods for Assuring Access to Covered Medicaid Services,” will allow states and CMS to make more informed decisions when considering whether proposed changes to Medicaid fee-for-service payment rates are sufficient to ensure the beneficiaries’ access to those services. States will have to create access review plans that outline how states will ensure access to health care services and to examine how cuts to provider payments will affect the care received.

The rule strengthens CMS’s oversight of Medicaid reimbursement and beneficiary access to providers. It will go into effect in January and CMS issued a Request for Information (RFI) to get feedback on how to make sure access requirements are being met. Comments will be accepted until no later than 5 p.m. on Jan. 4, 2016.

EEOC Issues Proposed Rule Amending the Genetic Information Nondiscrimination Act (GINA)

On Oct. 30, the U.S. Equal Employment Opportunity Commission (EEOC) issued a proposed rule clarifying when, under the Genetic Information Nondiscrimination Act (GINA), employers who offer wellness programs as part of group health plans can provide incentives to an employee’s spouse to provide information about his or her current or past health status. (This is different from the April EEOC proposed rule related to the Americans with Disabilities Act.) The proposed rule clarifies that an employer can offer limited incentives in exchange for the employee’s spouse providing information about his or her current or past health status. EEOC will accept comments on the new proposed rule through Dec. 29, 2015.

A press release on the proposed rule can be found here.

CMS Soliciting Comments on Episode Groups as Required by MACRA

The Centers for Medicare and Medicaid Services (CMS) is soliciting comments on episode groups and on specific clinical criteria and patient characteristics to classify patients into care episode and patient condition groups as required by Section 101(f) of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), enacted April 16, 2015. The purpose of this commentary is to provide background and context to solicit stakeholder input on the episode groups that CMS has developed pursuant to Section 3003 of the Affordable Care Act (ACA). CMS is also seeking stakeholder input on the future role of episode groups in resource use measurement.

Comments should be sent to episodegroups@cms.hhs.gov by 11:59 p.m. EST on Feb. 15, 2016.

FDA Seeks Comments on Whether It Should Define “Natural” and If So, How?

Because of a series of competing citizen petitions, GMO labeling issues and congressional concern, the U.S. Food and Drug Administration (FDA) is seeking public input on whether it should define the term “natural” for use on food product labels, and, if so, how to do so.

On Nov. 12, FDA published a request for feedback. FDA policy to date has not restricted the use of the word “natural” on food labeling unless the product has added color, synthetic substances or flavoring.

FDA has received four citizen petitions over the past two years asking the agency to issue regulations on the use of the term, and in July the House of Representatives passed a proposal on GMOs that would require FDA to define the term “natural” for product labeling.

FDA seeks feedback on the following questions:

  • What types of foods should be able to use the term?
  • Should only raw agriculture products be able to use the term?
  • Should only single-ingredient foods, such as bottled water or bagged spinach, be able to use the term?
  • If multi-ingredient foods can use the term, what types of ingredients would disqualify a product from using it?
  • What data or other information shows how consumers associate, confuse or compare the terms “natural” with “organic”?
  • What data or other information shows how consumers associate, confuse or compare the term “natural” with the term “healthy”?

The comment period is open until Feb. 10, 2016.

5. Reports

Paper Reveals that Consumers Tend to Make Poor Decisions Regarding Coverage

A recent paper from the University of Wisconsin and Carnegie Mellon University found more evidence that consumers do not understand their health insurance choices and make poor decisions regarding coverage. The paper examined decisions of over 50,000 employees who were provided with four plan options. Over 50 percent of the employees chose more expensive plans that did not offer any additional coverage. The paper estimated that these employees could have saved an average of $353 per year by choosing different plans.

ACA Paper Looks at Patient Care Implications of “Concierge” Medicine

On Nov. 10, the American College of Physicians (ACP) published a paper in the Annals of Internal Medicine looking into “concierge” medicine and other forms of direct patient contracting practice (DPCP). The paper concludes that there is little evidence on how “concierge” medicine affects quality and costs, and that it might limit low-income patients’ access to care. It proposes several policies to mitigate any adverse effects on underserved patients and makes recommendations to physicians interested in pursuing DPCPs — including that they should be transparent with their patients about financial responsibilities.

Study Finds Readmission Rates Falling Among Adults Receiving Joint Replacements

According to a new study from AARP, a growing number of Americans are electing for hip and knee replacements, and hospital readmissions after those procedures are falling. Between 2009 and 2013, 73 percent more Americans got hip replacements and 46 percent more got knee replacements — and readmission rates dropped by 20 percent. The results were mostly driven by a drop in readmissions for patients between 65 and 84 years old, so researchers attribute a large amount of that to the new Medicare penalties for readmission.

Study Shows That Health Care Industry Isn’t Providing Adequate Security

Forrester released a new cybersecurity study showing that the health care industry still does not provide adequate security for American’s health data and records. The industry has only complied with regulations at the lowest possible cost, according to the study. Results showed that health care companies invest only 14 percent of IT budgets in security. Health data can draw $50 per record on the black market, which is a much larger amount than with stolen credit cards or the like. This study comes after five huge data breaches in the last 14 months.